Citations of general articles (in English) on the place of Good Clinical Practice (GCP) in clinical research. GCP means clinicians are following high standards for carrying out clinical trials. GCP ensures that trials are "designed to produce meaningful data, conform to international ethics regulations, and provide assurances that data are reported in a credible and reliable manner. The Food and Drug Administration (FDA) and federal government have outlined the necessary components of clinical trials in the Code of Federal Regulations (CFR). These include institutional review boards (IRBs), standard operating procedures (SOPs), sites, sponsors, investigators, and patients." [K. Li, 2012: Urologic Oncology, 30(4 Suppl), S28-32.]
Effective October 1, 2014, all UNC-CH investigators and research staff who are involved in the design, conduct, or reporting of clinical trials involving human subjects AND a drug, device, or biologic are expected to document completion of GCP training. The completion of the initial training is effective for 2 years. At the end of a 2 year period, a GCP refresher course will be required.
Citations for articles about Data Monitoring Committees in clinical trials. According to the NIH, "[Data Monitoring] Committees [are] established to review interim data and efficacy outcomes in clinical trials. The findings of these committees are used in deciding whether a trial should be continued as designed, changed, or terminated. Government regulations regarding federally-funded research involving human subjects (the "Common Rule") require (45 CFR 46.111) that research ethics committees reviewing large-scale clinical trials monitor the data collected using a mechanism such as a data monitoring committee. FDA regulations (21 CFR 50.24) require that such committees be established to monitor studies conducted in emergency settings."
Citations of articles on Informed Consent in clinical trials. The NIH defines informed consent: "Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment."
A guidance document from the FDA. These guidelines have no regulatory force.
"This guidance assists sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations thereof."