medical management of serious adverse events (SAEs) and intercurrent illness in clinical trials. This ensures participants receive appropriate medical care, while maintaining compliance with regulatory requirements and ensuring timely communication with sponsors and regulators.

Scope

This SOP applies to investigators, sub-investigators, study physicians, and healthcare staff involved in the medical management of participants experiencing SAEs or intercurrent illnesses during clinical trials. It covers medical assessment, treatment, documentation, follow-up, and reporting.

Responsibilities

• Principal Investigator (PI): Responsible for clinical oversight, assessment, treatment decisions, and documentation of SAEs and intercurrent illnesses.
• Sub-Investigators/Study Physicians: Provide direct medical care, document assessments, and ensure treatment aligns with the protocol.
• Study Coordinator: Supports documentation, follow-up scheduling, and reporting to sponsor and EC/IRB.
• Sponsor/CRO: Provides medical monitoring, evaluates impact on safety, and oversees regulatory reporting.
• Quality Assurance Officer: Reviews medical management records during audits and inspections.

Accountability

The PI is accountable for ensuring timely and appropriate medical management of SAEs and intercurrent illnesses. The sponsor is accountable for safety oversight and regulatory reporting.

Procedure

1. Initial Assessment
Immediately assess the subject presenting with SAE or intercurrent illness.
Record clinical signs, symptoms, vital signs, and initial diagnosis in source documents.
Determine if hospitalization or emergency care is required.

2. Treatment and Stabilization
Provide medical treatment per standard of care and protocol requirements.
Document all medications, doses, and procedures performed.
Ensure subject safety and monitor response to treatment.

3. Communication
Notify the sponsor within 24 hours of an SAE requiring medical intervention.
Inform EC/IRB of medically significant events as required.
Provide periodic updates during ongoing management.

4. Follow-Up Care
Continue clinical monitoring until subject recovers, stabilizes, or reaches a defined outcome.
Document follow-up visits in SAE Follow-Up Form (Annexure-1).

5. Documentation
Complete SAE Medical Management Form (Annexure-2).
File all medical records, lab reports, and treatment notes in ISF and TMF.

6. Intercurrent Illness
Document any non-SAE illness occurring during the trial in the Intercurrent Illness Log (Annexure-3).
Assess potential impact on investigational product and study outcomes.

7. Archiving
Archive all SAE and intercurrent illness medical records for at least 5 years post-trial or as required by law.

Abbreviations

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

Documents

1. SAE Follow-Up Form (Annexure-1)
2. SAE Medical Management Form (Annexure-2)
3. Intercurrent Illness Log (Annexure-3)

References

• ICH E6(R2) – Good Clinical Practice
• US FDA – Safety Reporting and Medical Management
• EMA – Pharmacovigilance Guidelines
• CDSCO – Clinical Trial Safety Rules
• WHO – Clinical Trial Safety and Pharmacovigilance

Version: 1.0

Approval Section

Prepared By	Rajesh Kumar, Clinical Research Physician
Checked By	Sunita Reddy, QA Officer
Approved By	Dr. Anil Sharma, Principal Investigator

Annexures

Annexure-1: SAE Follow-Up Form

Subject ID	Event	Date of Onset	Treatment Provided	Follow-Up Outcome	Date of Resolution
CT2025-SITE01-121	Severe Allergic Reaction	12/09/2025	Antihistamines, IV fluids	Recovered	15/09/2025

Annexure-2: SAE Medical Management Form

Date	Subject ID	Medical Intervention	Outcome	PI Signature
13/09/2025	CT2025-SITE01-121	Hospital admission, supportive care	Stabilized	Signed

Annexure-3: Intercurrent Illness Log

Date	Subject ID	Illness	Treatment	Impact on Study
18/09/2025	CT2025-SITE01-125	Viral fever	Paracetamol	No impact

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
26/08/2025	00	Initial version	New SOP creation	Head, Clinical Research

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