Standard Operating Procedure for Training of Clinical Staff on Protocol Amendments in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/101/2025 |
| Supersedes | SOP/BA-BE/101/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To define the procedure for training all relevant clinical staff on protocol amendments to ensure proper implementation and regulatory compliance in BA/BE studies.
2. Scope
This SOP applies to investigators, sub-investigators, study nurses, pharmacists, CRCs, and other staff directly or indirectly involved in the execution of amended protocols at clinical research units conducting BA/BE studies.
3. Responsibilities
- Principal Investigator (PI): Ensures understanding and implementation of amended protocol.
- Quality Assurance (QA): Verifies that training has been conducted and documented.
- Training Coordinator: Organizes, schedules, and maintains training records for all protocol amendments.
- Clinical Research Coordinator (CRC): Ensures attendance and acknowledgment of training by staff involved in respective procedures.
4. Accountability
The PI and QA Head are jointly accountable for ensuring that protocol amendments are trained prior to implementation and that deviations from the amended protocol do not occur due to lack of awareness.
5. Procedure
5.1 Receipt of Protocol Amendment
- Once a protocol amendment is approved by the Ethics Committee and sponsor, the copy shall be received and filed in the site master file (SMF).
- Assign the amendment a version number and date for traceability.
5.2 Training Plan Development
- Training Coordinator creates a training plan that includes:
- Summary of changes in the amendment
- List of impacted study procedures
- List of staff requiring training
- Timeline for training completion
- Document plan using Annexure-1: Protocol Amendment Training Plan Template.
5.3 Conduct of Training
- Training may be conducted via:
- Group sessions
- One-on-one discussions (for specific roles)
- Recorded webinars with assessment
- Trainer to use Annexure-2: Protocol Amendment Summary Slides and maintain attendance sheet (Annexure-3).
5.4 Assessment and Documentation
- Post-training, each staff must:
- Sign the acknowledgment log (Annexure-4)
- Pass assessment if applicable (Annexure-5)
- Training records must be archived in the Training File section of the TMF.
5.5 Implementation and Follow-Up
- No procedures under the amended protocol are to begin until training is completed.
- QA to verify training completion before the first implementation activity and record in Annexure-6: QA Compliance Checklist.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- PI: Principal Investigator
- CRC: Clinical Research Coordinator
- QA: Quality Assurance
- TMF: Trial Master File
7. Documents
- Protocol Amendment Training Plan – Annexure-1
- Training Slide Summary – Annexure-2
- Attendance Sheet – Annexure-3
- Acknowledgment Log – Annexure-4
- Training Assessment Sheet – Annexure-5
- QA Compliance Checklist – Annexure-6
8. References
- ICH E6(R2) – Good Clinical Practice
- Indian GCP Guidelines
- Schedule Y – Drugs and Cosmetics Rules
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Protocol Amendment Training Plan
| Amendment Version | Date | Key Changes | Impacted Staff | Deadline |
|---|---|---|---|---|
| V2.1 | 15/04/2025 | Change in PK sampling times | Nurses, CRCs | 18/04/2025 |
Annexure-2: Summary Slide Sample
| Slide Title | Slide Description |
|---|---|
| PK Sample Changes | Sampling window reduced from ±5 to ±3 min |
Annexure-3: Attendance Sheet
| Name | Designation | Signature | Date |
|---|---|---|---|
| Rajesh Kumar | Study Nurse | Signed | 17/04/2025 |
Annexure-4: Acknowledgment Log
| Name | Protocol Amendment No. | Understanding Confirmed | Signature |
|---|---|---|---|
| Sunita Reddy | Amendment V2.1 | Yes | Signed |
Annexure-5: Training Assessment Sheet
| Name | Score | Result | Trainer Signature |
|---|---|---|---|
| Ajay Verma | 90% | Pass | Trainer |
Annexure-6: QA Compliance Checklist
| Item | Verified | Comments | QA Signature |
|---|---|---|---|
| Attendance Logs | Yes | Complete | QA Officer |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 10/01/2022 | 1.0 | Initial release | New process | QA Head |
| 17/04/2025 | 2.0 | Annexures and process flow added | GCP alignment | QA Head |