Options for Creating Protocols	Top

There is no shortage of options for creating Protocols:

Regardless of the option you choose, creating a Protocol or Protocol Template From Scratch always opens the Edit Protocol Page for this purpose.

Creating a Protocol Template	Top

Like Plans, the most flexible approach to creating Protocols is to create a Protocol Template, then reuse it as needed.

Choose the Protocol Templates menu item. The Protocol Template List Page opens.

In the Protocol Template List Page, click "Add".

In the dialog:

Supply a Template Name. This is an identifier for the Protocol Template.

Choose how the Protocol will be created:

The menu item switches from Protocol Template to Protocol, and the Edit Protocol Page opens. This is where you setup your Protocol.

Creating a Protocol	Top

Choose the Protocol menu item. The Protocol List Page opens.

In the Protocol List Page, click "Add".

As described in Options for Creating Protocols, you have three choices. In the dialog:

Editing Protocols	Top

As shown in Fundamental Relationships, a Protocol associates Plans with Products. The Edit Protocol Page is where you make these associations.

Specify Protocol management details.

In the Product Plan Combinations detail you can associate testing Plans with Products.

Click "Add Product". then choose the desired Product from the Lookup page. Note that you can locate Products by Search or Query (you may have more or less Queries than shown in the example below).

For the Container Type, choose the container you will be using for this Product. Define the size and the unit of the Container. Container is needed to get the material for the pull tasks.

Based on the size of the selected Container Type the total number of Containers (needed for the pull tasks) is derived during inventory calculation (see Stability Inventory Calculation).

Container Tracking lets you determine how you want to track the Containers in their respective Storage Locations. Use of this feature requires familiarity with Trackable Items and Storage Locations. If we now divert to an explanation of these arcane concepts, we may never finish explaining Protocols.

So, suffice it to say that...

When you create a Study Request, the Plan Form on the Study Page contains a Storage and Quantities section where you can assign the single or multiple Trackable Items to a Storage Location.

The Type of Pull (Product from container) permitted. Choose Whole Pull (for each distinct laboratory), Partial Pull or Partial Distribution.

The total number of containers is determined by dividing the total raw material by the container size.  See Calculations Based on Pull Type for information about how container information is calculated based on Pull Type.

This associates a Plan with the Product you have added above.

Click Add Plan.

In the dialog:

To associate the Product with the Plan, click "Add Product/Plan". If the Plan has already been built and contains Pull Sample Tasks, the display expands to show information regarding pull quantities (also note that the total pull quantity of the Plan is shown in the header). Here's an example:

The total number of containers needed for each Plan is auto-calculated and displayed, provided that the auto-calculation flag is checked in the "Add Condition" window during Plan creation.

Upon changing properties like the container size (in Container Type dropdown), or changing the Pull Type, the Protocol recalculates the recommended number of containers for each Product/Plan combination.

Before changing properties
After changing properties

Clicking the icon to the right of the calculated number of containers opens the Inventory Calculation Report showing how the number of containers is calculated.

An example of the Inventory Report is shown below. For details, see Stability Inventory Calculation.

Calculations based on Pull Type

Use the following example to compare the different calculations performed, based on the Pull Type selected.

The Plan requires three tests, each requires 50 ml, each within a different Lab.		The available Container Type is the same for each, 100 ml bottle. Note the change in required number of containers depending on the Pull Type.

The Inventory Report (click the icon) provides details about the calculations performed.

Whole Pull	Partial Pull	Partial Distribution

If you want to disassociate a Product from a Plan, click "Remove Product/Plan" (un-check).

Protocol Versioning	Top

Protocol Versions

Protocols are versioned:

On the Protocol List Page, New Version loads the Edit Protocol Page for that Protocol and increments the Version number. In the example below, we requested a New Version of the Provisional protocol02.

After exiting the Edit Protocol Page, we returned to the Protocol List Page. The Version number of protocol02 was incremented from 1 to 2.

If you create a new Version of a Current Protocol, the new Version is Provisional.

To approve Protocol Versions, use Approve Version in the Toolbar of the Edit Protocol Page.

Only Provisional versions can be approved. Choose the version, then click Approve Version. Operation is as follows:

Approve Version opens the Electronic Signature Page, which prompts for a password and reason.