How to create and share a protocol for a project?

Detailed Instructions for Central Management of a Project Protocol

Managing a protocol effectively involves a comprehensive understanding of its lifecycle. This guide provides step-by-step instructions for handling protocols in a clinical project, focusing on adding multiple versions, archiving, cloning, sharing, overriding drafts, and publishing protocols.

1. Adding Multiple Versions of a Protocol to a project

The system supports the creation of multiple protocol versions for a single project. This is particularly useful for iterations and updates during a trial's lifecycle.

1. Navigate to the Protocol tab under the selected project.
2. Click on the + (Add) button to create a new protocol version.
3. Fill out the required fields in the modal:
   • Version Name: Enter a unique name for the version.
   • ICF Version: Specify the corresponding informed consent form version if applicable.
   • Description: Provide details about the changes or purpose of this version.
4. Confirm by clicking Save.
5. The new protocol version will appear in the list with the Draft status, indicating it is not yet active or shared.
   
   

2. Archiving a Protocol

Archiving a protocol removes it from the active list, ensuring it cannot be shared or used further. However, archived protocols remain visible for reference.

1. Locate the protocol you wish to archive in the protocol list.
2. Click the three-dot menu next to the protocol name.
3. Select Archive.
4. A confirmation modal will appear. Review the message, which states the protocol cannot be shared again.
5. Click Archive to finalize.
6. The protocol's status will update to Archived, and it will no longer be available for editing or sharing.
   

3. Cloning a Protocol

Cloning allows you to create a new protocol version based on an existing one. This is helpful when minor changes are needed without starting from scratch.

1. Identify the protocol you want to clone in the list.
2. Click the three-dot menu and select Clone.
3. A modal will appear, prompting you to enter the following information:
   • Version Name: Assign a name to the cloned version.
   • ICF Version: Specify the corresponding ICF version, if applicable.
   • Description: Explain the reason for cloning or describe the changes in this version.
4. After entering the details, click Save.
5. The cloned protocol will appear as a new entry with the Draft status, ready for further modifications.
   
   

4. Sharing a Protocol

Sharing a protocol allows you to distribute it to specific trials/sites within the project. This ensures controlled access to the protocol version.

1. Click on the three-dot menu of the protocol you want to share.
2. Select Share.
3. A modal will display all available trials  associated with the project.
4. Select the trials or sites where you want to share the protocol.
5. Confirm by clicking Done, and the protocol will be shared with the selected locations.
   

5. Overriding Draft Protocols

When sharing a protocol to a trial/site with an existing draft protocol, the system allows you to override the draft. This ensures consistency and prevents conflicting versions.

1. During the Share process, if a draft protocol already exists, a warning modal will appear.
2. Review the details of the existing draft.
3. Click Override Drafts to replace the existing draft with the protocol being shared.
4. The draft at the trial/site will be updated to match the shared protocol.
   

6. Publishing a Protocol

Publishing a protocol makes it active and deployable across trial/sites. Only published protocols can be marked as active.

1. Select the protocol version you wish to publish from the list.
2. Click the three-dot menu and select Publish.
3. A confirmation modal will appear, indicating the protocol will become active and replace the current version at all linked sites.
4. Confirm by clicking Publish.
5. The protocol's status will update to Active.
   
   

Notes and Best Practices

• Draft Status: Draft project protocols are editable but not deployable. Ensure all changes are finalized before publishing.
• Version Tracking: Use clear version names and descriptions to avoid confusion between multiple protocol versions.
• Archiving: Only archive protocols when they are no longer needed for reference or use.
• Cloning: Use the cloning feature to save time when creating similar protocols.
• Share with Care: Double-check trial and site selections when sharing protocols to avoid unintentional distribution.
• IMPORTANT: Sites are restricted to update protocol shared by project!

By following these steps, you can ensure efficient and organized management of protocols throughout the lifecycle of a clinical project.