The recent draft guidance from the FDA on electronic records and signatures (March 2023) provides information for sponsors, clinical investigators, institutional review boards, contract research organizations, and other interested parties on the use of electronic systems, electronic records, and electronic signatures in clinical investigations of foods, medical products, tobacco products, and new animal drugs under FDA regulations. The FDA draft guidance revises the draft guidance for industry issued in June 2017 entitled Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 — Questions and Answers and, when finalized, will supersede the guidance for industry entitled Computerized Systems Used in Clinical Investigations (May 2007).
The recent draft guidance provides recommendations regarding the requirements, including the requirements under 21 CFR part 11, under which the FDA considers electronic systems, electronic records, and electronic signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. While it provides insight and clarification, it does not include any new requirements for the industry. As with all guidance documents from the FDA, it provides the Agency’s most current thinking on a subject.
Documents contained in the TMF/eTMF 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.
The plethora of data, both structured database records and unstructured data, such as documents, PDFs, Excel spreadsheets, and other key artifacts makes the assembly of a clinical TMF/eTMF a daunting effort. There are many stakeholders sending in key data about the trial to the sponsor. The many artifacts come from a variety of systems based on differing technologies and platforms and using differing communication protocols and file formats.
In order to be in a position to assemble these cohesively, once received, the sponsor company should prepare a technology and data roadmap. Knowing what must be submitted, how it should be handled, and where the new clinical trial supporting data and documentation should be received, evaluated, and stored can provide a frame of reference that will ultimately streamline efficiency in preparing for the onslaught.
For example, it is important that each stakeholder who will be submitting data been audited to find out if the source systems that will be used by them have been fully validated. The specifics about the data and documents coming in should be understood, including the file format and how they were reviewed and approved by stakeholders. When asked this question, most practitioners involved in establishing and maintaining a TMF/eTMF have admitted they did not think about this aspect of oversight. They typically have not taken such a step, and are working under the assumption the data and/or documents will be fine.
Business process mapping (BPM) provides a visual representation to help understand how the functions included work, both individually and in concert with each other. It also helps practitioners understand what key elements need to be evaluated, and in how much depth. Ultimately, it can help identify ways to streamline and improve the overall process for greater efficiency.
In addition to defining the process, those creating the process map(s) should understand who is responsible for key areas of work, what systems, data and documents are in scope. It will provide key information about how communication and transmission of data and documents will be done, and what factors should be considered when defining the ultimate repository for all these artifacts.
Standardizing procedures can provide consistency across all clinical trial processes and help to meet audit requirements. Those procedures or processes within the map(s) that are repeated can be evaluated in order to remove any duplication of effort. There also may be further automation opportunities that have not yet been explored.
Furthermore, the process map(s) can become templates for future trials, tweaking them as necessary. This would provide stakeholders a better view into how their contribution to the trial will be received, used and stored. This might even lead to further suggestions for improvement by them.
Areas Covered:-
This webinar includes the following key objectives:
Background:-
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.
Why You Should Attend:-
Anyone involved in a clinical investigation with responsibility for data, documents, and other artifacts that must be created and maintained with integrity must understand how systems interact, how data flows, and how these critical assets are managed through their entire life cycle. In particular, they are regulated by the FDA and must meet all Agency requirements, including those for validation, 21 CFR Part 11, the FDA’s guidance for electronic records and electronic signatures, data integrity, and Good Clinical Practice (GCP).
Whether you are working for a Clinical Sponsor, CRA, laboratory testing clinical trial samples, or in any way involved in the mechanics of setting up a clinical TMF or eTMF, you will benefit by learning about how to meet compliance, improve the quality of data, documents, and artifacts, and reduce overall costs.
Business process mapping (BPM) & Business Process Re-Engineering (BPR) are very powerful and robust tools, and can help those participating in the process flow to better understand how their part of the process fits in with others. It also shines a light on key areas of the process that may be streamlined or otherwise improved.
Who Should Attend:-
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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.
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