scientific-skills/clinical-reports/assets/clinical_trial_sae_template.md
Report Type: [ ] Initial Report [ ] Follow-up Report [ ] Final Report
Report Number: [SAE-YYYY-####]
Report Date: [MM/DD/YYYY]
Reporter: [Name and title]
Reporter Contact: [Email and phone]
Follow-up Number: [If follow-up: #1, #2, etc.]
Previous Report Date: [If follow-up]
Protocol Number: [Protocol ID]
Protocol Title: [Full study title]
Study Phase: [ ] Phase I [ ] Phase II [ ] Phase III [ ] Phase IV
Study Sponsor: [Sponsor name]
IND/IDE Number: [IND or IDE number if applicable]
ClinicalTrials.gov ID: [NCT number]
Principal Investigator: [Name]
Site Number: [Site ID]
Site Name: [Institution name]
Subject ID / Randomization Number: [ID only, no name]
Subject Initials: [XX] (if permitted by regulatory authority)
Age: [Years] OR Date of Birth: [Year only: YYYY]
Sex: [ ] Male [ ] Female [ ] Other
Race: [Category]
Ethnicity: [Hispanic or Latino / Not Hispanic or Latino]
Weight: [kg]
Height: [cm]
Study Arm / Treatment Group: [ ] Treatment A [ ] Treatment B [ ] Placebo [ ] Blinded
Date of Informed Consent: [MM/DD/YYYY]
Date of First Study Drug: [MM/DD/YYYY]
Date of Last Study Drug: [MM/DD/YYYY]
Study Drug Status at Time of Event: [ ] Ongoing [ ] Completed [ ] Discontinued
Reported Term (Verbatim): [Exact term reported by investigator/patient]
MedDRA Coding:
Event Description: [Detailed narrative description of the adverse event]
Date of Onset: [MM/DD/YYYY]
Time of Onset: [HH:MM] (if known and relevant)
Date of Resolution: [MM/DD/YYYY] OR [ ] Ongoing
Duration: [Days/hours if resolved]
Event Location: [ ] Inpatient [ ] Outpatient [ ] Home [ ] Other: ________
This event is considered serious because it resulted in or required:
Hospitalization Details (if applicable):
Severity (Intensity):
Note: Severity is not the same as seriousness
Date of Final Outcome (if resolved): [MM/DD/YYYY]
Relationship to Study Drug:
Relationship to Study Procedures:
Relationship to Underlying Disease:
Relationship to Concomitant Medications:
Rationale for Causality Assessment: [Detailed explanation of causality determination, including temporal relationship, biological plausibility, dechallenge/rechallenge if applicable, alternative explanations]
Is this event expected based on the Investigator's Brochure or protocol?
Reference: [IB version and section, or protocol section]
Dechallenge: [ ] Positive (improved after stopping) [ ] Negative [ ] Not done
Rechallenge: [ ] Positive (recurred after restarting) [ ] Negative [ ] Not done
Treatments Given for This Event:
[Medication/Procedure]
[Additional treatments]
Hospitalization Interventions:
Pre-existing Conditions Relevant to This Event: [List conditions that may be related to the event]
Concomitant Medications at Time of Event:
| Medication | Indication | Dose/Frequency | Start Date | Stop Date |
|---|---|---|---|---|
| [Name] | [Indication] | [Dose] | [MM/DD/YYYY] | [MM/DD/YYYY or Ongoing] |
Relevant Laboratory Values:
| Test | Result | Units | Reference Range | Date | Relation to Event |
|---|---|---|---|---|---|
| [Test] | [Value] | [Units] | [Range] | [MM/DD] | [Before/During/After] |
Imaging/Diagnostic Studies:
ECG/Monitoring: [Results if relevant]
[Comprehensive chronological narrative of the event]
Minimum elements to include:
Example Structure:
A [age]-year-old [sex] with a history of [relevant medical conditions] enrolled in
Study [protocol] on [date] and was randomized to [treatment arm]. The patient had
been receiving [study drug] at [dose] for [duration] when, on [date], the patient
developed [initial symptoms].
[Describe progression of symptoms, timeline, clinical findings...]
[Describe diagnostic workup performed and results...]
[Describe treatments given and patient response...]
[Describe outcome and current status...]
The investigator assessed this event as [causality] related to study drug because
[reasoning]. Alternative explanations include [list alternative causes considered].
Investigator's Comments: [Additional relevant information, clinical interpretation, conclusions]
Does this event meet criteria for expedited reporting to regulatory authorities?
Information Pending (if initial or follow-up report):
Expected Date for Follow-up Report: [MM/DD/YYYY]
Sponsor Safety Assessment: [To be completed by sponsor]
IRB Notification:
Investigator Signature:
Name: [Principal Investigator name]
Title: [MD, credentials]
Signature: ____________________
Date: [MM/DD/YYYY]
I certify that this report is accurate and complete to the best of my knowledge.
Sponsor Representative (if applicable):
Name: [Name]
Title: [Medical Monitor, Safety Officer]
Signature: ____________________
Date: [MM/DD/YYYY]
Regulatory Timeline Requirements:
Key Points: