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) or electronic trial master file (eTMF).
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, including managing data with integrity.
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.
Why should you 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 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 Trial Sponsor, a Contract Research Organization (CRO), a laboratory testing clinical trial samples, or in any way involved in the mechanics of setting up and managing 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) is a very powerful and robust tool, 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.
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Carolyn Troiano has more than 40 years of experience in the pharmaceutical, medical device, tobacco 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’s expertise includes traditional Computer System Validation (CSV), Computer Software Assurance (CSA), the System Development Life Cycle (SDLC) Methodology (waterfall and agile), 21 CFR Part 11, FDA’s Guidance for Electronic Records and Electronic Signatures, Data Integrity, and Data Privacy. Her experience spans multiple types of system platforms, software types, and automation tools. She has implemented and validated very large-scale and complex enterprise-wide applications in all GxP areas of operation.
Carolyn provides webinar and seminar training, as well as consulting with life science industry clients. She is an Industry Advisor for InGenious Dataworks and serves as a Compliance Authority for RiskCortex Limited.
