Signing Off a CRF

As of version 3.1.9.2 the TrialDriver EDC application includes a simplified CRF sign-off procedure for investigators

First a couple of basics:

• Only a designated Site Investigator can sign off on a CRF
• After a CRF is signed, no further changes to the CRF data are permitted
• A CRF can be "unsigned" if changes must be made. Study Coordinators can unsign a CRF, but only Investigators can sign
• If the CRF contains invalid or missing data, it cannot be signed off.
• Empty pages and visits must be confirmed before a CRF can be signed
• Although not all people can sign-off or unsign, anybody can check the sign-off status of a CRF by following these instructions
• The SDV (source doc verification) status of the CRF pages does not affect your sign-off capabilities

1) Open the CRF Sign-Off window

1. Click the "CRF SIGN-OFF" button in the lower button bar
2. The Sign-Off window opens and calculates the sign-off status of the CRF, as shown below

2) Review the CRF Status

1. Please now review the Sign-Off status for the CRF
   
2. Visits with a icon are OK for sign-off
   Visits with a icon require confirmation of empty pages
   Visits with a icon have data validation issues and cannot yet be signed off
   (Click the "+" icon next to a visit to see the individual pages)
   
3. To confirm an empty page or visit, place a check mark next to the item
   Or click "Confirm All" to confirm all pages and visits as "intentionally blank"
   
4. Double click a page or visit to navigate to that item in the main CRF view
   
5. If you make changes to CRF data, click the "Refresh" button to update the sign-off status list

3) Confirm and Sign-Off

• After you have fixed all data validation issues and confirmed all "intentionally blank" items, review the CRF status once more
  
• The list indicates which sections of the CRF will be marked as "not done" (if any)
  
• If you are satisfied with the status, Click the "Sign-Off and Lock CRF" button
  
• The application will ask for one more confirmation

• The application displays which signatures will now be applied to the CRF (only if multiple signatures)
  
• All signatures will be applied and timestamped with the current date
  
• Click OK to complete the process
  
• All outstanding pages and visits will be submitted to the study server and the CRF will be locked
  
• The Sign-Off window updates to show the new sign-off status.

• The Sign-Off window now shows the "Unsign CRF" button to appropriate personnel
• Only unsign a CRF if changes to CRF data must be made
• For each page which must be changed, a reason for change must be entered.
• Re-Sign the CRF as soon as possible. Sign-off dates will be updated appropriately.