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Hi Debra and Eldin, I would agree. I think filing this with the Trial Mangement Plan makes sense. If you system allows you to file to multiple studies at one time, but might be a good option.
Kind regards,
DonnaHi Sally, This should be filed with the rest of the training documents in Zone 1.4.4 Trial Team Evidence of Training. If you want to align the training to a specific vendor you can always add that as metadata in that artifact. I would not recommend filing training with the CVs as this will make it more difficult to find the CVs in the event of an inspection
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.
Hi Sarah and Deb, I would just like to add a couple of thoughts for you to consider.
1. The volume of emails in studies can be overwhelming. Emails should be uploaded to the TMF on a regular basis as complete communications. I recommend filing them at the lowest level of granularity. This makes finding them much easier. For example an email explaining a PIs affiliation with the investigator site could be filed with the PI CV. Then if a question comes up about the affiliation, the email explaining is right there. If this email were buried with a couple hundred other emails, no one would even know that it exists.
2. If an email has attachments that are filed elsewhere in the TMF, then I question if the email is even TMF content. If it does contribute to the story of the study, then go ahead and file the email without the attachment since it is already located elsewhere in the TMF. Hopefully the email references the attachment clearly and you can make the connection to the attachment when you are reviewing the communication.
3. Keep in mind if your practice is to file emails on a USB, that USB now becomes part of the TMF and should be managed as such.Hope that this information is helpful.
Regards – Donna