March 20, 2020 at 1:46 pm #2927Janna GonzalezParticipant
My question is for eTMF system. when you Upload a document do you need the Receive Date of the Document?
March 20, 2020 at 1:53 pm #2928Eldin RammellParticipant
I hear this question asked quite often and there are different perspectives. One is to think about what the process was before we started to use eTMF systems. It was very rare to capture the date that a document was received…. perhaps on a TMF Transmittal form but probably not for all documents. So why should we change our process just because we now have new technology?
On the other hand, if you have an SOP that states you file documents within a specific time period, it seems logical that you should have some means of demonstrating compliance. This could be achieved by capturing the receive date.
So there is no specific regulatory requirement or expectation for a receive date. You just need to consider how you will be able to demonstrate that your TMF is contemporaneous. If you can do this without capturing the receive date, that should be acceptable.
March 20, 2020 at 1:59 pm #2929Leigh LawsParticipant
I agree with the above, from Eldin, and would also add that if you do require the document received date, you may be challenged to provide proof of that date during inspection. If you choose to go that route, I would have a process in place for providing the source of that data.
March 20, 2020 at 2:08 pm #2930Janna GonzalezParticipant
I’m organizing the Documents in my folder. I decided to run a Site Document Report. Filing Name Convention the meaningful Date and receive date. The document was upload Feb 2, 2019.
Example of Doc…
Document Name-PI-Meaningful date- Document received.
CV_Gonzalez_02Feb2018- Document Receive Date 02Feb2019.
March 20, 2020 at 2:10 pm #2931Kathie ClarkParticipant
A couple of points to add:
* Receipt Date can indeed be valuable in TMF Metrics, but of course it’s difficult to prevent users from “gaming the system” here. We know that Receipt Date must be greater than or equal to Document date, and less than or equal to upload/submission date. But it’s a sort of honor system as to when the document was received for filing in many cases. So it is then worth looking at the difference between document date and receipt date to see how long it is taking to receive a document after it is finalized.
* Certain document types, such as CVs, lab normals, etc. could have a document date that is a long time before receipt date and this is legitimate. For these documents, receipt date is actually more important in reconstructing the trial than document date.
March 20, 2020 at 2:24 pm #2932James OKeefeParticipant
You also need to be mindful of how many dates for a given document you are going to track and save in your eTMF, and is there real value in the effort.
Possible dates, for any single doc: Drafted, Issued, Approved, Sent, Received, Filed, Expiry, etc
Thats a LOT of dates.
March 20, 2020 at 7:54 pm #2935Donna DorozinskyParticipant
I agree with Jamie, when you start adding a multitude of dates you end up having to establish conventions for assigning dates. How do you define receipt. The date the monitor collects it, the date the monitor submits it for upload? It really becomes an honor system and how is that assessed? I recommend that companies assess timeliness based on records that have reliable document dates to measure timeliness. For example, study plans, protocols, Monitoring Visit Reports, ICFs, amendments, etc. If there are gaps in these documents, then that needs to be addressed as a priority. When you start looking at it across all documents you end up spending quite a bit of time explaining outliers. Essentially this is taking a risk based approach to timeliness.
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