Insights from Andy Fisher’s TMF Summit Q & A Session
January 16, 2019
- eTMF Events
- eTMF Resources
On the 17th of October at the TMF Summit in London, Andy Fisher, MHRA Inspector, provided a very welcome Q&A session for the conference attendees. Attendees could submit questions in advance or ask them during the session.
Some of the questions had been addressed on previous occasions, but others had never been addressed in writing or in any session that I attended before. In the list below, I’ve concentrated on what I thought were some of the more interesting and insightful answers.
- Failure to destroy paper for certified copies may be viewed as lack of confidence in the certification process.“If the original has not been destroyed, the MHRA may ask why. If you certify copies and then don’t destroy the originals, are you confident you have a certified copy because what is rationale for keeping the paper? Not necessarily a finding but would need explanation on why you would still be keeping the paper originals.” I have to say this point sent shock waves through the audience! What many organizations were viewing as an excess of caution was actually being viewed as a potential deficiency.
- Vendor managed inspector training is recommended. Recommendation that the “eTMF vendors keep records of inspector training and then provide to the sponsors for subsequent inspections to prevent inspectors having to take the training again.” I had always thought that sponsors / CROs would want to be entirely in charge of the training process, and that they would intersperse information about the organization of their systems into the “click here” training on how to use the system. However, as the inspectors usually see a few systems over and over, it seems that they would prefer to take the more mechanical training only once.
- Legacy audit trails can be archived in a location of choice, which does not have to be the active eTMF. Conformation was provided that, for migrated TMFs, legacy audit trails need not be stored in the target eTMF. “If you have a massive dataset you have to look at what is the best system to store in, you need to define that for yourself and just ensure that you are able to find them. Sponsors should receive the audit trail back with the eTMF from the vendor.” Trying to co-mingle audit trails from a legacy eTMF using different technology and a current eTMF can be problematic as they have different events and data, user names that don’t exist in the target system, and most systems don’t allow audit trail dates to be set to anything other than “now”. It was good to hear that the focus is on the “what” (ensuring that the audit trails are archived, and that data can be located) rather than the “how”.
- Organizations should perform UAT on their eTMF. “Sponsor should be testing requirements for the trial and executing UAT scripts – looking at failures and how they are fixed.” I have heard recently that some vendors have been saying that UAT is not necessary for a SaaS solution, so it was good to have the need for UAT confirmed.
- Remote access of eISF is not acceptable. MHRA has alluded to this before, but has now provided the full rationale. “Sponsor/CRO Organizations cannot remotely access an eISF as this is very different from accessing a ISF by sponsor/CRO representatives (Monitors) being physically present on-site. With remote access, anyone could be reviewing eISF remotely (sharing user log on details, more than one person viewing the screen etc.) and the investigator would not know but an Investigator would be aware who is looking at the ISF when this is done physically on-site.” Whether or not you agree with this position, it seems that you may be risking a finding if you access an eISF remotely.
If you were at the Summit, I would be interested to hear about what you thought was important in the Q&A.
Director, Product Management