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.
Hi Eldin, is there a requirement to file the final publication documentation for the public registry e.g. ClinicalTrials.gov or is it alright to file only the submission documentation in the TMF so archiving isn’t delayed?