Good Documentation Practice (GDP) is the cornerstone to ensuring a quality, inspection ready Trial Master File (TMF). TMF experts, LMK Clinical Research strongly believe that GDP is the responsibility of everyone that contributes (i.e. via submission or creation) clinical trial documentation to the TMF.
In this white paper, LMK evaluates the following:
- Regulations that support GDP
- Best practices on how document contributors can apply the golden rule of research to their TMF
- How to avoid writing too many and unnecessary Note-to-Files (NTFs)
- Tips on becoming inspection ready and staying that way
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