Upload a different version of a trial protocol

You can upload a different version of the same draft or final protocol or protocol synopsis after the initial upload, if necessary. You can upload multiple versions of the same protocol or synopsis.

Note:

For more information on uploading the original version of a trial protocol or synopsis, see Upload a trial protocol.

To upload a new version of the same trial protocol or synopsis:

1. Select the Trials tab at the bottom of the Life Sciences AI Agents Trials interface window. The Trials list opens. The last view you selected opens (All Trials, Ongoing Trials, Other Trials, or Trials in Planning). For example:
   
   

   

   
   
2. In the Status column, find the trial with a status of Ingestion Complete that you want to upload a new protocol version for, and at the top right, select Upload Protocol. The Upload Protocol option is available from any Trials list view (All Trials, Ongoing Trials, Other Trials, or Trials in Planning). The Upload Protocol panel opens.
   
   

   

   
   
3. In the Upload Protocol panel, add the updated protocol or synopsis file you want to upload.

   You can navigate to the file or drag and drop the file into the block at the top of the panel. The protocol must be in PDF or DOCX format and be 50 MB or less.

   Note:

   A progress bar opens and shows the status of the protocol extraction (also called ingesting) process. This step may take some time.
4. In the Project Start Date field, use the Calendar icon to select a date, or enter a date in MM/DD/YYYY format for the date you want costing to begin. If you do not enter a date, the field defaults to the current date.
5. When the ingestion process completes, if the new upload contains the same planning-specific elements and key study information, such as Study Type, Protocol ID, Phase, Therapeutic Area(s), Indication(s), and Product(s), an Existing trial detected message appears in the Upload Protocol panel. For example:

   
   
   

6. Scroll down and select the right arrow next to each heading in the panel to expand the section so that you can view and update any of the editable parameters as needed.

   Note:

   The parameters are populated with information from the previous version of the protocol or synopsis that you uploaded.
   • 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—Shows the following details:
     • Target sample size
     • Target locations—Required.
     • Inclusion Criteria—Required.
     • Exclusion Criteria—Required.
   • Study Design—Shows the following details:
     • Interventional Model
     • Number of treatment arms
     • Number of planned subjects per treatment arm
   • 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.
7. Select Save Changes.
8. Select Create Version [Number] to create a new version of the protocol.

   From the drop-down menu at the top of the [Trial Name] panel, you can view all versions of the protocol.