Standard Operating Procedure for Pre-Study Kickoff Meeting Conduct in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/034/2025
Supersedes	SOP/BA-BE/034/2022
Page No.	Page 1 of 12
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To define the procedure for conducting a pre-study kickoff meeting for Bioavailability/Bioequivalence (BA/BE) studies to ensure that all relevant stakeholders are aligned on study objectives, timelines, roles, and responsibilities prior to study initiation.

2. Scope

This SOP applies to all BA/BE studies coordinated or sponsored by the organization and involves all departments and stakeholders participating in study execution including Clinical, QA, Regulatory, Medical, Data Management, Pharmacovigilance, and CROs (if applicable).

3. Responsibilities

• Clinical Project Manager: Responsible for organizing and leading the pre-study kickoff meeting.
• Functional Department Heads: Present functional area responsibilities and confirm resource availability.
• Quality Assurance: Provides input on compliance expectations and audit readiness.
• Regulatory Affairs: Updates on submission status, approvals, and timelines.

4. Accountability

The Head of Clinical Operations is accountable for ensuring a formal pre-study kickoff meeting is conducted and documented for every BA/BE study prior to first subject screening.

5. Procedure

5.1 Meeting Planning and Scheduling

1. Schedule the kickoff meeting at least 2 weeks before the planned first subject screening date.
2. Circulate meeting invitation to all relevant stakeholders using Annexure-1: Kickoff Meeting Attendance List.
3. Prepare agenda using Annexure-2: Pre-Study Kickoff Agenda Template.

5.2 Meeting Content

1. The meeting must include discussion on the following:
   • Study objectives and overview
   • Study design (cross-over/parallel/fed/fasted)
   • Roles and responsibilities
   • Protocol highlights and critical procedures
   • Informed consent and EC submission status
   • Clinical supplies availability and randomization codes
   • Data management and CRF tracking
   • Adverse event reporting workflow
   • Quality assurance checks and audit timelines
   • Risk mitigation strategies

5.3 Documentation and Follow-Up

1. Record meeting minutes in Annexure-3: Kickoff Meeting Minutes Log.
2. Track open action items with responsible persons and deadlines in Annexure-4: Action Item Tracker.
3. Distribute signed attendance sheet and meeting minutes to all participants.
4. File documents in TMF and archive electronically.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• CRF: Case Report Form
• TMF: Trial Master File
• EC: Ethics Committee
• CRO: Contract Research Organization

7. Documents

1. Kickoff Meeting Attendance List – Annexure-1
2. Pre-Study Kickoff Agenda Template – Annexure-2
3. Kickoff Meeting Minutes Log – Annexure-3
4. Action Item Tracker – Annexure-4

8. References

• ICH E6(R2) – Good Clinical Practice
• CDSCO Guidance on Clinical Trial Management
• Organization’s Clinical Study Management Policy

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Kickoff Meeting Attendance List

Name	Department	Designation	Email	Signature
Rajesh Kumar	Clinical	Project Manager	rajesh.k@domain.com

Annexure-2: Pre-Study Kickoff Agenda Template

Agenda Item	Presenter	Time Allocated
Study Overview & Objectives	Meera Shah	10 min

Annexure-3: Kickoff Meeting Minutes Log

Date	Meeting Summary	Prepared By	Reviewed By
16/04/2025	Study BE-040 team aligned on FPFV plan	Sunita Reddy	Dr. Arvind Shah

Annexure-4: Action Item Tracker

Action Item	Owner	Due Date	Status
Submit EC approval letter to TMF	Regulatory Affairs	18/04/2025	Pending

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
15/01/2022	1.0	Initial SOP	New documentation	QA Head
17/04/2025	2.0	Added annexures and clarified attendee responsibilities	Operational standardization	QA Head