SAE Reporting at Ardent Clinical Research Services (ACRS)

Ensuring Timely, Accurate, and Compliant Safety Reporting. At Ardent Clinical Research Services (ACRS), Serious Adverse Event (SAE) reporting is handled with the highest level of diligence, accuracy, and regulatory compliance. Our experienced pharmacovigilance and medical monitoring teams are committed to ensuring that all safety events are identified, assessed, reported, and followed up promptly in accordance with ICH-GCP, CDSCO, US FDA, EMA, and other global regulatory requirements.

What Is an SAE?

A Serious Adverse Event (SAE) is any untoward medical occurrence that:

  • •Results in death
  • •Is life-threatening
  • •Requires hospitalization or prolongation of existing hospitalization
  • •Results in persistent or significant disability/incapacity
  • •Is a congenital anomaly/birth defect
  • •Requires medical or surgical intervention to prevent any of the above

ACRS Approach to SAE Reporting

1. Immediate Detection and Notification

  • Site personnel are trained to identify and report all SAEs within 24 hours of becoming aware of the event.
  • ACRS provides clear reporting timelines, forms, and guidance to investigators and study staff.
  • Our clinical monitors ensure that the Initial SAE Notification Form is promptly submitted to the sponsor, regulatory authorities, and ethics committee as per protocol and regulatory guidelines.

2. Medical Review and Assessment

  • Medical Monitors at ACRS assess each SAE for:
  • • Causality (relatedness to study drug or procedure)
  • • Expectedness (based on IB or protocol)
  • • Severity and outcome
  • The SAE report is medically evaluated and signed off before submission.

3. Regulatory Reporting

  • All reportable SAEs are submitted to the appropriate regulatory authorities (e.g., CDSCO, US FDA, EMA), sponsor, and ethics committees within the specified timelines:
  • • 7 calendar days for fatal/life-threatening SAEs
  • • 15 calendar days for other serious and unexpected SAEs
  • Our team ensures that narratives, case report forms, and follow-up reports are accurate, complete, and submitted on time.

4. Documentation and Follow-up

  • ACRS maintains comprehensive records of all SAE reports, related correspondence, and follow-up actions.
  • Ongoing follow-up is conducted until the SAE is resolved or a stable outcome is achieved.
  • The final SAE report includes updated information, causality reassessment, and outcome status.

5. Safety Data Reconciliation

  • The safety team conducts regular reconciliation between:
  • • Source documents
  • • Clinical trial databases
  • • Pharmacovigilance databases
  • • Sponsor safety systems
  • This ensures data consistency and audit readiness.

6. Safety Reporting Training

  • All ACRS staff involved in safety (CRAs, investigators, coordinators, monitors) undergo frequent training on:
  • • SAE definitions and detection
  • • Reporting processes and timelines
  • • Regulatory requirements
  • • Documentation and audit preparedness

Our SAE Reporting Team at ACRS

The SAE process is driven by a dedicated, cross-functional team, which includes:

Medical Monitors

Provide medical review and clinical judgment for each reported SAE. Ensure causality and seriousness assessments are accurate and defensible.

Pharmacovigilance Officers

Coordinate SAE collection, triage, entry, and regulatory reporting. Ensure compliance with sponsor SOPs and global PV regulations.

Clinical Research Associates (CRAs)

Support sites in SAE reporting and documentation. Ensure accurate and timely source verification and escalation.

Quality Assurance Team

Conduct internal audits of SAE processes. Ensure continuous compliance with internal SOPs and external regulations.

Why Sponsors Trust ACRS for Safety Reporting

  • •24/7 medical support for real-time SAE handling
  • •Proven expertise in global safety regulations and submissions
  • •Timely, consistent, and high-quality SAE reports
  • •Transparent communication and proactive risk mitigation