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Comment: Clarified checkout step.

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  1. Select a trial to validate by following the instructions in Selecting Trials that Require Validation. The Trial Identification page displays the trial details.
  2. On the Trial Identification page, check out the trial. For instructions,

    see

    refer to Checking In and Checking Out Trials. (This checkout step is optional for Super Abstractors.)

  3. On the Validation menu, click Trial Related Documents.
    The Trial Related Documents page appears.

    Trial Related Documents page

    Note
    titleSubmit a participating sites document for multi-site trials

    You must submit a participating sites document for a multi-site trial if the participating sites data are not included in the protocol document.

  4. Do one of the following to continue:
    • To add a new document, click Add and follow the instructions provided in Adding Documents.
    • To modify or replace an existing document, click the Edit icon and follow the instructions provided in Editing and Replacing Documents.
    • To delete a document other than a Protocol or IRB Approval document, click the Delete icon in the Delete column and follow the instructions provided in Deleting Documents.

      Note
      titleDocument modification rules

      You can add, edit, or delete only those documents that are not required. You only can replace the required ones.

  5. If you made any changes, click Save.