Setting Up Clinical Protocols

You can associate multiple protocols with a program. When you create a protocol record, you can also add extra information about the protocol, such as financial information, central laboratory information, and so on.

This task is a step in "Process of Managing Clinical Trials".

To set up a clinical protocol  

1. Navigate to the Administration - Clinical screen, then the Protocol List view.

2. In the Protocol list, create a new record and complete the necessary fields.

   Some fields are described in the following table.

   Field	Comments
   Protocol #	Type an identifying number for the protocol.
   Title	Type a descriptive title for the protocol.
   Status	Select the status of the protocol, such as Planned, In Progress, or Completed.
   Program	Select the name of the program for the clinical trial.
   Product	Select the product for the clinical trial. You can select only the products that are associated with the clinical program, through the Application field in the Program List view, in the Clinical Product and Indication dialog box. For more information about creating a clinical program, see "Creating Clinical Programs".
   Phase	Select the phase of clinical trial, such as Phase I, II, or III.
   Objective	Type the objective for the clinical trial.
   Sponsor	Select the clinical trial sponsor.
   Design	Select the type of study.
   Regions Required	Select this field to indicate the sites for this protocol must belong to a region. For information about regions, see "Setting Up Clinical Regions". When you select this field, you cannot create sites directly under protocols. You must create regions first, and then create sites that are associated with regions.
   Type	Select the purpose of the protocol.
   Team	Select the team members who need access to the protocol, such as the study manager and others who monitor the clinical trial. For more information, see Step 3.
   Approval Date	Select the date that the regulatory authority approves the protocol.
   Currency Code	Select the currency that is used to display the payments, costs, and budgets for the protocol. The default value is USD (United States dollars). Note: You must specify the currency code for the protocol.
   Planned Start Date	Select the planned start date for the study.
   Exchange Date	Select the date that determines the exchange rate of the currency. By default, the exchange date for the protocol is the date that you create the protocol.
   Planned End Date	Select the planned end date for the study.
   Withholding Amount	Type the amount to withhold from each of the payments to the investigators until the trial is complete. You can overwrite this value at the region and site levels.
   Actual Start Date	Select the date that the study begins.
   # Planned Sites	Type the number of planned sites for the protocol.
   # Planned Subjects	Type the number of planned subjects for the protocol.
   Withholding %	Type the percentage to withhold from each of the payments to the investigators until the trial is complete. You can overwrite this value at the region and site levels.
   Actual End Date	Select the date that the study concludes.

   
   

3. To add team members to the protocol, click the select button in the Team field to open the Team dialog box, and complete the following steps:

   1. Move the record for an available team member to the list of selected team members.

   2. Click Position Rolldown.

      Multi-selected team members are added to the protocol as well as to all regions and sites belonging to the protocol.

   3. Click OK.

      Each time a member is added to the team of a protocol, a tracking record is created in the Team History view with a proper start date for this tracking record. For more information, see "About Automatically Assigning Team Members to a Protocol Using the Position Rolldown Button".

      If you remove a member from the team of a protocol, then the end date of this record is automatically populated. For more information, see "About Removing Team Members From the Team of a Protocol".

4. Drill down on the protocol number field, and navigate to the More Info view to add more information.

   Some fields are described in the following table.

   Field	Comments
   Central Lab	Select the name of the laboratory associated with the study. You create this name in the Accounts screen.
   CRO	Select the name of the clinical research organization that sponsors the trial. You create this name in the Accounts screen.

   
   

5. Navigate to the Team History view to view the details of the team member that is automatically added to the protocol in Step 3.

   From the Team History view you can administer and track team members who work on the protocol. This view also provides details about the role as well as the start and end dates. To administer and track the history of team members who work on a protocol and to determine their role, see "Tracking and Revising Team Assignment History".