Education and Training for Research Personnel

The Office of Data Quality supports multiple educational opportunities and training requirements for DF/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 DF/HCC investigators, and coordinating an educational lecture series open to all DF/HCC institutions.

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

Resources

DF/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 DF/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

Investigators, study coordinators and other research staff are required to complete the appropriate HSP and GCP training prior to their IRB approved research activities.

Researchers must update their HSP and GCP training every 3 years, through the appropriate CITI refresher courses, or a comparable course. Please contact ODQ if you have questions about a particular course outside of the CITI website and whether it is accepted by DF/HCC.
All research personnel 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.

For additional clarifications on individuals that may be exempt from the GCP training requirement, please see: DF/HCC GCP Training Update Guidance & FAQ
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 updated every 3 years. Refresher courses are available in through CITI.
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 are accepted on a case-by-case basis. Any GCP courses stamped with the "TransCelerate" seal will be accepted. In other cases, ODQ needs to verify that the DF/HCC minimum requirements have been met. Most of the CITI training programs through a Harvard-affiliated institution will satisfy the DF/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 Overall PI of a study fails to meet the training requirement, the DFCI IRB will temporarily close the study until the training requirement is met.
- If the Site Responsible PI of a study fails to meet the training requirement, the DFCI IRB will temporarily close the study at that site until the training requirement is met.
- If a co-investigator of a study fails to meet the training requirement, the DFCI IRB will temporarily remove them from the study until the training requirement is met.
A Research Team Update Form must be submitted to the DFCI IRB once the individual has completed training for them to be officially added back to the study.
If you encounter technical issues, please contact the CITI Support Desk at support@citiprogram.org.

You may also contact the ODQ Education Coordinator with questions specific to DF/HCC training requirements at ODQEducation@dfci.harvard.edu.
At this time, DF/HCC does not require separate training on the GCP ICH E6(R2) Addendum.

However, some sponsors are requiring training, so we'd like to provide a couple of options for fulfilling this requirement:

Two ways to complete training on the addendum:

(1) CITI GCP Training (Basic or Refresher) - The addendum went into effect on December 15th, 2016. At that time, the addendum was incorporated into an updated GCP training in CITI. Anybody who has taken the CITI GCP training after December 15th, 2016 has already been trained on the addendum, and may use their training certificate as proof of training.

See here for more information from CITI: about.citiprogram.org/en/news/updated-gcp-modules-ich-e6-r2/

Instruction on completing GCP through CITI can be found on the ODQ Education Page.

(2) CITI Overview Slides - CITI has also provided slides to review the changes the addendum encompasses.

The slides may be viewed here: about.citiprogram.org/wp-content/uploads/2017/08/GCP-ICH-Revisions-Resource.pdf

To document training on these slides, please contact your institution's clinical trials office for more information.

Per EDU-100, all Principal Investigators conducting DF/HCC research must fulfill a DF/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.

DF/HCC eLearning Center

Welcome to eLearning Center, an online resource library that houses trainings intended to assist investigators and research personnel with maintaining compliance while conducting research at DF/HCC. Additionally, you can find recordings of previous presentations and lectures given on various topics relevant to DF/HCC research.

DF/HCC Comprehensive New Investigator & Researcher Training

This training is required for Principal Investigators, per policy EDU-100, however all DF/HCC research personnel are strongly encouraged to view this presentation, as it covers topics such as DF/HCC structure, systems, policies and requirements, and where to find additional resources relevant to conducting research at DF/HCC. This training runs about 40 minutes.

Click here to take training

Topic-Specific eLearning Modules

Writing an Informed Consent Form Using DF/HCC Templates (~40 minutes) Link
The NCI CIRB - Submission Process and Other Requirements for DF/HCC Sites (~30 minutes) Link
Single IRB Reviews and Processes at DF/HCC (~30 minutes) Link
Secondary Use and Not Human Subject Research Determinations (~20 minutes) Link
Documenting Delegation of Authority - DF/HCC Process (~7 minutes) Link
ABCs of GCPs (12:56) Details
An "Informative" Consent Document (10:59) Details
Design, Data and Statistical Analysis (32:10) Details
HIPAA Privacy Rule and Research (27:16) Details
Investigator's Brochure Details
Public Protocol Registraton (10:54) Details

Recorded Presentations

January 12, 2018

"Clinical, Regulatory, Logistical, and Financial Aspects of CAR-T and other Novel Cell Therapies"
Sarah Nikiforow, MD, PhD
Clinical Instructor, Stem Cell Transplantation Program
Asst. Medical Director, Cell Manipulation Core Facility
Dana-Farber Cancer Institute

Click here to watch recording

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April 29, 2016

"Ethical Issues Related to Research Biopsies and Stored Biospecimens"
Jeffrey Peppercorn, MD, MPH
Associate Professor of Medicine,
Massachusetts General Hospital

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MARCH 21, 2016

"Non-Clinical Research"
Sara Harnish, J.D.
Associate Director for Non-Clinical Research
Office for Human Research Studies

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January 22, 2016

"Unanticipated Problems and Adverse Events"
Michele Russell-Einhorn, JD

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Cultural Competency Training for new DF/HCC researchers

With growing concerns about racial and ethnic disparities in cancer care and the need for cancer centers to accommodate increasingly diverse patient populations, it is important that health care professionals are educated on how their own and their patients' culture influence health care delivery, health behaviors, and access to clinical trials. This self-directed program will stimulate your thinking about cultural competence and help you to understand how culture influences health care decisions and participation in clinical trials.

Part I: Reflections on Cultural Competence in Cancer Care

View below (speaker: Christopher Lathan, MD)

Presentation Archives (prior to 2010)

Considerations for Choosing among Types of Phase II Designs (Presented by Paul Catalano, ScD on July 23, 2010) Resource
CTCAE v4.0 (Presented by Vicki Duvall and Michele Copersino on May 28, 2010) Resource
Benefits and Risks of Cancer Imaging (Presented by Jeffrey Yapp, PhD on February 19, 2010) Resource
Investigator-Initiated Multi-Center Trials (Presented by Jeffrey Clark, MD on September 26, 2008) Resource
Cancer Care and Research at DF/HCC in 2015 (Presented by Barrett Rollins, MD, PhD on August 22, 2008) Resource
Investigator-Held IND Studies (Presented by Jeffrey Clark, MD on April 25, 2008) Resource
Response Assessment Criteria for Clinical Trials (Presented by Cheryl Sadow, MD on January 29, 2008) Resource

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