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).
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
- 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
Clinical Research Staff Meetings
Last Meeting: 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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Past Meetings
Clinical Research Staff Meetings
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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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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December 21, 2022
Clinical Research Staff Meeting
Presentation passcode: lYa4^a5@
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November 16, 2022
Clinical Research Staff Meeting
Presentation passcode: x65pW=yX
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September 21, 2022
Clinical Research Staff Meeting
Presentation passcode: nD@2c!2&
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August 17, 2022
CTMS updates with Jovanne Grace from PointB. HRPP/IRB SOP Policy updates. IRB Analysts present "Common Errors that may delay your IRB Submission". Sola Odesina - CIS document upload procedures.
Presentation passcode: b8!FUUdk
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July 20, 2022
All about Sponsored Programs: Melissa Quintero presents the community with a thorough description the Sponsored Program process, and notifies the community of important updates.
Presentation passcode: skAvF9.E
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