SOP Guide for Pharma

BA-BE Studies: SOP for Clinical Documentation of Adverse Events – V 2.0

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BA-BE Studies: SOP for Clinical Documentation of Adverse Events – V 2.0

Standard Operating Procedure for Clinical Documentation of Adverse Events in BA/BE Studies

Department BA-BE Studies
SOP No. SOP/BA-BE/069/2025
Supersedes SOP/BA-BE/069/2022
Page No. Page 1 of 10
Issue Date 17/04/2025
Effective Date 20/04/2025
Review Date 17/04/2026

1. Purpose

To define the standardized procedure for documenting all Adverse Events (AEs) occurring during the clinical phase of Bioavailability/Bioequivalence (BA/BE) studies in compliance with ICH-GCP and applicable regulatory guidelines.

2. Scope

This SOP applies to all clinical research staff involved in identifying, recording, evaluating, and reporting adverse events at the clinical site during BA/BE studies.

3. Responsibilities

  • Ward Nurse: Identifies
and informs CRC/Investigator of AEs observed or reported by subjects.
  • Clinical Research Coordinator (CRC): Ensures timely and complete documentation of AEs in source documents and CRFs.
  • Principal Investigator (PI)/Sub-Investigator: Assesses severity, causality, outcome, and signs off on AE forms.

    • 4. Accountability

    The Principal Investigator is accountable for ensuring that all adverse events are recorded accurately, evaluated for regulatory significance, and reported within specified timelines.

    5. Procedure

    5.1 AE Identification

    1. Monitor subjects continuously during the study for:
      • Volunteer-reported symptoms
      • Clinical signs during vitals or physical exams
      • Abnormal lab or ECG findings
    2. All suspected symptoms must be considered AEs until evaluated.

    5.2 Documentation Standards

    1. Record AEs in source documents immediately upon detection.
    2. Transfer details to:
      • Annexure-1: AE Log Sheet
      • Subject CRF AE section
    3. Ensure legibility, consistency, and completeness in AE records.

    5.3 AE Information to Capture

    1. Subject ID
    2. Event term (e.g., nausea, rash)
    3. Date and time of onset
    4. Severity (Mild, Moderate, Severe)
    5. Causality (Unrelated, Unlikely, Possible, Probable, Certain)
    6. Outcome (Resolved, Ongoing, Unknown)
    7. Action taken (None, Drug withdrawn, Concomitant medication, Hospitalized)

    5.4 Follow-Up and Final Outcome

    1. Monitor subject until resolution of AE.
    2. Update all logs with:
      • Resolution date
      • Final outcome
      • Follow-up investigations if required

    5.5 QA and Review

    1. All AE documentation must be reviewed by QA during TMF reconciliation or audits.
    2. Discrepancies between source and CRF must be reconciled and documented.

    6. Abbreviations

    • AE: Adverse Event
    • SAE: Serious Adverse Event
    • CRF: Case Report Form
    • PI: Principal Investigator
    • CRC: Clinical Research Coordinator

    7. Documents

    1. AE Log Sheet – Annexure-1
    2. Subject CRF (AE Section)
    3. Follow-up Forms (if applicable)

    8. References

    • ICH E6(R2) – Good Clinical Practice
    • ICH E2A – Clinical Safety Data Management
    • CDSCO GCP Guidelines

    9. SOP Version

    Version: 2.0

    10. Approval Section

    Prepared By Checked By Approved By
    Signature
    Date
    Name
    Designation
    Department

    11. Annexures

    Annexure-1: AE Log Sheet

    Subject ID AE Term Start Date Severity Causality Outcome Action Taken Final Date Investigator Signature
    VOL-069 Headache 17/04/2025 Mild Possible Resolved None 18/04/2025 Dr. Arvind Shah

    Revision History:

    Revision Date Revision No. Details Reason Approved By
    12/01/2022 1.0 Initial release GCP implementation QA Head
    17/04/2025 2.0 Expanded AE parameters and tracking process Audit requirement QA Head
    See also  BA-BE Studies: SOP for Backup and Archiving of Analytical Data - V 2.0
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