Clinical Research Times

February 28, 2025

Dear Colleague:

Researchers who collect or utilize research data are responsible for accessing, storing, transferring, and processing data on systems that have appropriate security measures for the classification of data being used. This month’s Feature Article discusses general considerations for Boston University (BU) Medical Campus researchers on managing data security in human subjects research studies; and includes examples of research data and corresponding BU data classifications, and answers to Frequently Asked Questions (FAQs).

Also check out:

• “Things to Know” on BMC’s new Clinical Research Unit (CRU); and a reminder about a recent deadline pertaining to Institutional Standard Operating Procedures (SOP) training
• “The CRRO Corner” on updates to eConsent guidance due to a major REDCap upgrade that includes changes to the eConsent: eConsent Framework 2.0. The new framework offers several enhancements as well as improved functionality that will help to streamline the consent process, improve data integrity, and enhance compliance with FDA and OHRP regulations and ICH GCP guidance
• “Getting to Know ClinicalTrials.gov” on accessing the ‘Classic’ and ‘Modernized’ versions of the ClinicalTrials.gov Protocol Registration and Results System (PRS), and a recommendation to continue using the ‘Classic’ version
• “Spotlight on SOPs” on the SOP entitled “Research Training”, which provides detail on available training for conducting clinical research. This includes required training, and additional training that may be applicable based on the roles delegated to investigators and research staff
• “Dear IRB” on BMC/BUMC IRB requirements when you are helping to disseminate recruitment materials for a study conducted by external investigators

Learn more at www.bu.edu/crtimes.

Matthew Ogrodnik, MS, CIP, Editor, CR TIMES
Director, Office of Human Research Affairs