Structure of TMF for CRF and Data Management Section
I would like to know if the following is correct as the TMF structure for the CRF and Data Management section:
[U]CRF[/U]
Approved blank CRF
CRF Sign-off approval form
CRF Amendments
CRF Amendment approval form
Signed, dated and completed CRFs
Questionnaires/ approval form
Help Text Guidelines (As we have an EDC system there are no CRF completion guidelines but help text is displayed in the system - should this be considered as an essential document for the TMF?)
Help Text Sign-off approval form
Significant CRF Correspondence
[U]Data Management[/U]
Data Management Plan/ approval form
Database Design
Annotated CRF/ approval form
Data Validation Specification/ approval form
UAT and Release
Data Transfer Specification/ approval form
Database Lock Documentation/ approval form
Significant Correspondence
Thank-you