Forum Replies Created
-
Posts
-
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.
In my experience, this is typically not part of the TMF. It is part of the Quality Management System / Audit files.
The applicable regulations do not specify any particular file type for electronic documents. Therefore, the file type chosen for an export of an eTMF from a CRO for transfer to the sponsor should be according to whatever has been specified in the contractual agreement between both parties. It is strongly recommended that the transfer process is discussed and agreed BEFORE the study commences. This ensures the requirements of the sponsor for archiving can actually be met by the technology being used.
However, there are several factors to take into account when agreeing what file types should be transferred. If the originating system is maintaining documents in their original file type and are being converted to PDF prior to transfer, there are specific regulatory requirements that must be complied with for the migration of documents from one format to another (the EMA TMF guidance specifically refers to this). In addition, regulatory inspectors often wish to open the original document, particularly Excel files as it is easier to search and navigate the content than PDF files. Also bear in mind any non-Office file formats. For example, does the source eTMF include file formats that are dependent upon specific software that might not be available to the sponsor; in this case, conversion to an alternative standard file format might be preferable to ensure ongoing access and readability.
There is usually a requirement to retain study-specific records for any type of clinical study, including those that are not regulated by Good Clinical Practice requirements (and therefore, not specific TMF requirements). So the set of documents are likely to be much smaller than for an IND/CTA clinical trial and it may not be referred to a “a TMF”, but you’ll still need to retain documentary evidence of what you have done. The TMF Reference Model Project has a sub-team that is developing a reduced Reference Model for this type of study, with many of the artifacts being advisory in the absence of specific global regulatory requirements.
I am not going to say that any specific vendor is more capable or less capable than another BUT please proceed with caution. There are very specific regulatory requirements relating to archiving. Many of these were written in the age of paper archives but the exact same principles MUST be applied when using a digital archive. In the same way that you would conduct a formal, documented assessment of an offsite paper document storage vendor (and possibly an audit), you must do the same for any technology solution for long-term digital storage of TMF content. You need to have assurance that the organization that you have outsourced the GCP-regulated archiving activity to is able to meet all applicable regulatory requirements.
The GLP guide on archives is a very useful document, in addition to the two HSRAA guides that Russell referred to.
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.