gender-specific variables.

Medical Officer: Conduct gender-specific evaluations and monitor subjects accordingly.

Study Coordinator: Ensure documentation of gender-based risk measures and communicate with staff regarding implementation.

Quality Assurance (QA): Audit and verify implementation of gender-related precautions and protocol adherence.

4. Accountability

The Clinical Operations Manager is accountable for ensuring that gender-specific risk management protocols are included in clinical plans, training modules, and site preparedness.

5. Procedure

5.1 Risk Identification and Classification

1. During protocol development, identify known gender differences related to:
   • Pharmacokinetics (e.g., metabolism, renal clearance)
   • Adverse event profiles (e.g., nausea, dizziness)
   • Hormonal influences (e.g., menstrual cycle, contraceptive use)
2. Refer to published literature and regulatory guidance for known sex-based drug behavior variations.

5.2 Subject Selection and Inclusion

1. Ensure eligibility criteria specify conditions for both male and female subjects, especially for:
   • Age
   • Body Mass Index (BMI)
   • Reproductive status
2. Female subjects must:
   • Have a confirmed negative pregnancy test (serum/urine)
   • Use approved contraception methods or provide documentation of sterilization
3. Exclude pregnant or lactating women from participation.

5.3 Screening and Pre-Dose Evaluation

1. Conduct gender-sensitive medical assessments:
   • Menstrual history
   • Hormonal therapy intake
   • Gynecological concerns (if applicable)
2. Ensure pregnancy test is conducted:
   • At screening
   • 24 hours prior to dosing
   • Post-study completion (if required by protocol)

5.4 Risk Communication and Informed Consent

1. Include gender-specific risk language in informed consent forms (ICF), such as:
   • Risks associated with hormonal fluctuations
   • Unknown drug effects on reproductive health
2. Ensure ICF is reviewed and signed in presence of study staff, with adequate time for questions.
3. Document risk communication in Annexure-1: Gender-Specific Consent Checklist.

5.5 Safety Monitoring During Clinical Phase

1. During the residential period:
   • Maintain privacy and segregation in accommodation and sanitation
   • Ensure dedicated medical support for female-specific issues (e.g., menstrual discomfort, gynecological symptoms)
2. Maintain separate adverse event records for male and female subjects to observe trend differences.
3. All unexpected symptoms should be escalated to the Medical Officer for assessment and documentation in Annexure-2: Gender-Based AE Log.

5.6 Post-Study Follow-Up

1. Offer optional post-study reproductive health consultation for female subjects.
2. Repeat pregnancy test if the protocol specifies follow-up testing post last dose.
3. Document outcomes and subject status in Annexure-3: Gender-Specific Follow-Up Log.

5.7 Training and Awareness

1. Conduct gender sensitivity training for all staff involved in clinical operations.
2. Ensure that standard training logs reflect completion of sessions on:
   • Privacy and ethics
   • Contraceptive counseling
   • Incident escalation procedures for gender-specific risks

6. Abbreviations

• BA/BE: Bioavailability/Bioequivalence
• PI: Principal Investigator
• AE: Adverse Event
• ICF: Informed Consent Form
• QA: Quality Assurance

7. Documents

1. Gender-Specific Consent Checklist – Annexure-1
2. Gender-Based AE Log – Annexure-2
3. Gender-Specific Follow-Up Log – Annexure-3

8. References

• ICH E6(R2) – Good Clinical Practice
• US FDA – Guideline for Inclusion of Women in Clinical Trials
• CDSCO – Bioavailability/Bioequivalence Guidance

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Gender-Specific Consent Checklist

Subject ID	Gender	Consent Date	Pregnancy Risk Explained	Signature
F1023	Female	15/04/2025	Yes	Signed

Annexure-2: Gender-Based AE Log

Subject ID	Gender	Date	AE Description	Severity	Outcome
F1023	Female	16/04/2025	Nausea	Mild	Resolved

Annexure-3: Gender-Specific Follow-Up Log

Subject ID	Gender	Follow-Up Date	Pregnancy Test	Remarks
F1023	Female	21/04/2025	Negative	No issues reported

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP release	New gender-focused protocol	QA Head
17/04/2025	2.0	Added expanded procedures and annexures	Audit compliance	QA Head