Get insights into the key eTMF-related points of the paper and review recommendations to assist organizations in maintaining a TMF that facilitates trial management, GCP compliance and inspection.
Recently, the European Medicines Agency (EMA) issued a draft “Reflection paper on GCP compliance in relation to trial master files (paper and/or electronic) for management, audit and inspection of clinical trials”.
This paper is the first published framework for eTMF for an entire region. EMA states that the paper is provided in response to the numerous questions they have been receiving regarding TMF / eTMF, as well as in response to inspection findings.
EMA states that the aim of the paper is to “set out the requirements for the TMF as covered in directives and guidance and to give recommendations to assist organizations in maintaining a TMF that facilitates trial management, GCP compliance and inspection. The paper also addresses archiving of the TMF, clarifying retention times and gives some recommendations regarding destruction of paper documentation.”
IQVIA has studied the paper to ensure that we comply with the key points. We also used the paper 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.