Considerations for the conduct of clinical trials of medical products during major disruptions due to disasters and public health emergencies: guidance for industry, investigators, and institutional review boards
- Collection:
- Health Policy and Services Research
- Contributor(s):
- United States. Food and Drug Administration. Office of Clinical Policy. issuing body. Center for Drug Evaluation and Research (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body. Center for Devices and Radiological Health (U.S.), issuing body. Oncology Center of Excellence (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, September 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Clinical Trials as Topic Disasters Emergencies Government Regulation Public Health United States
- Genre(s):
- Guideline Technical Report
- Abstract:
- Disasters and public health emergencies (PHEs) have the potential to cause major disruptions in the conduct of clinical trials for medical products. Such events can include (but are not limited to) hurricanes, earthquakes, military conflicts, infectious disease outbreaks, or bioterrorist attacks. FDA is issuing this guidance to provide general considerations to assist sponsors, institutional review boards (IRBs), and clinical investigators in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during disasters and PHEs that may lead to major disruption of clinical trial conduct and operations. The appendix to this guidance further explains these general considerations in a question-and-answer format. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (31 pages))
- NLM Unique ID:
- 9918716786406676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918716786406676