The SAE Reconciliation Handbook

TABLE OF CONTENT

1. INTRODUCTION p.5
2. AES AND SAES IN CLINICAL STUDIES p.5
   1. Why are AES and SAES so important? p.5
   2. Collection of AE/SAE p.6
   3. Processing of AE/SAE DATA p.6
      Coding p.6
      Edit Checks - Queries p.6
      Follow-up p.6
   4. Reporting and displaying of AE/SAE p.7
      Reporting p.7
      Reporting timelines p.7
      Display in clinical study reports p.7
      Public disclosure p.8
      Description in scientific publications p.8
3. SAFETY DATA RECONCILIATION p.8
   1. What is safety data reconciliation? p.8
   2. Reasons to reconcile safety data p.8
      Missing serious adverse events p.8
      Differences p.8
      Incomplete information p.8
   3. Scope of the safety data reconciliation p.9
      Studies p.9
      Events p.9
      Data p.9
   4. How to perform safety data reconciliation p.9
      Standard operating procedure (SOP) p.9
      Data management plan (DMP) p.9
      Plan p.10
      Procedures p.10
      Guidelines p.10
   5. Who is involved in safety data reconciliation? p.10
      Sponsor / CRO p.10
      Data Manager p.10
      IT Manager p.10
      Safety officer p.11
      Monitor p.11
      Medical Officer p.11
      Principal Investigator p.11
   6. Timing for safety data reconciliation p.11
4. PROCEDURES: E-RECONCILIATION IN 10 EASY STEPS p.11
5. SOFTWARE & DATA MANAGEMENT p.12
   1. Software requirements p.12
      Software validation (acceptance tests) p.12
      Software training p.12
      Software integration p.12
6. GLOSSARY p.12
7. BIBLIOGRAPHY p.15