History of Changes During R5.1 (DM0502)

Content

Document Revisions

Document Revisions

Top

Revision

Description

100323-51

Revision 100323-51 was the initial document revision that was released on 23 March 2010 to support the SAPPHIRE R5.1 release.

For descriptions of information provided in this document revision, see the Index to SAPPHIRE R5.1 New and Enhanced Functionality.

100618-51

Revision 100618-51 is the latest document revision that was released on 18 June 2010. In addition to the information described in the Index to SAPPHIRE R5.1 New and Enhanced Functionality, this latest revision also contains these changes:

Area

Change

Actions

System Action Javadoc
This document revision integrates the new Javadoc for System Action Public Interfaces into SAPPHIRE Documentation.

Descriptions of SAPPHIRE System Actions that implement public Interfaces are now listed in the Table of Contents under API References à System Actions à Actions Implementing Public Interfaces à Action Javadoc. This link opens the Javadoc for System Action Public Interfaces, which is built by a specially modified Javadoc that parses comments in the Interface code and renders them to show "Input Properties"," Output Properties", and any available "Additional Information".

SAPPHIRE System Actions that do not implement public Interfaces are listed in the Table of Contents under API References à System Actions à Other Actions.

Additionally, all links to these Actions have been redirected to the new Javadoc.

Corrections

•	In Actions Implementing Public Interfaces, the reference to private classes has been deleted. This reference could have been misinterpreted as authorizing the use of private classes.
•	Information concerning tables affected by the EditSDIWorkitem and SynchSDIDataSetStatus Actions has been corrected.

Enhancements

•	In the Additional Information section of the the AddDocument Action, noted that this Action sets Document Status to PD.

Deprecation

•	The AddDetailSDI Action has been deprecated. Use AddSDIDetail to deal with detail tables.

eForms

In the Document Status section of the eForm Document Reference, added a note to indicate that Document Status is set to PD when the AddDocument Action is used to create a Document.

Expressions

In the Notes for expressions available in the Expression Editor, clarified and corrected rounding rules for the sigfig( [x], n ), clpinorgsigfig( [x], n ), clporgsigfig( [x], n ), and maxsigfigdp( [x], n ) functions.

M18N

In SAPPHIRE M18N Support:

•	In About Database Time, clarified the relationship between database API calls (using database time) and Application Server time.
•	In the description of a user's time zone and locale settings, noted exceptions to when SAPPHIRE displays the time zone of the user's local machine.

Modules

In MR1 (Maintenance Release 1 of SAPPHIRE R5.1), the "eForms" module was split into an "eSubmissions" module and a "BioBanking EDC" module. The eForms description below has been modified to reflect this.

Index to R5.1 New and Enhanced Functionality

Top

These link to descriptions of new and enhanced features in R5.1:

Actions

CAPA

Message Types

Security

Action Block Editor

CTT

Monitoring

Specifications

Adhoc Queries

Data Entry

Policies

Storage Units

Approval Types

Data File Definitions

Products

Templates

AQC

Data Set Maintenance

Queries

Tests

Attachments

eForms

Reporting

Tramlines

Auditing

Java Public API

Sample Disposal

WPD Elements

Batch Management

JavaScript Global API

Sample Status

WPD Page Types

BioBanking ASL

Limits

Scheduler

WPD Interface

BioBanking SMS

Lookups

SDC Maintenance

WPD Wizards

Calculations

M18N

SEC

This links to a history of changes made from V1.1 (11/02/1999) through R5.0 (10/03/2008):

History of changes prior to R5.1

Actions

Top

Overview

A major effort has been put into System Actions for SAPPHIRE R5.1. This section describes all changes made to all SAPPHIRE System Actions in the new Action Public Interfaces.

New Action Public Interfaces
Most public SAPPHIRE System Action classes now implement public Interfaces (in sapphire.action) that declare properties for the Action. For example, the AddSDI Action class is declared as

public class AddSDI extends BaseSDIAction implements sapphire.action.AddSDI {

In the example above, the corresponding interface sapphire.action.AddSDI declares all properties associated with the AddSDI Action class.
It is important to note that the fundamental strategy for writing custom Actions has not changed. You declare each Action as you always have. However, the public static final string PROPERTY_XXX = "XXX" declarations for each Action have been moved from the class files into the public Interfaces. This means that to get a property from a System Action, you must now use the Interfaces. For example, to set the sdcid input property of AddSDI:

PropertyList actionProps = new PropertyList();
actionProps.setProperty( sapphire.action.AddSDI.PROPERTY_SDCID, "Sample" );

System Action Javadoc
The new Javadoc for System Action Public Interfaces has been integrated into SAPPHIRE Documentation. This is built by a specially modified Javadoc that parses comments in the Interface code and renders them to show "Input Properties"," Output Properties", and any available "Additional Information".

All links to these Actions have been redirected to the new Javadoc.

Action Reconciliation
All properties for Actions Implementing Public Interfaces have been reconciled to synchronize the Action class files, Interfaces, ActionProperty table, and SAPPHIRE Documentation.

New Actions
System Actions added to SAPPHIRE R5.1 are listed below.

Modified Actions
System Actions that have been modified in SAPPHIRE R5.1 are listed below. As part of the reconciliation effort, changes are listed for:

•	New properties (added to SAPPHIRE R5.1).
•	Newly exposed properties (these have always existed in the classes but were previously not exposed for public use).
•	Other changes (such as backward-compatible property changes and properties that are exposed in the Interfaces but are not exposed as public and reserved for internal use).

New Actions

These System Actions have been added to SAPPHIRE R5.1.

•	AddDocument adds a Document for use with eForms.
•	AddEvent creates a new LV_ParticipantEvent SDI for the provided Participant or Visit Event.
•	AddPackage adds a Package.
•	AddProtocolTest adds and applies required WorkItems to a Sample as defined by the Protocol.
•	AddSDIDocument adds Documents associated with SDIs (for use with eForms).
•	AddSDIFormRule adds an SDI Form Rule (for use with eForms).
•	DeleteSDIFormRule deletes an SDI Form Rule (for use with eForms).
•	AddStudySuite adds Study Suites.
•	AddTimepoint creates a new LV_ParticipantEvent SDI of type Timepoint for the provided Visit Event.
•	AddUpdProtocolSample creates and/or updates Sample and LV_SampleFamily SDIs.
•	AddUpdateParticipant creates a new LV_Participant SDI or finds an existing LV_Participant SDI and updates its column values.
•	AddReagentSample adds a Reagent Quality Sample to a Reagent Lot.
•	AdvanceReagentStatus sets Reagent status based on the Approval passed/failed and/or the Reagent Quality Sample Tested.
•	AddVisit creates a new LV_ParticipantEvent SDI of type Visit for the provided Participant.
•	ApplySamplingPlan applies a Sampling Plan to an SDI.
•	ApproveBiobankSample applies the Study specific approval rules to the provided Samples and if the Samples pass approval, updates the necessary approval fields and Sample storage status.
•	AssignStrgAndReceive assigns Samples to a Storage Unit. This actually performs the Assign Storage operation.
•	CopyCohort copies a Cohort to a new Cohort for the same Protocol.
•	CreateProtocol creates a new Protocol for a Study.
•	CreateQCBatch creates a QC Batch.
•	DeleteCohort deletes a Cohort from a Protocol.
•	DeleteProtocolRev deletes all versions of a Protocol revision.
•	DeleteSDIDocument deletes Documents associated with SDIs (for use with eForms).
•	DeleteStudySuite deletes Study Suites.
•	EvalProdVariantState evaluates the State of a Product Variant.
•	ExportPropertyTree exports Property Tree data.
•	ExportSDC exports SDC data.
•	ExportSDI exports SDI data.
•	ExportTable exports table data.
•	ExportWebPage exports Web Page data.
•	ImportDataFile imports a Data File.
•	MultiSampleChild creates Aliquots or Derivatives of multiple Samples.
•	QCCalcSpikeIUPACMeth and QCCalcSpikeConcMeth support IUPAC Recovery and Expected Concentration methods for calculation of %Recovery for Spike Sample Types.
•	ProcessManualMessage is a private Action for internal use.
•	ReadDataFile reads a data file.
•	ReagentEvent builds the Bulletin body based on the eventtype and executes the 'SendBulletin' action.
•	RegisterProtocolSamp interprets the Protocol for a Study and creates all underlying Protocol structures.
•	SetDocumentStatus sets the status of a Document (for use with eForms).
•	SetupSampleForWOComp Invokes the preWOComplete method on the Task associated with one or more Workorders.
•	SyncSDIDataSetStatus synchronizes the status of an SDI with its Data Sets and calculates the status of a Sample based on the status of its Data Sets.
•	SyncStorageLabelPath synchronizes a Storage Label path.
•	UndoSDIColumnValue reverts an altered value in an SDI column to its previous value.
•	UpRevSiteNPartcpnt updates the revision of Study Sites and/or Participants.

Modified Actions

These System Actions have been modified in SAPPHIRE R5.1. Some of these have had previously private properties exposed in their public Interfaces. Some have new properties and/or functionality. This distinction is made for each.

•	AddCategoryItem Newly exposed properties: applylock, rsetid, separator.
•	AddDataItem New properties: auditreason, auditactivity, auditsignedflag. Newly exposed properties: auditdt, propsmatch. Other changes: The delimiter property has been changed to separator, but delimiter continues to work for backward-compatibility.
•	AddDataSet New properties: auditreason, auditactivity, auditsignedflag, newdatasetinstancexml. Newly exposed properties: auditdt, paramid, paramtype, replicateid, and rsetid. Other changes: New capability to defined extended columns. Note that the following properties are exposed in the Interface, but are reserved for internal use only: adddataitems, matchusersequence, newds, param qcbatchid, qcbatchitemid, scheduleplanid, scheduleplanitemid, trackitemid.
•	AddFolder Newly exposed property: folderid.
•	AddReplicate New properties: auditreason, auditactivity, and auditsignedflag.
•	AddSDI New properties: auditreason, auditactivity, auditsignedflag. Newly exposed properties: applyworkitems. Other changes: New capability to copy details of Templates. When you pass SDI Templates into this Action, the Action now copies all Details of the Template, including Details and Details of Details.
•	AddSDIAddress Newly exposed property: rsetid. Note that the functiondt property is exposed in the Interface, but is reserved for internal use only.
•	AddSDIApproval Changed property: The delimiter property has been changed to separator, but delimiter continues to work for backward-compatibility.
•	AddSDIApprovalStep Changed property: The delimiter property has been changed to separator, but delimiter continues to work for backward-compatibility.
•	AddSDIDetail New property: detaillinkid (adds a new record to a Detail of a Detail Table).
•	AddSDIRole Newly exposed property: rsetid.
•	AddSDISpec: New properties: auditreason, auditactivity, auditsignedflag. Newly exposed properties: auditdt, rsetid.
•	AddSDIVersion New properties: newkeyid2, newkeyid3.
•	AddSDIWorkitem New properties: auditreason, auditactivity, auditsignedflag, workiteminstance. Newly exposed properties: auditdt, rsetid. Other changes: New capability to defined extended columns. Note that the following properties are exposed in the Interface, but are reserved for internal use only: duedt, groupid, groupinstance, qcbatchid, qcbatchitemid, scheduleplanid, scheduleplanitemid, sdigroupid, sdigroupinstance.
•	AddSDIWorkflow Newly exposed properties: addnewonly, separator.
•	AddStudy Newly exposed properties: containertypeid, eventnotify, studystatus.
•	AddToDoListEntry Newly exposed property: requestorid.
•	AddToWorkplan Newly exposed property: separator.
•	AddWorkgroupItem Newly exposed properties: eventnotify, separator.
•	AdjustTrackItemInv New properties: auditreason, auditactivity, auditsignedflag. Newly exposed properties: applylock, eventnotify.
•	ApplyDataItemLimits New properties: auditreason, auditactivity, auditsignedflag. Newly exposed properties: auditdt, eventnotify.
•	ApplyDataSetLimits New properties: auditreason, auditactivity, auditsignedflag. Newly exposed properties: auditdt, eventnotify.
•	ApplySDISpecs Newly exposed properties: applylock, eventnotify.
•	ApplySDIWorkitem New properties: auditreason, auditactivity, auditsignedflag. Newly exposed properties: auditdt, workiteminstance. Note that the matchusersequence property is exposed in the Interface, but is reserved for internal use only.
•	ApproveSDIStep New properties: auditreason, auditactivity, auditsignedflag.
•	CancelWorkflow Newly exposed property: deleteifnotstarted.
•	CheckDates Newly exposed properties: processactionid, processactionversionid.
•	CopyDataSet New properties: auditreason, auditactivity, auditsignedflag. Newly exposed properties: auditdt, rsetid.
•	CreateSECMessage New property: log.
•	DeleteCategoryItem Newly exposed properties: applylock, rsetid, separator.
•	DeleteChargeListItem Newly exposed properties: eventnotify, separator.
•	DeleteDataItem New properties: auditreason, auditactivity, auditsignedflag. Newly exposed property: auditdt.
•	DeleteDataItemLimit New properties: auditreason, auditactivity, auditsignedflag. Newly exposed property: auditdt.
•	DeleteDataSet New properties: auditreason, auditactivity, auditsignedflag. Newly exposed property: auditdt.
•	DeletePriceListItem Newly exposed properties: eventnotify, separator.
•	DeleteSDI New properties: auditreason, auditactivity, auditsignedflag. Newly exposed properties: auditdt, eventnotify.
•	DeleteSDIAddress Newly exposed properties: rsetid, separator.
•	DeleteSDIAttachment Newly exposed property: applylock.
•	DeleteSDIDetail Newly exposed property: separator.
•	DeleteSDIRole Newly exposed properties: rapplylock, rsetid, separator.
•	DeleteSDIWorkitem New properties: auditreason, auditactivity, auditsignedflag, forcedelete. Newly exposed properties: applylock, auditdt, eventnotify.
•	DeleteWorkgroupItem Newly exposed property: eventnotify.
•	EditChargeListItem Newly exposed properties: eventnotify, sdcid, separator, templateid.
•	EditDataApproval New properties: auditreason, auditactivity, auditsignedflag. Newly exposed properties: auditdt, propsmatch.
•	EditDataItem New properties: auditreason, auditactivity, auditsignedflag. Newly exposed properties: auditdt, applylock, propsmatch.
•	EditDataSet New properties: auditreason, auditactivity, auditsignedflag. Newly exposed properties: auditdt, propsmatch.
•	EditPriceListItem Newly exposed properties: eventnotify, keyid1, keyid2, keyid3, sdcid, separator.
•	EditSDI New properties: auditreason, auditactivity, auditsignedflag. Newly exposed property: auditdt.
•	EditSDIAddress Newly exposed properties: propsmatch, rsetid. Note that the functiondt property is exposed in the Interface, but is reserved for internal use only.
•	EditSDIDataRelation Newly exposed properties: applylock, propsmatch, rsetid.
•	Edit TrackItem New properties: auditreason, auditactivity, auditsignedflag.
•	EditWorkgroupItem Newly exposed property: eventnotify.
•	EnterDataItem New properties: auditreason, auditactivity, auditsignedflag, overridereleased. Newly exposed properties: auditdt, eventnotify, propsmatch.
•	EnterDataSet New properties: auditreason, auditactivity, auditsignedflag. Newly exposed properties: auditdt, eventnotify, propsmatch.
•	ExtendDataSet New properties: auditreason, auditactivity, auditsignedflag. Newly exposed property: auditdt. Other changes: The delimiter property has been changed to separator, but delimiter continues to work for backward-compatibility. Note that the replicateid property is exposed in the Interface, but is reserved for internal use only.
•	GetDataItemDate Newly exposed property: separator.
•	GetDataItemNumber Newly exposed property: separator.
•	GetDataItemString Newly exposed property: separator.
•	GetDataSetDate Newly exposed property: separator.
•	GetDataSetNumber Newly exposed property: separator.
•	GetDataSetString Newly exposed property: separator.
•	MoveStorageUnit New properties: auditreason, auditactivity, auditsignedflag. Newly exposed property: propsmatch.
•	Process File, ProcessFiles, ProcessInMessage, ProcessOutMessage, ProcessSAPMessage, ProcessSECMessage: All properties have been reconciled among the classes, Interfaces, and documentation.
•	RecordIncident New property: causaloblectflag.
•	RedoCalculations Note that the reversefksdcid property is exposed in the Interface, but is reserved for internal use only.
•	ReleaseDataItem New properties: allowmandatorynulls, auditreason, auditactivity, auditsignedflag. Newly exposed properties: auditdt, eventnotify.
•	ReleaseDataSet New properties: allowmandatorynulls, auditreason, auditactivity, auditsignedflag. Newly exposed properties: auditdt, eventnotify.
•	RemoveSDISpec New properties: auditreason, auditactivity, auditsignedflag. Newly exposed property: auditdt.
•	ResetSDIApproval The delimiter property has been changed to separator, but delimiter continues to work for backward-compatibility.
•	SendBulletin Newly exposed property: newkeyid1.
•	SendMail Newly exposed properties: cc, mailformat, to.
•	SetDataItemDate New properties: auditreason, auditactivity, auditsignedflag. Newly exposed properties: auditdt, propsmatch.
•	SetDataItemNumber New properties: auditreason, auditactivity, auditsignedflag. Newly exposed properties: auditdt, propsmatch.
•	SetDataItemString New properties: auditreason, auditactivity, auditsignedflag. Newly exposed properties: auditdt, propsmatch.
•	SetDataSetDate New properties: auditreason, auditactivity, auditsignedflag. Newly exposed properties: auditdt, propsmatch.
•	SetDataSetNumber New properties: auditreason, auditactivity, auditsignedflag. Newly exposed properties: auditdt, propsmatch.
•	SetDataSetString New properties: auditreason, auditactivity, auditsignedflag. Newly exposed properties: auditdt, propsmatch.
•	SetSDIVersionStatus New properties: auditreason, auditactivity, auditsignedflag. Newly exposed property: auditdt.
•	SetSDIWIIComplete Note that the replicateid property is exposed in the Interface, but is reserved for internal use only.
•	StartWorkflow Newly exposed properties: addnewonly, applylock, rsetid, separator.
•	SubmitSDIForApproval New property: newstatus.
•	TriggerWorkflow Note that the duedt property is exposed in the Interface, but is reserved for internal use only.
•	UnReleaseDataItem New properties: allowmandatorynulls, auditreason, auditactivity, auditsignedflag. Newly exposed properties: auditdt, eventnotify.
•	UnReleaseDataSet New properties: allowmandatorynulls, auditreason, auditactivity, auditsignedflag. Newly exposed properties: auditdt, eventnotify.
•	UpdateDataSetStatus New properties: auditreason, auditactivity, auditsignedflag.

Deprecated Actions

These System Actions have been deprecated in SAPPHIRE R5.1:

•	AddDetailSDI Use AddSDIDetail to deal with detail tables.

Action Block Editor

Top

Features

The Action Block Editor is a new user interface for configuring execution of an Action Block. This interface presents a declarative flowchart view of the structure of the Action Block, and shows arguments passed to each Action. New features include:

•	Conditional logic to skip execution of one or more of Actions in the Action Block.
•	Ability to calculate and pass Action Block variables to Action calls. Action Block Variables are set using Groovy code snippets.

The Action Block Editor is used:

•	In eForms to define Form Processing Rules.
•	In Data File Definitions to define processing of data in a Data File.
•	As a new Action that wraps an Action Block of other Actions.

Alternatively, the Action Block can also be coded using Groovy.

Document Changes

To support related functionality, these changes have been made to this document:

•	Added Action Block Editor.

Adhoc Queries

Top

Features

These enhancements have been made to Adhoc Queries:

Hibernate Upgrade
Hibernate has been upgraded to version 3.3.1. This change requires no action on your part. If upgrading, the new JARs will overwrite the old.

Additional Detail Types
Additional SDI Details including (Data Sets, Data Items, Trackable Items, Workitems, and eForm Document Fields) can now be defined as searchable in the SDI Detail property of the AdhocQuery Page Type, and are shown as Search Object Tree Nodes.

SDIAlias Searching
The SDIAlias is now searchable, and may be used to define an extended column (see the note in Adhoc Queries).

SDC Based Restrictive Where Clause
Using the AdhocQuery Page Type, a Restrictive Where Clause can be defined for each SDC and is honored in Adhoc Query searches.

eForm Integration
Adhoc Query has been modified to leverage associated Documents and their fields when searching for SDIs such as Samples, Subjects, and Visits (see Adding Document Fields).

Adhoc Integration with List Page
When Adhoc Query is integrated with List pages, the advancedsearch Element now lets you specify a configured Adhoc Query search page rather than the default page.

Document Changes

To support related functionality, these changes have been made to this document:

•

In Adhoc Queries:

•	Noted in the Overview that Hibernate has been upgraded to version 3.3.1. also listed the files now in sapphirehibernate.jar.
•	Added information about querying SDI Documents.
•	Added a note about using the "sdialias" object to configure extended columns.

•

In AdhocQuery Page Type:

•	In SDI Detail property: Added support for Data Set, Data Item, Trackitem, Document Field, and Workitem.
•	Added new Restrictive Where Clause property.
•	Added information about Adding Document Fields.

Approval Types

Top

Features

These enhancements have been made to Approval Types:

Unique Approvals
Unique approver for each step added to mandate that a different User must conduct Approval for each Approval Step.

Peer Approvals
Peer Required added to mandate that the User conducting Approval be different than the User who entered the data.

Also see Additional Information concerning Data Entry and Action support for these features.

Document Changes

To support related functionality, these changes have been made to this document:

•

In Approval Types, added:

•	Unique approver for each step, which forces a different User to conduct Approval for each Approval Step.
•	Peer Required, which forces the User conducting Approval to be different than the User who entered the data.
•	Additional Information concerning Data Entry and Action support for these features.

AQC

Top

Features

These enhancements have been made to AQC:

New QC Method Apply Action
In QC Methods, new choices are available for the Apply Action. "New QC Sample" executes the QCApplyAction. "Additional Tests" executes the QCApplyLinkTo Action, which adds Data Sets to the existing referenced Sample. This is typically used when referencing existing Samples or Controls for Duplicate and Spike Sample Types.

Specification Based Evaluation
In the QCMethod, you can use a Specification (Eval Spec) to evaluate a QC Batch.

New AQC Spike Calculation Actions
New alternate Calculation Actions QCCalcSpikeIUPACMeth and QCCalcSpikeConcMeth support different approaches of calculating %Recovery for AQC Spike Samples.

New AQC QCBatch Creation Action
A new CreateQCBatch Action creates a QC Batch.

Modifications to the QCBatch Data Entry Page
A new QCBatch Data Entry page is provided with clickable icons that open QCSampleInformation and a QC Charting page.

Document Changes

To support related functionality, these changes have been made to this document:

•

In QC Methods:

•	In Apply Action, added "New QC Sample" (executes the QCApplyAction) and the new alternative "Additional Tests" (executes the QCApplyLinkTo Action to add Data Sets to the existing referenced Sample. This is typically used when referencing existing Samples or controls for Duplicate and Spike Sample Types. Also noted that in this case, the Link To field is mandatory.
•	Added Eval Spec to evaluate a QCBatch based on a Specification.
•	In Reagent Type, added description of how Samples are updated with Reagent information.

•

Added two new Actions to support IUPAC Recovery and Expected Concentration methods for calculation of %Recovery for Spike Sample Types:

•	QCCalcSpikeIUPACMeth
•	QCCalcSpikeConcMeth

In QC Calculations, added formulas for IUPAC Recovery Method and Expected Concentration Method to support these new Actions. With the existing QCCalcSpikePRecovery Action, this now provides 3 Actions for calculation of %Recovery for Spike Sample Types.

•

For the QCMethod Apply Action, added alternative "Additional Tests" selection. Also added Eval Spec feature for evaluating a QCBatch based on a Specification.

Attachments

Top

Features

These enhancements have been made to Attachments:

New AttachmentManager Page Type
This is the basis for new pages that manage Attachments (supports a number of enhancements).

Built-in Inline Editing
You can now edit an Attachment without first saving a local copy.

Support of SDIAttachment User Fields
You can now add user fields to an SDIAttachment and manage them in the new Attachment Manager pages.

Data Set and Data Item Attachments
Attachments are now supported for individual Data Sets and Data Items.

Attachment Request Command
A new Attachment request command has been added to support the required operations.

Attachment Restrictions Based on File Type
New "Attachment Excludes" property for the AttachmentForm Page Type permit restricting Attachment uploads to certain file extensions.

Document Changes

To support related functionality, these changes have been made to this document:

•

Added new functionality to support Attachments:

•

AttachmentManager Page Type, which:

•	Performs operations defined by all Attachment Types.
•	Manages DataSet and DataItem Definition SDCs, with detail Element support in both Maintenance Form and Enhanced Data Entry pages.
•	Can be driven by a Request Controller command.
•	Is not associated with any specific SDC (accepts SDC and SDI keys as inputs).

•

OOB Attachment Maintenance page based on this Page Type.

•

In the AttachmentForm Page Type, added Attachment Excludes property to exclude files based on their extensions.

Auditing

Top

Features

These enhancements have been made to Auditing:

TraceLog Enhancement
New "Activity" and "SignedFlag" columns in the TraceLog table record a description of the audited event, as well as identify ESig events.
Improvements have been made to the ESig dialog to return an activity to the TraceLog table. This activity is essentially the operation that is shown in the statement of signing that is part of the ESig dialog.
The ViewAudit page has also been modified to show this activity in addition to the Reason for modification.

ESIG Window Return
The ESig dialog now returns a flag to indicate that the audit record was recorded with an Electronic Signature. This new flag is maintained in the TraceLog table. This provides the ability to record a Reason for modification without capturing an Electronic Signature. Note that previously SAPPHIRE required that the Electronic Signature and Reason be related, i.e., the existence of a Reason implied that the operation was also Electronically Signed.

Detail table Audit Columns
All detail tables now have ModBy, CreateBy, ModDate and CreateDate columns. Formerly, the user and date information was captured in the primary SDI record. These are now redundantly recorded on the individual detail records.

AuditView Page Type Enhancements: Detail Tables
Audit View pages now present details of the primary SDI based on DDT-based detail tables (such as ParamListItem), many-to-many tables (such as SysUserDepartment), and SDC Reverse FK details (such as QCMmethodSampleType-toQCMethod). Also, the "Advanced Configuration" property collection of the auditdetails Element allows freeform SQL-driven details. A typical use is where the physical relationship is not clearly a detail but the page should present it as such (such as Trackable Items and Samples).

AuditView Page Type Enhancements: Display of CLOB
The Audit View page now displays XML stored in CLOBs.

AuditView PageType Enhancements: Printing
A Print button has been added to Audit View pages (see Audit Pages and AuditView Page Type).

AuditView PageType Enhancements: Enumerate all Columns
The "Display All Table Columns" property has been added to automatically show all columns of an SDC or detail without having to express them in the property collection.

New OOB Audit Pages
Audit pages are provided OOB for these SDCs: Batch, BioBanking Sample, Department, Incident, Package, ReagentLot, SampleFamily, StabilityStudy, Subject, ParamList, Product, QCBatch, Sample, BioBanking Study, TrackItem, and User.

Document Changes

To support related functionality, these changes have been made to this document:

•

Added new capability to print the Audit details to the Audit Pages description of the Interface and the AuditView Page Type.

•

In Concepts of Auditing:

•	Added new "Activity"and "SignedFlag" columns to the TraceLog table. The TraceLog now records "Reason", "Activity" (description of the audited event), and "SignedFlag" (to identify ESig event).
•	Added a list of preconfigured AuditView pages.

•

Also added support in the auditdetails Element for detail, many-to-many, and reverse foreign key links, can now display XML in CLOBs, new properties for showing all SDI columns and filtering columns by SQL clauses and key columns).

Batch Management

Top

Features

Batch Management is a new module in SAPPHIRE R5.1.

The Batch Management module provides all functionality associated with the Batch life cycle of raw material and manufacturing batches. The Batch life cycle includes creation of Batches, Batch Receipt, Lab Data Entry, Batch Release and printing of Batch COAs.

During Batch creation, the Batch Management module (along with its Sampling Plans) defines the number and types of Samples created when the Batch is created, along with required Tests and Specifications.

As part of Batch creation, the Batch Management module provides rich Skip Lot and Reduced Testing rules, plus evaluation that depends on suppliers and/or manufacturers.

The Batch life cycle is integrated with the Sample life cycle.

Document Changes

To support related functionality, these changes have been made to this document:

•

Added new Batch Management module:

Added these new topics:

•	Batch Management Overview
•	Batch Life Cycle
•	Batch Operations
•	Sampling Plans

•	Product Variants
•	Product Variant Rules
•	Count Rules

To support Batch Management, also:

•	Updated the Product Maintenance Page to support general Batch Management functionality.
•	Add the BatchSamplePolicy and SamplingPlanPolicy.

BioBanking ASL

Top

Features

These enhancements have been made to ASL:

Improved ASL Maintenance Pages
Configuration of the ASL Maintenance pages for Storage Unit, Box, and Physical Store has been improved.

Force Custody versus Transfer Custody
The Force Custody operation was actually broken in SAPPHIRE R5.0. It displayed a warning that the process could not be undone, but after that it just did a "Transfer Custody". Therefore, if the Sample was in some other Custodial Domain or in the possession of another Custodian, it said that you could not perform the operation. This was incorrect. By definition, "Force Custody" means you do not care where the Sample is, just give Custody of the Sample to the User who is performing the Force Custody operation. That has been corrected in SAPPHIRE R5.1. The Force Custody now bypasses all validations and gives Custody to the User.

Child Storage Unit Validation Improvement
The validation of allowed child Storage Units that can be placed in an existing Storage Unit is now based on the current definition of its Storage Unit Type. There is now no need to recreate a Storage Unit after editing its definition of allowed child Storage Unit Types.

TISM Page Enhancements:

•	TISM Page Prompting The TISM page now supports prompting for information while scanning Samples while UnPacking a Package.
•	TISM Option to AutoCreate SDI A new option on the TISM page automatically allocates a Sample while scanning a Sample that does not exist.
	TISM Page Usability Improvement to file Boxes Filing a Box after filing Samples into a Box has been improved. After filing Samples into a Box, the TISM page has a new facility to file the Target Storage Unit into another Storage Unit without leaving the TISM page. The TISM page now also lets you adjust the division of the page between the Source and Target frames.
	TISM Page Support of Custom Validation The TISM page now defines a class to be used for custom validation of the scanned item before the scanned item is filed.
	TISM Page Freeze Thaw Improvement The TISM page now presents Freeze Thaw status while scanning for individual Samples. Previously, Freeze Thaw integrated only when Autofiling an entire Package.
	TISM Session Report A new option in the TISM page remembers the list of Samples filed to be used for printing of a Storage Report to show where each Sample was filed.

Improved ASL Maintenance Pages
Configuration of ASL Maintenance pages for Storage Unit, Box and Physical Store has been improved.

Document Changes

To support related functionality, these changes have been made to this document:

•

Added ASL updates to these topics:

•	Boxes
•	Physical Stores
•	TISM Page

BioBanking SMS

Top

Features

These new BioBanking Clinical modules have been added to SMS:

Protocol Management Module
SAPPHIRE's Protocol Management module lets you manage a Protocol "one-to-one" for a BioBanking study. This Protocol represents the planning aspect for the Study. It allows the definition of the requirements of the Subjects, along with which Samples to collect and testing to analyze. All of this is combined into the single LIMS system (as opposed to separate LIMS and Protocol systems) for a single integrated view.
The Protocol defines the Cohorts that are required, and defines which Visits and Timepoints occur, which may introduce Samples into the BioBanking system.
The Protocol defines individual Kits and consumables used during Sample collection, and forms that should be completed for additional information about Visits, Participants, or Samples.
The new Protocol Management functionality can be leveraged to run clinical trials.

Kit Management Module
Kits are used for the collection of Samples from different collection sites. The SAPPHIRE Kits Management module provides complete Kit management, which can be integrated with the Protocol functionally or used stand-alone.
SAPPHIRE Kit Management can manage the complete life cycle of Kits, including Definition, Generation, and Labeling. Included is how (and in what quantity) to ship Kits to the collection sites. Disposing, and expiration of Kits is included. The returned Kit items ultimately will become the actual Samples received in the BioBanking TISM page.
SAPPHIRE Kit Management also provides detailed inventory capability to manage the individual supplies used when assembling either intermediate Kits or a complete Kit assembly.

Integration of Clinical eForms Module
SAPPHIRE eForms have additional security and restrictions when associated with BioBanking Studies and Clinical Sites. Users associated with either the Study or Site are restricted to seeing the content of only Forms that are associated with their Study or Sites.
SAPPHIRE eForms are associated with Samples, Participants, Subjects, and Visits either automatically (depending on a stated Event) or on-demand, as defined by the Study Protocol.

Collectively, these enhancements have been made throughout SMS:

Result Data Entry
Data Entry recording has been integrated with results and observations against BioBanking Samples. This includes the ability to enumerate testing requirements during Study maintenance on specific Sample Types for Samples of a Study, use the new Add Tests capability on the Lab Operations Sample List page, redirect to the SAPPHIRE result entry pages for Result Entry and Data Set Approvaland track the status of Test results with an icon on all Sample List pages.

New Study Based Approval Rules
Defining BioBanking Sample requirements was formerly controlled by two radio buttons on the Study Maintenance page: Requires Link To Subject and Requires Sample Collection Info. These requirements corresponded to the fact that a fixed set of columns had to be entered in the SMS Data Entry page before Sample status was changed to InCirculation.
A new, more general solution has been introduced to define the fields required on a Study-by-Study basis. This flexibility is provided by defining the Approval Rules in the BioBanking Policy.
Upon upgrading to SAPPHIRE R5.1, the BioBanking Policy is setup to provide the required backward-compatibility. All existing Studies are also automatically updated to set Approval requirements according to the previously set Requirement Flags RequiresLinkToSubject and RequiresSampleCollection, which have been deprecated.
Properties that control the Approval rules that were configured in the SMSDataEntry Page Type were deprecated in favor of using Study-specific Approval requirements.

Policy Driven Biobanking Rules
Some BioBanking business rules can be disabled if required. The BioBanking Policy can be used to do this globally throughout the configuration.

Study Enhancements:

•	Study Templates A new option lets you select and utilize a Template when creating new Studies. Templates are a typing aid to supply information that is the same across multiple Studies. The primary goal of using Study Templates is to define whether or not the Study is Protocol-driven. Protocol-Driven studies is a new feature of SAPPHIRE R5.1. Study Templates also define the new BioBanking Sample approval rules and the BioBanking Study approval types. The Study Template is defined on the Template tramline of the Lab Admin sitemap. To continue to create new Studies without a Study Template, modify the BioBanking Policy to indicate that no Study Templates are desired.
•	Study Approval When using Study Templates, you can associate Approval Types so that new Studies must be approved prior to being able to activate the Studies for allocation of Samples.
•	Study Life Cycle The new BioBanking Study life cycle includes approval, activation, completion, and cancellation of the Study.

Discrepancies and Deviations
The ASL Deviation was rebranded as Discrepancies to avoid confusion with CAPA Deviations. BioBanking can now record either Deviations (which opens CAPA Deviations), or Discrepancies (which simply adds a note to the Sample detail).

SAPPHIRE now supports adding a Discrepancy to multiple Samples in Sample List pages and TISM pages.

SAPPHIRE can now be configured to either select a predefined Discrepancy or enter a free-text value.

Specimen Type
A new column has been added to the Sample SDC to generalize the concept of Container Types. In SAPPHIRE R5.1, the Specimen Type is the Container type. The Specimen Type is shown in the BioBanking Sample Edit pages.

Verification By Role
In addition to providing a Verification User, a new option has been added to the BioBanking Study to permit verification by a user who has a Role.

Document Changes

To support related functionality, these changes have been made to this document:

•

Added SMS updates and new Clinical functionality to these topics:

New topics:

•

BioBanking Accessioning

•

BioBanking Forms

•

BioBanking Kits:

•	Kits		•	Kit Lots
•	Kit Types		•	Example

•	BioBanking Protocols
•	BioBankingPolicy

Updated topics:

•	BioBanking Data Entry
•	BioBanking Sample Operations
•	BioBanking Studies
•	BioBanking Subjects

Calculations

Top

Features

These enhancements have been made to Calculations:

Data Set Reference
Data Sets can now be referenced by an SDIData column (see Referencing Data Sets by an SDI Data Column). This can be used to reference Data Sets in the current Workitem and Workitem Instance (see "Source Workitem" below).

Workitem-Specific Data Set Reference
This feature is a specific implementation of the "Data Set Reference" mechanism described above. SAPPHIRE maintains a parent-child relationship between SDIWorkitem and SDIData records. SDIData now records the Workitem and WorkItem Instance from which each Data Set was created.
Note that SAPPHIRE continues to support multiple SDIWorkitems sharing one SDIData record. In this case, the SDIWorkitem that caused the SDIData to be created is stored in the SDIData table.
The Workitem and Workitem Instance are displayed in the Data Set tab of Enhanced Data Entry pages only for information purposes. This lets you know which Workitem defines a given Parameter List.
Also, the Workitem and Workitem Instance can be used to write Workitem-based Calculations.
An example is shown in Referencing Data Sets by an SDI Data Column.

Expression Helpers
Expression Helpers have been added to the Expression Editor to assist you in creating Calculations.

New Editor
A multi-line editor for Calculation Rules has been added to Parameter List Maintenance Page (see Parameter List Maintenance Reference tab).

New Calc Report
A new Calculation Report shows details of a calculated Data Item. This report is launched by a new button that has been added Data Entry pages.

Consistent Behavior of Null Values in if( [b], [t], [f] ) Function
Evaluation of the first argument ( [b] ) has been made consistent for a given operator when nulls are involved. Previously, the Calculation engine may (or may not) have thrown an error under certain circumstances. This change ensures consistent behavior. See the note in the Expression Editor documentation.

Document Changes

To support related functionality, these changes have been made to this document:

•

In Concepts of Transformations and Calculations, added Referencing Data Sets by an SDI Data Column. This describes a new Calculation feature that lets you reference a Data Set by specifying its associated Workitem.

•

In Expression Editor, add new Expression Helpers.

•

In Parameter List Maintenance Reference tab, added multi-line editing feature for Calculation Rules.

•

In Concepts of Transformations and Calculations, corrected a typographical error in the SDI Data Relation example. The sdidatarelation should reference only the RelationType (Salient):

Changed this...

CD1	= Concentration measured for Data Set 1
	= 15
	= [Volume]*[sdidatarelation:Reagent:Salient\|ParamList\|C]

To this...

CD1	= Concentration measured for Data Set 1
	= 15
	= [Volume]*[sdidatarelation:Salient\|ParamList\|C]

•

Added Calculation Report feature to Data Entry Common Functionality.

•

Added a note in the Expression Editor documentation that provides examples of the if( [b], [t], [f] ) function.

CAPA

Top

Features

These enhancements have been made to SMS:

Add Adhoc Incidents
The New Incident List page can now add adhoc Incidents that are not necessary associated with any other SDIs in the system. The Add button prompts for an Incident Template, then passes this to the RecordIncident Action.

Workorder Closure Improvements
Closing CAPA Workorders has been simplified. They can be closed directly from the Incident Maintenance page.
The CAPA Workorder List page now has clearer button captions to indicate that the Workorders must be selected prior to completing.

Workorder Maintenance Page Reviewed
A number of columns on the Workorder Maintenance page were removed, as they did not apply to CAPA Workorders.

Incident Uses of Text Area
A number of columns in the Incident Maintenance page have been changed to use text areas, as these are 2000-character columns.

Use of Location SDC
The Incident SDC reference to the Location SDC is now handled by Location Management on the Lab Admin sitemap.

Document Changes

To support related functionality, these changes have been made to this document:

•

In CAPA Incidents:

•	In Specialized Operations in the New Incident List Page, added new Add Incident functionality for adding adhoc Incidents using Incident Templates. Also updated New Incident List page to include minor cosmetic and organizational changes.

•

In CAPA Workorders:

•	On the Workorder List page, changed "Mark for Completion" to "Select for Completion".
•	On the Workorder Completion page, changed "Mark for Completion" to "Complete All".
•	On the Workorder Maintenance page, removed Grace Period, Grace Period Unit, Window Start Date, Window End Date, Deviation Template, Deviation Flag, Study, and Source SDC.

Configuration Transfer Tools (CTT)

Top

Features

These enhancements have been made to CTT:

CTT Operations through the CTT User Interface:

•	FK-related tables can be exported (see Export FK related tables) using new SDCDetailLink support in SDC Maintenance to provide export of detail items.
•	A new feature prevents recursive exports.
•	A new option prevents overwriting existing files.
•	New options have been added for Data File import and commit scope.

CTT ANT Tasks

•	A new Excluded attribute has been added to the SDIDetail ANT task to exclude a detail table.
•	A new option has been added to the SDC ANT task to use wildcards for SDCIds (exports all SDCs).
•	An enhancement to the Table ANT task lets you take all tables defined in the schema.

Document Changes

To support related functionality, these changes have been made to this document:

•

In Configuration Transfer Tools, added:

•	Enhancement to Export FK related tables (uses new SDCDetailLink support in SDC Maintenance to provide export of detail items).
•	New feature that prevents recursive exports.
•	New option to prevent overwriting existing files.
	New options for Data File import and commit scope.

•

In CTT ANT Task Reference, added:

•	New excluded attribute added to SDIDetail ANT task (excludes a detail table).
•	New option for SDC ANT task to use wildcards for SDCIds (exports all SDCs).
•	Enhancement to Table ANT task lets you take all tables defined in the schema.

•

In Configuration Transfer Tools, added a note about importing Specifications that have been exported with the "Force Update" option set.

Data Entry (Enhanced Data Entry Pages)

Top

Features

Enhanced Data Entry pages replace the older Classic Data Entry pages that used dataentrygrid and dataentrylist Elements. To provide backward-compatibility, Classic Data Entry pages remain fully functional in SAPPHIRE. Enhanced Data Entry pages:

•	Address performance, usability, and functionality.
•	Can be used with the older Classic Data Entry pages to facilitate easy migration to the new pages.
•	Introduce a new DataEntryGridDetail Page Type and a new gwtdataentrygrid Element.

Enhanced Data Entry pages provide the features described below.

Marking Outliers
Data Items can be marked as "Outliers" to exclude from Calculations. See:

•	New icons in the Enhanced Data Entry Page Toolbar.
•	The Excluding Data section of Concepts of Transformations and Calculations.

Data Item Filtering
The page can be filtered to show only certain Data Items. The filter can be controlled by server-side page configuration or by the user to only show Data Items of specified Data Sets, Parameters, or Parameter Types.

See the description of the Enhanced Data Entry page OOB configuration.

Absurd Limits
Absurd Limits can be defined by a Limit Rule. These are visually rejected by the Data Entry page.

Detail Tabs
The page supports the display of detail tabs, which show information related to the current Data Item (cell). This information can include the primary SDI, Data Set, Data Item, or a custom detail tab. Custom detail tabs are configured OOB to show:

•	Information about Parameter Limits and Specification Limits for the Data Item.
•	Audit history of the current Data Item.
•	SOP Attachment for the current Data Set. The SOP attachment is an Attachment to the corresponding Parameter List.
•	Trend plot for the current Data Item.

See the description of the Enhanced Data Entry page OOB configuration.

Data Set and Data Item Attachments
Attachments can be associated with individual Data Sets and Data Items. This is integrated with the previously mentioned detail tabs.

See the description of the Enhanced Data Entry page OOB configuration.

Configurable Options for Data Items
For each Parameter List Item, new Parameter List options indicate how the Data Item is presented:

•	Configurable Lookup page for each Data Item.
•	Configurable Restrictive Where clause.
•	For SDI references, option to use a dropdown rather than a Lookup page.

These options are configurable in the Parameter List Maintenance Reference detail ("Web Lookup URL", "Extended SQL", and "Edit style").

Data Set Approvals
Data Set Approvals have been redesigned to provide easy Approval or Rejection for one or more Data Sets in a single operation.
Data Set Approvals can be configured to provide Data Set alerts using the "Data Set Status Alert Rule" in the gwtdataentrygrid Element. These alerts are configured OOB to alert for:

•	Data Entry: Override Analyst Training Certification and Override Instrument Certification.
•	Data Sets: Missing Reagent Lot selection.
•	Data Items: Modified Data Entry values and failed Specifications.

A new tramstop has been added to support Data Set "Approve Tests by Test" (see Approve Tests), leveraging the DataEntryByQuery Page Type and Queries to choose Data Sets that are shown in the Approval page.

Data Set Assignment
A new tramstop Assign Instruments has been added to assign the Instrument using the Data Entry page.
Both Analyst and Instrument Assignment have been preconfigured using the Enhanced Data Entry pages.

No Value Tags
No Value Tags allow text (such as BDL, NIL, NA, TMTC) to be entered on numeric results. Although SAPPHIRE has always permitted these textual tags on numeric results, they can now do the following when they match the Limits associated with the Parameter:

•	Trigger the Limit Rule's "When Met" option. You can therefore now substitute a numeric value in place of the textual value. This is useful when the Data Item may be used in a Calculation. This behavior (which may affect backward-compatibility), is controlled by the Data Entry Policy.
•	Be displayed as possible entries in the Data Entry page.

Miscellaneous Enhancements
These additional new features have been added to Enhanced Data Entry pages

•	Calculation Report feature provides Calculation information.
•	ExpandAll/CollapseAll functionality.
•	"TestsByCurntUsrsDept" Query added to Data Entry by Sample Selection for Enhanced Data Entry Pages and Data Entry by Sample Selection for Classic Data Entry Pages.
•	In Prep by Sample Selection, Data Entry on the Procedural Data Sets is now prevented until data for the corresponding Preparation Data Sets have been entered/Released/saved.
•	New Add Replicates operation.

Document Changes

To support related functionality, these changes have been made to this document:

•

In DataEntry Page Type, added new views resulting from Enhanced Data Entry pages.

•

Added description of Enhanced Data Entry page OOB configuration.

•

Modified Data Entry OOB description to serve as a launch point in either of the two kinds of Data Entry pages.

•

Modified Approve Tests to indicate that this has been split into two tramstops ("Approve Tests by Sample Selection" and "Approve Tests by Test"), then modified to show Data Set Approval for both Enhanced and Classic Data Entry pages.

•

Modified Prep by Sample Selection to show Prep for both Enhanced and Classic Data Entry pages.

•

Combined Assign Analyst and Assign Instrument to indicate that this has been split into two tramstops ("Asign Analyst" and "Assign Instrument"), then modified to show an example using the Enhanced Data Entry page.

•

In Parameter List Maintenance Reference detail, added Edit style, Web Lookup URL, and Extended SQL.

•

In Certifications, modified to show override Certification differences between Data Entry pages.

•

Moved common Data Entry functionality to a new topic (Data Entry Common Functionality) that is shared by both kinds of Data Entry pages.

•

Added new gwtdataentrygrid Element (see this entry in Web Page Designer below).

•

Added new DataEntryGridDetail Page Type (container for Enhanced Data Entry pages).

•

Added Data Entry Policy.

•

Added Calculation Report feature to Data Entry Common Functionality.

•

In Editing Features for Classic Data Entry pages, added new Expand All / Collapse All functionality.

•

Added Translation section to gwtdataentrygrid Element (describes new translation APIs), plus added a reference to this from the SAPPHIRE M18N Support description.

•

Added About "No Value" Tags to indicate that the Data Item Limit (detail) tab should show all valid Limit Types, including "No Value" limits.

•

Added new utility that marks Data Items as "Outliers" to be excluded in Calculations:

•	New icons in the Enhanced Data Entry Page Toolbar.
•	Reference in the Excluding Data section of Concepts of Transformations and Calculations.

•

In Data Entry by Sample Selection for Enhanced Data Entry Pages and Data Entry by Sample Selection for Classic Data Entry Pages, added a note about the new "TestsByCurntUsrsDept" Query.

•

In Prep by Sample Selection, added a note to state that Data Entry on the Procedural Data Sets is now prevented until data for the corresponding Preparation Datasets have been entered/Released/saved.

•

In Data Entry Common Functionality, added new operation to Add Replicates.

•

In Parameter Lists, added a note about Creating Your Own Display Format, indicating that a Display Format of .0000 results in unexpected behavior.

Data File Definitions

Top

Features

The Data File Definition and Data File Parser provide processing and transfer of Excel data.
The Data File Definition maps fields in the data file. The Action Block Editor defines how the data is posted to SAPPHIRE.
The Data File Definition defines parsing and processing rules of the Excel file. The processing rules are defined declaratively using the Action Block Editor to define how data are processed.
The Data File processing is integrated into these areas:

•	Using the SEC, a Message Type can transmit an Excel file to be processed.
•	Using the Process File Action.
•	OOB configuration that uploads an Excel file to execute the ProcessFile Action. This is a hidden button on the SampleList page, which imports the data file.

Document Changes

To support related functionality, these changes have been made to this document:

•	Added Data File Definition and Data File Parser.

Data Set Maintenance

Top

Features

These enhancements have been made to Data Set maintenance:

Cancel/Uncancel Data Set
A new utility has been added to Cancel and Uncancel Data Sets. This changes Data Set status for Parameter Lists marked as "Cancellable". See Cancellable option and Cancelling and Uncancelling Data Sets.

Availability Flag
The gwtdataentrygrid Element (for Enhanced Data Entry pages) has the "Data Item Display Rule" property, which can be used to leverage the sdidata.avaliabilityflag column to hide unavailable Data Sets until they become available.

Procedural Data Set Checking
When a Workitem contains both a Preparation and Procedural Data Set, the Procedural Data Set is not available until after the Preparation Data Set has been completed. See Prep by Sample Selection.

Initial Data Set Status
Data Set status is automatically set to "Initial" when a Data Set is created, regardless of how the Data Set is created in SAPPHIRE. Techniques previously required (such as using the UpdateDatasetStatus Action) are no longer necessary. See Data Set Status Transitions.

Document Changes

To support related functionality, these changes have been made to this document:

•

Added new utility to Cancel/Uncancel Data Sets (changes Data Set status):

•	New Cancellable option to mark Parameter Lists as "Cancellable".
•	Modified Data Set Status Transitions to include a note about Cancelling Data Sets.
•	New section in Concepts of Data Entry about Cancelling and Uncancelling Data Sets.

In Concepts of Data Entry, added a note to Data Set Status Transitions about new feature that automatically sets Data Set status to "Initial" when a Data Set is created, regardless of how the Data Set is created in SAPPHIRE.

•

In Prep by Sample Selection, added a note to state that Data Entry on the Procedural Data Sets is now prevented until data for the corresponding Preparation Data Sets have been entered/Released/saved.

eForms

Top

Features

eForms is a new user interface paradigm that creates WYSIWYG Data Entry interfaces that replicate the appearance and layout of paper-based forms. See the complete set of eForms documentation under "Document Changes" below. At a very high level, eForms contains these key features:

Form Builder
Easy-to-use Form Builder to design Forms. The Form Builder defines configurable rules that control validation, visibility, protection, and processing behavior. These rules can be expressed declaratively or using Groovy. The declarative rules provide easy configuration of complex client-side tasks (such as validation and dynamic display) without the need to write JavaScript.

Processing Rules
Processing rules simplify server-side processing methodologies, allowing for complex data processing without programmatic coding.

DDE, Reconciliation, and Approval
Rich form "workflow" with support for Double Data Entry, Reconciliation, and optional eForm Approval. These features provide preconfigured complex data collection scenarios.

Followups and Annotations
Information in a Form can be flagged for follow-up actions, notes, and annotations.

Linking
Once completed, a Form can be linked to other SDIs (an SDIDocument table maintains these associations).

Building Blocks
Forms can be constructed using a "building block" approach. You can predefine a library of individual Form "Fields" to ensure consistency among Forms. Partial building blocks (called "Formlets") can be used to construct more complex forms.

eForms technology is the basis of two new SAPPHIRE modules:

•	The "eSubmissions" module provides functionality to build Forms.
•	The "BioBanking EDC" module provides eSubmissions functionality, plus additional capabilities such as Double Data Entry and BioBanking integration.

Document Changes

To support related functionality, these changes have been made to this document:

•

Added these new tools for building eForms:

•	Introduction to eForms
•	Form Definitions
•	Form Builder: Overview Fields Groups Sections Pages APIs

•	eForm Manager
•	eForm Document Reference
•	eForm Data Entry Examples
•	Field and Formlet Definitions

Java Public API

Top

Features

New and Enhanced Methods
Various additions and enhancements have been made throughout the Java Public API. The most significant changes are new methods in sapphire.accessor.DAMProcessor (createRSet, createRSetQ, createLockedRSet, createRSetDS, createLockedRSDS) and sapphire.accessor.QueryProcessor: (getSqlDataSet, getPreparedSqlDataSet, getCount).

More than 5 Query Arguments
Support has been added to the DAMProcessor and QueryProcessor classes for more than 5 Query Arguments.

Action Interfaces
New SAPPHIRE Action Public Interfaces have been added (see ACTIONS).

Document Changes

To support related functionality, these changes have been made to this document:

•	Updated the Javadoc for the Java Public API.

JavaScript Global API

Top

Features

New Objects and Methods
Various additions and enhancements have been made throughout the JavaScript Global API, including 14 new objects and 14 objects that have been enhanced with new methods.

Document Changes

To support related functionality, these changes have been made to this document:

•	Updated the JavaScript Global API.

Limits

Top

Features

These enhancements have been made to Limits:

Absurd Limits
New Absurd Limits feature of Limit Rules lets you reject a value if a Limit is met.

Limits Stored as Numeric
Two new columns (Value1Num and Value2Num) have been added to the ParamLimits and SpecParamLimits tables. While upper and lower values for Parameter and Specification Limits continue to be stored as Strings in the Value1 and Value2 columns, SAPPHIRE's M18N utilities now convert the entered Strings to Numeric data types and store them in the new Value1Num and Value2Num columns for numeric evaluation. This allows a user in an American Locale to enter a Limit of "7.0" and a user in a French Locale to enter the same value as "7,0", with each user seeing the value formatted to his Locale and the correct value being numerically evaluated.
For Specification Limits, see Examples of Operators and Values.
For Parameter Limits, see Specifying Limit Values.

Fractional Limits
Fractional Parameter Limits and Specification Limits (such as 1/4 and 2 1/2) can now be entered. When a fraction is entered, SAPPHIRE converts it to a decimal and stores the decimal in the new Value1Num and Value2num columns that have been added to the ParamLimits and SpecParamLimits tables. All Limit evaluation functionality now uses these new columns if they contain data.
For Specification Limits, see Examples of Operators and Values and Fractional Specification Limits.
For Parameter Limits, see Specifying Limit Values and Fractional Parameter Limits.

Document Changes

To support related functionality, these changes have been made to this document:

•	Added feature to handle Absurd Limits (to reject a value if a Limit is met).
•	For Specification Limits, added a note to Examples of Operators and Values, and added the description of Fractional Specification Limits.
•	For Parameter Limits, added a note to Specifying Limit Values, and added the description of Fractional Parameter Limits.

Lookups

Top

Features

These changes are covered in the Lookup Columns property collection in the maint Element, and the New Item Details and Lookup Page Columns property collection in the sdclinkmaint Element):

•	Caller Driven Lookup Returns Changes have been made to improve how Lookups are called. This lets the caller of a Lookup specify which columns of the Lookup are returned to the caller and mapped to the columns of the caller.
•	Pass in Restrictive Where The caller can now pass a Restrictive Where to the Lookup.
•	Dynamic Lookup Configuration The caller of a Lookup detail can determine what should be presented on the Lookup without having to have a specific configured Lookup page.
•	Standard Add button supported from Lookup pages The ability to use an Add button is now enhanced in the Lookup page. This is similar to the behavior of the Add Param button when looking up Parameters in the Parameter List Maintenance page. This is accomplished by the Store Selection property of the advancedtoolbar Element.

Document Changes

To support related functionality, these changes have been made to this document:

•	In the maint Element: Added the Lookup Columns property collection. This is a Lookup page enhancement to determine the content and behavior of the Lookup page.
•	In the sdclinkmaint Element: Added New Item Details and Lookup Page Columns property collections. These are Lookup page enhancements to determine the content and behavior of the Lookup page.

M18N

Top

Features

These enhancements have been made to M18N:

Date Format Policy
The Date Format Policy is a new global utility for centralized configuration of date formats.

Configurable Date Format for Queries
SAPPHIRE Queries with date input parameters are tied to the application server's locale. If you install SAPPHIRE on a machine with a different locale, potentially all SAPPHIRE Queries with date input parameters would have to change the dateformat pattern in the to_date function such that these match the application server's locale.
Two properties in the Date Format Policy are available to deal with this, allowing a SAPPHIRE database to assume a fixed format pattern in SAPPHIRE Queries. "SAPPHIRE Query Date Format" specifies the Date format used in SAPPHIRE Queries using the Locale specified on the machine hosting the Application Server. "SAPPHIRE Query Date Format Locale" specifies the Locale to use for the Date format in SAPPHIRE Queries (defaults to the Locale specified on the machine hosting the Application Server).

Utility to View Locale's Date Formats
As part of the configuration maintenance the ability is provided to view the date formats for each locale. The "Apply and Show Test Formats" button on the Date Format Policy lets you view the date formats for each Locale.

Document Changes

To support related functionality, these changes have been made to this document:

•	Added Date Format Policy.

Message Types

Top

Features

These enhancements have been made to Message Types:

Integration of Data File Definitions
New options added to Message Types support Process Action Modes and Data File Definitions (specific to Data File Definition).

Message Log Change
View Process Files added to Message Log (specific to Data File Definition).

Document Changes

To support related functionality, these changes have been made to this document:

•

Moved Message Types and Message Log to separate topics (they are no longer used with only SEC), and made these changes:

•	In Message Types, added new options to support Process Action Modes and Data File Definitions (specific to Data File Definition).
•	In Message Log, added View Process Files (specific to Data File Definition).

Monitoring

Top

Features

These enhancements have been made to Monitoring:

Performance Statistics
Capability added to monitor these Performance Statistics: Actions with SDCId input property identified by SDC, SDC Rules grouped by applicable SDC, and RSet activity logging.

Document Changes

To support related functionality, these changes have been made to this document:

•

In Performance Statistics, added:

•	Actions with SDCId input property now identified by SDC.
•	SDC Rules grouped by applicable SDC.
•	RSet activity logging.

Policies

Top

Features

Policies let you set global properties. A Policy is defined by a Property Tree similar to those used for Page Types and Elements.
Policies are supplied OOB for BatchSample>, BioBanking, >DataEntry, DateFormat, FileLocation, and SamplingPlan.

Document Changes

To support related functionality, these changes have been made to this document:

•

Added new >Policy maintenance feature for defining project-specific properties:

•	BatchSamplePolicy
•	BioBankingPolicy
•	DataEntryPolicy

•	DateFormatPolicy
•	FileLocationPolicy
•	SamplingPlanPolicy

Products

Top

Features

These enhancements have been made to Products:

Product Maintenance Page
The Product Maintenance page has been modified to include support for the new Batch Management module. These include Product Type, Batch Sample Count, Batch Sample Template, Tests and Specifications detail, and Product Variant detail.

Document Changes

To support related functionality, these changes have been made to this document:

•	Modified the Product Maintenance page to include support for Product Type, Batch Sample Count, Batch Sample Template, Tests and Specifications detail, and Product Variant detail.

Queries

Top

Features

These enhancements have been made to SAPPHIRE Queries:

Arguments
The number of Arguments specified for a Query SDI has been increased from five to twelve in the Query Maintenance page, and more using the Java Public API. See About Arguments in the Query Maintenance page.
Support for up to 12 parameters has been added to the advancedsearch Element on List pages.

Document Changes

To support related functionality, these changes have been made to this document:

•	In the description of the Query Maintenance page, added About Arguments to reflect that the number of Arguments specified for a Query SDI has been increased from five to twelve in the Maintenance page, and more using the Java Public API.

Reporting

Top

Features

These enhancements have been made to Reporting:

Report List Page Run Report button
The new Report list page supports a Run Report button to execute any report (see Execute Reports). This opens the report execution dialog from which you choose where and how the report is output.

BOXI Date Formats
The System Configuration now can set the format that SAPPHIRE uses when passing date arguments to a BOEXIR2 report.

BOEXIR2 Test Connection
A new option in System Configuration and User Profile lets you test the connection to the BOEXIR2 server.

Jasper Reports Upgrade
Jasper Reports was upgraded from 2.0.5 to 3.5.2.

Warning on Controlled Report Regeneration
When printing a Controlled Report, a warning message is displayed when a Controlled Report already exists for a given Sample (or other SDI).

Cascading Arguments
The Report Argument Prompting page now supports cascading arguments similar to that supported by Query arguments.

GenerateReport File Substitution
The GenerateReport Action now supports substitution in the generation of the file name when using either the file or email option.

OOB Configuration BO 6.5 Reports Removed
The OOB Configuration which previously called the ReportManager Page Type to execute BO 6.5 reports have been modified to call Jasper equivalent reports.

New OOB Reports
These new OOB reports have been provided:

•	BatchCOA (COA report for all Samples in a Batch).
•	BatchPrelimCOA (COA report for all Samples in a Batch, but with a watermark implying this is a preliminary report).
•	BatchSummaryCOA (COA report showing minimum, maximum, and average value across multiple Samples of a Batch).
•	BBMasterSampleHistory (BioBanking report showing location and custody history of a Sample).
•	BBSampleDetail (BioBanking report showing all details of a BioBanking Sample for Oracle only).
•	BBSampleDisbursement (BioBanking report showing Custodial Domain transfers).
•	ShippingManifest (ASL report showing the contents of a Package).
•	TrackitemPicklist (ASL report showing the location of a set of Samples. Integrated with the TISM page to generate a filing report that shows where all Samples were filed).

Document Changes

To support related functionality, these changes have been made to this document:

•	Added new Execute Reports functionality to the Report interface descriptions, plus rewrote and reorganized sections to accommodate redundant functionality.
•	In Concepts of Reporting, added a reference to the new "Execute Reports" functionality.
•	Added "BO Crystal Date Format", "BO Desktop Date Format", "BO Webi Date Format", and "Test Connection" to System Configuration User Options. "User Profile" in the User Maintenance page points to this, as the properties are identical.
•	In Reports and Execute Reports, added a note about suppressing prompts.
•	Throughout affected areas of the Jasper Reports section of Concepts of Reporting, reflected upgrade of Jasper Reports version from 2.0.5 to 3.5.2.
•	In Controlled Reports, added a section about configuring Report Generation Checks that prevent generating a Controlled Report for a KeyId that is already associated with a Report Event.
•	In Reports and Execute Reports, added a note about Using Unicode with Jasper Reports.
•	In System Configuration User Option, added option to set the format that SAPPHIRE uses when passing date arguments to a BOEXIR2 report.
•	In System Configuration User Option, added option to test the connection to the BOEXIR2 server.
•	In Reports and Execute Reports, added a note about setting the BO "defaultpagesize" property (reports will be incorrectly rendered if the number of items in the BO root folder exceeds the value of "defaultpagesize").

Sample Disposal

Top

Features

These enhancements have been made to Sample Disposal:

New Rules to Dispose Samples
The Product Maintenance page now drives the rules for when a Sample is targeted to be Disposed. These rules include defining the duration past a Sample date when the Sample is to be Disposed.

Sample Maintenance Page Disposal Support
The Sample Disposal Target Date has been added to Sample Maintenance pages.

Document Changes

To support related functionality, these changes have been made to this document:

•

Added new facilities to Dispose Samples:

•	Added new topic on Sample Disposal.
•	Added new Sample Disposal settings (Disposal Based on Rule, Disposal Offset, and Disposal Offset Unit) to Product Maintenance page.
•	Added new Sample Disposal setting (Disposal Target Date) to Sample Maintenance page.

Sample Status

Top

Features

These enhancements have been made to Sample Status:

Initial Sample Status Set
When a Sample is created, Sample status is automatically set to "Initial" if it has not already been specified (see Sample Status Transitions).

New Sample Status Facilities
The previous Change Status page had no control over the status a user may assign to a Sample. Accordingly, this functionality has been deprecated.
Facilities now exist to return Sample statuses to their prior status in the event they were advanced in error. For example, on the Sample Manage page, a new UnReceive button can be used to reverse the Receive operation. Similar buttons exist on other Sample List pages.
The UnReceive operation utilizes the new UndoSDIColumnValue, which works by examining the Audit table to restore the SDI back to its prior status. See the "UnReceive" operation in Sample Manage.

New Historical Samples page
A new Historical Samples List page shows all Samples with a status of Reviewed, Disposed or Cancelled. This page has an UnReview and UnCancel button in the event they are needed. See the "Unreview" and "UnCancel" operations in Historical Samples.
The Manage Samples page now has a restriction clause to not show all Reviewed, Disposed or Cancelled Samples.

OOB Sample List page Includes Data Entered Icon
The OOB Sample List page now includes a new icon to indicate that all Data Entry has been completed for all Data Sets, and that the Sample is now pending Release or Approval. The Sample status remains at InProgress until all Approvals have been completed.

AutoReceiveFlag honored in Business Rules
The Sample AutoReceiveFlag is automatically honored when a Sample is created. This is controlled by the BatchSamplePolicy. This flag sets Sample status to Received and updates the Sample's ReceiveDT and ReceiveBy fields. Typically, this is set either in the Sample Template or by the user during Sample creation.

ReceiveRequiredFlag honored
The SampleReceiveList page honors a Sample's ReceiveRequiredFlag. You can set this "N" if you do not require Receipt of a Sample. Typical uses would be for Reagent Quality Samples or AQC QC Samples.

ReviewRequiredFlag honored
The Sample's ReviewRequiredFlag is used to specify when a Sample Review is required to consider the sample as Finished. This is used to know when to roll the corresponding Batch status to PendingRelease. This is used in the Batch Management module as part of the Batch Life Cycle.

Document Changes

To support related functionality, these changes have been made to this document:

•

Added new facilities to change Sample Status (replaces the "Change Status" functionality):

•	Deleted information concerning old "Change Status" functionality that is no longer applicable.
•	Added "UnReceive" operation to Sample Manage.
•	Added "Unreview" and "UnCancel" operations to Historical Samples.
•	In Sample Life Cycle, added a note to Sample Status Transitions about new feature that automatically sets Sample status to "Initial" when a Sample is created (applies if Sample status has not already been specified).

Scheduler

Top

Features

These enhancements have been made to the Scheduler:

New System SDC
The SchedulePlan SDC is now a System SDC that is supported by a Maintenance page. This SDC can now be configured with user fields as required. See Scheduler Mechanics: Overview of Internal Mechanisms.

Document Changes

To support related functionality, these changes have been made to this document:

•	In Scheduler Mechanics: Overview of Internal Mechanisms, added a note that the SchedulePlan SDC is now a System SDC and supported by a MaintenanceForm page.

SDC Maintenance

Top

Features

These enhancements have been made to SDC Maintenance, and are covered in many areas throughout the SDC Maintenance documentation.

Detail Maintenance Supported
You can now define detail tables under the primary or user SDC table.

Column Maintenance on Existing Product Detail tables
You can now add user columns and user links to any detail table of a System or User SDC. For example, you can add additional columns to the ParamListItem table, which is a detail of the ParamList SDC.
You can also add user columns to tables that define a many-to-many relationship.

New Pseudo SDCs Added
The SDC Maintenance page has always provided maintenance of adding user fields for the SDIData, SDIDataItem, and SDICOC tables even though they are not System or Core SDCs. Now, more of the SDI-level detail tables are treated in the same way. These include the SDIWorkitem, SDIAttachment, SDISpec, SDIWorkflow and SDIDocument detail tables. You can also now add user columns and user links to these detail tables.

Index Maintenance
You can now use the SDC Maintenance page to add Indexes for either the primary SDC or detail tables.

CLOB and BLOB Data Types
The SDC Maintenance page now supports adding columns of data type CLOB and BLOB.

Link Delete Behavior
The SDC Maintenance page now lets you determine behavior when someone attempts to delete a referenced item that is defined in a link. Previously, the default behavior was to null the referenced link unless business rules were coded. Now, alternate behaviors can be configured to either raise an error or propagate the deletion.

Link Deletion Behavior Defined for existing SDCs
All product links in Product SDCs were reviewed and defined to be either null out, raise error, or propagate the deletion.

Document Changes

To support related functionality, these changes have been made to this document:

•

Added these features to SDC Maintenance:

•	Add new detail tables to System and User SDCs.
•	Add/remove new columns to any table of a System or User SDC (including detail tables and many-to-many tables).
•	Add/remove user-defined columns in the SDIWorkitem, SDIAttachment, SDISpec, SDIWorkflow, and SDIDocument tables. New SDCs allow editing of these, and are maintained in the same way as standard SDCs (with restricted functionality).
•	Define links (foreign key, reference) on detail tables in the same manner as on the primary table.
•	Add/remove unique and non-unique indexes to any table of the SDC.
•	Added a warning to refresh the view if you add/delete columns to/from tables on which a view is based.

SEC

Top

Features

These enhancements have been made to the SEC:

Process Action Mode
A new Process Action mode indicates that the incoming Web-based Message is to be processed Synchronously, Asynchronously, or Manually (see Incoming Web-Based Processing).

Data File Integration
SEC Message Types and Message Logs have been modified to support integration between SEC and the new Data File Definitions.

Logging on Failure
A new option supports logging of Messages only when an error occurs.

Document Changes

To support related functionality, these changes have been made to this document:

•	Modified Incoming Web-Based Processing to describe new Process Action Modes for synchronous, asynchronous, or manual message processing.
•	Modified Message Types and Message Logs to support both SEC and Data File Definitions.

Security

Top

Features

These enhancements have been made to SAPPHIRE Security features:

Case Sensitive Passwords
A "Case Sensitive Passwords" setting has been added to System Configuration Security Options and User Maintenance Page for configuring case-sensitive passwords.

New Open Role Level Access
A new option is available for Role-Level Security. Previously with "Restricted Role" Level access, if an SDI had no Roles assigned, no one could ever access that SDI. Now with "Open Role" Level access, if an SDI has no Roles assigned, all users can access the SDI (until a Role is assigned to it). See Access Control in SDC Maintenance.

LDAP Improvements
Enhancements to External Authentication:

•	A new property "Sync LDAP User Password to SAPPHIRE" breaks default synchronization of a User's LDAP password with his SAPPHIRE password.
•	In addition to searching for users LDAP tree nodes defined by "The RDN for the User Search" property, SAPPHIRE now also searches all sub-tree nodes for the user if a user is not in the defined node.

Improved Module User Management
A new "Manage User Modules" option has been added to the User List page ( see User List Page). A list a users can be fed directly to the Module User Management page. This permits editing modules on a smaller set of users at one time.

Option to Expire All Pages
By default, SAPPHIRE does not immediately expire pages downloaded to the browser. To immediately expire all pages, add this line to SAPPHIRE_HOME\sapphireconfig.props:

com.labvantage.sapphire.server.expirepages=true

Document Changes

To support related functionality, these changes have been made to this document:

•

In System Configuration Security Options and User Maintenance Page, added new "Case Sensitive Passwords" setting for configuring case-sensitive paswords.

•

In Role-Level Access and SDC Maintenance Access Control options, changed to reflect that Role-Level Access now depends on the Access Control option set in the SDC Maintenance page.

•

In External Authentication, added this new and changed functionality:

•	New property "Sync LDAP User Password to SAPPHIRE" breaks default synchronization of a User's LDAP password with his SAPPHIRE password.
•	In addition to searching for users LDAP tree nodes defined by "The RDN for the User Search" property, SAPPHIRE now also searches all subtree nodes for the user if a user is not in the defined node.

•

Added "Manage User Modules" option to the User List Page.

Specifications

Top

Features

These enhancements have been made to the SEC:

Use Current Version
During Sample Login, a new Use Current Version for Spec and Data Set property to wzCreateSDI Page Type associates the current version of the Specification to the Sample, regardless of the version of the Specification that is associated with the Product. The Default is yes, i.e., use the current version as configured in the Sample Login Wizard pages.

Specification Icons
A new feature in the Sample Review, Sample Manage, and Batch List pages shows a different icon representing the Spec Conditions for a Sample or Batch (see Multiple Spec Conditions).

Specification Failed Warning
A warning message is displayed when printing a COA report if one or more Specifications has failed (see Samples for Review).

Document Changes

To support related functionality, these changes have been made to this document:

•

Added new feature that, during Sample Login, associates the Current version of the Specification to the Sample, regardless of the version of the Specification that is associated with the Product:

•	Added new Use Current Version for Spec and Data Set property to wzCreateSDI Page Type.
•	In Product Maintenance description, added a note about Use Current Version OOB configuration.
•	In Quick Login and Multiple Login, added a reference to the information above.

•

In Sample Review, added new feature to that shows multiple Spec Conditions associated with a Sample. Also linked Sample Manage to this as the functionality is similar.

•

In Samples for Review, added new feature to notify that one or more Specifications has failed prior to generating a C of A. This functionality is also in the Historical Batches page.

Storage Units

Top

Features

These enhancements have been made to Storage Units:

Assign Storage Operation
A new Assign Storage button has been added to the Sample Receive, Manage, and Review pages that store Samples in a Storage Location without requiring ASL and bypassing all custodial ASL rules. This is for use in a non-BioBanking system. A Trackable Item is automatically created when assigning Storage to non-ASL Samples.

Marking Samples As Retain
During the Assign Storage operation, a new option lets you mark the Sample to be retained. This is done by setting the Disposal status to "Make Retain".

Document Changes

To support related functionality, these changes have been made to this document:

•

Added new "Assign Storage" operation to store Samples in a Storage Location (bypasses all custodial BioBanking and ASL business rules):

•	Added description of the Assign Storage operation, including new "Make Retain" Disposal status setting.
•	Referenced the above description in Sample Receive, Manage, and Review pages.

•

In Freeze-Thaw Tracking for Trackable Items, changed Check In description to indicate that "thawed" is no longer the default (you must now manually increment thawed items).

Templates

Top

Features

These enhancements have been made to Storage Units:

OOB Configured use of Templates
Maintenance pages for ReagentTypes, QCMethod, Specification, Forms, and Users are configured to use Templates. See Templates tramline.

Multi-Key Support for Templates
Multi-key SDCs can now use Templates. Also, the templateselector Element has been updated to support Templates for multi-key SDCs.

Document Changes

To support related functionality, these changes have been made to this document:

•

Added new Template functionality:

•	Added new Templates tramline for creating and managing Templates for Samples, Studies, Incidents, and Batches. Also made note of new capability to create Templates for multi-key SDCs.
•	Deleted information concerning the "Sample Templates" tramstop.
•	In templateselector Element, noted that Templates can now be created for multi-key SDCs.

Tests

Top

Features

These enhancements have been made to Storage Units:

New Add Tests Button on Sample List pages
A new button provided on Sample List pages adds multiple Tests to multiple Samples in a single click. See Adding Tests to Samples.

Document Changes

To support related functionality, these changes have been made to this document:

•	In Concepts of Data Entry, rewrote example of Adding Tests to Samples to reflect new functionality (you can now add multiple Tests to multiple Samples).

Tramlines and Tramstops

Top

Every attempt has been made to reflect these changes throughout the documentation:

Tramlines Moved to LabAdmin
Management of Product-related master data (previously on the Reference tramline) management of Certifications (previously on the Certification & Resources tramline) has been moved to the Lab Admin sitemap.
To continue to access these pages from the SAPPHIRE sitemap, make the old tramline visible (it is simply hidden). The pages will then be accessible from both the SAPPHIRE and Lab Admin sitemaps.

BioBanking Study Tramline
A new BioBanking tramline containing Study status-based List pages and Subject List pages has been added. The BioBanking Study and Subject tramstops were therefore moved to the new BioBanking Tramline.

Reagent Types Moved to LabAdmin Sitemap
The Reagent Type tramstop was on the Reagents tramline of the SAPPHIRE sitemap. It has been moved to the Process tramline of the Lab Admin sitemap. A correction has been made to the Reagent Example.
To continue to access this page from the SAPPHIRE sitemap, use Evergreen to make the old tramstop visible (it is simply hidden). The page will then be accessible from both the SAPPHIRE and Lab Admin sitemaps.

New Templates Tramline
A new Lab Admin tramline has been added to manage Templates. Tramstops are available for Sample Templates, Incident Templates, Batch Templates, and Study Templates. Sample Templates has been hidden in the Samples tramline because the Sample Template has been moved to the Lab Admin sitemap.
CAPA Incident Templates has been hidden in the CAPA tramline because CAPA Incident Templates has been moved to the Lab Admin sitemap.
To continue accessing these pages from the SAPPHIRE sitemap, use Evergreen to make the old tramstops visible (they are simply hidden). These pages will then be accessible from both the SAPPHIRE and Lab Admin sitemaps.

Web Page Designer Elements

Top

Features

These enhancements have been made to Web Page Designer Elements:

advancedsearch Element Supports Adhoc Searching
New properties have been added to the advancedsearch Element for choosing the Adhoc Query page to use when Adhoc Query is used to return SDIs back to the List page.

advancedsearch Element Can Hide Search Types
A new Show property was added to the advancedsearch Element to disable showing of the inherited search types.

advancedtoolbar Element Validation Improvements
The advancedtoolbar Element now has declarative properties to check for how many SDIs may be selected before executing the button or operation.
The advancedtoolbar Element can now call a second JavaScript function after the JavaScript called by the first validation.

advancedtoolbar Element Supports Groovy for Visibility
The advancedtoolbar Element supports Expression Based Properties for configuring when buttons are hidden.

advancedtoolbar Element Improved Action Button interface
Execution of Action buttons has been streamlined by automatically passing necessary column values to the Action without having to write JavaScript to first place the value into the ACTION_xxx field. Arguments are now automatically passed simply by configuring the Action properties to reference the column as [xxx]. This is supported only in List and Maintenance pages.

maint Element Retains Selected Tab
The maint Element has been enhanced to reselect the selected tab after a Save.

maint Element Fires OnKeyUp event
OnKeyUp was added as an event that can be configured in the maint Element.

maint, sdclinkmaint and gwtdataentrygrid Element Lookup Improvements
The improvements described for caller-generated Lookups are supported from these Elements. This includes the ability to let the caller specify columns to display, return, and map to the caller's columns. These Elements include additional properties and column collections to support this functionality.

sdidetailmaint Element supports SDIDocument and SDIFormRules
The sdidetailmaint Element now supports the additional SDI detail tables for managing eForm (Documents and Forms).

detailmaint, sdidetailmaint, linkedsdimaint and trackitemlist Elements support Javascript Includes
These Elements now support JavaScript includes (they no longer need to be applied to each page that uses the Element).

Detail Elements Performance Improvement
Detail Elements in pages based on the MaintenanceForm Page Type (including detailmaint, sdidetailmaint, and linkedsdimaint) have been optimized to load faster.

sdclinkmaint Element detail Maintenance Improvements
Detail maintenance of the sdclinkmaint Element has been improved. You can now use this Element for reverse FK details, where one SDC acts as a child of another SDC. Additionally, this Element can now be used to manage many-to-many relationships.
Changes to sdclinkmaint include:

•	New detail link information has been added to SDCProperties (DDTConstants and DDTService updated to build SDCProperties with full detail link information, including link columns and any other required information).
•	The maint column has been updated to interrogate SDCProperties for detail columns as well as primary columns.
•	Detail columns can now get type and link information in the same manner as the primary column.
•	Checkboxes can lookup values from a Reference Type rather than using only the Display Value.
•	DataView.class, SDITagUtil.class, SDCLinkMaint.class, and dataview.js have been updated to let the dataview and sdclinkmaint Elements use the new SDC Maintenance detail table support. These Elements can now get more link information for detail links, provide a more accurate sdiinfo object to the maint Element and Maint Column, and get reverse foreign key link information.

list Element Shows Number of Selected SDIs
The list Element now shows the number of SDIs selected on the List or Lookup page.

list Element Open Popup Window Improvements
When opening links, the opened window size can be specified using new properties in the list Element. This option can open the window in the browser frame or as a modal SAPPHIRE dialog.

New prodvariantrulestate Element
This is a new Element that renders details of a Product Variant Rule (supports new Batch Management module).

promptrenderer Element Supports onChange property
The promptrenderer Element now supports the onChange property to permit cascading inputs. The promptrenderer also now supports configuration of JavaScript includes.

auditdetails Element Improvements
The auditdetails Element now has the "Display All Table Columns" property to automatically enumerate all columns in the table rather than having to individually enumerate them.

New spdetailitem Element
This is a new element that render details of a Sampling Plan (supports new Batch Management module).

storageunitrenderer Element New Properties
The storageunitrenderer Element now has these new properties: Show Legends (shows/hides legends), Mode (view/edit), and tab (configures Tab Groups).

Document Changes

To support related functionality, these changes have been made to this document:

•

In the advancedsearch Element:

•	Added the "adhocsearch" property (to choose the page loaded for an Adhoc search).
•	Added "Identifier" property (HTML ID attribute) and "Show" property (to show/hide Search Type).

•

In the advancedtoolbar Element:

•	Added "First Validation", "First Validation Selection", and "Second Validation JavaScript" properties.
•	To describe new enhancements, added notes Concerning Action Buttons.
•	Added "Store Selection" property.
•	Added a link from the "Show" property (for Buttons) to Expression-Based Properties, which contains information about new support for this Element.

•

In the auditdetails Element:

•	Added support for detail, many-to-many and reverse foreign key links.
•	Noted that the Element can now display XML in CLOBs.
•	Added "Display All Table Columns" property for showing all SDI columns.
•	Added "Advanced Configuration" property to filter columns by SQL clauses and key columns.

•

In the detailmaint Element, added JavaScript Includes property.

•

In the linkedsdimaint Element, added JavaScript Includes property.

•

In the list Element:

•	For the "Selector Type" property, added new feature that shows the number of SDIs selected.
•	For the Columns à Link property, added "New Window Width" and "New Window Height" properties (to override default settings) and "Open In SAPPHIRE Dialog" property (to open Lookups in a SAPPHIRE dialog rather than a browser window).
•	In the Selector Type, added the info label [x selected] to show the number of selected SDIs.

•

In the maint Element:

•

Added the Lookup Columns property collection. This is a Lookup page enhancement to determine the content and behavior of the Lookup page.

•

Added the OnKeyUp event support in the Event property for Columns (specifies JavaScript events).

•

Added a link from the "Mode" property (for Columns) to Expression-Based Properties.

•

In Tab Groups and Field Groups, added enhancement that re-selects the selected tab after a save. During this enhancment, Limit Rules were made to render correctly when tab state is recalled.

•

Corrected a typographical error in the Tab and Field Groups section:

Changed this...

Note that the Maint Form can render both tabs and fieldsets, while the Maint Grid can render only tabs.

To this...

Note that the Maint Form can render both tabs and fieldsets, while the Maint Grid can render only fieldsets.

•

Added new prodvariantrulestate Element to support Batch Management.

•

In the promptrenderer Element, added the "onChange" property for creating dependent cascading inputs. Also added an example of using onChange.

•

In the sdclinkmaint Element, added new properties to support these enhancements, which support the R5.1 detail table structure and Lookup enhancements:

•	New detail link information added to SDCProperties (DDTConstants and DDTService updated to build SDCProperties for full detail link information, including link columns and any other required information).
•	Maint maint column updated to interrogate SDCProperties for detail columns (as well as for primary columns). The detail columns can now obtain type and link information in the same manner as the primary column.
•	Checkboxes can look up values from a Reference Type (rather than using only the display value).
•	DataView.class, SDITagUtil.class, SDCLinkMaint.class, and dataview.js updated to let dataview and sdclinkmaint Element use the new SDC Maintenance detail table support. These Elements can now get more link information for detail links, provide a more accurate sdiinfo object to the maint Element and Maint Column, and get reverse foreign key link information.
•	Added a section on adding an sdclinkmaint Element to a MaintenanceForm page.
•	Added Include in Request property to MaintenanceForm Page Type to support the new sdclinkmaint Element features.
•	Added New Item Details and Lookup Page Columns property collections. These are Lookup page enhancements to determine the content and behavior of the Lookup page.

•

In the sdidetailmaint Element:

•	Added new Detail Types: "SDIDocument" and "SDIFormRule" associate data in those tables with SDIs.
•	Added new Disable Record on Data Entry property to disable a record if Data Entry was conducted on the Data Item.
•	Added JavaScript Includes property.

•

Added new spdetailitem Element for rendering details of a Sampling Plan.

•

Added new sqlview Element for rendering SDI details from query results.

•

In the storageunitrenderer Element, added the Show Legends, Mode, and Tab properties.

•

In the templateselector Element:

•	Noted that Templates can now be created for multi-key SDCs.
•	Added new Label Texts property.

Web Page Designer Page Types

Top

Features

These enhancements have been made to Web Page Designer Page Types:

New AttachmentManager Page Type
A newAttachmentManager Page Type performs operations defined by all Attachment Types and manages Data Set and Data Item Definition SDCs, with detail Element support in both MaintenanceForm and Enhanced Data Entry pages. This can be driven by a Request Controller command and is not associated with any specific SDC. It accepts SDC and SDI keys as inputs.

AttachmentForm Page Type Excludes Files
The AttachmentForm Page Type has new Attachment Excludes properties to exclude files based on their extensions.

New DataSpecLimitView Page Type
A new DataSpecLimitView Page Type has been added to show results of checking data against Parameter Limits and Specification Limits, and provide formatting of retrieved data in Enhanced Data Entry pages.

AdhocQuery Page Type Supports Restrictive Where
A new property has been added to the AdhocQuery Page Type to configure a Restrictive Where clause for each SDC used in the page.

AdhocQuery Page Type Detail Support
Additional properties have been added to support the detail types that are supported by Adhoc Queries (such as Document Fields).

TrackItemManagement PageType New Properties
The following new properties were added to the TrackItemManagement Page Type:

•	Pre Scan Validation Class to perform an AJAX validation on the scanned item before the item is filed.
•	Scanning Properties for adding SDIs that do not yet exist.
•	These collections are now Role-enabled: Allowed Lookup Types for Storage Unit Lookups in Source and Target frames, and SDC Element Collection property.

Dashboard supports Role Controlled Gizmos
The Dashboard Page Type now supports a property collection to enumerate the Gizmo Elements. This collection can therefore be Role-enabled to hide certain Gizmos from selected Users.

Maintenance Page Clones Support Attachment Element
The ProtocolMaintForm, QCBatchMaintForm, StudyMaintForm, and StorageUnitMaintForm Page Types (which were made by copying the original MaintenanceForm Page Type) now support the attachment Element.

Document Changes

To support related functionality, these changes have been made to this document

•

Added new functionality to support Attachments:

•

AttachmentManager Page Type, which:

•	Performs operations defined by all Attachment Types.
•	Manages DataSet and DataItem Definition SDCs, with detail Element support in both Maintenance Form and Enhanced Data Entry pages.
•	Can be driven by a Request Controller command.
•	Is not associated with any specific SDC (accepts SDC and SDI keys as inputs).

•

OOB Attachment Maintenance page based on this Page Type.

•

In the AttachmentForm Page Type, added Attachment Excludes property to exclude files based on their extensions.

•

In AdhocQuery Page Type:

•	In SDI Detail property: Added support for Data Set, Data Item, Trackitem, Document Field, and Workitem.
•	Added new Restrictive Where Clause property.
•	Added information about Adding Document Fields.

•

Added new CategoryReport Page Type that shows SDCs and SDIs belonging to a specified Category.

•

In the Dashboard Page Type, added "Gizmos" property.

•

Added new DataSpecLimitView Page Type that shows results of checking data against Parameter Limits and Specification Limits, and provide formatting of retrieved data in Enhanced Data Entry pages.

•

In the MaintenanceForm Page Type, added a link from the "Show" property (for Elements) to Expression-Based Properties.

•

Updated TrackItemManagement Page Type to reflect BioBanking enhancements. Most notably, this includes rmoval of the Reftype/Incident Template" property, and addition of "Discrepancy Reference Type" (for adding discrepancies to Samples) and "Incident Template for CAPA Deviations" (CAPA Incident template used for adding CAPA Incidents to Samples).

•

In the wzCreateSDI Page Type, added the Use Current Version for Spec and Data Set property.

Web Page Designer Interface

Top

Features

These enhancements have been made to the Web Page Designer Interface:

Quick Page Creation Wizard
When creating pages, you can automatically create a minimal set of pages for an SDC (a MaintenanceList, MaintenanceForm (or Grid), MaintenanceView page, and Lookup).

Improved General Editing Functions
Improvements to Web page editing:

•	New Copy and Paste option lets you move collection items between pages.
•	New capability to delete multiple collection items.
•	New Add Column Dialog adds multiple columns to a column collection.
•	Navigation has been improved when editing a referenced page from another page, and editing a page from the runtime display in the Web application.

Simplified Addition of Action calls
For Action buttons and post-Save Action references, SAPPHIRE now automatically imports the Action property definition to the argument collection. See Customizing Buttons.

New Quick Edit Searching
A new facility lets you quickly search for Pages, Page Types, Elements, and Layouts.

Multiple Layouts per page
You can now have multiple Layouts per Page. This allows a Page to appear and be accessible from multiple sitemaps. See Layouts Overview>.

Evergreen Search Improved
Evergreen Search page now permits additional directives to be passed, thus limiting the scope of the search to an Element, Page, or property.

Default of Selected Tab and Menu
For any page, you can now specify a default setting for the selected tab and menu based on the menu that was last accessed. See Special Processing for Tabs and Menus.

Document Changes

To support related functionality, these changes have been made to this document

•

Added Quick Page Creation Wizard. This new feature that quickly creates a set of pages for an SDC (Maintenance List, Maintenance Form/Grid, and Lookup).

•

Added new General Editing Functions.

•

Added URL References.

•

Added new Action property lookups and latest interface changes to Customizing Buttons.

•

In Expression Based Properties:

•	Added support in the advancedtoolbar Element.
•	Described exposed objects.

•

Evergreen Search page updated to allow passing additional directives into search criteria.

In Layouts Overview:

•	Added new feature to add multiple Layouts and separate Layout from page definition.
•	Added Special Processing for Tabs and Menus.

Web Page Designer Wizards

Top

Features

These enhancements have been made to Web Page Designer Wizards:

Request Parameters
A new feature passes additional request parameters to a wizard page, then provides access to the request parameter from the page within the wizard. See Passing Parameters to Wizards.

Document Changes

To support related functionality, these changes have been made to this document

•	In Creating Custom Wizards, added Passing Parameters to Wizards. This feature passes additional request parameters to a wizard page, then accesses the request parameter from the page within the wizard.