Paragon's Michael Agard and I were so gratified by the attendance for our webinar “Practical Application of the TMF Reference Model” on November 14, 2012. We exceeded capacity, and, based on submitted feedback, the audience found it valuable. (If you joined anticipating a “TMF Reference Model 101”, that content is in development by experts on the TMF RM Interoperability team).
We really enjoyed talking about workable ways to incorporate the model into your Trial Master File (TMF) management and content considerations to move you further along in your company’s TMF maturity.
What were the key points to take away from the Trial Master File Reference Model (RM) webinar?
- Information architecture is critical to any clinical trial technology initiative, and that’s especially true for Trial Master Files. If you don’t know what is needed, what its called or who’s got it, then you’re in a real pickle come inspection time. Never mind getting the information to actually work for you during the trial.
- Using the TMF Reference Model as the basis of your TMF information architecture only makes good sense. Hoards of life science TMF geeks wrote the TMF Reference Model, the regulatory agencies approve of it (not that there is a mandate) and many sponsor and vendor companies work with it, so it’s a solid foundation for your company’s architecture exploration. Future-wise, maintaining your map to model can help enormously with like-minded vendors, and in partnerships and M&A events. Right way you can move the bar to ensuring your trial’s inspection readiness.
- It’s not pretty or easy, and it’s worth it. It’s not pretty as the TMF RM is a group sourced standard and so has to be precisely assessed line-by-line for your company, along with your current SOP landscape and all your trial processes. It’s far from easy as initiatives go “out of bounds” into every role involved in a clinical trial. When’s the last time your biostats, IT, safety, contracts, shippers, DSMB, or anyone beyond clinical team understood their TMF responsibilities? But it’s worth it, because doing this work the right way makes obvious the WIIFM (What’s In It For Me?) of robust content creation and stewardship. Imagine a time when everyone on the trial understands their daily role in an always-inspection-ready TMF, and the TMF content supports critical clinical trial process. You won’t get there without robust information architecture.
How do you do it?
In my experience it is critical to follow these guidelines:
- Survey the landscape: Get a sponsor, educate mgmt, gather TMF SOPS, know your TMF problems
- Differentiate the issues: what can you accomplish, and more essential - what you will not solve
- Level the playing field: TMF 101, definitions of terms, ingest complex Excel 30x244 workbook
- Prepare the tools: develop index, set norms, prepare for rigor, establish parking lot
- Get the job done: be iterative, celebrate wins and effort, tell everybody everything, apply results, safeguard the map
This is not rocket science – many solid PMP methods will get the job done. Whatever methodology is followed to achieve robust TMF information architecture, some additional TMF mapping considerations include:
- Definition baselines are critical for all parties: for ex, what does IP release mean in your role?
- Structure / buckets / containers do not matter, don’t let it break the stride
- Agree to and use a parking lot: focus on final content, creation process is a black hole
- Keep a laser inspection focus: Is it required for a future inspection? Do our SOPs say we produce it? If requested, who is responsible and where is the artifact?
- Make it personal: “If you’re in the room with an inspector…”
After I covered the details on process steps to applying the TMF RM, Michael delved into some critical areas of TMF RM content considerations: is the artifact applicable at each trial, county and site? What are the date conventions on creation, collection and expirations? How much metadata is too much?
To start working with the TMF Reference Model follow these steps:
- Filter the zone and section data to get a small sub-section of documents to work with.
- Confirm the required and optional documents (Core / Recommended)
- Identify the milestone when the Core documents are required.
- Determine the document approval process: Wet ink signature, Electronic Approval, etc.
- Determine which documents need version control and how it will be managed.
Next, look at the entire lifecycle of the document from creation to storage:
- Look at the TMF Reference Model Columns for Trial, Country and Site
- Review the document creation process: template > study specific >country specific > site specific
- Determine where paper and electronic files will be stored.
Some trials have additional special considerations that need to be addressed for complete TMF content maps. Some examples include trial phase, therapeutic area, patient population, controlled substances, country specific regulatory requirements, company specific documents mandated by SOP/process.
When approaching the metadata related to TMF mapping, there are some potential additional factors to track in your index:
- Audit trail requirements
- SOPs and templates associated to an artifact
- Documents requiring translations and relationship to the original
- Key document dates, definitions and format, especially if they are used for metrics.
It is easy to get carried away with too much metadata. Focus on the purpose of the metadata for search, sorting, filtering and reporting purposes. Define if the data will be system generated, inherited, obtained by a system interface, or user input. Restrict the user input to the fewest possible fields, and make sure you’re collecting data that will be acted upon. Just because you can collect it doesn’t mean you should collect it.
Some key metadata considerations include:
- Trial and protocol information
- Country and site data
- Names and roles of study site personnel
- Creation and approval dates
- Vendor, Lab and IRB/EC names
Hard to believe we covered all that ground in 30 minutes, and that we can talk about it all day. As part of the certified (and certifiable) TMF brain trust, we want to drive future seminar topics based on attendees’ feedback, and would love to know your perspective. Our next webinar will be on practical considerations for eTMF. What more would you like to hear? How has TMF RM work been going for your life science company?