You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
Have you ever done a regulatory review and noticed a protocol signature page that wasn’t signed by the Principal Investigator? Or, have you seen a protocol that does not have a signature page? It may make you wonder if a signature page is required.
Topics: Principal Investigator, Clinical Investigational Plan, FDA, 1572 Form, ICH GCP E6 8.2.2
Have you ever done a regulatory review and noticed a protocol signature page that wasn’t signed by the Principal Investigator? Or, have you seen a protocol that does not have a signature page? It may make you wonder if a signature page is required.
Topics: Principal Investigator, Clinical Investigational Plan, FDA