- What do companies do with respect to confidentiality by subjects on a trial?
No company attempts to obtain confidentiality agreements from patients, and investigators are not asked to do this. - Are there any guidelines or legal information available on the release of patient medical records or information to CRO for the purposes of identifying potential study patients?
The investigator has a responsibility according to ICH GCP Guideline E6 section 4.2.1 "to demonstrate a potential for recruiting…subjects" but this does not mean providing personal patient information or medical records. The ICH guidelines covering confidentiality indicate that medical records should not be released to companies for such purposes. In addition, the sponsor company should not have access to the patient’s medical records to be able to release them to a third party.
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