Review the uploaded trial protocol and generate the trial plans

After you upload a trial protocol, you can review it and, if needed, add or modify some of the trial parameters.

You can review and edit protocols with a status of Ingestion Complete. You can review the trial objectives, study design, population characteristics, assessment plan, and optional planning parameters.

To review an uploaded trial protocol and generate the trial plans:

1. Ensure that you have uploaded a trial protocol.
2. Open the list of trials you can access, and filter the list for Trials in Planning, as described in View the list of trials you can access.
3. In the Trials list, in the Status column, find a trial with a status of Ingestion Complete, and in the Study column, select the identifier of the trial you want to see the protocol details for. The [Protocol Name] panel opens. For example:
   
   

   

   
   
4. Expand each section and provide updates as needed.
   • Study Overview—Shows the following details:
     • Protocol ID
     • Study Type—Select Interventional or Observational.
     • Study Title
     • Study Acronym
     • Phase
     • Product(s)
     • Indications and Therapeutic Areas—Add or remove the indications and therapeutic areas as needed.
   • Objectives & Endpoints—Shows the following details for each objective:
     • Type
     • Objective
     • Endpoint(s)
   • Population Characteristics—Add and remove inclusion and exclusion criteria as needed.
     • Target sample size—Update as needed.
     • Target locations
     • Inclusion Criteria
     • Exclusion Criteria
   • Study Design—Shows the following details:
     • Interventional Model
     • Number of treatment arms
     • Number of planned subjects per treatment
   • Assessment Plan—Shows the following details:
     • Screening—Provide the Duration, Unit (Days, Weeks, or Months), and the Number of visits per subject/patient.
     • Treatment—Provide the:
       • Duration, Unit (Days, Weeks, or Months), and the Number of visits per subject/patient
       • Cycle Duration, Unit (Days, Weeks, or Months), and Number of cycles.
     • Follow-up—Provide the Duration, Unit (Days, Weeks, or Months), and Number of visits per subject/patient.
   • Specify Agent Constraints—Shows the following details:
     • Study Duration from Project Start—Enter a value for the expected study duration, and in the adjacent Units drop-down menu select Days, Weeks, Months, or Years.
     • Budget ($M)—Enter a value and in the adjacent Currency drop-down menu select EUR or USD. The currency value you select is used for all monetary amounts that appear in the interface.
     • Include specific sites—Select Add Sites to open the Add Sites panel. Select the check box next to each site you want to add, and select Apply Changes. The Add Sites panel closes and the [Trial Name] panel becomes active again.
5. Select Save changes. The Save changes button is disabled by default until you make changes.
6. To generate the trial plans, select Generate Plans . The Generating plans for [Trial Name] panel opens. A progress bar shows the status as Life Sciences AI Agents generates the trial plan recommendations.

   Note:

   After Life Sciences AI Agents generates the trial plans, you can review and compare the three plan recommendations. If necessary, you can adjust some of the trial plan details. For more information, see Review the AI-generated trial plans.