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Standard Operating Procedure for Selective Safety Data Collection (ICH E19)

Purpose

The purpose of this SOP is to establish processes for selective safety data collection in clinical trials, in alignment with ICH E19. This approach ensures optimization of safety data collection where comprehensive data are not required, while maintaining subject protection, regulatory compliance, and integrity of safety evaluation.

Scope

This SOP applies to sponsors, CROs, investigators, and pharmacovigilance (PV) teams involved in safety data management in clinical trials. It covers identification of trials eligible for selective data collection, definition of selective data parameters, documentation, and reporting procedures.

Responsibilities

• Sponsor: Defines rationale for selective safety data collection and ensures regulatory approval.
• CRO: Implements selective data collection procedures across sites.
• Investigator: Collects and documents only the predefined safety data points.
• PV Department: Ensures selective data is analyzed and reported appropriately.
• QA: Audits selective safety data processes for compliance with ICH E19.

Accountability

The Sponsor’s Pharmacovigilance Head is accountable for ensuring selective safety data collection aligns with ICH E19 guidance and does not compromise patient safety or trial integrity.

Procedure

1. Identification of Eligible Trials
1.1 Determine trial types suitable for selective safety data collection (e.g., late-phase or pragmatic trials).
1.2 Justify the rationale in trial protocols.
1.3 Document in Trial Eligibility Log (Annexure-1).

2. Defining Selective Safety Parameters
2.1 Define which safety data (AEs, SAEs, concomitant medications) will be collected.
2.2 Obtain regulatory and EC approval.
2.3 Record in Safety Parameters Log (Annexure-2).

3. Investigator Training
3.1 Train investigators and staff on selective safety data collection.
3.2 Document training in Investigator Training Log (Annexure-3).

4. Data Collection and Reporting
4.1 Collect only predefined safety data at site level.
4.2 Record in Selective Safety Data Collection Log (Annexure-4).
4.3 Report aggregated data to sponsor and regulators.

5. Analysis and Oversight
5.1 Analyze collected data for trends and risk signals.
5.2 Escalate unexpected safety concerns to regulators.
5.3 Document in Oversight Log (Annexure-5).

6. Archiving
6.1 Archive selective safety data and related approvals in TMF.
6.2 Record in Safety Archiving Log (Annexure-6).

Abbreviations

• SOP: Standard Operating Procedure
• PV: Pharmacovigilance
• ICH: International Council for Harmonisation
• AE: Adverse Event
• SAE: Serious Adverse Event
• CRO: Contract Research Organization
• QA: Quality Assurance
• TMF: Trial Master File
• EC: Ethics Committee

Documents

1. Trial Eligibility Log (Annexure-1)
2. Safety Parameters Log (Annexure-2)
3. Investigator Training Log (Annexure-3)
4. Selective Safety Data Collection Log (Annexure-4)
5. Oversight Log (Annexure-5)
6. Safety Archiving Log (Annexure-6)

References

• ICH E19 – Selective Safety Data Collection
• ICH GCP Guidelines
• FDA Guidance on Selective Safety Data Collection

Version: 1.0

Approval Section

Annexures

Annexure-1: Trial Eligibility Log

Annexure-2: Safety Parameters Log

Annexure-3: Investigator Training Log

Annexure-4: Selective Safety Data Collection Log

Annexure-5: Oversight Log

Annexure-6: Safety Archiving Log

Revision History

For more SOPs visit: Pharma SOP