The Trial Master File (TMF) Reference Model consists of standardized taxonomy that outlines the clear definition and organization of TMF content using standard nomenclature. This model, developed by a working group of the DIA Document Management Special Interest Area Community (SAIC), is a reference for the industry and should not be considered mandatory, but rather as an opportunity for standardization across the industry. The TMF Reference Model can be adapted equally to an electronic or a paper TMF. It does not endorse, nor by design, require, any specific technology for application. The model can be downloaded HERE.
The TMF Reference Model presents a consensus position of the TMF Reference Model Team regarding the content of the TMF to include all essential documents that individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced, in accordance with regulatory requirements, industry opinion and best practices. The TMF Reference Model team is composed of approximately 274 representatives from more than 165 bio-pharmaceutical companies, contract research organizations (CROs), consultancies, technical vendors, industry groups, healthcare, academia, not-for-profit / NGO and regulatory agencies.
V1.0 of the TMF Reference Model, first released in June of 2010, was updated in February, 2011 (V1.1) and again in December, 2011 (V1.2), based on feedback provided as the model was widely implemented.
Who Benefits from the TMF Reference Model?
- Biopharmaceutical sponsor companies of any size, both commercial and institutional, involved in clinical trials.
- Clinical study team members, including trial and data management, clinical supplies, biostatistics, etc.
- Contract Research Organizations and vendors supporting TMFs.
- TMF Consultants.
- Site staff, including investigators and coordinators.
- Regulators challenged with varying TMF terminology and file structures, which create inefficiency and a higher degree of variability during sponsor audits
V2.0 includes additional details for Investigator Site Files, Device Studies, Investigator Initiated Studies, and Process-based metadata.
You can participate in discussions related to the TMF Reference Model by joining the LinkedIn group.
The Trial Master File Reference Model (TMF RM), a supported initiative through the Document and Records Management SIAC of the Drug Information Association (DIA) is a standard reference for the contents of a Trial Master File. First published in 2010, it is a single, unified interpretation of the regulations and best practices and was collaboratively developed through a volunteer effort that includes more than 150 companies. The TMF RM is free and available here. Version 2 (due mid 2012) will include additional details for Investigator Site Files, Investigator Initiated Studies, Process-based Metadata and Device Studies.
A quick online survey has been designed by members of the TMF Reference Model team to provide valuable insight into Trial Master File practices, both paper and electronic, to identify common problem areas, assess changes in practice and reveal opportunities for improvement. All respondents who complete the survey and provide contact information will be provided with the survey results. This will be a valuable industry tool so please do click on this link and complete the survey by June 1, 2012.
Disclaimer: In accordance with the DIA Volunteer Code of Conduct, no volunteer shall use any information provided by the Association or acquired as a consequence of volunteer’s services to the Association in any manner other than in furtherance of his or her volunteer duties with DIA. Volunteers are expected to act at all times in the best interests of the Association and not for personal or third-party gain or financial enrichment. DIA reserves the right to reproduce, license, sell, display, and distribute copies of materials posted to the DIA website, in any medium or technology (including online) consistent with DIA’s non-profit and tax exempt purposes.
As an industry, I think records managers and archivists have generally welcomed the emergence of PDF and PDF/A as a standard for the creation and preservation of documents. At last we have a format that enables us to view documents as they were originally intended to be viewed on a wide variety of platforms. In addition, the problems of software obsolesence have perhaps been virtually wiped away with the availability of PDF/A. However, even PDF presents certain problems, most notably with the ability to conveniently view documents on portable devices such as smartphones, iPADs and e-Readers.
I have just read a really thought-provoking article on the AIIM website by Serge Huber who suggests that PDF may need to make way for a new document format which is closer to HTML5 and EPUB3. I won’t attempt to summarise Serge’s article here; click the link to read it for yourself. As records managers and archivists we need to understand what the limitations of our current document formats are. We also need to try to understand where advances in technology may be leading us so that we are prepared when new file formats are thrust upon us. And perhaps even be there encouraging our organizations to migrate to these new formats?
This is just a quick notification that as a result of restructuring of the DIA (Drug Information Association) website, the link to the EDM Corner has now changed. The EDM Corner contains links to Trial Master File Reference Model and also to the draft Framework for the Destruction of Paper. If you have not already done so, please update your browser bookmarks with this link.
Health Canada has recently released a publication summarising the results of GCP inspections carried out between April 2004 and March 2011. It makes for interesting reading compared to a similar document released by the MHRA three years ago.
At 24.5% of findings, records management issues account for a much higher percentage of inspection findings than for the earlier MHRA report. Many of the findings were due to documentation simply not being present in the file but the examples quoted in the report reveal some interesting points:
- Example 2 confirms the inclusion in the TMF Reference Model of IVRS validation artifacts; the trial master file is more than just the minimum list of documents identified in ICH GCP Chapter 8
- Health Canada accept archiving of electronic records but Example 3 highlights the need for an archive strategy that ensures accessibility and readability of those records for a minimum of 25 years
- In regards to electronic records again, Example 6 highlights the need for audit trails to demonstrate that data has not been changed.
As in the MHRA report however, the categorisation of findings actually disguises the true extent of records-related problems. For example, findings categorised as “Qualifications, Education and Training of Personnel” were:
- “No CVs were available for three sub-investigators”
- “No documented evidence that the personnel were trained…”
- “No explicit documentation to indicate that all […] had been informed…”
In my mind, these are actually records management issues i.e. failure to generate required documentation for the Trial Master File. Similar examples can be seen against the other inspection finding categories.
So what does this tell us? That we are still struggling to manage the vast quantities of records that our regulations require us to generate and retain. Initiatives such as the emergence of an industry TMF Reference Model will help to ensure consistent and comprehensive content but we also need tools to ensure that content is properly managed.
When it comes to destroying records at the end of their retention period, I’m guessing that most records managers and archivists will have a well-established program to ensure such records are destroyed securely. There are industry standards for secure destruction, including for example, BS EN 15713:2009 Secure destruction of confidential material and I know many of my colleagues destroy to this standard either in-house or via reputable vendors.
However, are you sure the same is true for electronic records? I don’t mean the deletion of expired records from network drives and backup tapes but the physical destruction of storage media. A recent report from the Information Commissioner’s Office highlighted a big problem in this area. They asked a security company to purchase used hard drives, memory sticks and mobile phones from a variety of sources and identify the contents, if any. 48% of the hard drives still contained data, including 11% containing personal data some of which could enable identity theft to occur. Given that many large companies outsource removal and destruction of hard drives and the like to third parties, can we be sure that our data is actually being securely destroyed?
I’ve just come across a White Paper from AIIM on the use of digital signature technology. As this makes for interesting reading, I thought I’d just share some highlights and provide a link to the full report:
- In 63% of organizations without digital signature systems, more than half of the printed process documents are printed just to add a signature.
- Speeding up approval processes and saving staff time are considered to be the biggest benefits by those who have implemented a digital signature solution.
- For 40% of people not using digital signatures, half or more of their electronic document workflows are interrupted by the need for physical sign offs. For 23% of non-users, this results in a week or more of process delay on average.
- 63% of digital signature users achieved a ROI in 12 months or less (i.e. the technology is cheap!!)
- 43% of SharePoint users would like to apply digital signatures to SharePoint workflow processes.
- 24% of research respondents are already using digital signatures. A further 21% plan to implement them in the next 12 months.
The report can be located HERE.