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Form is a record that typically has just one person in its scope, this is the one sent to Sponsors from Sites. Each Site person working on the study in an investigator capacity completes one, so there are many per study.
Summary is a record (generally one per study) generated by the Sponsor and included in the regulatory submission for approval. It pulls/aggregates data from the individual Forms for all people across all sites who worked on the study. This record is not shared with Investigators.
It is surprising to me that the “Investigator Document” column indicates that Investigator records file into these artifacts. Perhaps this needs to be re-evaluated?
It is generally not expected to have any ISF records that file to those artifacts in Zone 10, because EDC systems are generally under the control of the Sponsor. If anything, perhaps a system/study specific account access form completed by site staff?
Likewise for artifact 11.2.6, as this refers to a process that is most often internal to a Sponsor.
Jessy – as far as I am aware, there is no “standard” answer to your question as it depends on the capabilities/best practices for the eTMF you are using. eTMF systems each have their own way of identifying different versions of the same document.
What is minimally important from an inspection perspective is that all expected superseded versions are present in your TMF.
The primary consideration for daily operations would be “can your staff easily identify the current version of a given record, separate from its superseded versions?”
Hi Christina:
eTMF systems usually have guided steps for a user to complete a particular process such as certifying a record as a copy. The first minute of this video shows what that process looks like to an end user in one particular site eTMF system (I am not trying to be self-promotional, but linking to this video is much more effective answer than trying to describe it in words here).
An organization’s SOPs should provide guidance as to when their staff would need to execute such a process (some organizations may not actually destroy certain paper records, thus even if uploaded to a system those records would not need to be certified as copies).
If an organization does not have an eTMF system or if for some reason a certified PAPER copy of an original paper record needed to be generated, I don’t know of a ‘typical’ approach…but off the top of my head, I could see something like a ‘certified copy attestment’ page being appended to the copy and signed by the person who declared the copy a true reproduction of the original.
Regards
ToddI don’t have a sponsor answer for you, but there is a related thread on this topic here, and the final message in that thread from Kathie links to some recent regulatory commentary on use of certified copies.
Those documents you are getting from the site do not need to be certified as copies, since they are site originals; it is the site’s responsibility to certify the paper as copy if the site decides to destroy the paper.
Hello Gunilla – this has been proposed once before (about two years ago) as a sub-group initiative, however one of the reasons we did not pursue this is because the documents required for this milestone vary by country, by company policy, by intervention type, and other factors. Beyond that, we could not see an effective way to accurately maintain such a resource over time (as country regulations change).
From time to time, TMF RM members have shared (in this forum and in others) various online resources they use to gather this kind of information.
Hi Janna – That filing is probably OK. Keep in mind though that correspondence records need not be limited to filing in the zone-specific “Relevant Communications” artifacts…in certain cases it may make sense to file such records in a more specific artifact.
In case it is relevant to your situation, a subteam of the RM recently developed specific guidance for emails, which you can learn more about here: https://tmfrefmodel.com/announcing-guidance-for-managing-trial-related-emails
Hi Caitlin…opinions on this topic vary, as does the meaning of “in the eTMF” (if a document version is in an eTMF system but that version is not visible to an auditor user…does that mean the version is in the eTMF? 🙂
In the USA, my experience has been that most Sponsors/CROs feel interim versions should not be present in an eTMF. Some eTMF systems will purposefully delete interim versions when a given document is approved.
For auditors that are taking a business process approach (e.g. MHRA), you’ll want to have some way of proving that your SOPs were followed. Having interim versions of documents can sometimes help with this, but may not be needed depending on your eTMF’s capabilities in this regard.
Even if you have interim versions in your eTMF system, an auditor may not have permission to see them. Again this depends on your eTMF’s capabilities.
Hi Janna there are two primary TMF artifacts related to IRB Submissions:
04.01.01 IRB or IEC Submission
04.01.02 IRB or IEC ApprovalEssentially, any cover letters or submission confirmations go into 04.01.01; anything you get back from IRB regarding their decision (or requests for more information) goes in 04.01.02
Hi Janna – those are typically filed in 03.01.04 (Regulatory > Study Approval > Public Registration).
Hi Janna,
There is a column in the reference model (“Dating Convention”, column AA) that indicates the best practice date to be associated with any given artifact. Even further, there is a guidance document here that describes more detail about how to interpret that column. For ICF it looks like the model expects Version Date to be the key identifying date for the record.
If using an eTMF, the TMF RM expects that you should at least be able to capture one date specific to each record filed. Of course some systems may allow more than one or may provide other means of associating an ICF checklist with a particular ICF version…but the TMF RM itself doesn’t yet take any position on such additional attributes.
Todd
Hello Gill:
It does seem like an X is missing from the Country Level column (W). Can you file a feedback request to the Change Control Board with your suggestion? https://tmfrefmodel.com/feedback
A “General” section of 4 artifacts exists in each zone. Despite our best efforts over the years, getting 100% consistency in every zone for these General artifacts has been a bit elusive.
I recall when I was working on v3.0 of the model with others we sometimes used a rule of thumb, if there is at least one country level artifact in a different section of the zone, then the country level is indicated for each of these “General” artifacts, unless it seemed nonsensical. Same logic holds for site level. But I’m not certain others saw things exactly the same way.
Flagging this for the change control board should help.
Todd
Hello Christy:
I advise my customers (I am an eTMF/eISF vendor) to file such records only once, and to attribute them to as many studies as are relevant to the record. The studies are not de-identified and may be visible as record metadata in addition to being within the readable record content. In this way, the same exact record is never duplicated within the customers’ eTMF.
I have heard from a few customers some concern that if the TMF for Study A includes a reference to Study B, then there is a risk that an inspector may then expand scope of their inspection to Study B. While I can understand that perspective, I also assume that if the inspector does decide to expand the scope, there must be a good reason for it…and it is better for all parties (including patients) that such problems be identified early rather than late.
Todd
My understanding of these agreements is that they are a better fit in Relevant Communications (despite generally trying to avoid that artifact) because the nature of an agreement has some kind of scope whereas “Compliance Documentation” is for the IRB as a whole.
Depending on your perspective I could see it falling into either Zone 4 (if you are a sponsor and filing a reliance agreement for an IRB that will cover multiple sites) or Zone 5 (if you are a sponsor and filing a reliance agreement for a single site’s local IRB).