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

1. 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).
2. Assign the amendment a version number and date for traceability.

5.2 Training Plan Development

1. 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
2. Document plan using Annexure-1: Protocol Amendment Training Plan Template.

5.3 Conduct of Training

1. Training may be conducted via:
   • Group sessions
   • One-on-one discussions (for specific roles)
   • Recorded webinars with assessment
2. Trainer to use Annexure-2: Protocol Amendment Summary Slides and maintain attendance sheet (Annexure-3).

5.4 Assessment and Documentation

1. Post-training, each staff must:
   • Sign the acknowledgment log (Annexure-4)
   • Pass assessment if applicable (Annexure-5)
2. Training records must be archived in the Training File section of the TMF.

5.5 Implementation and Follow-Up

1. No procedures under the amended protocol are to begin until training is completed.
2. 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

1. Protocol Amendment Training Plan – Annexure-1
2. Training Slide Summary – Annexure-2
3. Attendance Sheet – Annexure-3
4. Acknowledgment Log – Annexure-4
5. Training Assessment Sheet – Annexure-5
6. 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