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Safety Reporting in Industry-Sponsored Trials and Case Studies – Part 1

1.5 credits


Full course description

The Georgia Clinical & Translational Science Alliance- Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI have collaborated to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.


An expert medical safety officer will discuss the role of the sponsor in pharmacovigilance for adverse event collection and reporting, and criteria for reporting on drugs and medical devices.


  1. Collection of Adverse Events (AEs)
    • Adverse Event vs. Adverse Reaction
  2. Serious Adverse Event (SAE)
    • SAE Reporting Decision Tree
    • Who makes SAE assessments?
      • Seriousness
      • Severity
    • Sponsor Responsibilities
      • Related vs. Unrelated
      • Expected vs. Unexpected
      • Analysis of Similar Events
      • Sponsor Medical Comment
  3. Reporting
    • 7-day alert / 15-day alert
    • Unblinding/Unmasking
  4. Medical Device
    • Definitions - 21 CFR 803.3
    • Public health emergency - 21 CFR 803.12
    • Manufacturer: 5-day report - 21 CFR 803.53
    • MDR: 30-day report - 21 CFR 803.50(a)
    • Complaints: Evaluate for Medical Device Reporting - 21 CFR 820.198(a)(3)
    • Who reports? - 21 CFR 803.3
  5. Exercise 1: Clinical Trial Adverse Event


Julie Hoegi, M.D., is a pharmacovigilance physician with 19 years of pharmaceutical industry experience in clinical research and clinical/postmarket safety.  Successes include adverse event management compliance during global mergers and acquisitions, 12 country globalization of the Argus Safety System, and signal detection and management as well as successful completion of pharmacovigilance inspections conducted by FDA, Health Canada, Inspectorate of the Netherlands, and MHRA.  Dr. Hoegi currently focuses on oncology product


Beginner:This course is designed for Clinical Research Assistant/Associates or Clinical Research Coordinators in academia, clinics, hospitals, industry, or CRO with 1- 2 years of clinical research experience.Individuals may be new to clinical research with limited knowledge of clinical trial conduct, good clinical practices, regulations and common terminology associated with clinical research.

Learner Level: Beginner

Contact Hours:

Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation. Attendees to this CNE activity will be awarded 1.5 Continuing Nursing Education contact hours from ENPDC.

Need Help with Registration? Please contact us at or 404-727-9208.

Program Information: This is the fourth course in a six (6) course program. To complete the entire program and earn a badge CLICK HERE.

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