Home Forums Where do I file…. ? 10.03.01 – Database Requirements Reply To: 10.03.01 – Database Requirements

Janna Gonzalez

Hi Istvan,

The TMF RM Document types shows:
“Database Requirements

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

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!