3. Responsibilities

• Clinical Operations Manager: Oversees role allocation and approval of role responsibility matrices.
• Principal Investigator (PI): Ensures that responsibilities are aligned with protocol requirements and regulatory expectations.
• HR/Training Coordinator: Maintains training records and ensures all staff are aware of their designated responsibilities.
• Department Heads: Validate role-specific SOPs and clarify team deliverables.

4. Accountability

The Clinical Research Director or Head of Clinical Operations is accountable for ensuring effective implementation of this SOP and resolution of any role-based conflict or ambiguity.

5. Procedure

5.1 Role Identification and Allocation

1. Prepare a Role and Responsibility Matrix (Annexure-1) prior to study initiation based on protocol tasks, site needs, and ICH-GCP guidelines.
2. Define key positions including but not limited to:
   • Principal Investigator (PI)
   • Sub-Investigator
   • Study Coordinator
   • Pharmacist
   • Phlebotomist
   • Bioanalytical Scientist
   • Quality Assurance Officer
3. Each role should have defined primary and secondary responsibilities documented and approved by the Department Head.

5.2 Communication of Roles

1. Conduct a Study Kickoff Meeting where the role matrix is presented and explained to all staff.
2. Circulate signed copies of the matrix to all team members and post it in the study control room.
3. Staff must acknowledge their understanding of roles by signing the Role Acknowledgment Log (Annexure-2).

5.3 Role-Based Training and Competency

1. Assign training modules based on specific roles using applicable SOPs and study protocol sections.
2. Training must be documented in the Staff Training Log (Annexure-3) with trainer signature and date.
3. Conduct assessments, if required, for critical roles (e.g., dosing, sample processing, SAE reporting).

5.4 Handling Role Ambiguities or Overlaps

1. In case of ambiguity:
   • Raise a formal clarification request to the Clinical Operations Manager.
   • Update matrix and communicate revised roles to all stakeholders.
2. In case of staff unavailability, alternate persons should be cross-trained and designated in the matrix.

5.5 Monitoring and Compliance

1. QA team to verify role compliance during study audits and monitoring visits.
2. Any observed deviation from designated roles must be documented and addressed via CAPA.
3. Updates to roles or reassignment must be approved by PI and documented in an updated matrix version.

5.6 Documentation and Archiving

1. All role-related documents must be filed in the study-specific Trial Master File (TMF).
2. Archived records must be retained for at least 5 years post-study or as per regulatory requirements.

6. Abbreviations

• BA/BE: Bioavailability/Bioequivalence
• PI: Principal Investigator
• QA: Quality Assurance
• CAPA: Corrective and Preventive Action
• TMF: Trial Master File

7. Documents

1. Role and Responsibility Matrix – Annexure-1
2. Role Acknowledgment Log – Annexure-2
3. Staff Training Log – Annexure-3

8. References

• ICH E6(R2) – Good Clinical Practice
• Schedule Y – Indian GCP Guidelines
• Company Training Policy and HR SOPs

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Role and Responsibility Matrix

Role	Primary Responsibilities	Backup Staff
Pharmacist	IMP receipt, labeling, storage, accountability	Sunita Reddy
PI	Subject safety, protocol compliance	Dr. Vinay Pawar

Annexure-2: Role Acknowledgment Log

Name	Designation	Role	Signature	Date
Rajesh Kumar	Study Coordinator	Subject randomization, CRF updates	Signed	15/04/2025

Annexure-3: Staff Training Log

Staff Name	Role	Training Topic	Date	Trainer	Remarks
Ajay Verma	Phlebotomist	PK sample collection	14/04/2025	QA Officer	Trained

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial release	Role management SOP introduction	QA Head
17/04/2025	2.0	Expanded procedure and annexures for training and role sign-off	Audit preparation	QA Head