When a serious event happens, the site has to get the facts to the sponsor fast and consistently. This template is a structured SAE report with the fields every protocol asks for, built to replace the fax-and-email form with one record in the study database.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Event
Event term (diagnosis if known)
Onset date
Date site became aware
Seriousness criteria
Assessment
Causality (study treatment)
Action taken with study treatment
Outcome
What this template gives you
Design basics
An SAE report has a different job from an adverse event log row. The AE form records every event for the safety dataset. The SAE report is a time-critical message: it is written within a day or so of the site learning about the event, usually incomplete, and updated as discharge summaries and results arrive. Good SAE forms therefore make the first report quick and the follow-ups traceable.
The core of the report matches the AE record, so keep the two consistent. Capture's adverse event eCRF holds the event term, dates, severity and the same six seriousness flags; the SAE report adds what an expedited report needs on top: the date the site became aware, the narrative, relevant tests and history, and the investigator's sign-off. Medications from the concomitant medications form and conditions from the medical history form should be referenced rather than retyped.
Record the onset date, the date the site became aware, and the date the report was sent. Reporting clocks usually run from awareness, and a record that holds only the onset date cannot show whether the deadline was met.
A report type field (initial or follow-up) and a follow-up number let the sponsor tell versions apart. With Capture's audit trail every edit to an existing SAE keeps its history, so a corrected causality assessment is visible as a change, not an overwrite.
A good narrative states the participant, the treatment and dose, the event and its timing relative to dosing, relevant history and concomitant medication, tests and results, treatment given, outcome and the investigator's reasoning on causality. Provide a prompt list in the field help text so sites cover the same points every time.
SAE timeline
SAE reported
Day 0 · 09:12
Safety alert acknowledged
Medical monitor · 09:40
Site staff attestation
Study coordinator · 11:05
AE sign-off (PI / Sub-I)
Awaiting signature
Template
| Field | Question type | Values | Why it is there |
|---|---|---|---|
| Report type | Single choice | Initial, follow-up | Separates versions of one event |
| Event term | Text | Diagnosis if known, else sign or symptom | Coded later to a dictionary term |
| Onset date and time | Date, time | Date, hh:mm | Start of the event |
| Date site became aware | Date | Date | Starts the reporting clock |
| Seriousness criteria | Multiple choice | Death, life-threatening, hospitalisation or prolongation, persistent or significant disability, congenital anomaly, important medical event | Shows why the event qualifies |
| Death date and cause | Date, text | Shown if death selected | Required detail for fatal events |
| Severity | Single choice | Mild, moderate, severe (or CTCAE grade) | Intensity, separate from seriousness |
| Causality to study treatment | Dropdown | Not related, unlikely, possibly, probably, related | Investigator judgement |
| Action taken | Dropdown | None, dose reduced, interrupted, withdrawn | Treatment decision |
| Outcome | Dropdown | Recovered, recovering, not recovered, recovered with sequelae, fatal, unknown | Status at report time |
| Narrative | Long text | Free text | Clinical story for the safety reviewer |
| Relevant tests and results | Long text | Free text | Supports the assessment |
Adapt every list to your protocol's safety plan. If your sponsor requires its own report form, build that instead and keep this layout as a starting point.
Reporting clock
Reporting deadlines depend on the regulator and on whether the event is fatal or life-threatening. Check them against your protocol and the applicable regulation.
This tool times a case you have already assessed as serious, unexpected and with a reasonable possibility of being caused by the drug. It does not decide seriousness, expectedness or causality.
Reference aid, not legal or regulatory advice and not validated software. Periods are calendar days counted from the date shown (that date is day 0, so day 7 is seven days later); weekends and public holidays do not extend them. Your protocol, the sponsor's safety management plan, the regulator's letter or approval conditions and any IRB or ethics committee requirements govern, and they can be shorter. Other regions (UK MHRA, Health Canada, PMDA and others) have their own rules that this tool does not cover. Confirm the current text of the cited provisions before relying on a date. Nothing is stored or sent.
Workflow
Answering Yes to Serious on the AE form raises a safety alert routed by your study notification rules and acknowledged by whoever receives it. The SAE timeline then tracks the event through site staff attestation to PI or sub-investigator sign-off, including under delegation.
Event reported at site
Day 0 · 09:12
Safety alert acknowledged
Medical monitor · 09:40
Site staff attestation
Study coordinator · 11:05
Investigator sign-off
Awaiting PI signature
Follow-up report
When discharge summary arrives
The free sandbox has the template library, sample data and the SAE sign-off flow. Report a test event and sign it as the investigator.
Before go-live
Fields, deadlines and recipients copied from the protocol's safety reporting section.
Who is alerted when Serious = Yes, and who acknowledges.
Term, onset, awareness date, seriousness, causality and outcome required on submission.
Only staff delegated for safety assessment can sign off; check the delegation log.
Who updates the report when new information arrives, and within how many days.
One fictitious SAE reported, queried, signed and exported by the team.
No. It is a generic site-completed SAE eCRF with the fields most protocols ask for. If your sponsor requires its own or a CIOMS-style form, build that layout instead.
An event that results in death, is life-threatening, requires hospitalisation or prolongs it, causes persistent or significant disability, is a congenital anomaly, or is an important medical event. The template records each criterion separately.
Answering Yes to Serious raises a safety alert routed by your study notification rules. The SAE timeline then tracks site attestation and investigator sign-off under electronic signature.
Yes. Use the report type and follow-up number fields, and edit the existing record. The audit trail keeps old values, new values and the reason for change.
Severity is intensity (mild, moderate, severe). Seriousness is a regulatory outcome-based classification. The two are separate fields.
Capture provides safety listings and an E2B export for downstream safety systems. Submission to regulators follows your sponsor's process.
Yes, in the free sandbox with the rest of the template library. You pay only when a study goes live.
Keep exploring
Adverse event eCRF
The AE log that feeds the SAE workflow.
Adverse event reporting software
The full AE and SAE workflow.
Concomitant medications eCRF
Medications taken at the time of the event.
Medical history eCRF
Relevant history for the narrative.
Delegation log template
Who may assess and sign off safety events.
Data management plan template
Where safety data handling is documented.
Build the form, route the alert and sign off a test event in the free sandbox. No credit card.