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Standard Operating Procedure for Pregnancy Reporting and Follow-Up

Purpose

The purpose of this SOP is to define procedures for reporting and managing pregnancies occurring in clinical trial participants or partners of participants exposed to investigational products (IP). It ensures maternal and fetal safety, regulatory compliance, and accurate documentation.

Scope

This SOP applies to investigators, study coordinators, and sponsors involved in clinical trials where pregnancy occurs during participation. It covers pregnancy reporting, follow-up, documentation, and submission to sponsors, EC/IRB, and regulatory authorities when required.

Responsibilities

• Principal Investigator (PI): Responsible for assessing, documenting, and reporting pregnancy cases and ensuring medical follow-up.
• Study Coordinator: Collects pregnancy details, maintains logs, and files records in ISF and TMF.
• Sponsor/CRO: Reviews pregnancy cases, ensures regulatory reporting, and monitors outcomes for safety evaluation.
• Quality Assurance Officer: Audits pregnancy reporting compliance during site monitoring and inspections.

Accountability

The PI is accountable for timely pregnancy reporting and follow-up documentation. The sponsor is accountable for regulatory submissions and pharmacovigilance oversight.

Procedure

1. Identification
Conduct routine pregnancy testing as per protocol for women of childbearing potential.
Upon confirmation of pregnancy, document immediately in source notes and Pregnancy Report Form (Annexure-1).

2. Initial Reporting
Notify sponsor within 24 hours of pregnancy confirmation.
Submit completed Pregnancy Report Form to sponsor and file in ISF.
Inform EC/IRB as per local regulations.

3. Medical Management
Discontinue investigational product unless sponsor/EC decides otherwise.
Ensure appropriate obstetric care for the subject.
Record all interventions, treatment, and progress.

4. Follow-Up
Collect follow-up data throughout pregnancy and after delivery (maternal outcome, fetal outcome).
Update Pregnancy Follow-Up Form (Annexure-2) until pregnancy outcome is known.

5. Regulatory Reporting
Sponsor evaluates case for potential SAE/SUSAR reporting.
Submit to authorities when required.

6. Documentation
Maintain Pregnancy Log (Annexure-3).
File all reports, correspondence, and acknowledgments in ISF and TMF.

7. Archiving
Archive pregnancy-related records for at least 5 years post-trial or as per applicable laws.

Abbreviations

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• IP: Investigational Product
• SAE: Serious Adverse Event
• SUSAR: Suspected Unexpected Serious Adverse Reaction
• CRO: Clinical Research Organization
• QA: Quality Assurance
• ISF: Investigator Site File
• TMF: Trial Master File
• EC: Ethics Committee
• IRB: Institutional Review Board

Documents

1. Pregnancy Report Form (Annexure-1)
2. Pregnancy Follow-Up Form (Annexure-2)
3. Pregnancy Log (Annexure-3)

References

• ICH E6(R2) – Good Clinical Practice
• US FDA – Guidance on Pregnancy in Clinical Trials
• EMA – Pharmacovigilance for Pregnancy Cases
• CDSCO – Pregnancy and Safety Reporting Guidelines
• WHO – International Pharmacovigilance Guidelines

Version: 1.0

Approval Section

Annexures

Annexure-1: Pregnancy Report Form

Annexure-2: Pregnancy Follow-Up Form

Annexure-3: Pregnancy Log

Revision History

For more SOPs visit: Pharma SOP