Clinical Trial Safety Reporting

Clinical trial safety reporting is an integral part of the clinical study process. GCP guidelines give clear requirements regarding the reporting of serious adverse events (SAEs) and abnormalities.

Adverse Event (AE)

An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Tracking all AEs is important as this:

  • Helps timely mitigation of serious harm to study participants
  • Decides whether a clinical study needs to be revised or terminated
  • Develops accurate drug toxicity profiles
  • Ensures compliance with regulatory requirements
Serious Adverse Event

A serious adverse event (SAE) or serious adverse drug reaction (serious ADR) is any untoward medical occurrence that at any dose:

  • results in death,
  • is life-threatening,
  • requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or
  • is a congenital anomaly/birth defect
GCP Guidelines for Safety Reporting

GCP guidelines for safety reporting in clinical trials state that:

  • All serious adverse events (SAEs) should be reported immediately to the sponsor
  • - Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations should be reported to the sponsor
  • - For reported deaths, the investigator should supply the sponsor and the IRB/IEC with any additional requested information (e.g., autopsy reports and terminal medical reports).
New FDA Rule

FDA has introduced stricter requirements for safety reporting in clinical trials, which became effective in September 2011.

The purpose of this new rule is to:

  • Clarify definitions of adverse events with regards to expectedness, relatedness and seriousness
  • Use internationally acceptable definitions and standards
  • Revise requirements for expedited reporting
  • Clarify circumstances for un-blinding ongoing study
  • Clarify format and frequency of reporting
  • Clarify FDA- and IRB-reportable adverse events to minimize "noise"
  • Make BA/BE studies subject to IND safety reporting requirements
ComplianceOnline webinars on clinical safety reporting

Safety Reporting in Clinical Trials: Are you Ready for the New FDA Rules Effective from 28 Sept 2011?

This webinar on safety reporting in clinical trials focuses on the major revisions that FDA made to its IND safety reporting requirements.

Why is Accurate Adverse Event Reporting essential for drug safety - How to Assess the Causality Relationship

This clinical research training provides invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product research involving human subjects.

Clinical Trial Regulations and GCP Compliance as they relate to Adverse Events - How to Assess and report AEs and SAEs

This compliance training webinar discusses the clinical trial regulations requirements with respect to adverse event and explain how to assess and report AEs and SAEs.

How Accurate Adverse Event Reporting is the Key to Subject Safety of approved drugs

This clinical compliance training teaches how to assess record and manage the adverse events occurring during conduct of clinical research utilizing human subjects and how to avoid the common mistakes.

How Due Diligence in Accurate Adverse Event Reporting is the Key to a clean FDA Audit

This training on Adverse Event Reporting in Clinical Trials shows how to accurately observe and report AEs and SAEs, avoid common mistakes in AE / SAE reporting and successfully clear an FDA audit.

Practical tips to comply and implement the Adverse Event Reporting requirement of the new Dietary Supplement and Nonprescription Drug Consumer Protection Act

The Webinar discusses recordkeeping requirements of serious and non-serious adverse events reported to a dietary supplement manufacturer, packer, or distributor.