This month’s intriguing question …
Who is responsible for the content of the Investigator Site File?
Few years ago, we were confronted with the presence of a randomization list in the Investigator Site File at a clinical site. This was a big issue because it was a double blind study and there was no correspondence or other document that could prove when this list was filed in the investigator’s file. When we confronted the investigator with this list, he got very upset with the monitor, who in his opinion had filed this list by ignorance or mistake in the Investigator Site File. Who is to blame?
ICH E6 GCP clearly states in 4.9.4. that the investigator/institution should maintain the trial documents as specified in Essential Documents for the Conduct of a Clinical Trial and as required by the applicable regulatory requirement(s). The investigator is thus responsible for his Investigator Site File, This file should represent the information to which the investigational team had access in order to make decisions regarding the study. Although it is very common that monitors “arrange” the Investigator Site File, the responsibility for the contents remains with the investigator. We recommend that investigators and their team take much more ownership of the Investigator Site File.