Human Subjects Protection Training
All individuals conducting research with human participants must complete Human Subjects Protection (HSP) training modules through the CITI Program before the Human Subjects Research Office will review an application. Visit the HSR CITI page for guidance to create an account (or link an existing account) and complete the required training.
Upon successful completion of HSP training, a completion certificate must be retained by the researcher. This training requirement covers not only Principal Investigators, but also all individuals identified as study personnel. Personnel external to UT Dallas who conduct human subjects research at or with UT Dallas must also complete the required training or provide proof of equivalent training.
HSP training must be renewed every 3 years.
Good Clinical Practice Training
All investigators and staff engaged in clinical trials are required to complete Good Clinical Practice (GCP) training every 3 years through the CITI Program. This requirement is to comply with NIH Policy, effective January 1, 2017. Visit the HSR CITI page for guidance to create an account (or link an existing account) and complete the required training.
As defined by the NIH:
Clinical Trial: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
Investigator: The individual responsible for the conduct of the clinical trial at a trial site. If a clinical trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.
Clinical Trial Staff: Individuals, identified by the investigator, who are responsible for study coordination, data collection and data management. The central focus of clinical trial staff is to manage participant recruitment and enrollment, to maintain consistent study implementation, data management, and to ensure integrity and compliance with regulatory and reporting requirements. These individuals may also seek informed consent from prospective participants, enroll and meet with research participants, and collect and record information from research participants. Clinical trial staff may also be called the research coordinator, study coordinator, research nurse, study nurse or sub-investigator.
Upon successful completion of GCP training, a completion certificate must be retained by the researcher. This training requirement covers not only Principal Investigators, but also all individuals identified as study personnel.
GCP training must be renewed every 3 years.
Question, Persuade, Refer (QPR) Training
Investigators and staff engaged in research dealing with suicidal ideation (i.e., use of surveys such as the Beck Depression Inventory (BDI), or populations at higher risk for suicidal ideation) who will be interacting with participants or their identifiable data are required to complete and document QPR training. QPR is offered throughout the calendar year by the Student Wellness Center and is supported by the Human Subjects Research Office. Once completed, QPR training does not expire.