The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidance for Industry E6(R2) Section 5.18.1 notes that "the purposes of trial monitoring are to verify that:
(a) The rights and well-being of human subjects are protected.
(b) The reported trial data are accurate, complete, and verifiable from source documents.
(c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).”
The protocol oversight service provided by the NINDS Clinical Trials Unit, is charged with providing auditing and monitoring of all active clinical research within the intramural research program. on assisting the Clinical Neuroscience Program in the dissemination of applicable NIH and FDA policy to ensure compliance with the policies governing good clinical research and the protection of human subjects. To accomplish these goals, the quality assurance team performs scheduled, random and for-cause quality assurance audits of intramural research protocols and on-going monitoring of FDA-regulated protocols to determine if research is conducted in a manner that is compliant with the protocol and applicable regulations and policies.
- Site Initiation Visits for new protocols
- Monitoring of FDA-regulated trials
- Quality Assurance audits for minimal risk and more-than-minimal risk protocols
- For-cause Quality Assurance audits, as requested
- Monitoring of NSR device study protocols and protocols utilizing PET ligands under an IND
- Oversight of the external monitoring of FDA-regulated protocols
- Assist with clinicaltrials.gov results reporting, for applicable clinical trials