Review & Sign-off Process

Record Locking & Signoff

The following represents one possible approach to record locking and sign-off for Health Canada regulated clinical trials hosted in REDCap.

Detailed instructions are included at the bottom of this page.

Summary

The signature of the investigator or authorised member of the investigator’s staff is considered as the documented confirmation that the data entered by the study staff and submitted to the Sponsor are attributable, legible, original, accurate, complete and contemporaneous (ALCOA).

Once a site, or a significant group of participants within a site, has completed the study, records must be locked and signed. Records will be locked by the study data manager. Once locked, the entire record may be signed by the site investigator (QI) or designated member of the study team.

Locking

All records require locking, but only enrolled participants require signing.
Data management processes should be complete for the target records. This means:
- No outstanding queries
- All AEs are coded
- All logged AEs, protocol deviations, and unanticipated problems are individually signed by the QI.
- All instruments should be marked as complete with one exception. Instruments that have been signed by the QI despite not being shown complete need not be edited and resigned.
Once these conditions are met, the investigator signoff form is locked by the data manager, then the entire record is locked. (For screen failures the record is locked, but not the sign-off form, since these records do not require sign-off).

Investigator Signoff

The QI signs the entire participant record by applying their REDCap electronic signature to the Investigator Signoff form in the locked record. Detailed instructions follow at the end of this document.

For some studies it may be appropriate for a designated member of the study team to sign off on the records. This subject is discussed on this page.

Subsequent Data Changes

After locking and signing, if data needs to be changed, the following process should be followed.

Study coordinator unlocks the entire record, and then the signoff form. Unlocking the signoff form clears the signature on the form.
The coordinator applies changes to the relevant instrument. In the case of AEs, PDs, etc, the instrument may need resigning as per existing procedure.
The QI then locks/resigns the form.
After locking the form the QI locks the entire record.

Investigator Signing Instructions

Log in to REDCap as usual
Select Record Status Dashboard from the left hand menu.

This will display your records.

3. Depending on the study your data manager may have created a dashboard that displays only the enrolled participants.

4. Click All status types

This will display the lock status for individual instruments next to the status indicator for each instrument. It will also display the record lock status next to the Patient Study Number.

Instruments that are already signed will display a green shield and need not be resigned unless the participant's data has changed.

5. From here you have two options. You can drill into the participant record by clicking on the Patient Study Number this will allow you to review the data for the entire record prior to signing the record. Alternatively, you can scroll to the right of the dashboard where you will see the status indicator for the Investigator Signoff Instrument.

6. Whichever approach you choose you will need to drill into the Investigator Signoff Instrument to apply your E-signature.

7. The form should display two red banners. The first indicates that the entire record is locked. The second indicates that the instrument is locked.

8. You may now apply your REDCap E-signature by clicking in the checkbox at the bottom of the instrument and entering your password.

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