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Hi Jaclyn: So long as this question does not require you to provide confidential information, can you give a couple of examples of the type of database that you are referring to in your question? That might help to give a correct response. Thanks.
Hi Tina.
There is no regulatory requirement or regulatory expectation to find publications in the Trial Master File. If you choose to file publications in the TMF, a sub-artifact of 01.10.10 might be an appropriate location, so that you have the Publication Policy and the publications themselves co-located. Having said that, per the CT Regulation, the publication policy must be included in the protocol so the use of standalone publication policies is becoming more infrequent.
It should be noted that publications often appear many years after closure of a clinical trial. Filing in the TMF may have an impact on archiving timelines and may require locked eTMFs to require unlocking simply to file a publication.
Kind regards,
Eldin.Hi Catherine
I may be mistaken but isn’t the PEP and Report device-specific, rather than being study-specific? The TMF is a study-specific collection of documents. In a device context, it is those documents that relate to a specific clinical investigation, rather than a clinical summary for the device itself, si it would not contain the PEP and Report. Perhaps I’m mistaken so happy to be corrected.
Kind regards
Eldin.Hi Elizabeth
There is an expectation that your TMF should provide document identification and version history. TMF regulatory guidance suggests that metadata should include information about versions. It can be assumed therefore that you need to implement some kind of system that easily allows you to identify that a document has been superseded by another. There is no simple answer how you achieve this. Ideally, your eTMF solution will provide you with a feature that clearly shows the version number and allows you to easily see when a document has been replaced by another. If the system does not provide this, then annotating superseded documents in some way (like you described) may be an acceptable alternative. That process should be documented so that it is consistently applied.
Hi Elizabeth,
Yes – a good eTMF solution should enable you to identify documents that have been superseded. There are different ways of achieving this. For many documents, a new version simply replaces the prior version (which, by definition, become superseded). So the eTMF solution should enable you to clearly distinguish between different versions of the same document and to show you the most up-to-date version. For some documents – especially those that have a defined period of applicability – this may be by use of an “effective until” date or a “status” field.
Kind regards,
Eldin.Hi Chelo,
I think the answer to your question depends on the type of document (I’m not familiar with a Translation Plan). If this is a general plan that applies across all of your clinical trials, then perhaps it should be treated in the same way as your other process documents (SOPs, WIs etc). These are generally not filed in the TMF but rather, a list of procedures is included (artifact 01.01.04).
However, if the plan varies from trial to trial, then I think there are two primary options open to you. It could be considered as filling the definition of a TMF Plan 01.01.01 (“To describe how records for the trial will be managed and stored during and after the trial….”) or within the scope of artifact 01.01.05 Operational Procedure Manual (“To describe trial-related processes not covered by formal standard operating procedures…”).
I don’t believe I’ve ever come across a Translation Plan being written as a stand-alone document, hence my hesitation in being more definitive in my response! Translation requirements/processes are more typically described in other documents. The TMF Plan or a TMF SOP then describes how translations, back translations and translation certificates are managed in the TMF. Hope this helps.
Any other perspective on this query from others?
Kind regards,
Eldin.
Head of QA, Phlexglobal.Hi Pauline,
Section 5.4.12 provides flexibility for those sponsors who wish to keep the follow-up documentation separate; they may not have the ability to use sub-artifacts to help specifically search for follow-up records. If section 5.4.12 was removed, sponsors who adopt the Reference Model would then be forced to file follow-up documentation in the same location as the original monitoring visit records (section 5.4.3) and may be more difficult to locate without the use of sub-artifacts.
Kind regards,
Eldin.Hi Ellin,
Even in the absence of an electronic TMF I would advise looking at solutions that enable you to retain the emails digitally. You need to ensure you are meeting the relevant regulatory guidance for managing documents electronically but these are not particularly arduous. An option might be to manage emails within your email system while the trial is ongoing – BUT ensuring you have appropriate processes to ensure they are actually managed and not just dumped into folders! – and then exported at the end of the trial and saved to a suitable repository e.g. read-only, access-controlled and designated area of a network storage device.
A critical benefit that you achieve by retaining digitally is the ability to search through the content. This could be invaluable in the event of an inspection.
Whatever you come up with as a solution, make sure it is properly documented and any tech qualified for use.
Eldin.
So per ICH GCP, patient data collected via an EDC system is part of the TMF. However, there is no requirement to manage all TMF components in a single system, especially when the primary system might not be suitable for managing data sets.
You should therefore manage the data sets in a system where they can be retrieved easily for business purposes (trial conduct) but also for potential inspection. This is still part of your TMF but may not be your primary eTMF. Most sponsors do not manage these data sets in their primary eTMF, which are usually best suited to documents.
There are no regulations that would prevent you storing EDC data sets in an eTMF (since they are part of the TMF) but you need to be sure there is appropriate roles / permissions and security model to restrict access appropriately. Actually, this would apply to any TMF content…. the security model should restrict access only to those with appropriate authorization.
Eldin.
With >1,500 colleagues subscribing to this forum, it would have been a really useful benchmark for us all to see how we are using digital signature technology as an industry. However, with only two people completing the poll, I don’t think that is going to help us much!
If we’re interested in seeing trends etc and learning from them, then we need to spend a minute or two every now and then to make a contribution ourselves. The poll is anonymous 🙂
Hoping that a few more people will take the time to click a button…..
Hi Amrita
The filing level is always determined by the content. The Model indicates the likely filing level for artifacts.
KR,
Eldin.Hi Alexa
This is a matter of personal choice; the model provides a recommended approach but nothing is mandatory. Many sponsors prefer to group country level documents in their own files as this facilitates easier management and compliance monitoring by staff in those countries. When using electronic systems, it is easier to manage access control to those documents when filed at country level (particularly important to comply with data processing laws).
Kind regards
Eldin.The MHRA have stated in their GCP Guide that this approach is unlikely to meet the applicable regulatory requirements. For example, no audit trails and limited security features. I’d advise reviewing carefully all requirements pertaining to the TMF and checking those against the functionality provided by network file storage.