Education and Training for Research Personnel

The Office of Data Quality supports multiple educational opportunities and training requirements for HCC research personnel. Our program includes maintaining the Human Subject Protection (HSP) and Good Clinical Practice (GCP) training through the CITI website, providing policy and regulatory training for new HCC investigators, and coordinating an educational lecture series open to all HCC institutions.

Policy Training and Signature Record Step by Step: CITI HSP/GCP Training Contact Us

Resources

HCC Policies and Operations

EDU-100: Training Requirements for Research Personnel

HSP and GCP Staff Training Lists

Research Staff with the appropriate OnCore access may download real-time reports to verify the current HSP/GCP training and expiration dates for all active HCC research personnel. For instructions on accessing these reports, please click here:

Instructions: Accessing HSP/GCP Training Reports in OnCore

Frequently Asked Questions - HSP and GCP Training

All research personnel, including ancillary reserach support staff (e.g., research administration, biostats, research pharmacy roles, etc) must complete HSP training.
All research personnel except those working exclusively on Not Human Subject Research (NHSR) or IRB-Exempt research, must complete GCP training.
One way to think about it is if an individual needs an OnCore profile and/or access to any HCC research systems to fulfill their role, they should be compliance with training per EDU-100.
The user group you are required to complete depends upon the nature of your research work.
Individuals involved in controlled clinical trials, retrospective chart reviews, tissue banking or similar types of research involving human subjects (including minimal risk biomedical trials) should take the BioMedical course (Group 1).
Individuals involved solely with quality of life studies and community-based research should take the Social/Behavioral Course (Group 2).
Individuals involved exclusively with Not Human Subject Research (NHSR) or IRB-Exempt research should take the BioMedical Minimal Risk or Exempt Course (Group 3). *Note: GCP training is not required for this group.
Individuals involved in both biomedical research and social/behavioral research should take the combined Social/Behavioral and BioMedical Course (Group 4).
IRB and SRC members should take the course that corresponds to the type of research they are reviewing.
*Note: Groups 1, 2 and 4 can be taken as individual courses, OR can be taken as a combined HSP and GCP (refresher option also available). For instructions, please see: CITI Step by Step Instructions - HSP & GCP Training
Both HSP and GCP training must be completed every 3 years. Refresher courses are acceptable.
On the Main Menu screen, under the word "Status" it will say "Passed" and list your training completion date. On this same page, you can print or share your completion certificate.
Other training courses, including the MGB Clinical Research Boot Camp and GCP courses, may be accepted in lieu of CITI training. For example, the MGB Clinical Research Boot Camp (HSP) and Good Clinical Practice (GCP) courses are accepted. Any external GCP courses stamped with the "TransCelerate" seal will be accepted. In other cases, ODQ needs to verify that the HCC minimum requirements have been met. Most of the CITI training programs through a Harvard-affiliated institution will satisfy the HCC requirements. Please contact the ODQ Education Coordinator at ODQEducation@dfci.harvard.edu with questions or to determine if another program qualifies.
Automatically retrieve your username and/or password by clicking "Forgot login information" on the CITI main page.
Users should download their individual certificates directly from the CITI site by selecting "view previously completed coursework" on the Main Menu page. You can then select "share/print" for a specific course to download a PDF of your completion certificate.
The CITI website does generate automatic reminders to individuals when their training is due to expire. Additionally, ODQ will alert staff with active OnCore profiles that their training will be expiring, or has already expired.
Individuals who do not meet the training requirement may not be involved in human research activities. A protocol with non-compliant staff will be held up at submission or continuing review.
- If the PI of a study fails to meet EDU-100 training requirements, activation of the study at their site may be held up, or the study may be temporarily closed util they are in compliance.
- If a sub-investigator or other reserach team member fails to meet the training requirement, they may be required to be temporarily removed from the study until the training requirement is met.
If you encounter technical issues, please contact the CITI Support Desk at support@citiprogram.org.
You may also contact the ODQ Education Team with questions specific to HCC training requirements at ODQEducation@dfci.harvard.edu.

Per EDU-100, all Principal Investigators conducting HCC research must fulfill a HCC New Investigator Training requirement, as set by ODQ.

There are two versions available. One focuses on Clinical Research (Drug/Device) and the other on Non-Clinical Research, including Social-Behavioral studies. Please contact ODQEducation@dfci.harvard.edu if you are unsure of which version to complete. This training can be completed as an e-learning here:

New Investigator Training for Clinical Research New Investigator Training for Non-Clinical/Social-Behavioral Research

Please contact ODQEducation@dfci.harvard.edu with any questions regarding this training requirement.

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