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3 Working with Protocols (Sponsor)

This chapter contains the following topics:

• Protocol Characteristics

• Protocol Status

• Creating a New Protocol

• Editing an Existing Protocol

• Managing Protocol Team Members

• Defining Eligibility Criteria

• Executing Eligibility Criteria

• Designating Protocol as Recruitment Ready

• Creating Recruitment Request

• Initiating Recruitment

• Viewing Recruitment Results

• Stopping Recruitment

• Closing a Protocol

• Deleting a Protocol

3.1 Protocol Characteristics

Following are the characteristics of a protocol:

Table 3-1 Protocol Characteristics

Attribute	Description
Title	The protocol title. This is unique within a company.
Purpose	Brief summary on the goals, objective or purpose of the study.
Description	Detailed information on the study (goals, methodology, key details).
Contact Information	Information for the person(s) to contact regarding the study.
Population Summary	Summary note about the protocol population to be recruited.
Recruitment Notes	Inclusion or exclusion narrative that cannot be structured with the criteria builder.
Protocol Number	Sponsor's unique study ID.
Phase	Most clinical trials are designated as phase I, II, III, or IV, based on the type of questions that study is seeking to answer.
NCT # (CT.gov Id)	The national identifier for the study (from the national clinical trials registry).
Target Population	Eligibility instructions that may not be structured in the criteria (to assist Partners with recruitment nuances).
Target Recruitment Start Date	Target date for starting the recruitment process for the actual study.
Target Recruitment End Date	Target date for completing the recruitment for the actual study.
Accept Healthy Volunteers?	Indicates whether or not healthy volunteers can be accepted into the study.

3.2 Protocol Status

Each Protocol has a status, which contributes to determining the functions available. As you progress through the business processes, the protocol status changes. The following table identifies the range of status values for a protocol and a patient, across the protocol life cycle:

Table 3-2 Status Values for a Protocol and a Patient

Business Process	Protocol Status
Create New Protocol	New
Execute Protocol Criteria	Feasibility
Feasibility Complete	Recruitment Ready
Delete Protocol	Deleted
Shared for Recruitment	Validating
Initiate Recruitment	Recruiting
Stop Recruitment	Done

3.3 Creating a New Protocol

Perform the following steps to create a new protocol:

1. In the My Protocols panel of the company home page, click Create Protocol. The Create Protocol screen is displayed.

   Figure 3-1 Create Protocol

   
   Description of "Figure 3-1 Create Protocol"
   
   

2. The Create Protocol screen includes the following fields and tabs:

   • Partner

   • Protocol Number

   • Phase

   • (nct)Number

   • Target Population

   • Target Recruitment Start Date

   • Target Recruitment End Date

   • Title

   • Purpose

   • Description

   • Contact Information

   • Population Summary

   • Recruitment Notes

   • Accept Healthy volunteers?

     Note:

     Fields marked with * are mandatory.

   Figure 3-2 Protocol Details

   
   Description of "Figure 3-2 Protocol Details"
   
   

3. Click Create.

4. The protocol details are displayed and the home page is updated with the new protocol. This protocol will have a default status Validation.

   Note:

   By default, the user who created the protocol is added to team as LEAD.

   Figure 3-3 New Protocol

   
   Description of "Figure 3-3 New Protocol"
   
   

3.4 Editing an Existing Protocol

Perform the following steps to edit a protocol:

1. In the My Protocols panel of the company home page, click the protocol you want to edit. The protocol details are displayed.

2. In the Protocol Details panel, click Actions > Edit Protocol.

   Figure 3-4 Edit Protocol Attributes

   
   Description of "Figure 3-4 Edit Protocol Attributes"
   
   

3. The protocol details are displayed.

   Figure 3-5 Edit Protocol Details

   
   Description of "Figure 3-5 Edit Protocol Details"
   
   

4. You can add data to attributes previously null, delete or revise data from attributes previously populated. After editing the relevant details, click Update.

5. The new protocol with edited details will be displayed.

   Note:

   Multiple users cannot edit the same protocol at the same time.

3.5 Managing Protocol Team Members

Depending on your role, you can designate additional users from the same organization as team members, providing access to the same protocol. Protocol Team members can:

• view the protocol and eligibility criteria definitions

• edit the protocol

• execute the eligibility criteria to view counts of patients

• edit the protocol's eligibility criteria

3.5.1 Adding Team Members

Perform the following steps to manage protocol team members:

1. In the My Protocols panel of the company home page, click the protocol you wish to edit. The protocol details are displayed.

   Figure 3-6 Protocol Details

   
   Description of "Figure 3-6 Protocol Details"
   
   

2. In the Team panel, click Manage. The following screen is displayed, with users currently assigned to that protocol. Initially, only the user who created the protocol will be displayed.

   Note:

   By default, the user who created the protocol is the lead. You can change this in the following screen.

   Figure 3-7 Select Team

   
   Description of "Figure 3-7 Select Team"
   
   

3. You can add (assign) one or more other users to the protocol team and also select their roles. You can search for users based on the user login name.

4. Click Save to confirm your changes. The system updates protocol and displays each team member's name and role as part of the protocol's summary.

3.5.2 Removing Team Members

Perform the following steps to remove team members:

1. In the My Protocols panel of the company home page, click the protocol you wish to edit. The protocol details are displayed.

   Figure 3-8 Protocol Details

   
   Description of "Figure 3-8 Protocol Details"
   
   

2. In the Team panel, click Manage. The following screen is displayed, with users currently assigned to that protocol.

   Figure 3-9 Edit Team Members

   
   Description of "Figure 3-9 Edit Team Members"
   
   

3. Select the Delete check box for users you want to remove.

4. Click Save to confirm your changes. The system updates protocol and displays each team member's name and role as part of the protocol's summary.

3.6 Defining Eligibility Criteria

You can define inclusion or exclusion statements as a logical definition of the patients to be searched (matched) for the protocol.

1. In the My Protocols panel of the company home page, click the protocol you wish to edit. The protocol details are displayed.

2. Click Criteria on the top right.

   Figure 3-10 Create Criteria

   
   Description of "Figure 3-10 Create Criteria"
   
   

3. In the New Criterion panel, enter your criteria. You can do this either by typing into the text box or selecting criteria from the pop up list.

   Figure 3-11 Select Criteria

   
   Description of "Figure 3-11 Select Criteria"
   
   

   Note:

   All dimensions populated are provider-specific. The list displays only those values supported by the specific provider.

4. Click Submit or press Ctrl+Enter on your keyboard. The criteria is updated in the Criteria Set panel as shown below.

   Figure 3-12 Criteria Set Added

   
   Description of "Figure 3-12 Criteria Set Added"
   
   

3.6.1 Editing Existing Eligibility Criteria

Perform the following steps to edit the existing set of eligibility criteria:

1. In the My Protocols panel of the company home page, click the protocol you wish to edit. The protocol details are displayed.

2. Click Criteria on the top right.

   Figure 3-13 Criteria Set Added

   
   Description of "Figure 3-13 Criteria Set Added"
   
   

3. You can now:

   • add to the existing eligibility criteria

   • select a previously defined criterion and either edit or delete it

   • edit (change) how the selected criteria are grouped (revise the AND,OR groupings)

   Use the criteria action bar (Figure 3-14) to work on selected criterion. Buttons include (pause, resume) to ignore or permit during query, delete, edit and arrows to move selected criterion to a new position.

   Figure 3-14 Criteria Action Bar

   
   Description of "Figure 3-14 Criteria Action Bar"
   
   

4. The criteria is updated in the Criteria Set panel as shown below.

   Figure 3-15 Edited Criteria Set

   
   Description of "Figure 3-15 Edited Criteria Set"
   
   

3.6.2 Local Codes in Criteria Editor

You can edit criteria in the partner's local codes. You can access and select owned protocol with the role of validator or higher.

1. In the My Protocols panel of the company home page, click the protocol you wish to edit. The protocol details are displayed.

2. Click Criteria on the top right.

3. In the New Criterion panel, select a dimension such as Diagnosis to select codes.

   Figure 3-16 Select Dimension with Local Code

   
   Description of "Figure 3-16 Select Dimension with Local Code"
   
   

4. Select operator such as one of. A list of codes is displayed that are local to the selected partner.

   Figure 3-17 Select Operator

   
   Description of "Figure 3-17 Select Operator"
   
   

5. Select local code value.

   Figure 3-18 Select Local Code Value

   
   Description of "Figure 3-18 Select Local Code Value"
   
   

   You can select multiple codes by clicking Choose Many.... The Select Many window is displayed from where you can select multiple options. Once done, click Save to save your options and return to the criteria editor.

   Figure 3-19 Select Multiple Values

   
   Description of "Figure 3-19 Select Multiple Values"
   
   

6. Click Submit or press Ctrl+Enter on the keyboard to add criteria.

   Figure 3-20 Submit Criteria

   
   Description of "Figure 3-20 Submit Criteria"
   
   

3.6.3 Omics in Criteria Editor

For a protocol with access rights of validation or higher, the partner selected for protocol offers omics service to the sponsor.

1. In the My Protocols panel of the company home page, click the protocol you wish to edit. The protocol details are displayed.

2. Click Criteria on the top right.

3. Select Gene or Mutation.

   Figure 3-21 Select Dimension

   
   Description of "Figure 3-21 Select Dimension"
   
   

   Note:

   You can view these two options only if the provider offers omics.

4. The operators include is, is not or one of. Select from a common list of gene or mutation.

   Figure 3-22 Select Operator

   
   Description of "Figure 3-22 Select Operator"
   
   

5. Select the value.

   Figure 3-23 Select Value

   
   Description of "Figure 3-23 Select Value"
   
   

6. Click Submit or press Ctrl+Enter on the keyboard to add criteria.

   Figure 3-24 Submit Criteria

   
   Description of "Figure 3-24 Submit Criteria"
   
   

   Since these criteria are visible only if the provider offers them, you cannot add gene or mutation below the top level of inclusion or exclusion, or move them into a group.

3.7 Executing Eligibility Criteria

You can submit the protocol eligibility criteria to search for matching patients from each of the selected DM Partners. Each request is executed against each DM Partner's data, distinctly and the result is displayed as a count of patients. No detailed patient information is available or accessible. The purpose of this process is to gauge the feasibility of the protocol. The protocol status accordingly changes to Feasibility. In this process, you can:

• view count for each AND and OR grouping

• view a count for each independent criterion

• refresh the current counts to view an updated summary

You can execute criteria either from the criteria editor panel or from the Analysis panel.

3.7.1 Validating from the Criteria Editor

On creating and submitting valid criteria, the start validation button is enabled. Perform the following steps to execute eligibility criteria:

1. In the My Protocols panel of the company home page, click the protocol you wish to edit. The protocol details are displayed.

2. Click Criteria on the top right.

3. In the Validation Results for Partner panel, click Start Validation.

   Figure 3-25 Start Validation

   
   Description of "Figure 3-25 Start Validation"
   
   

4. The results are displayed for the partner. If criteria is removed, the Start Validation button is not available. After first validation, if valid criteria is entered, the Refresh Now button is displayed.

   Figure 3-26 Validation Results

   
   Description of "Figure 3-26 Validation Results"
   
   

3.7.2 Executing Criteria from the Analysis Panel

Perform the following steps to execute eligibility criteria:

1. In the My Protocols panel of the company home page, click the protocol you wish to edit. The protocol details are displayed.

2. Click Analysis on the top right. The Criteria Analysis screen is displayed.

   Figure 3-27 Criteria Analysis

   
   Description of "Figure 3-27 Criteria Analysis"
   
   

3. Click Start Analysis. The results of the analysis are displayed in the Analysis Results for Partner pane.

   Figure 3-28 Analysis Results

   
   Description of "Figure 3-28 Analysis Results"
   
   

   To run the analysis again and avail up-to-date information, click Refresh Now in the Analysis pane.

3.7.3 Cancelling the Query Request

You can select one or more query requests and cancel them before they complete. Perform the following steps to cancel an analysis:

1. In the My Protocols panel of the company home page, click the protocol you wish to edit. The protocol details are displayed.

   Figure 3-29 Protocol Details

   
   Description of "Figure 3-29 Protocol Details"
   
   

2. Click Analysis on the top right. The Criteria Analysis screen is displayed.

   Figure 3-30 Analysis Results

   
   Description of "Figure 3-30 Analysis Results"
   
   

3. Click Actions > Cancel Analysis.

   Figure 3-31 Criteria Analysis

   
   Description of "Figure 3-31 Criteria Analysis"
   
   

4. A confirmation screen is displayed. Click Yes.

5. All analysis for that protocol will be cancelled.

   Figure 3-32 Analysis Requests Cancelled

   
   Description of "Figure 3-32 Analysis Requests Cancelled"
   
   

3.8 Designating Protocol as Recruitment Ready

Once the protocol team is satisfied with the protocol's definition and has performed sufficient feasibility activity, one of the team member's is expected to promote the protocol to a new status, indicating that the feasibility activity is complete. The team's organization may have an internal review (outside the team) to approve the protocol before it is submitted to an outside organization as a recruitment request.

Note:

The act of completing the feasibility is distinct from submitting the protocol as a recruitment request to a partner.

Perform the following steps to share a recruitment request:

1. Select the protocol you want to share.

2. In the Protocol Details panel, click Actions > Start Sharing.

   Figure 3-33 Sharing Protocol

   
   Description of "Figure 3-33 Sharing Protocol"
   
   

3. A confirmation screen is displayed. Click Yes.

4. The protocol status changes to Ready to Share and the Recruitment Status panel will have the option to start recruiting or qualifying.

   Figure 3-34 Ready to Share

   
   Description of "Figure 3-34 Ready to Share"
   
   

3.9 Creating Recruitment Request

The protocol team leader has permission to send a protocol to one or more DM Partners as a recruitment request. Once the request is created, the protocol becomes accessible (visible) to the selected partners. It is possible that the partners selected for recruitment are different from the partners selected during feasibility.

Perform the following steps to create a recruitment request:

1. Select the protocol you want to share.

2. In the Partner Status panel, click Actions > Start Qualifying.

   Figure 3-35 Ready to Share

   
   Description of "Figure 3-35 Ready to Share"
   
   

3. The partner status changes to Shared for Qualification.

   Figure 3-36 Shared for Qualification

   
   Description of "Figure 3-36 Shared for Qualification"
   
   

3.10 Initiating Recruitment

Once the sponsor is satisfied with the count of qualified patients, the protocol team leader can initiate recruitment. Once the sponsor updates the protocol status for one or more DM Partner(s), the partner can view the updated status of their recruitment request and move to the next step in the recruitment process.

Perform the following steps to initiate recruitment:

1. Select the protocol for which you want to initiate recruitment.

   Figure 3-37 Protocol Details

   
   Description of "Figure 3-37 Protocol Details"
   
   

2. In the Partner Status panel, click Actions > Start Enrolling.

   Figure 3-38 Initiate Enrollment

   
   Description of "Figure 3-38 Initiate Enrollment"
   
   

3. The protocol status changes to Enrollment and partner status changes to Enrollment. Enrollment will be initiated with the DM partners.

   Figure 3-39 Enrollment Initiated

   
   Description of "Figure 3-39 Enrollment Initiated"
   
   

3.11 Viewing Recruitment Results

The Protocol Team (Sponsor organization) can view updates to counts, from across all Partners in the Recruitment results by Partner panel. Perform the following steps to view recruitment results:

1. Select the protocol for which you want to view recruitment results.

2. The recruitment results are visible in the Recruitment results by Partner panel.

   Figure 3-40 Recruitment Results by Partner

   
   Description of "Figure 3-40 Recruitment Results by Partner"
   
   

3. In the Partner Status panel, click Actions > Refresh Patient Count.

   Figure 3-41 Refresh Patient Count

   
   Description of "Figure 3-41 Refresh Patient Count"
   
   

4. You can view the results in the Recruitment results by Partner panel.

   Figure 3-42 Refreshed Results

   
   Description of "Figure 3-42 Refreshed Results"
   
   

3.12 Stopping Recruitment

Once recruitment has identified a sufficient number of Qualified or Enrolled patients, the sponsor may determine that no further recruitment activity is necessary. At this point, you can stop recruitment, for a particular DM Partner. The status is updated, and the recurring execution of the protocol's eligibility criteria is stopped.

Perform the following steps to stop recruitment:

1. Select the protocol for which you want to stop recruitment.

   Note:

   The protocol should have the status Enrollment.

2. In the partner status panel, click Actions > Done Recruiting.

   Figure 3-43 Recruiting Done

   
   Description of "Figure 3-43 Recruiting Done"
   
   

3. The partner status changes to Recruitment Done and the protocol status changes to Stopped Sharing.

   Figure 3-44 Recruitment Done

   
   Description of "Figure 3-44 Recruitment Done"
   
   

3.13 Closing a Protocol

Perform the following steps to close a protocol:

1. Select the protocol you want to close.

   Note:

   The protocol should have a status of either New, Feasibility, Ready to share or Stopped sharing.

2. In the Protocol details panel, click Actions > Close Protocol.

   Figure 3-45 Close Protocol

   
   Description of "Figure 3-45 Close Protocol"
   
   

3. A confirmation screen is displayed. Click Yes.

4. The protocol will be closed and its status is changed to closed.

   Figure 3-46 Status Closed

   
   Description of "Figure 3-46 Status Closed"
   
   

To reopen a closed protocol, in the protocol details panel, click Open Protocol.

Figure 3-47 Open Protocol

Description of "Figure 3-47 Open Protocol"

3.14 Deleting a Protocol

Prior to being shared for recruitment, the sponsor may make an internal decision to discontinue the protocol. In this situation, a protocol team lead will delete the protocol, which changes the state from Active to Inactive.

Perform the following steps to delete a protocol:

1. Select the protocol you want to delete. You can only delete protocols that have not been shared.

2. In the Protocol Details panel, click Actions > Delete Protocol.

   Figure 3-48 Delete Protocol

   
   Description of "Figure 3-48 Delete Protocol"
   
   

3. Click Yes to confirm your choice.

4. The protocol status will be updated to deleted and is no longer displayed in your list of available protocols.