1. Purpose

To define how adverse events and serious adverse events are identified, assessed, documented and reported to the sponsor and the IRB, so that subject safety is protected and regulatory reporting obligations are met.

2. Scope

Applies to all adverse events occurring in subjects from the time of consent through the protocol-defined follow-up period, in every interventional study conducted at the site.

3. Responsibilities

• Principal Investigator or Sub-Investigator: Assesses severity, seriousness, causality and expectedness, and signs all safety reports.
• Clinical Research Coordinators and Research Nurses: Elicit and document events, collect source data, and prepare and transmit safety reports.
• Clinical Research Manager: Oversees timeliness of reporting and maintains the safety reporting log.
• Regulatory Affairs: Submits safety information to the IRB according to its policy and files acknowledgments.

4. Definitions

Adverse event (AE)

Any untoward medical occurrence in a subject administered a pharmaceutical product, whether or not related to that product.

Serious adverse event (SAE)

An event that results in death, is life-threatening, requires inpatient hospitalisation or prolongs existing hospitalisation, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is an important medical event based on medical judgment.

Causality

The investigator's assessment of the relationship between the event and the investigational product, recorded using the protocol's defined scale.

Site awareness

The moment any site staff member first learns of the event, regardless of how or from whom.

5. Procedure

1. Elicit adverse events at every subject contact using non-leading, open-ended questions, and review concomitant medications, laboratory results and diary cards for unreported events.
2. Record every adverse event in the source document at the time of discovery, including the diagnosis or sign, onset date, severity, action taken and outcome.
3. Assess each event for seriousness against the SAE definition, and record the assessment and the assessor in the source document.
4. For any serious adverse event, notify the Principal Investigator immediately and report to the sponsor within twenty-four hours of site awareness, using the sponsor's designated form and transmission method.
5. Record the exact date and time of site awareness, the date and time of transmission, and retain the transmission confirmation as source documentation.
6. Obtain investigator assessment of severity, causality and expectedness for every serious event before transmission where possible; never delay the initial twenty-four hour report to complete the assessment.
7. Submit follow-up information for serious events, including discharge summaries and resolution, within the timeframe specified by the protocol, and continue follow-up until resolution, stabilisation or the protocol-defined endpoint.
8. Report serious adverse events and unanticipated problems involving risks to subjects to the IRB in accordance with the IRB's written policy, and file the acknowledgment in the regulatory binder.
9. Report pregnancies, overdoses, medication errors and events of special interest according to the protocol, even when they do not meet the SAE definition.
10. Redact or limit protected health information in safety reports to the minimum necessary, using the subject's study identifier rather than name or medical record number, per HIP-001.
11. Enter adverse events into the electronic case report form within the protocol-specified interval and reconcile the case report form against the safety database at every monitoring visit.
12. Maintain a safety reporting log recording event, subject identifier, date of awareness, date reported to sponsor, date reported to IRB, and current status.
13. Escalate any report that misses its required timeline to the Clinical Research Manager and Quality Assurance the same business day, and file a deviation report under CON-002.
14. Review the aggregate adverse event profile at each study team meeting to identify safety trends requiring investigator or sponsor attention.

6. References

• 21 CFR Part 312.64 — Investigator reports
• 21 CFR Part 312.32 — IND safety reporting
• 21 CFR Part 56 — Institutional Review Boards
• ICH E6(R3) Good Clinical Practice
• CON-002 Protocol Deviations & Violations

7. Revision History

• v4.0 · Feb 06, 2023 — Added mandatory recording of site awareness date and time.
• v5.0 · May 19, 2025 — Added events of special interest and pregnancy reporting.
• v5.1 · Apr 13, 2026 — Added minimum necessary PHI guidance for safety reports.