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.
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
- Schedule the CIM at least 2 weeks prior to the start of clinical phase.
- Send invitation email/letter to all participants along with agenda using Annexure-1: CIM Invitation Template.
5.2 Agenda Preparation
- 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
- Use Annexure-2: CIM Agenda Template.
5.3 Meeting Conduct
- Designate CRA or sponsor representative as chairperson.
- Distribute CIM folders including protocol, ICFs, CRFs, SOP summary, and training logs.
- Conduct session with PowerPoint support and address questions from investigators and site team.
- Use Annexure-3: CIM Attendance Sheet to record all attendees.
5.4 Documentation
- Record minutes of meeting using Annexure-4: CIM Minutes Template.
- All attendees must sign Annexure-5: Investigator Training Acknowledgment Form.
- File all documents in Investigator Site File (ISF) and Trial Master File (TMF).
5.5 Follow-up Actions
- Address any unresolved questions, protocol clarifications, or requests raised during CIM.
- 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
- CIM Invitation Template – Annexure-1
- CIM Agenda Template – Annexure-2
- CIM Attendance Sheet – Annexure-3
- CIM Minutes Template – Annexure-4
- 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
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 |