What Happens After a Suspected SAE Is Reported?

 

 

This guide breaks down the complete end-to-end workflow in simple, real-world language—exactly how it works inside CROs, hospitals, and sponsor organizations.

What Is an SAE?

An SAE is any untoward medical event that results in:

• Death

• Life-threatening condition

• Hospitalization/prolongation

• Disability/incapacity

• Congenital anomaly

• Important medical event requiring intervention

Once detected, the clock starts immediately. But what happens next?

Also Read: Medidata rave explained beginner

SAE Workflow: Step-by-Step Process

1. Site Identifies the Potential SAE

The process begins at the study site.
The PI (Principal Investigator) or Sub-I assesses the event and determines whether it meets the criteria for an SAE.

Sources of detection:

• Patient visit

• Lab abnormalities

• Phone call from subject

• Hospital admission records

Once confirmed, the site completes the SAE form in the EDC or sponsor safety system.

2. Initial SAE Notification to Sponsor/CRO

Sites typically have 24 hours to report the SAE.
They submit:

• SAE form

• Relevant medical notes

• Labs, imaging, discharge summary

• PI’s initial causality assessment

The CRO’s Safety Team/Pharmacovigilance Team receives the alert.

3. CRO Safety Team Performs Quality Check

The safety specialist reviews the received information for:

• Completeness

• Consistency

• Missing medical records

• Correct causality & expectedness

• Clear timeline

If anything is unclear, a SAE query is sent back to the site.

4. Data Entry Into Safety Database (Argus/ArisG/Veeva Vault Safety)

Once QC is complete, the SAE is entered into the sponsor’s validated Safety Database, separate from EDC systems like Medidata Rave.

This step includes:

• Coding using MedDRA

• Seriousness, causality, and expectedness classification

• Case narrative creation

5. Medical Review

A Safety Physician/Medical Monitor performs clinical evaluation:

• Does the event relate to Investigational Product (IP)?

• Does it match known risks?

• Does it change the risk–benefit profile?

• Does it require medical judgement to reclassify?

Sometimes the medical reviewer updates seriousness or causality based on clinical reasoning.

6. Expedited Reporting (If Required)

If the SAE is related to the IP and unexpected → it becomes a SUSAR.

Timeline usually:

• 7 days → fatal or life-threatening SUSAR

• 15 days → all other SUSARs

The sponsor reports to:

• Regulatory authorities

• Ethics Committees/IRBs

• Investigators (via Safety Letters)

7. Sponsor Sends Safety Letter to All Investigators

Investigators receive:

• CIOMS form / SUSAR report

• Updated Investigator Brochure sections (if applicable)

• Safety alert notifications

Sites must acknowledge receipt for compliance.

8. Follow-up Information Collection

SAEs rarely stay static.
The site sends updates until the event is:

• Resolved

• Stabilized

• Reached a clear outcome

Each follow-up triggers:

• Narrative updates

• New medical review

• Possible additional reporting

9. Reconciliation Between EDC and Safety Database

Because EDC (e.g., Medidata Rave) and the safety database are separate systems, CRO teams perform SAE reconciliation every cycle.

They check:

• All AE/SAE in EDC appear in the safety database

• Coding matches

• Event dates match

• Outcomes match

Any mismatch → query to site.

If you're interested in a career in clinical research or want to learn more about CROs, stay tuned to BioTrialHub for more insightful articles!

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