The AE form every interventional study needs: term, onset, severity or CTCAE grade, seriousness criteria, causality, action taken and outcome. Copy it into a study in minutes, then adjust it to your protocol.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Adverse event term (verbatim)
AETERMOnset date
AESTDATPartial date accepted
CTCAE grade
AETOXGRSerious?
AESERRelationship to study treatment
AERELOutcome
AEOUT14
fields in the template, each mapped to a CDASH-style variable
6
seriousness criteria captured as separate flags
2
signatures: site attestation and investigator sign-off
1
audit trail row per changed field, per AE
What this template gives you
Design basics
An adverse event is any untoward medical occurrence in a participant, whether or not it is considered related to the study treatment. That breadth is why the AE form is the most-used and most-queried form in most interventional studies: every headache, rash and lab abnormality the investigator judges clinically significant ends up here, and every one of them has to be complete enough to support safety analysis and, for serious events, expedited reporting.
A good AE eCRF separates the facts of the event (what happened, when it started and stopped) from the clinical judgements about it (how severe it was, whether it was serious, whether the drug caused it). Mixing the two in one free-text box is the single most common reason AE listings need weeks of cleaning before a database lock.
Regulators and sponsors expect at least an event term, an onset date, a seriousness assessment and a severity or toxicity grade for every AE, plus a causality assessment whenever the event is serious. Capture enforces exactly this set when a site submits the form. A coordinator can still save a partial draft while waiting for the investigator, but submission names the missing field instead of silently accepting an incomplete record, and the same check runs on the server so it cannot be bypassed.
Severity describes intensity: a severe headache is still a headache. Seriousness is a regulatory classification based on outcome: death, a life-threatening event, hospitalisation or prolonged hospitalisation, persistent or significant disability, a congenital anomaly, or an important medical event. A mild event can be serious, and a severe event can be non-serious. The template keeps them as separate questions, and breaks seriousness into six criteria so the reason an event qualified is never ambiguous.
The investigator assesses the relationship to study treatment on a fixed scale (the template uses not related, unlikely, possibly, probably and related, which you can collapse to a binary scale if your protocol does). Action taken with the study treatment and the event outcome use controlled lists, so they tabulate cleanly and map to standard terminology later.
Criteria met (select all that apply)
Date site became aware
Field specification
Variable names follow CDASH-style conventions. Required-when rules are the defaults in the template; adjust them to your protocol and safety plan.
| Field | Variable | Question type | Required when | Notes |
|---|---|---|---|---|
| Adverse event term | AETERM | Text | Always | Verbatim term as reported. Coded to MedDRA later, never replaced. |
| Onset date | AESTDAT | Date | Always | Partial dates such as UNK-JUN-2026 accepted. |
| Ongoing at end of study? | AEONGO | Single choice | Always | Drives whether an end date is expected. |
| End date | AEENDAT | Date | Not ongoing | Edit check: cannot be before onset date. |
| Severity | AESEV | Single choice | If grading by severity | Mild, moderate, severe. |
| CTCAE grade | AETOXGR | Linear scale 1 to 5 | If grading by CTCAE | Use instead of severity in oncology and many early-phase studies. Patients can report symptoms alongside with PRO-CTCAE. |
| Serious? | AESER | Single choice | Always | Yes opens the seriousness criteria. |
| Seriousness criteria | AESDTH, AESLIFE, AESHOSP, AESDISAB, AESCONG, AESMIE | Multiple choice | Serious = Yes | At least one criterion required. |
| Relationship to study treatment | AEREL | Dropdown | Serious = Yes (recommended always) | Five-point scale by default. |
| Action taken with study treatment | AEACN | Dropdown | Always | Dose not changed, reduced, interrupted, withdrawn, not applicable. |
| Outcome | AEOUT | Dropdown | Always | Recovered, recovering, not recovered, recovered with sequelae, fatal, unknown. |
| Treatment given for the AE? | AECONTRT | Single choice | Always | Yes prompts a matching concomitant medication entry. |
| Adverse event of special interest? | Sponsor-defined | Single choice | If the protocol defines AESIs | Links to the AESI form. |
| Comments | Sponsor-defined | Long text | Optional | Keep clinical narrative out of coded fields. |
Capture templates carry an OID and the SDTM domain label (AE) on the form. They are not a validated SDTM transformation: your programmers still map exports to SDTM.
Log, not visit form
AEs do not respect the visit schedule. The template is built as a log form with repeating rows rather than a form repeated at every visit, so an event that starts between visits and resolves weeks later is one record that sites update, not five near-duplicates that data management has to reconcile.
Cannot submit yet
Causality is required because the event is serious.
Serious events
Marking an event serious raises a safety alert straight away, routed by your study notification rules and acknowledged by the person who receives it. The SAE timeline then tracks the event from site awareness to investigator sign-off.
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
The free sandbox has the full template library, sample data and the SAE sign-off flow.
Avoid rework
Most AE queries are design problems, not site problems. These are the patterns data managers most often have to clean up after the fact, and how the template avoids them.
Pick one grading approach per study. If some sites grade with CTCAE and others with mild, moderate and severe, the safety tables cannot be pooled. The template has both fields, and you delete the one you are not using before approving the form.
Conditions present before consent belong in medical history. Only a worsening after consent is an AE. Put the rule in the form help text and make sure the medical history and demographics forms are completed at screening, before the first AE can be entered.
Participants often cannot remember the exact day a symptom started. Forcing a full date invites guesses that later conflict with source documents. Capture accepts partial dates and preserves them in exports.
Controlled lists make these fields countable. Free text has to be recoded by hand before any table can be produced.
A log form avoids the "new record every visit" pattern. When severity changes, follow your protocol convention (a new record per severity change, or the maximum severity on one record) and write it into the CRF completion guidelines.
If an AE was treated, the drug should appear in the concomitant medication log. The "treatment given" question in the template is a prompt to keep the two in step, and a data manager review of both logs before lock catches the gaps.
Before you approve the form
Forms move from draft to approved in Capture, and only approved forms appear in the casebook. Run through this list before approving.
Severity or CTCAE grade, not both. Delete the unused field in the draft.
State in help text when AE collection starts (consent or first dose) and ends.
If the protocol defines adverse events of special interest, keep the AESI question and its linked form.
End date after onset, criteria required when serious, causality required when serious. Test with sample entries in the sandbox.
Mark AE term, seriousness and causality for source data verification; skip low-risk comment fields.
Export the blank eCRF PDF for your ethics or IRB submission package.
It is the electronic case report form sites use to record adverse events during a clinical trial: the event term, dates, severity or grade, seriousness, causality, action taken and outcome. See what a CRF is for the wider context.
Yes. The AE form is part of the Capture template library and available in the free sandbox. You pay only when a study goes live with real participants.
Field names follow CDASH-style conventions (AETERM, AESTDAT, AESER and so on) and the form carries the SDTM AE domain label. It is not a validated SDTM transformation, so your programmers still produce the SDTM datasets.
Oncology and many early-phase studies use CTCAE grades 1 to 5. Other therapeutic areas commonly use mild, moderate and severe. Choose one per study and remove the other field before approving the form.
Answering Yes to Serious opens the seriousness criteria and raises a routed safety alert. The SAE timeline then tracks site attestation and investigator sign-off under an electronic signature.
Yes. MedDRA coding uses dictionaries scoped to your sponsor organisation. The verbatim term is always kept alongside the code.
Yes. A clinically significant lab result can raise an AE directly, without losing the lab data already entered.
Yes. Templates copy into your study as draft forms. Add, remove or reword fields, then approve the form when it matches your protocol.
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Copy the template, adjust it to your protocol and test it with sample data. No credit card.