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BA-BE Studies: SOP for Clinical Investigator’s Meeting Conduct – V 2.0

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BA-BE Studies: SOP for Clinical Investigator’s Meeting Conduct – V 2.0

Standard Operating Procedure for Conducting Clinical Investigator’s Meeting in BA/BE Studies

Department BA-BE Studies
SOP No. SOP/BA-BE/122/2025
Supersedes SOP/BA-BE/122/2022
Page No. Page 1 of 9
Issue Date 17/04/2025
Effective Date 20/04/2025
Review Date 17/04/2026

1. Purpose

To describe the procedure for organizing and conducting Clinical Investigator’s Meetings (CIMs) in Bioavailability/Bioequivalence (BA/BE) studies to ensure protocol comprehension, role clarity, GCP compliance, and standardized procedures across all stakeholders.

2. Scope

This SOP applies to all study team members including Principal Investigators (PIs), Sub-Investigators, study coordinators, site staff, QA, CRAs, and sponsor representatives involved in BA/BE study execution.

3. Responsibilities

  • Sponsor/Project Manager: Initiates the CIM, coordinates with CRO/site, and approves agenda.
  • Clinical Research Associate (CRA): Facilitates meeting logistics, prepares presentations, and records attendance.
  • Principal Investigator: Participates in discussions and signs training acknowledgments.
  • QA Officer: Ensures compliance with GCP training and audits documentation.
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4. Accountability

The Project Director or Clinical Trial Manager is accountable for ensuring successful and documented conduct of all CIMs before first subject enrollment in each study site.

5. Procedure

5.1 Planning and Scheduling

  1. Schedule the CIM at least 2 weeks prior to the start of clinical phase.
  2. Send invitation email/letter to all participants along with agenda using Annexure-1: CIM Invitation Template.

5.2 Agenda Preparation

  1. Prepare agenda covering:
    • Protocol objectives, design, and timeline
    • Eligibility criteria and ICF process
    • Dosing procedures and sample collection
    • AE/SAE reporting
    • Roles and responsibilities
    • GCP and Schedule Y compliance
  2. Use Annexure-2: CIM Agenda Template.

5.3 Meeting Conduct

  1. Designate CRA or sponsor representative as chairperson.
  2. Distribute CIM folders including protocol, ICFs, CRFs, SOP summary, and training logs.
  3. Conduct session with PowerPoint support and address questions from investigators and site team.
  4. Use Annexure-3: CIM Attendance Sheet to record all attendees.
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5.4 Documentation

  1. Record minutes of meeting using Annexure-4: CIM Minutes Template.
  2. All attendees must sign Annexure-5: Investigator Training Acknowledgment Form.
  3. File all documents in Investigator Site File (ISF) and Trial Master File (TMF).

5.5 Follow-up Actions

  1. Address any unresolved questions, protocol clarifications, or requests raised during CIM.
  2. Circulate summary of meeting and action items to all stakeholders within 5 working days.

6. Abbreviations

  • BA: Bioavailability
  • BE: Bioequivalence
  • CIM: Clinical Investigator’s Meeting
  • CRA: Clinical Research Associate
  • PI: Principal Investigator
  • GCP: Good Clinical Practice
  • ISF: Investigator Site File
  • TMF: Trial Master File

7. Documents

  1. CIM Invitation Template – Annexure-1
  2. CIM Agenda Template – Annexure-2
  3. CIM Attendance Sheet – Annexure-3
  4. CIM Minutes Template – Annexure-4
  5. Investigator Training Acknowledgment Form – Annexure-5

8. References

  • ICH E6(R2) – Good Clinical Practice
  • Schedule Y – Drugs and Cosmetics Rules, India
  • FDA Guidance on Investigator Responsibilities

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9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: CIM Invitation Template

Date To Subject Study Code Meeting Date
10/04/2025 Investigator Sites Clinical Investigator’s Meeting BE-122 15/04/2025

Annexure-2: CIM Agenda Template

Time Topic Presenter
10:00–10:30 AM Protocol Overview Rajesh Kumar
10:30–11:00 AM Informed Consent Process Sunita Reddy

Annexure-3: CIM Attendance Sheet

Name Designation Institution Signature
Ajay Verma Sub-Investigator ABC Clinical Unit Signed

Annexure-4: CIM Minutes Template

Date Discussion Summary Action Items Responsible
15/04/2025 Clarified fasting requirements Update protocol appendix CRA

Annexure-5: Investigator Training Acknowledgment Form

Name Study Code Date Trained Signature
Dr. Meena Joshi BE-122 15/04/2025 Signed

Revision History:

Revision Date Revision No. Details Reason Approved By
10/01/2022 1.0 Initial Release Regulatory Compliance QA Head
17/04/2025 2.0 Agenda and acknowledgment forms standardized Audit Recommendation QA Head
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