phlebotomists, and support staff during the execution of BA/BE studies.

3. Responsibilities

• Project Manager: Coordinates overall staff planning and ensures alignment with study timelines.
• Clinical Operations Lead: Reviews staffing rosters and deployment plans.
• Human Resource (HR) Department: Provides qualified personnel as per resource request.
• QA Officer: Audits staffing logs and verifies role-based training and GCP compliance.

4. Accountability

The Head of Clinical Operations is accountable for ensuring that the clinical unit is staffed adequately in accordance with ICH-GCP, protocol specifications, and regulatory expectations.

5. Procedure

5.1 Staffing Needs Assessment

1. Upon receipt of the approved study protocol and clinical calendar, the Project Manager shall initiate staffing assessment using Annexure-1: Staffing Requirement Worksheet.
2. Consider the following:
   • Study design (e.g., crossover/fed/fasted)
   • Number of subjects per group and period
   • Sampling points and critical time intervals
   • Dosing days and washout periods
   • Weekday vs. weekend workload
3. Calculate required Full-Time Equivalents (FTEs) per role (nurse, phlebotomist, physician, etc.).

5.2 Preparation of Staff Roster

1. Clinical Operations Lead shall develop the Staff Duty Roster using Annexure-2.
2. Rosters must ensure:
   • Minimum of 1 physician per 20 subjects on dosing day
   • 1 nurse per 10 subjects for pre- and post-dose monitoring
   • 1 phlebotomist per 8–10 subjects for intensive sampling windows
3. Include shift timings, names, responsibilities, and standby personnel.

5.3 Staff Qualification and Training Verification

1. Only personnel trained in GCP, protocol procedures, and their assigned responsibilities shall be deployed.
2. Maintain training records in Annexure-3: Study Staff Qualification Log.
3. Cross-train team members for overlapping roles (e.g., phlebotomy + nursing support) for flexibility.

5.4 Contingency Planning

1. Prepare Annexure-4: Staff Backup Roster in case of sudden absenteeism.
2. Ensure availability of on-call physicians and nurses, especially for overnight stays and emergencies.
3. Maintain standby staff pool for peak activities like dosing, ECGs, or PK sampling.

5.5 Daily Briefing and Attendance

1. Conduct pre-activity briefing at least 1 hour before each dosing or sampling session.
2. Use Annexure-5: Staff Attendance Register to document presence and duty start times.
3. Communicate role assignments, safety instructions, and contact protocols during briefing.

5.6 Staff Performance Monitoring

1. Designate team leads to supervise each function (medical, sample handling, data recording).
2. Document any deviations from assigned responsibilities or delays in Annexure-6: Staff Performance Log.
3. Report repeated issues to HR and QA for retraining or reassignment decisions.

5.7 Post-Study Staff Debrief and Feedback

1. Conduct a post-study review meeting to discuss staff performance, workload challenges, and process gaps.
2. Record feedback using Annexure-7: Staff Feedback Form and archive with the trial master file.

6. Abbreviations

• BA/BE: Bioavailability / Bioequivalence
• FTE: Full-Time Equivalent
• GCP: Good Clinical Practice
• QA: Quality Assurance
• HR: Human Resources

7. Documents

1. Staffing Requirement Worksheet – Annexure-1
2. Staff Duty Roster – Annexure-2
3. Study Staff Qualification Log – Annexure-3
4. Staff Backup Roster – Annexure-4
5. Staff Attendance Register – Annexure-5
6. Staff Performance Log – Annexure-6
7. Staff Feedback Form – Annexure-7

8. References

• ICH E6(R2) – Good Clinical Practice
• Schedule Y – Drugs and Cosmetics Rules, India
• WHO Handbook for Good Clinical Research Practice

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Staffing Requirement Worksheet

Role	FTE Needed	Based On
Phlebotomist	4	40 subjects × 10 time points

Annexure-2: Staff Duty Roster

Name	Role	Shift	Contact
Rajesh Kumar	Nurse	06:00–14:00	Ext. 101

Annexure-3: Study Staff Qualification Log

Name	Role	GCP Trained	Protocol Trained
Sunita Reddy	Pharmacist	Yes	Yes

Annexure-4: Staff Backup Roster

Role	Primary Staff	Backup Staff
Medical Officer	Dr. Ajay Sharma	Dr. Neha K.

Annexure-5: Staff Attendance Register

Date	Name	Role	In-Time	Out-Time	Remarks
17/04/2025	Ravi Mishra	Phlebotomist	05:55	14:10	On Duty

Annexure-6: Staff Performance Log

Date	Staff Name	Issue Observed	Action Taken
16/04/2025	Priya Sinha	Late arrival	Verbal warning

Annexure-7: Staff Feedback Form

Name	Role	Feedback	Suggestions
Akshay Patel	Nurse	Sampling was well managed	Need more breaks during long shifts

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP release	Site Preparedness SOPs	QA Head
17/04/2025	2.0	Expanded staffing ratios, annexures, and performance tracking	Audit feedback and operational revision	QA Head