Essential study documents
To generate data that are scientifically valid, reliable, and robust, essential study documents must be filed. These essential study documents must be available prior, during and after study conduction. For IVD studies two important guidelines have to be considered:
- Detailed information on good study practice documentation is listed in Annex H of the ISO20916.
- The ‘ICH: E 6 (R2) Guideline for good clinical practice – Step 5’ provides information on essential documents for the conduct of a clinical trial (see section 8).
All essential documents have to be filed in an (e)Trial master file.
