Safety Oversight

Principal Investigator (PI) Oversight

For some studies, an individual might be both the PI and the (Regulatory) Sponsor. In this case, both sets of responsibilities mentioned apply.

Content coming soon.

Sponsor Pharmacovigilance

Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem.

The main purpose of PV is to protect public public health by maintaining accurate, up-to-date, and complete safety information on investigational and marketed interventional therapies.

The exact definition of PV differs slightly between different agencies on definitions including medicine, drug, or vaccine related. Although none of the agencies specially refer to medical devices, this work instruction applies to all products studied in research settings, including medical devices.

For some studies, an individual might be both the PI and the (Regulatory) Sponsor. In this case, both sets of responsibilities mentioned apply.

PV Training

• Sponsor Pharmacovigilance (PV) Management

This training provides basic information needed for IND and IDE sponsor pharmacovigilance (safety) activities. It is intended for those taking on the role of a safety lead and medical monitor/director. Others working on the sponsor team may also benefit from understanding the basics of pharmacovigilance, and where more information may be obtained.

PV Resources

• PSOM Sponsor SOP 005 – Pharmacovigilance and Safety Reporting
• Pharmacovigilance Work Instructions

Provides comprehensive information on sponsor responsibilities related to pharmacovigilance.

• PSOM and ACC Adverse Event Assessment Guidance

Provides guidance to investigators regarding adverse event management.

• Serious Adverse Event (SAE) Form

Template that may be used for SAE Reporting to the Sponsor

• Data and Safety Monitoring Boards (DSMBs) may be established by the sponsor for certain studies based on risk. Additional information and resources on DSMBs are available.

FDA Guidance related to PV

• Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies
  • Note that while bioavailability/bioequivalence studies may be conducted without an IND (IND exempt), they have FDA safety reporting requirements. See section X(A) of the guidance.
• Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices
• Pharmacovigilance Planning
• Premarketing Risk Assessment

For additional guidance, please contact OCR Regulatory via psom-ind-ide@pobox.upenn.edu.