IQVIA eTMF: Response to MHRA Good Clinical Practices Guide
TMF Related Elements
White Paper
Jul 18, 2019

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.

 

Download to read more
RELATED SOLUTIONS
Compliance

Simplify compliance, save your bottom line

Patient Engagement

Effectively engage with patients to help improve adherence, drive better disease understanding, and deliver treatment value.

Clinical Content Management

Manage trial master files from planning through archive with solutions designed to improve workflow efficiency, promote collaboration, and support compliance.

You may also be interested in
Contact Us
Contact Us
Contact Us

Email Us

Get in touch today to discover the right solutions for you.

Call Us

We are pleased to speak with you during our standard business hours.

U.S. Toll-Free only
+1 866 267 4479

For international call please find a number in our toll-free list.