DF/HCC Training and Education

Training requirements for DF/HCC research personnel are governed by policy EDU-100, and are outlined in the New Research Staff Checklist. Utilize the checklist, as well as the resources on this page to fulfill all training requirements prior to starting research at DF/HCC.

Required Training for All Research Staff

All research personnel are required to complete Human Subject Protection (HSP) and Good Clinical Practice (GCP) training prior to starting research. A refresher course of each must then be completed every 3 years.
Instructions:
Typically HSP and GCP are completed through the CITI program. Use the following guidance to access the appropriate courses.
CITI training completed under DFCI is automatically sent to ODQ for record keeping.

Note: If you complete CITI training outside of the DFCI affiliation (e.g. under BIDMC or BCH) OR you complete the MGB Healthstream HSP/GCP trainings, then be sure to send your completion certificates directly to ODQEducation@dfci.harvard.edu.
DF/HCC SYSTEMS TRAINING
Required in order to obtain access to certain systems. Follow the instructions on the New Research Staff Checklist. See DF/HCC Systems Access for more information.
DF/HCC POLICY TRAINING
Typically provided by direct supervisor or institutional clinical trials office.
- Review all DF/HCC Policies
- Document Training
PROTOCOL-SPECIFIC TRAINING
Required. This will be provided by the protocol PI or designee.

Additional Required Training for PIs

All Principal Investigators (PIs) are required to complete a one-time training, provided by the Office of Data Quality (ODQ).
Instructions:
Review either the Clinical or Non-Clinical e-learning below, depending on the type of research you are primarily working on, and e-sign the form at the end to attest to completing this training:
- Principal Investigator Training for Clinical Research
- Principal Investigator Training for Non-Clinical Research
Note - These work best when opened in a Chrome or Firefox browser.
Contact ODQEducation@dfci.harvard.edu with questions about this requirement.
Any DF/HCC investigator holding an IND must complete appropriate training on IND-holder responsibilities and regulations. This training is provided by the investigator's home institution, and proof of completion must be provided to ODQ for centralized tracking.
Instructions:
To complete this training requirement, please reach out to your designated institutional contact listed below:
- BIDMC: CCTO-QM@bidmc.harvard.edu
- DFCI & BCH: DFCI_ClinicalTrials@dfci.harvard.edu
- MGB (MGH & BWH): ceoffice@mgb.org
- HSPH/HMS & BCH when not affiliated with DFCI: ODQEducation@dfci.harvard.edu
For questions or more information on this requirement, please reach out to ODQEducation@dfci.harvard.edu
Any DF/HCC PI serving as the sponsor of an investigator-sponsored multi-center trial must complete a one-time training prior to activating their multi-center trial.
Instructions:
Review the ~20 minute e-learning below, and e-sign the form at the end to attest to completing this training.
- Multi-Center Sponsor-Investigator Training
Note - This training works best when opened in a Chrome or Firefox browser.
Contact ODQEducation@dfci.harvard.edu with questions about this requirement.

iRIS Education and Training

Visit the iRIS Training and Resources Page to access all of our iRIS resources, including:

iRIS Submission Basics e-Learning Series - a 7-module course covering all of the basics from creating a submission, how submissions are routed and reviewed, activation steps, managing subsites, and more!
iRIS WIKI - detailed guidance and work instructions for investigators and study teams on a variety of iRIS topics
Archived iRIS Office Hours Webinars - review previously recorded live webinars focusing on specific iRIS topics, system updates, and more

Other Educational Resources

IND Safety Reporting Policy Updates - RCO-204 (27 minutes)
July 29, 2025
Kye updates to DF/HCC policy RCO-204, INDSR guidance, and operational workflows for INDSR review and reporting for both externally-sponsored and investigator-sponsored trials.
View Slides Only

DFCI IRB SAE and IND Safey Reporting (INDSR) Policy Updates (49 minutes)
March 12, 2025
Overview of the revised DFCI IRB SAE and INDSR Reporting Policy, clarifying the timelines for reporting and the responsiblities of the investigator/sponsor consistent with FDA regulations and guidance.
View Slides Only

Informed Consent Policy and Guidance Updates - Session 2 (48 minutes)
January 16, 2025
FAQ for recent consent-related updates, including a focus on the new requirement for translation of the full ICF following use of a short form
View Slides Only

Informed Consent Policy and Guidance Updates - Session 1 (57 minutes)
December 16, 2024
In-depth walk through of consent related updates, including to CON-100, CON-101, DFCI IRB Reconsent Guidance, DFCI IRB LAR Policy, and Consent Form Templates
View Slides Only

New Pre-Submission Form Process (45 minutes)
April 22, 2024
Overview of the new Pre-Submission Form, submitted in iRIS prior to the NPA submission to facilitate contracts, budget and finance review for applicable trials.
View Slides Only

New DF/HCC Policy RCO-104: New Protocol Submission Requirements(45 minutes)
July 2023
Overview of the requirements for new protocol submission to DF/HCC as outlined in new policy RCO-104 (effective August 1, 2023).
View Slides Only

iRIS Office Hours: November 15, 2023 (36 minutes)
Topics include:
- New - Operational Feasibility Form
- iRIS form changes
- Administrative Modifications - Sponsor Correspondence
- Subsite status changes
  View Slides Only
General Reminders and Updates: iRIS, OnCore, and More
October 3, 2023
Topics include:
- Subsite and secondary team management/oncology groups
- Changes to dose levels/arms
- Deviations/violations tracking
- Duplicate subject registrations
- Responsible contacts for adding study staff to iRIS and OnCore
- Revising consent forms in iRIS
- Consent form translation - best practices
- Language shift: changing "therapeutic" to "treatment"
- Reminder: NCI CTEP systems and ID.me integration
  Access this recording and slides through the OnCore WIKI
New DF/HCC Policy RCO-104: New Protocol Submission Requirements(45 minutes)
July 2023
Overview of the requirements for new protocol submission to DF/HCC as outlined in new policy RCO-104 (effective August 1, 2023).
View Slides Only

iRIS Updates and OHRS/ODQ Reminders(23 minutes)
February 22, 2023
Overview of recent iRIS updates including routing of administrative modifications to Pharmacy review, Outcome letters and additional email notifications, process change for adding external sites to multi-center trials including the New Institution Selection Form, language added to the amendment form for changing dose/cohort arms to "closed", and additional reminders from ODQ & OHRS.
View Slides Only

Recording Deviations/Violations in OnCore (55 minutes)
January 25, 2023
Overview of the new process for recording deviations/violations in OnCore as well as a roundup of recent updates from OHRS and ODQ including external SRC review for new protocol submissions, recent DF/HCC policy updates, new IND-holder training requirement and more.
Access this recording and slides through the OnCore WIKI

Policy Updates including AE/SAE Reporting Requirements, Pre-iRIS Submission ICOI Review Request Form, and iRIS WIKI Updates/Demo(48 minutes)
September 21, 2022
A review of recent updates to the DFCI IRB SAE policy, upcoming DF/HCC policy updates (effective 9/30/22), rollout of the new pre-iRIS Submission Review Request Form for ICOI, and an overview and demo of updates to the iRIS WIKI, including improved navigation and searchable pages.
View slides only

Alert Page Process Change, with additional iRIS/OHRS Updates(49 minutes)
May 19, 2022
An in-depth overview of the new Alert Page policy and process, plus a brief overview of the May 26 iRIS release, and OHRS process and forms updates, including External SRC approvals, the new Continuing Review Pre-Review Committee, adding Secondary Management Groups in iRIS/OnCore, and a live panelist Q&A session.
View slides only View FAQ

Investigator Review of External IND Safety Reports (48 minutes)
January 7, 2022
Overview of recent updates to policy RCO-204, expectations of investigators and sponsors when it comes to INDSR review, and strategies for our investigators to deal with sponsor overreporting of INDSRs, including a live panelist Q&A session.
View slides only

Non-Therapeutic Research at DF/HCC (55 minutes)
October 7, 2021
Representatives from central DF/HCC support offices discuss types of non-therapeutic research that is submitted under DF/HCC and the support and resources available.
View slides only

OHRS Office Hours - Top 10 IRB Conditions (25 minutes)
June 22, 2021
The Office for Human Research Studies (OHRS) discusses the top 10 most common issues the IRB finds in protocol and consent form submissions that require correction from the study team.
View slides only
These resources reflect DFCI-specific systems and institutional policies that may not be applicable at other DF/HCC institutions.
- e-Learning Course on Using Adobe Sign for Obtaining Informed Consent
  (25 minutes)
  This training is intended for DFCI research teams and covers the regulations and requirements for electronic signatures and informed consent, provides an overview of the process, and step by step instructions for preparing and sending consent forms for signature.
- e-Learning Course on Using Adobe Sign for Regulatory Documents
  (25 minutes)
  This training is intended for DFCI research teams and provides instructions and case study examples for using Adobe Sign to electronically complete and sign regulatory documents including INDSRs, Covers Letters, Attestation Forms, and DOA Logs.
- NEW: Quick Guide to ClinicalTrials.gov e-Learning
  Review brief modules and demos covering DF/HCC processes for requesting new clinicaltrials.gov accounts, registering new trials, updating and maintatining your trial record and preparing for results reporting.
- How to submit results to Clinicaltrials.gov
  This resource for sponsor-investigators and statisticians walks through the requirements and step by step instructions for reporting results to Clinicaltrials.gov.
DF/HCC has subscribed to the All-Access Webinar package to benefit our investigators and research personnel!

This provides our staff with access to all current and future recorded webinars, including topics like:
- Remote Informed Consent
- Race in Clinical Research: Ethics and IRB Decision Making
- Getting Started in Grant Writing
- Understanding Consent Requirements under the Revised Common Rule
- Social Media and Research Recruiting
...and many more!

How to Access Webinars

All DF/HCC researcher personnel, no matter your home institution, are encouraged to affiliate with DFCI in CITI in order to access these webinars. Please use the guidance below to do so:
- Step-by-Step Guide: Affiliate with DFCI in CITI and Access Webinars
- Log into CITI