HOW CAN WE HELP YOU? Call 1-800-TRY-CHOP
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 1, 2020, CITI’s Good Clinical Practice (GCP) course is 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.
Arcus and/or CDW Training is required for users of either Arcus or the CHOP Data Warehouse (“CDW”) and represents a streamlined training path for users who have not otherwise completed HRPP training. The Arcus and/or CDW Training provides an introduction to research principles before focusing on records-based research and data management. The training module can be accessed from the CITI website.
Recertification for HRPP 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.
Recertification for HRPP training may be satisfied through the CITI Biomedical, Social & Behavioral, Administration Supporting Research (whichever is most relevant to the individual), GCP 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).
There are no refresher requirements for Good Clinical Practice training, unless participating in an NIH-funded clinical trial. For study team members involved in NIH-funded clinical trials, the CITI GCP refresher course must be completed every 3 years.
The Arcus and/or CDW Training must be refreshed every 3 years via the CITI website module, unless another HRPP course has been completed in that time period.
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) for any individual with an ongoing Penn affiliation. If you have completed the training through Penn within the past three years, please forward your CITI certificate(s) or completion report to researchtraining [at] chop.edu so that we may update our records to indicate that you have satisfied the training requirement.
For CHOP study team members who have completed CITI courses at other institutions, please “add an affiliation” with CHOP under your current CITI account. Affiliated CITI users will be credited for modules held in common between institutions, and prompted to take the additional modules required for CHOP’s CITI courses. The inclusion of the current CHOP email address into current CITI profiles, in addition to the prompt creation of an eResearch account, will ensure that any CITI training is reflected in CHOP’s institutional research training database in a timely fashion.
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 researchtraining [at] 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.