Challenges with the interpretation of CDISC - Who can we trust?
Linda Palm Simonsson · 2014
Many smaller companies have none or very little knowledge of biometrics and turns to one or several CROs to help them conduct their trials or a submission. A small company expects the CRO to be the expert and since many small companies lacks a biometric department they also lack internal resources, routines and expertise to do a qualified QC of the SDTM and the ADaM packages received from a CRO. Sometimes the difficulties for the sponsor begins already at understanding what's included in the proposal vs what's needed according to FDA or other agency. Other difficulties may be inconsistency between e.g. SDTM IG and FDAs requirements. This presentation will address some errors, misunderstandings and difficulties seen in the interpretation of different documents and showing some inconsistencies between different sources.