Compliance with Good Clinical Practice and ICH guidelines will ensure subject safety, quality data, and speed up the review process. When the Personal Investigator signs Study Protocol for any Global study or, in the US, the FDA form 1572 (for IND studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations.The responsibilities are clearly described in The ICH GCP Guidelines of E6 (4.1 to 4.13).
The responsibility for the safety of the subjects is clear in the Guidelines.
The 3rdprinciple of GCP states that the rights, safety, and well being of trial subjects must remain the top priority. The single most important function of the Principal Investigator and the study conduct team is the awareness, assessment, and management of Adverse Events occurring during the conduct of clinical research with drugs or devices utilizing human subjects. AE’s are one of the key ways the Clinical Investigator has of monitoring the safety of subjects or patients in her/his charge.
Subject safety is clearly delineated in the study protocol and as the 4thprinciple of GCP states; trials must be scientifically sound, and described in a clear, detailed protocol.Further, the 5th principle states that the trial must be conducted exactly as stated in the protocol that has received prior oversight committee (IRB, IEC, REB) approval.Tags: Clinical Practice, clinical research