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