How to create a protocol for a project?

1. Open: Protocol

   Within your selected project, click on the “Protocol” tab located on the left side of the screen.

   This will display a list of protocol versions associated with your project.

2. To create a new protocol version:

   • Click on the plus (+) symbol located in the top right corner of the screen.
   • A window titled “New protocol version” will appear.
   • Enter the Protocol version name and the ICF (Informed Consent Form) version if applicable.
   • Click Create to proceed.
     
     
     

3. Building your protocol:

   You will now be able to add and configure various components of the protocol:

   • Add Visit: Click on the plus icon next to “Visit.” A new visit block will be added, and you can click the pencil icon to edit the visit details, such as visit type, visit interval, and tolerance level.
   • Assign Procedures: Assign procedures to each visit by marking the circle icon in the visit block.
   • Add Arms: Right-click on the visit name to add multiple arms to your study. New arms will appear below the main path.
     
     
     
     

4. Save and manage the protocol version:

   Once you’ve added all necessary elements, click Save draft to save your protocol version.

   You can choose to Publish, Validate, or continue editing as required.

Important Note:

1. ⚠️ Protocol Statuses - Active and Draft:

   • Draft Protocol: When a protocol is in draft status, it will not be published to the level of assigned trials. You can continue to edit the protocol until it's ready for use.
   • Active Protocol: Once the protocol is marked as active, it will be published at the trial level in the draft status. It is then required to verify the protocol at the trial level, introduce any necessary adjustments for the site, and proceed with publishing the protocol for use.