HRPP Education Requirements & Tools
Education Requirements
In order to ensure that research is being conducted ethically and following all regulations, all study members of human subjects’ research teams are required to complete Collaborative Institutional Training Initiative (CITI) online training. Before submitting a project package in IRBNet, you must have your CITI certification completed. Please see Education Requirements to review the CITI requirements.
In addition, if any research staff whom are involved in the handling and/or shipment of specimens or biological materials Dangerous Goods must be trained, tested and certified. As the initial education requirement, the research staff must complete or possess a current Saf T Pak training. Subsequently, research staff may complete Saf T Pak or the CDC Packing and Shipping Dangerous Goods training to renew and to be in compliance with the training requirement. In order to create an account and sign-in for the training, you will need a product key. To receive the product key, email Samantha Ramirez (Pathology).
Collaborative Institutional Training Initiative (CITI)
All Baystate Health investigators and staff (or any member being added to the Baystate Health Core Data Form for an IRBNet submission), are required to complete the Collaborative Institutional Training Initiative (CITI) online training.
Please follow the chart below to determine what CITI trainings are required for you and your particular study. Please keep in mind that what is required for one study may differ than what is required for another but Biomedical will always be required. If you have questions on whether your study qualifies as a “clinical trial”, please view the NIH’s Definition of a Clinical Trial website to complete their walkthrough.
If you have an existing CITI account, please add (or affiliate) with Baystate Health. To do this, log in to CITI and select “Add Institutional Affiliation”. When adding this new affiliation, you do not need to remove any other affiliations. CITI will transfer any credits or applicable courses over to Baystate, so you do not need to complete the same trainings or modules twice. You are required to complete all modules required by Baystate Health prior to submission to IRB and ensure that your CITI certification does not lapse.
If you have any questions or issues with the CITI website such as logging in or transfer credits, please reach out to CITI support directly.
| Type of Project | CITI Training Required | Explanation |
|---|---|---|
| NIH Funded “Clinical Trial” OR Study involving an FDA Drug or Device |
All members listed on the Core Data Form must submit current Biomedical and GCP CITI trainings. | https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html ICH E6 (R2) 1.24 Good Clinical Practice (GCP) |
| Sponsor/Internally Funded “Clinical Trial” | Principal Investigator must submit current Biomedical and GCP CITI training. All other members listed on the Core Data Form must submit current Biomedical CITI training. | ICH E6 (R2) 1.34 Investigator |
| Non “Clinical Trial” Studies | All members listed on the Core Data Form must submit current Biomedical CITI training. |
Education Tools
In preparing your research study or IRBNet application, you may have some questions about the process; what category would this fall under, or what happens after I click submit? While we have a research community meetings monthly, we understand you may not always be able to attend. We compiled resources to assist you with everything from creating an initial package to submitting a study closure and everything in between.
IRBNet Processes
User Guides
- Creating Package 1 (SPA)
- Creating Package 2 (IRB)
- Creating Subsequent IRBNet Packages
- Five Steps of the Researcher
- IRBNet Notes - Training Credentials
- IRBNet Create User Profile
- IRBNet Exempt Package
- IRBNet New User Registration
- IRBNet Subsequent Packages
- IRBNet Training and Credentials
- IRBNet Training New Project Submission
- IRBNet Training Post Submission Advance
- IRBNet Notes Subsequent Packages
- Managing Training and Credentials in IRBNet
- How to link to your external CITI account
Clinical Research Staff Meetings
Last Meeting: November 19, 2025
Clinical Research Staff Meeting Presentation -Susan Garrow-Sloan, RN, CCRP, and Vanessa Roxo, MPH presented on Post IRB Approval and Auditing of Research. The aims for this presentation were to differentiate between a not-for-cause, targeted and for-cause audit; describe the purpose of not-for-cause audits; describe the components of a remote versus in-person audit; and describe the steps to take when notified of an audit.
Passcode: 5L=AAG%M
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Past Meetings
2025
October 15, 2025
Clinical Research Staff Meeting Presentation - Lauryn Esposito, CIP and Michael Boland presented on The Basics of Getting Started to Submit a Research Project to the IRB. The aims for this presentation were to identify IRB-specific forms and documents and set-up IRBNet profiles, including adding a CITI Program account and uploading CV's; illustrate how to submit a clinical trial through IRBNet, including the types of submissions; and review the purpose of ancillary reviews, including the Information Security reviews, Unaffiliated Investigator submissions and more.
Passcode: iJ0^k&Az
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September 17, 2025
Clinical Research Staff Meeting Presentation - Susan Garrow-Sloan, RN, CCRP, Sola Odesina, MA, Vanessa Roxo, MPH, and Jillian Tozloski, CCRP, MS presented on Documenting Consent Forms and Procedures; Documenting Research Enrollment—Utilizing Systems Adequately.
The aims for this presentation were to differentiate between documentation of consent and the consent process; identify accepted electronic locations where consent documents may be stored (CIS, Florence); describe the process of entering consent information into OnCore (on study process) and describe effective methods of documenting informed consent (checklist, if patient has asked questions and how that is included within the process note).
Passcode: JDt.A4mk
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August 20, 2025
Clinical Research Staff Meeting Presentation - Susan Garrow-Sloan, RN, CCRP, and Vanessa Roxo, MPH presented on Conducting Participant-Centered Informed Consent Processes. The aims for this presentation were to describe the components of participant-centered informed consent; determine the ability to Identify elements of a consent document that may appear confusing to the participant; describe how providing “context” helps participants understand information; and to identify “word choices” that may impact participant understanding of the informed consent document.
Passcode: Ap33C*K=
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July 16, 2025
Clinical Research Staff Meeting Presentation - Susan Garrow-Sloan, RN, CCRP, and Peter DePergola II, PhD, ThDc, MTS, HEC-C presented on “Ethics Considerations in Research”. The aims for this presentation were to summarize the OHRP and FDA requirements for human subjects research training; distinguish how CITI training achieves part of the federal requirements; and describe the terms therapeutic misconception and clinical equipoise as they relate to ethical conduct of research.
Passcode: +yBq5@+w
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June 18, 2025
Clinical Research Staff Meeting Presentation - L. Cliff Rhodes, MBA, CIP, and Jennifer Pacheco, MPH, CHRC, CIM, CIP presented on “Single IRB-internal and external IRBs; use of commercial IRBs”. The aims for this presentation were to recognize the need to consult with the IRB to determine permission to cede; describe the various ceded/reviewing determinations and the types of external IRBs; connect how the differences between university/non-profit IRBs and commercial IRBs may affect reliance agreements; and manage the responsibilities of study teams for relying and reviewing IRB submissions. Also, Sarann Ton spoke on a new clinical research workflow that has started.
Passcode: &q3.PAz2
View the Single IRB-internal and external IRBs Powerpoint
View the New Clinical Research Workflow Powerpoint
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May 21, 2025
Clinical Research Staff Meeting Presentation - AnneMarie Mal, MDiv, CIM, IRB Analyst, and L. Cliff Rhodes, MBA, CIP, presented on “Understanding the Differences Between Exempt, Expedited, and Greater than Minimal Risk research”. The aims for this presentation were to compare the federal regulations and submission requirements for exempt, expedited and full board research, navigate the IRB submission process and execute follow-on submissions. Also, Vanessa Roxo, MPH, Education and Compliance Specialist, reviewed the importance of CIS Alerts and how to request them.
Passcode: =sa*1R7?
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April 16, 2025
Clinical Research Staff Meeting Presentation - AnneMarie Mal, MDiv, CIM, IRB Analyst, presented on “Determining What Qualifies as Non-Human Subjects Research”. The aims for this presentation was to differentiate between Human Subjects Research and Non-Human Subjects Research to determine what requires IRB oversight.
Passcode: 5$47aLML
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March 19, 2025
Clinical Research Staff Meeting Presentation - L. Cliff Rhodes, MBA, CIP, presented on The history of human subjects research and foundations for regulations. Also, Jennifer Pacheco, MPH, CHRC, CIM, CIP presented updates on Baystate policies and procedures.
Passcode: E@.v6^q2
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February 19, 2025
Clinical Research Staff Meeting Presentation - L. Cliff Rhodes, MBA, CIP, IRB Regulatory Specialist , presented on Registries and Repositories as they relate to research at Baystate . Also, Jennifer Pacheco, MPH, CHRC, CIM, CIP, Director of Healthcare Research Compliance & HRPP/IRB, reviewed two policy updates regarding Participant Payments and Translations and Use of Interpreters in Research.
Passcode: bzX+*XY9
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Registries and Repositories
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January 15, 2025
Clinical Research Staff Meeting Presentation - Susan Garrow-Sloan, RN, BSN, CCRP, HRPP Education and Compliance Specialist, presented our annual research community game show. This edition, called “Two Truths and a Lie”, covered research policies, fiscal responsibilities, and email, fax and privacy responsibilities.
Passcode: 2!G.KGj%
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Two Truths and a Lie
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2024
December 18, 2024
Clinical Research Staff Meeting Presentation - Vanessa Roxo, MPH, Education and Compliance Specialist, presented common audit findings discovered by the EQA team between 2022 and 2024. The most common issues involved protocol deviations, inadequate regulatory documentation, inadequate documentation of subject records and informed consent issues.
Passcode: 7dN&b6?N
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November 20, 2024
Clinical Research Staff Meeting Presentation - Three new SPA policies were reviewed: BC 10.135 Cost Principles and Unallowable Costs Policy; BC 10.145 Sponsored Programs Equipment; and BC 10.140 Labor and Non-Labor Cost Transfer Policy. Also, an update to policy BC 10.400 Disclosure of Financial Interests and Management of Financial Conflicts of Interest for US Public Health Service Funded Research, was discussed.
Passcode: Kx5i^FAg
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October 16, 2024
Clinical Research Staff Meeting Presentation - Dr. Susan Shaw, Professor in the Department of Health Promotion and Policy and the Center for Community Health Equity Research Director at the University of Massachusetts, Amherst, presented techniques to help study participants better understand consent forms.
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September 18, 2024
Clinical Research Staff Meeting Presentation - Dr. Peter Friedmann, Chief Research Officer and Associate Dean for Research at Baystate, presented on the allowable costs and cost principles in grant management.
passcode: X61#8^XI
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August 21, 2024
Clinical Research Staff Meeting Presentation - Cliff Rhodes reviewed how to submit Continuing Reviews and Progress Reports to the IRB, the difference between the two and what is required for both; Sola Odesina presented on The importance of Regulatory Binders: The Requirements, The Guidelines and What to Include in the Binders. Also reviewed the policies regarding file maintenance.
passcode: HVQ57$.S
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July 17, 2024
Clinical Research Staff Meeting Presentation - Jennifer Pacheco did a Baystate Health Policy Review. The following policies were reviewed: Policy BC 6.800 Email and Policy BC 7.340 Privacy Incident Reporting & Mitigation. Linnea Rademaker discussed inclusive language efforts by OHRP and the FDA and changes to some of the IRB forms to reflect these efforts. AnnMarie Mal reviewed updates to our IRB meeting schedule and deadlines.
passcode: i%x080xk
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June 19, 2024
Clinical Research Staff Meeting Presentation - Demonstration of Service Now catalog for the Education and Quality Assurance team. Presentation by Cliff Rhodes on Artificial Intelligence in Research
passcode: &g=be#t2
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May 15, 2024
Clinical Research Staff Meeting Presentation - Demonstration of Redesigned Baystate Health website by Matt Hamel; Rebranding of the HRPP Education and Compliance Specialists to Education and Quality Assurance (EQA); Introduction of Service Now catalog for the Education and Quality Assurance team.
passcode: pb7B.+jc
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April 17, 2024
Clinical Research Staff Meeting Presentation - Transitioning from Department SOPs to Institutional Policies; Data Use Agreements; and Infection Control Recommendations
passcode: 1#yLJ^?s
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March 20, 2024
Clinical Research Staff Meeting Presentation - Fiscal Responsibility Sponsored Projects - Part 2
passcode: ?n3!q3en
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February 21, 2024
Clinical Research Staff Meeting Presentation - Baystate Health Interpreter & Translation Services and Clinical Research
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January 17, 2024
Clinical Research Staff Meeting Presentation - Fiscal Responsibilities: Using Sponsored Money Wisely; Using Resources Effectively and Efficiently
Presentation passcode: a779%!rz
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2023
December 2023
No clinical research meeting in the month of December.
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November 15, 2023
Clinical Research Staff Meeting Presentation - Review of New and Updated Policies that Pertain to Research
Presentation passcode: J83$x8g?
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October 25, 2023
Clinical Research Staff Meeting Presentation - Test Your Knowledge about HRPP
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September 20, 2023
Clinical Research Staff Meeting Presentation - Florence: Learn about eLogs
Presentation passcode: # bp#?!$6E
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July 19, 2023
Clinical Research Staff Meeting Presentation Presentation
passcode: #V9D7B6*
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May 17, 2023
Clinical Research Staff Meeting Presentation
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April 19, 2023
Clinical Research Staff Meeting Presentation
Presentation passcode: pN9h1r^.
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February 15, 2023
Clinical Research Staff Meeting
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January 18, 2023
Clinical Research Staff Meeting
Presentation passcode: BMr!G2HV
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