FAQs – Frequently Asked Questions

QUESTION:
When we perform our document preparation for the eTMF, we use blue pencils to code documents e.g. zone, section and artifact. It has been suggested that it is not acceptable to annotate final TMF documents and we should erase the information from these documents. Would any regulatory authority have issue with the use of blue pencil for coding purposes? Isn’t this an acceptable industry practice?

ANSWER:
We are not aware of any regulations that preclude you from following this practice. It would be advisable to describe the coding process in an SOP so that you can explain why there are blue annotations on the documents. There is potentially an issue if an original paper document is subsequently scanned for regulatory submission purposes e.g a marketing authorisation application. The Regulatory Operations function usually like to have pristine documents to work from and may object to hand-writing on the documents. However, I’m not sure this would actually contravene a regulation….. it just makes the submission look better if the documents are “clean”.


 QUESTION:
When using an eTMF, do companies have a ‘softlock’ where the access of contributors is changed automatically to “Read Only”, keeping only the Project Manager and a limited number of other roles as Contributors? The study would be “softlocked” during the close-out phase after all documents have been uploaded, to prevent other documents from being uploaded, and to ensure a smooth export or transfer of the documents for archival purposes.

ANSWER:
We are aware that some companies do follow this process and during our consultancy projects we usually recommend that the sponsor defines how and when content is to be locked….. ideally on a site by site basis as individual sites are closed out and then for the whole study when the clinical study report is finished.

However, most sponsors seem to perform this operation manually. In one company we have worked with, a Business Administrator modifies the user access rights at a predefined milestone in the study to change the access to read-only, except for a small number of users. This is followed up by a further lock-down to everyone except the nominated archivist a specified period of time after the clinical study report is finalised. The study is then deemed to be “archived”. We are aware of another organisation who follow a similar process, where they change access rights once specific milestones are reached.

We are not aware of any eTMF system that performs this action automatically i.e. an administrator tells the system that the study is closed and then the software automatically changes access rights. If eTMF vendors know otherwise, please let us know!

In terms of locking an eTMF, we often encourage our clients to consider locking down specific content while the study is ongoing. For example, if you have content linked to a “site set-up” milestone and the site is active, you would not expect any more content to be loaded. So why not lock down that content once it has been QC’d? Equally, if you have just performed QC on a batch of documents and confirmed them to be acceptable and complete, it makes sense to lock-down that content so that it cannot be subsequently changed, thereby undoing your QC activity. This all facilitates inspection readiness.


 QUESTION:
If an investigator site receives drug but does not enroll or consent any patients, do they need to retain their Investigator Site File (ISF) per usual retention period? And if the site creates or receives some documents but is cancelled PRIOR to receiving drug from the sponsor, do they need to retain their ISF?

ANSWER:
Different countries/agencies have different rules about when the trial is deemed to have started. For example, in the UK and Europe, this is considered to be the first administration of IMP. In the first scenario (drug received by the site), I would suggest that the site retains the ISF for the required minimum period (2 years in the US, 5 years for Europe). In the second scenario (no drug received at the site), I would suggest there is not a need for the investigator to retain the minimal documents that have been received/created, but the sponsor should retain that small set of documents to show what decisions took place i.e. to maintain a documentation audit trail.


 

QUESTION:
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