Working with Study Data

Access reports, dashboards, and analytics to maintain compliance

Providing Signatures

Note Only available when turned on by your study sponsor/CRO.

This feature allows site users with the Investigator role to review and sign survey data to endorse it is complete and accurate.

Viewing Survey Signature Statuses

You can view participant signature status information by completing the following steps:

  1. On the participant list, select the Action menu (…) and select Survey Signatures. The following statuses may be displayed:
    • Not Applicable: The participant has no surveys that require a signature.
    • Partial: Some surveys require a signature. The number of surveys reviewed and total surveys requiring signature are shown.
    • Complete: All surveys are signed.
  2. Select a cell in the Survey Signatures column to view the surveys for that participant.

Signing a Single Survey

  1. Open a participant record.
  2. From a participant’s record, view the All Past Surveys list.
  3. Filter the Signature Status column to show Needs Signature.
  4. Select the survey name to open and review the completed survey.
  5. Select the Action menu (…) and select Apply Signature.
  6. Review the signature statement, and select Continue.
  7. Sign using your eCOA login information.

Signing Multiple Surveys

You can apply signatures to up to 50 surveys at one time.

  1. From a participant’s record, view the All Past Surveys list.
  2. Filter the Signature Status column to show Needs Signature.
  3. Select the Action menu (…) and select Apply Signature.
  4. Select the checkbox next to each survey you reviewed, or select the checkbox in the header to select all surveys on the current page.
  5. Select Sign Surveys.
  6. Sign using your eCOA login information.

Actions that Break Signatures

If site staff changes a survey that has already been signed, the system responds in the following ways:

  1. Site Staff Change Data: The signature is broken, and the survey is returned to the Needs Signature status. You must review and sign the survey again.
  2. Site Staff Remove a Survey: The signature is broken, and a signature is no longer required. If the survey is restored later, the survey is returned to the Needs Signature status, and you must review and sign the survey again.
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