Sunday, April 4, 2010

Annual Safety Report Composition and Quality Control

Annual Safety Reports (ASRs) are required by pharma each year for a drug, device and/or biologic, under clinical development and is triggered by an anniversary date linked to safety timelines, IND, CDP, subject exposure, safety of subjects on clinical trial and serious adverse reports (SARs). The Table of Contents (TOC) is much the same, generic in fact, for clinical development programs with agreed upon expansion, between pharma and FDA. An Annual Safety Report TOC for a inhalation device delivery system for example is presented below.

List of Appendices

List of Abbreviations and Definitions of Terms

  1. Introduction
  2. Review of Subjects Safety on Clinical Trial
  3. Overall Safety Evaluation
  4. Conclusion

Appendix A

Appendix B

Appendix C

Appendix D

Section 2, Review of Subjects Safety on Clinical Trial...

  • Relation of Safety Information with Dose, Duration and Time of Onset of Adverse Reaction
  • Reversibility of Serious Adverse Reports (SARs)
  • Previously Unidentified or Other Increased Frequency of Adverse Reactions
  • Overdose
  • Drug Interactions or Other Associated Risk Factors
  • Special Subject Groups
  • Pregnancy and/or Lactation
  • Product Abuse
  • Risks Related to the Investigational or Diagnostic Procedures of the Clinical Trial
  • Risks Which Might Be Associated with Insufficient Quality of the Investigational Medicinal Product.

ASR submission supporting text, data and documentation must be referenced, appended and quality controlled and quality assured. The ASR is submitted electronically to FDA and is expected to be received on the anniversary date for the ASR. There must be an appendix which includes a line listing of all suspected SARs (Appendix A) and another appendix (Appendix B) with a summary tabulation of all suspected SARs. It is strongly recommended that the line listing and the tabulation of all suspected SARs are quality controlled for consistency, data, documentation and accuracy vs. ASR intext tables and text.

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