When the eCRFs have been marked as “Complete” (all data entered and all queries resolved), ensure the Qualified Investigator signs off on the subject case book. The Qualified Investigator must be the one to sign off on all data forms. This task cannot be delegated to another member of the team. To sign off on the data forms, please follow the steps below:
1. Find the subject that you have completed all the data forms for in the subject matrix. At the end of the row you will see the signed icon , indicating that all the forms for this subject have been completed and you can now “Sign off” on this subject. The signed icon will only appear for the Qualified Investigator.
2. Click the “Signed” icon to sign off on the data and send it to the MiTy Coordinating Centre for review.
3. Enter the user name and password you used to log in to OpenClinica, and press “Submit.” All forms for that subject should now be marked as “Signed”
Please note, once you have signed off on all the MiTy Data Forms for a particular subject, it is considered submitted, and therefore you should NOT make further changes to the data unless we contact you with queries derived from the subject’s data. It is as if you had sent the paper forms to the MiTy Coordinating Centre in the mail.