Standard Operating Procedure for Study Timelines and Milestone Management in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/041/2025 |
| Supersedes | SOP/BA-BE/041/2022 |
| 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 process for planning, monitoring, and managing study timelines and key milestones in Bioavailability/Bioequivalence (BA/BE) studies to ensure adherence to project deadlines, resource coordination, and regulatory deliverables.
2. Scope
This SOP applies to all BA/BE studies conducted or sponsored by the organization and involves all internal teams and external vendors responsible for study execution, data generation, and regulatory submission.
3. Responsibilities
- Clinical Project Manager (CPM): Prepares and maintains the study timeline tracker and ensures milestone adherence.
- Functional Department Leads: Provide timeline estimates and update progress for their respective deliverables.
- Quality Assurance: Reviews milestone completion status during internal audits and inspections.
4. Accountability
The Head of Clinical Operations is accountable for ensuring the implementation and compliance with project timelines and escalation of deviations to senior management.
5. Procedure
5.1 Timeline Planning
- At project initiation, define the detailed timeline using Annexure-1: Study Timeline Tracker Template.
- Include all critical milestones such as:
- Protocol finalization
- Ethics committee approval
- Site readiness
- First volunteer screened
- Last volunteer dosed
- Sample analysis completion
- Statistical report delivery
- Final CSR and regulatory submission
5.2 Tracking and Updates
- Update the tracker weekly or as per the project governance model.
- Review progress during weekly study team meetings.
- Record deviations in Annexure-2: Timeline Deviation Log with justification and impact analysis.
5.3 Escalation and Corrective Actions
- If a milestone is delayed by more than 5 working days:
- Initiate an internal escalation to the study oversight committee.
- Identify root cause and corrective actions.
5.4 Completion and Closure
- Upon completion of the final study milestone (CSR sign-off or regulatory submission), conduct a milestone reconciliation review.
- Document closure in Annexure-3: Milestone Closure Summary Sheet.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- CPM: Clinical Project Manager
- CSR: Clinical Study Report
- SOP: Standard Operating Procedure
7. Documents
- Study Timeline Tracker Template – Annexure-1
- Timeline Deviation Log – Annexure-2
- Milestone Closure Summary Sheet – Annexure-3
8. References
- ICH E6(R2) – Good Clinical Practice
- Internal Clinical Project Management 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: Study Timeline Tracker Template
| Milestone | Planned Date | Actual Date | Status |
|---|---|---|---|
| Protocol Finalization | 10/04/2025 | 12/04/2025 | Completed |
Annexure-2: Timeline Deviation Log
| Milestone | Expected Date | Actual Date | Reason for Delay | Corrective Action |
|---|---|---|---|---|
| EC Approval | 15/04/2025 | 19/04/2025 | EC meeting postponed | Submitted follow-up email for priority review |
Annexure-3: Milestone Closure Summary Sheet
| Study Code | Final Milestone Achieved | Closure Date | Verified By |
|---|---|---|---|
| BE-045 | CSR Submission | 16/07/2025 | Sunita Reddy |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 15/01/2022 | 1.0 | Initial SOP | Project governance framework | QA Head |
| 17/04/2025 | 2.0 | Added annexures and escalation procedure | Timeliness compliance | QA Head |