Forum Replies Created
-
Posts
-
Remember that a DSUR is not a trial-specific document (unless you only have 1 clinical trial in development). For this reason, many sponsors do not file the DSUR (or PSUR) in the TMF but rather file it in the Pharmacovigilance system. However, the TMF will hold any trial-specific notifications related to the DSUR e.g. notification to Ethics Committee.
Hi Manuela,
Can you clarify what it is you’d like advice or recommendations on. Are you asking about the long-term archiving of electronic files with Iron Mountain? Or are you asking about whether emails should be archived as a PST file?
Is there an artifact in the model that captures agreements or financial information? If so, I guess that would be the most likely place.
Hi Mariz,
Different inspectors will have their own preferences but usually they require direct access to the system. I recommend getting this clarified before the inspection actually happens ie. in your pre-inspection communications.
Kind regards,
Eldin.Hi Mariz,
You could try the HSRAA online course:
HSRAA is a not-for-profit.
Kind regards
EldinHi Maria
I would say it meets this definition: A regulatory statement from the investigator (required by certain health authorities).
Kind regards
EldinHi Rebecca,
Then I suspect you are not downloading the correct file. The main TMF Reference Model has 249 artifacts whereas the Real-world study index has only 131. The index can be downloaded from the main Resources page (look under the “TMF Tools section) and a direct link to the index is HERE.
Kind regards,
Eldin.Hi Vicki,
Do you have a reference for a specific regulatory requirement for a Data Management Plan or wording in a regulation that makes it very clear this is an expectation? If so, it would be good to get this added as a reference. Thanks.
Eldin.
Is there a regulation that describes in detail what content must be in a CV? Conversely, is there a regulation that identifies content that should not be included? A CV should demonstrate qualifications and experience. Other than this, I’m not aware of other specific regulatory guidance. Any “restrictions” that I’ve seen (eg a 1-page CV) have been sponsor requirements.
Inclusion of other sponsors on a CV may be a confidentiality issue for those sponsors but I don’t think this is a regulatory issue (perhaps a legal one if they’re under a confidentiality agreement!).Hi Jane Marie,
I’m not sure if the query is looking for how to ensure the long-term archiving/retention of emails for x years, or whether it is simply how emails should be filed/integrated into the TMF. Archiving means actions taken to ensure the long-term safety, security and integrity of records so not sure how this would necessarily be different for emails, other than maybe different file formats. Only reason I’m asking is that the question is posted in the “archiving” forum.
Having said that, just to let you know that there is a TMF Reference Model sub-team looking specifically at best practice for the management of electronic mail, including the long-term preservation of email records. Shouldn’t be too long before they have something available for us!
Hi Dee,
Where I’ve seen some differences is between filing of submissions versus approvals. Often, the full submission is filed in the regulatory system but only the documentary evidence of approval is filed in the TMF. It is essential the TMF Index identified which system both documents are filed in.
Eldin.
This is an individual sponsor decision but my inclination would be to avoid updating a TMF structure specifically for COVID-19. This is certainly a significant risk currently but I’m not seeing a justification for classifying the documents in a different way to how they would ordinarily be classified. If you need a means of quickly identifying all COVID-19 related documents for a study, you can use a naming convention and/or search capabilities to achieve this. Letters to a site that concern action you’ve taken with regards to COVID-19 should be processed and filed in the same way as for any other site communication. Whilst this is an extraordinary situation, we do not create filing exceptions for any other clinical trial risks.