staff present in clinical units, sampling rooms, dosing areas, and biological sample handling zones within BA/BE study environments.

3. Responsibilities

• Clinical Investigator: Ensures overall adherence to hygiene protocols and infection prevention.
• Nursing Staff: Comply with hand hygiene during dosing, sampling, and subject handling activities.
• Housekeeping Staff: Maintain daily disinfection routines and proper waste segregation.
• Quality Assurance (QA): Conducts periodic audits of hand hygiene compliance and documents observations.

4. Accountability

The Facility-in-Charge or Clinical Operations Manager is accountable for ensuring the implementation of hand hygiene policies, availability of sanitation infrastructure, and staff training.

5. Procedure

5.1 Hand Hygiene Protocol

1. All staff must perform hand hygiene:
   • Before and after direct contact with study subjects
   • Before performing any aseptic procedure (e.g., blood collection)
   • After exposure to bodily fluids or contaminated surfaces
   • Before donning and after removing gloves
2. Acceptable methods:
   • Handwashing with antimicrobial soap and water (minimum 20 seconds)
   • Use of 70% alcohol-based hand rubs (ABHR) when hands are not visibly soiled
3. Use designated hand hygiene stations at entry/exit points of clinical and sampling areas.

5.2 PPE and Gowning Requirements

1. Clinical staff must wear:
   • Clean lab coats or scrub suits
   • Disposable gloves (changed between each subject)
   • Face masks when performing close-contact procedures
2. Use Annexure-1: PPE Gowning Checklist before entering sampling or dosing areas.

5.3 Environmental Disinfection

1. High-touch surfaces (e.g., bedrails, dosing chairs, doorknobs) to be disinfected:
   • Twice daily and after each sampling session
2. Use freshly prepared 1% sodium hypochlorite or hospital-grade disinfectants.
3. Document cleaning using Annexure-2: Disinfection Record Log.

5.4 Infection Control in Sampling and Dosing

1. Use sterile, single-use supplies (needles, vacutainers, alcohol swabs).
2. Label samples in a clean zone, separate from blood collection sites.
3. Dispose sharps immediately in puncture-proof containers.

5.5 Volunteer Education and Monitoring

1. Educate volunteers during screening and admission about:
   • Hand hygiene stations
   • Respiratory etiquette
   • Reporting of symptoms or illness
2. Provide access to hand rubs and tissues near volunteer beds and common areas.

5.6 Compliance Monitoring and Training

1. Train all staff annually on hand hygiene and infection control procedures.
2. Use Annexure-3: Staff Training Attendance Log for documentation.
3. QA to conduct monthly hand hygiene audits using Annexure-4: Compliance Observation Checklist.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• PPE: Personal Protective Equipment
• QA: Quality Assurance
• ABHR: Alcohol-Based Hand Rub

7. Documents

1. PPE Gowning Checklist – Annexure-1
2. Disinfection Record Log – Annexure-2
3. Staff Training Attendance Log – Annexure-3
4. Compliance Observation Checklist – Annexure-4

8. References

• WHO Guidelines on Hand Hygiene in Healthcare
• CDC Infection Control Guidelines
• ICH E6(R2) – Good Clinical 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: PPE Gowning Checklist

Date	Staff Name	Gown	Mask	Gloves	Compliant
16/04/2025	Sunita Reddy	Yes	Yes	Yes	Yes

Annexure-2: Disinfection Record Log

Date	Area	Disinfectant Used	Time	Done By
16/04/2025	Dosing Room	1% NaOCl	08:00 AM	Ajay Verma

Annexure-3: Staff Training Attendance Log

Name	Department	Date Trained	Trainer	Signature
Meena Joshi	Clinical	14/04/2025	QA Officer	Signed

Annexure-4: Compliance Observation Checklist

Observer	Date	Area Observed	Hand Hygiene Compliance (%)	Remarks
QA Team	15/04/2025	Sample Collection	95%	2 missed entries

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
05/01/2022	1.0	Initial Release	GCP Compliance	QA Head
17/04/2025	2.0	Expanded sections on PPE and audit procedures	Post-pandemic SOP upgrade	QA Head