Clinical Trial Systems: Trial Master File (TMF) and eTMF, & FDA’s Recent Draft Guidance for Electronic Records/Signatures Used in Clinical Trials

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.  Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF).  All of the data and documents supporting the planning, conduct and evaluation of a clinical trial must be of the highest integrity, which must be maintained through their entire life cycle.  Computer System Validation will be discussed as a key methodology for meeting all of these requirements and assuring data/document integrity.
The TMF includes all of the documentation that a sponsor must record to demonstrate that they have met their obligations for the conduct of a clinical trial.  Alternately, an electronic Trial Master File, or eTMF, can be used to collect/create and manage all of the necessary data and documentation.  We will discuss the benefits and challenges of moving to an eTMF, or maintaining a hybrid solution that includes both a paper TMF and eTMF.
The Code of Federal Regulations states in 21 CFR 312.50:
“Sponsors are responsible for… ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND.”
The European Directive 2005/28/EC states:
“…trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.”
ICH GCP, Section 8.1 describes “essential documents” as those that individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced.
A consolidated guidance for industry on Good Clinical Practice (GCP) in 1996 was published by the International Conference on Harmonization (ICH).  The objective was to provide a unified standard for the United States, European Union, and Japan to facilitate mutual acceptance of clinical data by the regulatory authorities in these global jurisdictions.
The ICH document provided guidance for companies in all ICH regions to establish trial master files that contain key documents that enable the evaluation of the conduct of a trial and the quality of data produced uniformly by all jurisdictions involved.  In the US, there is no specific requirement from FDA for companies to prepare a trial master file, but if the regulatory authority requires ICH GCP to be followed, then there is consequently a requirement to create and maintain a trial master file.
Documents contained in the TMF must be available for inspection by the appropriate regulatory authorities at any time during and after the conduct of a clinical trial, and must be submitted to support the request for product approval.  This is true for pharmaceuticals, biologics and medical devices.  More recently, tobacco and tobacco related products have come under regulation by FDA, and will also be discussed.
Finally, we will cover the new DRAFT Guidance from FDA on the Use of Electronic Records and Electronic Signatures in Performing Clinical Trials.

Why You Should Attend

Speaker(s)

Carolyn Troiano

Carolyn Troiano has more than 40 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn participated in the FDA/Industry team that drafted 21 CFR Part 11, the FDA Guidance for Electronic Records and Electronic Signatures (ER/ES). She is active in seeking ways to streamline the validation process and do what she terms “Common Sense Validation,” removing tasks that do not add value, but carefully taking a risk-based approach and using critical thinking to drive plans and activities.

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