The subject casebook can be signed by the QI once data for all eCRFs has been entered, reviewed, and all queries resolved and the eCRF is marked as completed.
An eCRF that has been started but does not contain any data will prevent casebook signoff.
If an eCRF has been started (as identified by a yellow box ) but you are unable to complete it (eg due to participant being unable to attend visit), please inform the CC. We can remove this data form for you in order to allow casebook sign off.
We recommend starting data entry only when you are able to complete the form. If you would like to view the form, please select . This will prevent the status of the form from changing to ‘Initial Data Entry’.
Please note that a signed-off casebook with new queries will cause the form to revert back to ‘Data entry started’. This casebook will need to be signed off by the QI again. This is to ensure that data revisions have been reviewed by the QI.