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Zhongwei Li
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skills/clinical-reports/assets/clinical_trial_sae_template.md
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skills/clinical-reports/assets/clinical_trial_sae_template.md
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# Serious Adverse Event (SAE) Report Template
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## Report Information
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**Report Type:** [ ] Initial Report [ ] Follow-up Report [ ] Final Report
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**Report Number:** [SAE-YYYY-####]
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**Report Date:** [MM/DD/YYYY]
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**Reporter:** [Name and title]
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**Reporter Contact:** [Email and phone]
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**Follow-up Number:** [If follow-up: #1, #2, etc.]
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**Previous Report Date:** [If follow-up]
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---
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## Study Information
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**Protocol Number:** [Protocol ID]
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**Protocol Title:** [Full study title]
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**Study Phase:** [ ] Phase I [ ] Phase II [ ] Phase III [ ] Phase IV
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**Study Sponsor:** [Sponsor name]
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**IND/IDE Number:** [IND or IDE number if applicable]
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**ClinicalTrials.gov ID:** [NCT number]
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**Principal Investigator:** [Name]
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**Site Number:** [Site ID]
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**Site Name:** [Institution name]
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---
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## Subject Information (De-identified)
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**Subject ID / Randomization Number:** [ID only, no name]
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**Subject Initials:** [XX] (if permitted by regulatory authority)
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**Age:** [Years] OR **Date of Birth:** [Year only: YYYY]
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**Sex:** [ ] Male [ ] Female [ ] Other
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**Race:** [Category]
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**Ethnicity:** [Hispanic or Latino / Not Hispanic or Latino]
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**Weight:** [kg]
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**Height:** [cm]
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**Study Arm / Treatment Group:** [ ] Treatment A [ ] Treatment B [ ] Placebo [ ] Blinded
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**Date of Informed Consent:** [MM/DD/YYYY]
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**Date of First Study Drug:** [MM/DD/YYYY]
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**Date of Last Study Drug:** [MM/DD/YYYY]
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**Study Drug Status at Time of Event:** [ ] Ongoing [ ] Completed [ ] Discontinued
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---
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## Adverse Event Information
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**Reported Term (Verbatim):** [Exact term reported by investigator/patient]
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**MedDRA Coding:**
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- **Preferred Term (PT):** [MedDRA PT]
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- **System Organ Class (SOC):** [MedDRA SOC]
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- **MedDRA Version:** [e.g., 25.0]
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**Event Description:**
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[Detailed narrative description of the adverse event]
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**Date of Onset:** [MM/DD/YYYY]
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**Time of Onset:** [HH:MM] (if known and relevant)
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**Date of Resolution:** [MM/DD/YYYY] OR [ ] Ongoing
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**Duration:** [Days/hours if resolved]
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**Event Location:** [ ] Inpatient [ ] Outpatient [ ] Home [ ] Other: ________
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---
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## Seriousness Criteria
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**This event is considered serious because it resulted in or required:**
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- [ ] **Death** - Date of death: [MM/DD/YYYY]
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- [ ] **Life-threatening** - Immediate risk of death at time of event
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- [ ] **Hospitalization (initial or prolonged)** - Dates: [MM/DD/YYYY to MM/DD/YYYY]
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- [ ] **Persistent or significant disability/incapacity**
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- [ ] **Congenital anomaly/birth defect**
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- [ ] **Medically important event** - Explanation: _________________
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**Hospitalization Details (if applicable):**
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- Admission Date: [MM/DD/YYYY]
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- Discharge Date: [MM/DD/YYYY] OR [ ] Still hospitalized
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- Hospital Name: [Name and location]
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- ICU Admission: [ ] Yes [ ] No
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- If yes, dates: [MM/DD/YYYY to MM/DD/YYYY]
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---
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## Severity Assessment
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**Severity (Intensity):**
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- [ ] **Mild** - Noticeable but does not interfere with daily activities
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- [ ] **Moderate** - Interferes with daily activities but manageable
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- [ ] **Severe** - Prevents usual daily activities, requires intervention
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*Note: Severity is not the same as seriousness*
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---
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## Outcome
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- [ ] **Recovered/Resolved** - Complete resolution, returned to baseline
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- [ ] **Recovering/Resolving** - Improving but not yet fully resolved
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- [ ] **Not Recovered/Not Resolved** - Ongoing without improvement
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- [ ] **Recovered/Resolved with Sequelae** - Persistent effects remain
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- [ ] **Fatal** - Event resulted in death
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- [ ] **Unknown** - Unable to determine outcome
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**Date of Final Outcome (if resolved):** [MM/DD/YYYY]
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---
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## Causality Assessment
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**Relationship to Study Drug:**
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- [ ] **Not Related** - Clearly due to other cause
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- [ ] **Unlikely Related** - Doubtful connection to study drug
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- [ ] **Possibly Related** - Could be related, but other causes possible
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- [ ] **Probably Related** - More likely related to study drug than other causes
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- [ ] **Definitely Related** - Certain relationship to study drug
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**Relationship to Study Procedures:**
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- [ ] Not Related [ ] Unlikely [ ] Possibly [ ] Probably [ ] Definitely
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**Relationship to Underlying Disease:**
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- [ ] Not Related [ ] Unlikely [ ] Possibly [ ] Probably [ ] Definitely
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**Relationship to Concomitant Medications:**
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- [ ] Not Related [ ] Unlikely [ ] Possibly [ ] Probably [ ] Definitely
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- Suspected medication(s): _____________________
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**Rationale for Causality Assessment:**
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[Detailed explanation of causality determination, including temporal relationship, biological plausibility, dechallenge/rechallenge if applicable, alternative explanations]
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---
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## Expectedness
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**Is this event expected based on the Investigator's Brochure or protocol?**
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- [ ] **Expected** - Listed in IB/protocol with similar characteristics
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- [ ] **Unexpected** - Not listed OR more severe than documented
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**Reference:** [IB version and section, or protocol section]
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---
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## Action Taken with Study Drug
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- [ ] **No change** - Study drug continued at same dose
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- [ ] **Dose reduced** - New dose: ______ (from ______)
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- [ ] **Dose increased** - New dose: ______ (from ______)
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- [ ] **Drug interrupted** - Dates: [MM/DD to MM/DD]
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- [ ] Resumed [ ] Not resumed
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- [ ] **Drug permanently discontinued** - Date: [MM/DD/YYYY]
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- [ ] **Not applicable** - Event occurred after study drug discontinued
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**Dechallenge:** [ ] Positive (improved after stopping) [ ] Negative [ ] Not done
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**Rechallenge:** [ ] Positive (recurred after restarting) [ ] Negative [ ] Not done
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---
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## Treatment and Interventions
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**Treatments Given for This Event:**
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1. **[Medication/Procedure]**
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- Dose/Details: _________________
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- Route: _________________
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- Start Date: [MM/DD/YYYY]
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- Stop Date: [MM/DD/YYYY] OR [ ] Ongoing
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- Response: [ ] Effective [ ] Partially effective [ ] Not effective
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2. **[Additional treatments]**
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**Hospitalization Interventions:**
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- [ ] IV fluids
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- [ ] Oxygen therapy
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- [ ] Mechanical ventilation
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- [ ] Surgical intervention - Procedure: ______________
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- [ ] ICU care
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- [ ] Other: ______________
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---
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## Relevant Medical History
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**Pre-existing Conditions Relevant to This Event:**
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[List conditions that may be related to the event]
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**Concomitant Medications at Time of Event:**
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| Medication | Indication | Dose/Frequency | Start Date | Stop Date |
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|------------|-----------|----------------|------------|-----------|
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| [Name] | [Indication] | [Dose] | [MM/DD/YYYY] | [MM/DD/YYYY or Ongoing] |
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---
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## Laboratory and Diagnostic Tests
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**Relevant Laboratory Values:**
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| Test | Result | Units | Reference Range | Date | Relation to Event |
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|------|--------|-------|----------------|------|-------------------|
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| [Test] | [Value] | [Units] | [Range] | [MM/DD] | [Before/During/After] |
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**Imaging/Diagnostic Studies:**
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- **[Study type] ([Date]):** [Key findings]
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**ECG/Monitoring:**
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[Results if relevant]
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---
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## Detailed Event Narrative
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[Comprehensive chronological narrative of the event]
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**Minimum elements to include:**
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- Patient demographics and study participation timeline
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- Relevant medical history
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- Chronological description of event development
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- Symptoms, signs, and clinical course
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- Diagnostic workup and results
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- Treatments administered and response
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- Clinical outcome and current status
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- Investigator's assessment of causality and reasoning
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**Example Structure:**
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```
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A [age]-year-old [sex] with a history of [relevant medical conditions] enrolled in
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Study [protocol] on [date] and was randomized to [treatment arm]. The patient had
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been receiving [study drug] at [dose] for [duration] when, on [date], the patient
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developed [initial symptoms].
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[Describe progression of symptoms, timeline, clinical findings...]
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[Describe diagnostic workup performed and results...]
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[Describe treatments given and patient response...]
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[Describe outcome and current status...]
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The investigator assessed this event as [causality] related to study drug because
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[reasoning]. Alternative explanations include [list alternative causes considered].
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```
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---
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## Investigator Assessment
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**Investigator's Comments:**
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[Additional relevant information, clinical interpretation, conclusions]
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**Does this event meet criteria for expedited reporting to regulatory authorities?**
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- [ ] Yes - Fatal or life-threatening unexpected SAE
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- [ ] Yes - Other unexpected SAE
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- [ ] No - Expected event
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---
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## Follow-up Information Required
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**Information Pending (if initial or follow-up report):**
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- [ ] Final outcome
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- [ ] Laboratory results
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- [ ] Pathology report
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- [ ] Imaging results
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- [ ] Autopsy results (if death)
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- [ ] Consultant reports
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- [ ] Medical records
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- [ ] Dechallenge/rechallenge information
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- [ ] Other: ______________
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**Expected Date for Follow-up Report:** [MM/DD/YYYY]
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---
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## Regulatory Reporting
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**Sponsor Safety Assessment:**
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[To be completed by sponsor]
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- Expectedness: [ ] Expected [ ] Unexpected
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- Relationship: [ ] Related [ ] Not related
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- Reportable to FDA/EMA: [ ] Yes [ ] No
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- Timeline: [ ] 7-day [ ] 15-day [ ] Annual
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**IRB Notification:**
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- Reported to IRB: [ ] Yes [ ] No [ ] Not required
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- Date reported: [MM/DD/YYYY]
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- IRB determination: _______________
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---
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## Signatures
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**Investigator Signature:**
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**Name:** [Principal Investigator name]
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**Title:** [MD, credentials]
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**Signature:** ____________________
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**Date:** [MM/DD/YYYY]
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**I certify that this report is accurate and complete to the best of my knowledge.**
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---
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**Sponsor Representative (if applicable):**
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**Name:** [Name]
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**Title:** [Medical Monitor, Safety Officer]
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**Signature:** ____________________
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**Date:** [MM/DD/YYYY]
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---
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## Attachments
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- [ ] Relevant laboratory reports
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- [ ] Imaging reports
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- [ ] Pathology reports
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- [ ] Discharge summary
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- [ ] Death certificate (if applicable)
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- [ ] Autopsy report (if applicable)
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- [ ] Consultant notes
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- [ ] Other: ______________
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---
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## Distribution List
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- [ ] Study Sponsor
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- [ ] FDA (if applicable)
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- [ ] IRB/IEC
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- [ ] Data Safety Monitoring Board (if applicable)
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- [ ] Site regulatory files
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---
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## Notes
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**Regulatory Timeline Requirements:**
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- **Fatal or life-threatening unexpected SAEs:** 7 days for preliminary report, 15 days for complete
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- **Other serious unexpected events:** 15 days
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- **IRB notification:** Per institutional policy (typically 5-10 days)
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**Key Points:**
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- Complete all sections accurately
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- Provide detailed narrative
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- Include temporal relationships
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- Document all sources of information
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- Follow up until event resolved
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- Maintain patient confidentiality
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- Use only de-identified information
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