Failure to adhere to study plans is the most common research error among US investigatorsBMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g4245 (Published 26 June 2014) Cite this as: BMJ 2014;348:g4245
- Michael McCarthy
Warning letters issued by the US Food and Drug Administration (FDA) to clinical investigators commonly cite failure by the researchers to stick to their stated plans, to protect the safety of trial participants, and to maintain good records, according to a new study.
Under US law the FDA is charged with regulating clinical research and has developed a bioresearch monitoring programme to safeguard patient rights and safety and to ascertain the quality and integrity of data being submitted to the agency.
To assure compliance with FDA regulations, the programme’s staff conducts site visits to clinical trial investigators, study sponsors and monitors, institutional review boards (IRBs), and others entities involved in research.