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Digital

Platforms

ICSR-SOURCES

Literature

review

health care professional/ consumer

INDIVIDUAL CASE SAFETY REPORTS:

INTRODUCTION

SOLICITED REPORTS

SPONTANEOUS REPORTS

STANDARDS OF REPORTING

ICSR

PSP (Patient support programme)

MRP(Market Research Programme)

Regulatory authority sources

NOT TO REPORT

clinical trial registries

contractual agreements

WHAT TO REPORT

internationally standardized procedure in order to

improve the quality of safety information and to harmonise the way of gathering and reporting information.

ICH E2A: guideline on pre-approval safety data management.

ICH E2D: Guideline for post approval safety data management.

DEFINITIONS:

-SERIOUS UNEXPECTED ADR

-IMPORTANT SAFETY FINDINGS (Teratogenicity, Mutagenicity, Carcinogenicity, increased mortality)

-OTHER OBSERVATIONS: Lack of efficacy, overdose, misuse, abuse, medication error, medication error.

-USE IN PREGNANCY/LACTATION.

-OFF LABLE USE

-SERIOUS EXPECTED

-NON SERIOUS UNEXPECTED

- NON SERIOUS EXPECTED.

-OTHER OBSERVATIONS- No serious AE/ADR

ADVERSE EVENT (AE)

ADVERSE DRU REACTION (ADR)

SERIOUS AE/ADR

UNEXPECTED SERIOUS ADR/AE

EXPECTED/ UNEXPECTED AE/ADR

ICH E2A & E2D GUIDELINES

CRITERIA & REPORTING TIMELINES

Clinical (E2A) & Post Approval (E2D) Safety Data Management Definitions & Standards for Expedited reporting

DR. RAVIKISHORE SADULA, MBBS,MD(PSY)

EMP NO: 1177011

TIMELINE

SERIOUS UNEXPECTED- 15 DAYS

MINIMUM CRITERIA:

1. IDENTIFIABLE PATIENT

2. IDENTIFIABLE REPORTING SOURCE.

3. SUSPECTED MEDICINAL PRODUCT.

4. EVENT OR OUTCOME- SERIOUS UNEXPECTED

EXPEDITED REPORTING

LIFE THREATENING- 7 DAYS+ ADDITIONAL 8 DAYS FOR REPORTING

NON SERIOUS AE- IN PSUR

SUMMARY

  • ICH E2A guidelines: clinical safety data mangement.
  • ICH E2D: revised by working committee in February 2024 (R1).
  • E2A guidelines describes the mechanism for handling expedited (rapid) reporting, in the investigational (i.e., pre-approval) phase.
  • E2D guideline was originally based on the content of the ICH E2A guidelines.
  • E2D guideline provides recommendations that are harmonised to the extent possible given differences in post-market safety reporting requirements among ICH regions.

REPORTING FORMAT

GOOD CASE MANAGEMENT PRACTICES

  • CIOMS 1
  • ICH E2B uses the Medical Dictionary for Regulatory Activities (MedDRA, ICH M1) for coding medical information.

  • Assesing patient and reporter identifiability.

(avoid case duplication, ensure authenticity, and facilitate follow-up of appropriate cases).

  • Proper case narrative.
  • Careful medical review is to ensure correct interpretation of medical information.
  • Proper follow-up of cases after prioritisation.
  • Proper contractual agreements.
  • Duplicate report management.
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