The U.S. National Institute of Health has established a registry and database service of publicly and privately supported clinical studies of human participants conducted around the world. A clinical study involves research using human subjects, with intention of adding medical knowledge. The human subjects receive specific interventions according to the research protocol created by the researchers (investigators). The interventions include but not limited to devices; procedures; or changes to subjects’ behavior.
Andrews University researchers who want to register their clinical study may provide (submit/upload) the clinical study through a Web-based data entry system called Protocol Registration System (PRS). You must have a PRS account to register the study information on ClinicalTrials.gov.
The Andrews University PRS Administrators oversees your PRS account activity. The Administrators will help you with how you can apply for PRS Account; Register Your Study; Edit Your Study; and will release the study to public.
Most trials require approval from the IRB. If your study requires approval, you may register your study on ClinicalTrials.gov prior to getting approval if the Overall Recruitment Status of the study is “Not yet recruiting."
If a study requires human subjects review board approval, approval must be obtained before the study’s Overall Recruitment Status is changed to Recruiting. When approval is obtained, please update the protocol section of the study record in the Protocol Registration System (PRS) and release the study for processing.
Once you have uploaded your clinical study please notify IRB Office via email@example.com or 269-471-6361.