View the details of a trial - Ingestion Complete status

You can view the details of a Trial in Planning that has a status of Ingestion Complete.

To view the details of a Trial in Planning with a status of Ingestion Complete:

1. 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.
2. In the Trials in Planning list view, in the Status column, find a study with a status of Ingestion Complete, and in the Study column, select the identifier of the trial you want to view the details for. The [Trial Name] panel opens that shows the operational parameters from the ingested protocol. For example:
   
   

   

   
   

   Note:

   If any required information is missing from the uploaded protocol, a detailed message appears at the top of the panel.
3. 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
   • 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, and Number of visits per subject/patient.
     • Treatment—Provide the Duration, Unit, Number of visits per subject/patient, Cycle Duration, Unit, and Number of cycles.
     • Follow-up—Provide the Duration, Unit, 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.
4. Do one of the following:
   • Select the X at the top right to close the panel without saving any changes.
   • Select Save changes to save any updates you made to the parameters.
   • Select Generate plans to generate the trial plans.