In This Section
Human Research Protection Program Training
Human Research Protection Program (HRPP) Training is required for anyone involved in clinical research, including staff in administrative roles supporting clinical research. This initial training is satisfied through the Collaborative Institutional Training Initiative (CITI) program. CITI training is accessible online via the CITI website, www.citiprogram.org. Instructions including screen captures are available to walk you through registering and completing the training are included here.
When registering for CITI training, there are three available options for satisfying training requirements on the CITI website: Biomedical Research, Social and Behavioral Research, and Administration Supporting Research. For study team members involved in interventional drug, biologic, or device studies, studies involving invasive procedures, or specimen collection studies, please complete the Biomedical Research Track. For study team members involved in research reviewing survey data, questionnaires, participant observation, or non-invasive physical measurements to study human attitudes, beliefs, or behaviors, please complete the Social and Behavioral Track. For staff who perform administrative functions but are not part of an investigative team, the Administration Supporting Research Track may be selected. The estimated time to complete the Biomedical Research or Social and Behavioral Research track is 3 hours. The estimated time to complete Administration Supporting Research is 1 hour.
The CITI website offers a complete online course in Good Clinical Practice (GCP) guidelines. These guidelines establish best practices for all researchers conducting clinical trials. Topic areas include FDA regulations and International Conference on Harmonization (ICH) guidance, managing investigational drugs and devices, and monitoring and inspections in clinical trials. Effective January 1st 2017, all investigators and staff who are involved in the conduct, oversight, or management of NIH-funded clinical trials at CHOP must complete training in Good Clinical Practice. Additionally, those responsible for the management of CHOP-sponsored Investigational New Drug or Investigational Device Exemption submissions to the FDA are required to complete GCP training.
Please note: Effective January 1, 2020, CITI’s Good Clinical Practice (GCP) course will be required for all research team members who are conducting clinical trials/interventional studies; this requirement applies to all funding sources and is consistent with the NIH’s requirements. A clinical trial/interventional study involves one or more human subjects who 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. If you are a research team member on a clinical trial/interventional study that is active as of January 1, 2020 you will need to complete the GCP course prior to January 1, 2020.
Recertification for HRPP training and, when applicable, GCP training, is required every three years based on the anniversary date of the initial training. Recertification is satisfied through “refresher” modules on the CITI website. You will receive email reminders for re-certification prior to the due date. Refresher training generally takes approximately 45 minutes to complete.
Please note, effective January 1, 2020, recertification for HRPP and/or GCP training may be satisfied through the CITI Biomedical, Social & Behavioral, Administration Supporting Research (whichever is most relevant to the individual), GCP refresher training, IND/IDE Support Program Sponsor Training, the University of Pennsylvania’s online Ethics of Human Research course, OR the completion of two hours of continuation education (with approval by the Office of Research Compliance). The NIH requirement for the completion of GCP refresher training every three years remains in effect.
CITI course completion data is uploaded into eIRB on a daily basis. Thus, training data does not need to be provided by research teams to the Institutional Review Board (IRB). The IRB reviews training completion dates, both for HRPP training and for GCP (when applicable), with each new study submission, continuing review submission, and amendment to add study team members.
CHOP accepts CITI HRPP and GCP training from the University of Pennsylvania (Penn). If you have completed the training through Penn within the past three years, please forward your CITI certificate(s) or completion report to HRPPTraining@email.chop.edu so that we may update our records to indicate that you have satisfied the training requirement.
Any external collaborators (not at CHOP) who have completed HRPP training or GCP training at their home institution may email the certificate(s) of completion to HRPPTraining@email.chop.edu. To be accepted in place of the CHOP CITI modules, training must have been completed within the past three years and comparable to CHOP’s CITI course modules.