10.03.01 – Database Requirements

Hi Istvan,

The TMF RM Document types shows:
“Database Requirements

Database Specifications
Coding Approval Document,
Coding Listing Form,
Coding Consistency Report,
Final Coding Listing,”

Others,
Database Programming Requirements, Database Design Listing, SAS Dataset Specification, Decoding Request, Randomization Release Request, Request for Access to Randomization (If Applicable to your study)
Please follow your SOPs.
Hope this helps!
Janna

Hi Istvan,

The TMF RM Document types shows:
“Database Requirements

Database Specifications
Coding Approval Document,
Coding Listing Form,
Coding Consistency Report,
Final Coding Listing,”

Others,
Database Programming Requirements, Database Design Listing, SAS Dataset Specification, Decoding Request, Randomization Release Request, Request for Access to Randomization (If Applicable to your study)
Please follow your SOPs.
Hope this helps!
Janna

”
Definitions.
To provide a detailed design framework for
the system(s) used to manage and store
subject/patient data captured via a paper
CRF or eCRF for the specified trial. Not to be
confused with specifications for the Electronic
Data Capture (EDC) system (see 10.04.02).
Reason for change:
Clarification”