This compliance position paper focuses on Chapter 10 of the guide, "Trial master file and archiving". It provides insights on how to comply with legislative requirements and gives recommendations on how effective TMF management can be implemented.
The Guide was published based on feedback from stakeholders, who felt that there was a lack of comprehensive and authoritative guidance on how the clinical trial regulations, and in particular GCP principles, should be implemented in practice.
This compliance position paper focuses on Chapter 10 of the guide, “Trial master file and archiving”, which covers the legislative requirements and gives recommendations on how effective TMF management can be implemented. The move to electronic records is also discussed in this chapter.
IQVIA has studied the guide to ensure that we comply with the key points. We also used the guide to enhance our product roadmap to include important requests from the regulators. The remainder of this paper provides insight into the key eTMF-related points of the paper and how IQVIA eTMF complies with or supports those requirements.
Much of this chapter was later incorporated into the European Medicines Agency (EMA) draft “Reflection paper on GCP compliance in relation to trial master files (paper and/or electronic) for management, audit and inspection of clinical trials”. As IQVIA has issued a position paper on compliance with the Reflection Paper (“IQVIA eTMF: Response to EMA Reflection Paper on GCP Compliance”), this paper only addresses elements unique to the MHRA GCP Guide.