Data and Safety Monitoring means the process to ensure and maintain the scientific integrity of human subject research and to protect the safety of human subjects, a system for appropriate oversight and monitoring to ensure the safety of participants and the validity of the data. The section of…

The processes of handling the data collected during a clinical trial from development of the study forms/CRFs through the database locking process and transmission to statistician for final analysis.

A Data Use Agreement (DUA) is a contractual document used for the transfer of data that has been developed, where the data is nonpublic or is otherwise subject to some restrictions on its use. Often this data is a necessary component of a research project and it may or may not be human subject…

Information that does not identify an individual and with respect to which there is no reasonable basis to believe that the information be used to identify an individual.  This includes that there is no means to re-identify individuals after the data have been de-identified (e.g., using a…

Giving subjects previously undisclosed information about the research project following completion of their participation in research. (Note that this usage, which occurs within the behavioral sciences, departs from standard English, in which debriefing is obtaining rather than imparting…

Deception is the intentional misleading of subjects or the withholding of full information about the nature of a research experiment or procedure. Misleading or omitted information might include the purpose of the research, the role of the researcher, or what procedures in the study are actually…

The World Medical Association adopted the Declaration of Helsinki (1964) as guidance for medical doctors undertaking biomedical research involving human subjects. The Declaration has been continuously revised. It addresses important issues including the principle of risk to benefit ratio in…