Can Chief Investigators have rights to enter and edit data for all sites, or is there an MHRA rule or guidance statement saying that CIs cannot enter/edit data for all sites?
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Can Chief Investigators have rights to enter and edit data for all sites, or is there an MHRA rule or guidance statement saying that CIs cannot enter/edit data for all sites?
I don't think I understand. What sort of data is this?? MHRA (like all other regulators) expect high quality data that conforms to ALCOACCEA. Of vital importance is attribution of all data and documentation. Best to read all of ICH E6 R2. Section 8 says that the investigator must be constantly in control of all of their data and documentation , essential documents , source documents and their transcribed data into CRFs. Also lots of other sections of ICH E6 say what the duties and responsibilties are of the investigator and a Chief Investigator cannot take those responsibilities. Best also to read MHRA GCP Guide 2012 which details what the duties of the CI are. .. So I'm at a bit of a lose to know what to say as I cant see how the CI can enter data for the PI.