and consent requirements are met.

Investigator: Assesses reproductive history, ensures pregnancy testing, and confirms eligibility.

Lab Personnel: Conduct pregnancy testing and maintain strict confidentiality of results.

QA Officer: Verifies that all logs, consents, and testing records meet compliance standards.

4. Accountability

The Principal Investigator is accountable for ensuring the inclusion of female participants follows ethical guidelines, safety precautions, and respects confidentiality.

5. Procedure

5.1 Eligibility Screening

1. Only healthy, non-pregnant, non-lactating females aged 18 to 45 years may be enrolled.
2. Women of childbearing potential (WOCBP) must commit to using acceptable contraceptive methods throughout the study period.
3. Record medical and reproductive history in Annexure-1: Female Volunteer Eligibility Form.

5.2 Pregnancy Testing

1. Conduct urine pregnancy tests:
   • At screening
   • Within 24 hours before dosing
2. Positive results result in exclusion from the study.
3. Document results in Annexure-2: Pregnancy Test Record Log and maintain confidentiality.

5.3 Informed Consent Process

1. Provide gender-specific information during consent discussion.
2. Explain potential risks including unknown drug effects on reproductive health.
3. Ensure the female volunteer signs the consent form independently and voluntarily (Annexure-3: Gender-Specific Consent Checklist).

5.4 Facility and Privacy Considerations

1. Provide separate changing areas and restrooms for female volunteers.
2. Ensure staff interacting with female volunteers are gender-sensitive and respectful.

5.5 Safety Monitoring and Reporting

1. Monitor for:
   • Menstrual irregularities
   • Symptoms suggesting possible pregnancy
2. Document adverse events in standard AE logs and inform the PI immediately.

5.6 Withdrawal and Follow-up

1. If a female volunteer withdraws due to pregnancy suspicion, perform a confirmatory test and document the outcome.
2. Initiate medical follow-up and inform Ethics Committee as required.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• PI: Principal Investigator
• CRC: Clinical Research Coordinator
• AE: Adverse Event
• WOCBP: Women of Childbearing Potential

7. Documents

1. Female Volunteer Eligibility Form – Annexure-1
2. Pregnancy Test Record Log – Annexure-2
3. Gender-Specific Consent Checklist – Annexure-3

8. References

• ICH E6(R2) – Good Clinical Practice
• Indian GCP Guidelines
• Schedule Y – Drugs and Cosmetics Rules
• Declaration of Helsinki – Ethical Principles for Medical Research

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Female Volunteer Eligibility Form

Volunteer ID	Name	Age	WOCBP	Contraceptive Method	Approved By
VOL-106-003	Anita Desai	26	Yes	Oral contraceptive	PI

Annexure-2: Pregnancy Test Record Log

Volunteer ID	Test Date	Result	Tested By	Verified By
VOL-106-003	15/04/2025	Negative	Lab Tech	CRC

Annexure-3: Gender-Specific Consent Checklist

Volunteer ID	Informed About	Understood Risks	Signed Consent	Witnessed By
VOL-106-003	Yes	Yes	Yes	Female Staff

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
12/01/2022	1.0	Initial SOP release	Inclusion of Female Volunteers	QA Head
17/04/2025	2.0	Updated with Annexures and enhanced ethical safeguards	Audit Feedback	QA Head