VCOM Institutional Policy and Procedure Manual

results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. Compliance: Adherence to all the trial related requirements, GCP requirements, and the applicable regulatory requirements. Non-compliance : Failure to follow trial related requirements, GCP requirements, and applicable regulatory requirements, from minor to serious issues or continuing non-compliance, evaluated on a case-by-case basis, whether intentional or unintentional. Documentation : All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, X-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken. Source Documents : Original documents, data, and records (hospital records, clinical and office charts, laboratory notes, subject diaries, pharmacy dispensing records, recorded data from automated instruments, and copies or transcriptions certified after verification). Investigator : A person responsible for the conduct of the clinical trial at a trial site, responsible leader of the team, called principal investigator. Monitoring : The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and the applicable regulatory requirements. PROCEDURES Compliance audit reviews will be categorized as follows: 1. Level I Protocol is found to be in compliance with HHS Regulations, in accordance with Good Clinical Practice (GCP), with consistency and completeness of regulatory and source documentation. a. VCOM IRB will determine and assign an excellent, satisfactory, or marginal rating of compliance. b. The Principal Investigator (PI) will be notified by letter as to the findings of the compliance review. No PI response is required. c. A hard copy of compliance findings will be kept on file with VCOM IRB. 2. Level II Protocol is found to be in compliance with HHS Regulations, in accordance with GCP, however, recommendations for improvement(s) to protections have been identified, requiring PI response. a. The IRB Coordinator will assimilate a list of recommendations as stipulated by the IRB, as well as determine the need for additional educational measures that may be suggested for the PI and/or research team. b. The PI will be notified by letter as to the findings of the compliance review, to include a detailed list of recommendations requiring a response from the PI within 14 days of receipt of the letter. c. A hard copy of the compliance findings/responses will be kept on file with VCOM IRB. 6.