Data integrity is a fundamental requirement of medical research and laboratory experimentation. All studies should be conducted according to the protocol guidelines and documented accurately and completely even if the data disproves or challenges the posted hypothesis. As researchers, it is our responsibility to make sure the study is conducted ethically and honestly. The results of the study are used to justify the effectiveness of a procedure, medical device or pharmaceutical. The goal is to improve the overall health and welfare of humans. Lack of data integrity could prove to be a disaster as something originally thought to be safe could cause unexpected pain or death.
This whitepaper examines the similarities and differences between various US and international regulations and place them within the context of any number of roles found within the realm of clinical research.