In general, the ISF and the sponsor TMF must be kept separate due to the regulatory requirement that forbids the sponsor from accessing documents which contain a subjectís identifying information.

However, when the Sponsor is not a separate company, but rather an academic institution or hospital where the investigator is employed, the Investigator file/TMF could be a combined sponsor and investigator TMF.

What I'm not clear on is the ISF/TMF requirements in the following scenarios:

  • Multi-centre study, sponsored by an institution that also employs the CI, but where PIs are in place at the investigator sites. Whilst good practice is for the PI to retain the ISF, is it allowable for a combined TMF/ISF(s), held by CI?

  • Multi-centre study where CI is undertaking research activities at the various sites via a letter of Access/Honorary Research Contract. PI's not in place at investigator sites. Again, is it it allowable for a combined TMF/ISF to be held by the CI?

Thanks in advance.