Edit Studies

To edit studies, follow the steps below.

  1. Click on the check box next to the name of the study.
  2. Click on the ‘Edit’ button from the top main menu.
  3. Make any necessary changes to the Study Details by expanding the following sections.
  4. General Information:
    1. Protocol Number
    2. Study Name
    3. Sponsor
    4. Primary Program
    5. Virtual Study
    6. Study Number
    7. Additional Program(s)
    8. Study State
    9. Products

  5. Protocol Information

    1. Protocol Title*
    2. Protocol Summary
    3. Indications
    4. Phase*
    5. Types
    6. Mechanisms
    7. Objectives
    8. Designs*

  6. Project Management
    1. Status
    2. Status Date
    3. Status Notes
    4. Recently Completed Milestone
    5. Projected Start Date
    6. Projected End Date
    7. Actual End Date
    8. Owner
    9. Database Lock Date
    10. Recruitment Months
    11. Site Recruitment Deadline
    12. Subject Recruitment Deadline

  7. Subject and Recruitment
    1. # Planned Trial Sites
    2. 1st Site Activated
    3. # Planned Subjects Entered Trial
    4. # Planned Subjects Entered Treatment
    5. # Planned Subjects Completed Treatment
    6. Actual Screened
    7. Actual Enrolled
    8. Actual Screen Failed
    9. Actual Completed.

Informed Consent

Add Informed Consent

To add informed consent, follow the steps below

  1. Click on the +Add button within the Informed Consent section.

  2. Enter the Name and Effective Date into the respective fields.
  3. Click on the Save button.

Delete Informed Consent

To delete an informed consent, follow the steps below.

  1. Select a record from the Informed Consent section to delete
  2. Click on the Delete button.
  3. On the confirmation popup, click on the Delete button.m

Partner Information

To make edits to the Partner Information section, follow the steps below.

  1. Expand the Partner Information section on the Study Details screen.
  2. Add Monitoring Partner, Data Management Partner, and Lab Handling Partner from the available dropdown options.

Additional Information

The Additional Information section displays the custom fields configured via Settings > Fields > Studies. The displayed fields vary based on the configurations set in the Settings section.

Close Study

The Close Study Section enables users to close a study when it is at the end of the life cycle.

  1. Click the ‘Save’ button for the changes to apply.