Institutions participating in clinical research strive to protect the safety of human research participants. Making certain that the most current version of the protocol and consent form is used when enrolling human participants in clinical research studies is a major safety intervention. This is often difficult to achieve because multiple versions of the protocol and the consent form often exist.
The aims of the proposed safety intervention include three major aims: (1) to design and implement an internal browser-based web application that houses essential information for each protocol including the most current version of the protocol and the consent form and the preprinted medical orders; (2) to educate the research staff to consistently use the intemal application to obtain the protocol, consent form and the preprinted medical orders each time these items are needed when implementing the research process and (3) to design the intervention so that it can be easily duplicated in other institutions conducting clinical research studies.
