Monthly News & Updates

October 2023 Issue

Please visit the HRPP Website to watch the October 25, 2023 Research Community Meeting and Past Meetings.

Visit our Website

The next Research Community Meeting will be held on Wednesday, November 15, 2023, from 2:00pm - 3:00pm.

Job Aid: Invoicing For Financial Events - Study Team Submissions to SPA

At Baystate, it is the Study Team’s responsibility to indicate when certain financial events within the study have occurred. This guide outlines the information required to accurately submit the financial event details so that these items can be invoiced to the Sponsor by SPA.

Click here for the Job Aid

Managing Training and Credentials in IRBNet

The IRBNet User Profile is a central location to house a CV, CITI Basic Biomedical Training (Baystate Health) and CITI GCP Training (Baystate Health). Research team members can link all training and credentials to project packages in IRBNet as opposed to having to upload them with each future package.

Effective February 1, 2024, the Baystate IRB office will require all research team members to link their CV's and CITI training to their IRBNet User Profile. A Standard Operating Procedure with IRBNet instructions has been created and is linked below.

Linking CV's and CITI Training in IRBNet

Baystate Health Florence Electronic Regulatory Binder

Policy and Procedure

Federal regulations require documentation of all study-related activities. Investigators are responsible for maintaining study documents in accordance with applicable federal regulations, International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines, Health Insurance Portability and Accountability Act of 1996 (HIPAA) requirements, and departmental procedures.

This Standard Operating Procedure (SOP) describes the identification and storage of regulatory Essential Documents for clinical research studies and trials in Florence eBinders™ and to establish the process by study-related responsibilities are delegated to applicable personnel and by which necessary information about each team member’s involvement in the study is maintained.

Florence Policy and Procedure

Spotlight on Linnea Rademaker, IRB Reliance Analyst

Linnea Rademaker, IRB Reliance Analyst, recently attended the OHRP Conference, "Making a Difference in Human Subjects Research: Empowering Participants, Engaging Communities, and Protecting Data", in Ann Arbor, MI.

Read Linnea's Conference Summary

Linnea also recently participated in a panel discussion entitled "Addressing Suicidal Ideation: Best Practices and Ethical Considerations". The link to the recording is below. The passcode for the recording is 7b^6h$1O.

Panel Discussion

Hosted by SUNY Downstate Health Sciences University

“My Wife is the Father” -- The Impact of Gendered Regulatory Language on LGBTQIA+ Participation in Research”

Date: October 31, 2023

Time: 2 PM (ET)

Duration: 1 hour

This session will be recorded and available to those who register.

Click For more information and free Zoom registration

Meet Our Newest Team Member: Brandon Williams

Hello! My name is Brandon Williams. I am excited to be joining Baystate Health as an IRB Analyst. I have a M.S. in Exercise Science and love sports. Before coming to Baystate, I have had the roles of HRPP Regulatory Compliance Analyst, Clinical/Translational Research Coordinator, and Research Data Specialist at Vanderbilt University Medical Center. Aside from my work here, I am also an Epidemiologist with the West Virginia Board of Pharmacy. I am really looking forward to working with the research community at Baystate and happy to help in any way I can.

The Innovator

Check out the Summer/Fall 2023 edition of the The Innovator, produced by the Office of Research.

Click here for The Innovator