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Clinical Research Times

April 30, 2024

Dear Colleague:

Screening is the process of collecting information to determine whether a potential subject meets a study’s eligibility criteria. This process can take many forms, including reviewing the medical record, asking questions of a potentially eligible individual, and conducting clinical procedures like a blood draw. This month’s Feature Article discusses screening processes, and provides guidance on the consent and HIPAA requirements that are associated with different types of screening activities.

Also check out:

  • “Things to Know” on recent revisions to the posted IRB consent form templates; new and revised HRPP Policies and Procedures that took effect this month; and a reminder about the new process for closing exempt studies without the need for submission of a Final/Closure Report form
  • “The CRRO Corner” on the updated eConsent Tools and Guidance that are now available for use by the research community
  • “Getting to Know” on “Good Cause Extension” requests for extending the results reporting deadline for Applicable Clinical Trials (ACTs) and NIH-funded clinical trials
  • “Spotlight on SOPs” on the current training requirements for the institutional Standard Operating Procedures (SOPs), which took effect on January 1, 2024
  • “Dear IRB” on the relationship between waivers of consent and waivers of HIPAA authorization, and information about the applicability of the HIPAA regulations in international research

Learn more at

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