10 KiB
Serious Adverse Event (SAE) Report Template
Report Information
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]
Study Information
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 Information (De-identified)
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
Adverse Event Information
Reported Term (Verbatim): [Exact term reported by investigator/patient]
MedDRA Coding:
- Preferred Term (PT): [MedDRA PT]
- System Organ Class (SOC): [MedDRA SOC]
- MedDRA Version: [e.g., 25.0]
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: ________
Seriousness Criteria
This event is considered serious because it resulted in or required:
- Death - Date of death: [MM/DD/YYYY]
- Life-threatening - Immediate risk of death at time of event
- Hospitalization (initial or prolonged) - Dates: [MM/DD/YYYY to MM/DD/YYYY]
- Persistent or significant disability/incapacity
- Congenital anomaly/birth defect
- Medically important event - Explanation: _________________
Hospitalization Details (if applicable):
- Admission Date: [MM/DD/YYYY]
- Discharge Date: [MM/DD/YYYY] OR [ ] Still hospitalized
- Hospital Name: [Name and location]
- ICU Admission: [ ] Yes [ ] No
- If yes, dates: [MM/DD/YYYY to MM/DD/YYYY]
Severity Assessment
Severity (Intensity):
- Mild - Noticeable but does not interfere with daily activities
- Moderate - Interferes with daily activities but manageable
- Severe - Prevents usual daily activities, requires intervention
Note: Severity is not the same as seriousness
Outcome
- Recovered/Resolved - Complete resolution, returned to baseline
- Recovering/Resolving - Improving but not yet fully resolved
- Not Recovered/Not Resolved - Ongoing without improvement
- Recovered/Resolved with Sequelae - Persistent effects remain
- Fatal - Event resulted in death
- Unknown - Unable to determine outcome
Date of Final Outcome (if resolved): [MM/DD/YYYY]
Causality Assessment
Relationship to Study Drug:
- Not Related - Clearly due to other cause
- Unlikely Related - Doubtful connection to study drug
- Possibly Related - Could be related, but other causes possible
- Probably Related - More likely related to study drug than other causes
- Definitely Related - Certain relationship to study drug
Relationship to Study Procedures:
- Not Related [ ] Unlikely [ ] Possibly [ ] Probably [ ] Definitely
Relationship to Underlying Disease:
- Not Related [ ] Unlikely [ ] Possibly [ ] Probably [ ] Definitely
Relationship to Concomitant Medications:
- Not Related [ ] Unlikely [ ] Possibly [ ] Probably [ ] Definitely
- Suspected medication(s): _____________________
Rationale for Causality Assessment: [Detailed explanation of causality determination, including temporal relationship, biological plausibility, dechallenge/rechallenge if applicable, alternative explanations]
Expectedness
Is this event expected based on the Investigator's Brochure or protocol?
- Expected - Listed in IB/protocol with similar characteristics
- Unexpected - Not listed OR more severe than documented
Reference: [IB version and section, or protocol section]
Action Taken with Study Drug
- No change - Study drug continued at same dose
- Dose reduced - New dose: ______ (from ______)
- Dose increased - New dose: ______ (from ______)
- Drug interrupted - Dates: [MM/DD to MM/DD]
- Resumed [ ] Not resumed
- Drug permanently discontinued - Date: [MM/DD/YYYY]
- Not applicable - Event occurred after study drug discontinued
Dechallenge: [ ] Positive (improved after stopping) [ ] Negative [ ] Not done
Rechallenge: [ ] Positive (recurred after restarting) [ ] Negative [ ] Not done
Treatment and Interventions
Treatments Given for This Event:
-
[Medication/Procedure]
- Dose/Details: _________________
- Route: _________________
- Start Date: [MM/DD/YYYY]
- Stop Date: [MM/DD/YYYY] OR [ ] Ongoing
- Response: [ ] Effective [ ] Partially effective [ ] Not effective
-
[Additional treatments]
Hospitalization Interventions:
- IV fluids
- Oxygen therapy
- Mechanical ventilation
- Surgical intervention - Procedure: ______________
- ICU care
- Other: ______________
Relevant Medical History
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] |
Laboratory and Diagnostic Tests
Relevant Laboratory Values:
| Test | Result | Units | Reference Range | Date | Relation to Event |
|---|---|---|---|---|---|
| [Test] | [Value] | [Units] | [Range] | [MM/DD] | [Before/During/After] |
Imaging/Diagnostic Studies:
- [Study type] ([Date]): [Key findings]
ECG/Monitoring: [Results if relevant]
Detailed Event Narrative
[Comprehensive chronological narrative of the event]
Minimum elements to include:
- Patient demographics and study participation timeline
- Relevant medical history
- Chronological description of event development
- Symptoms, signs, and clinical course
- Diagnostic workup and results
- Treatments administered and response
- Clinical outcome and current status
- Investigator's assessment of causality and reasoning
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 Assessment
Investigator's Comments: [Additional relevant information, clinical interpretation, conclusions]
Does this event meet criteria for expedited reporting to regulatory authorities?
- Yes - Fatal or life-threatening unexpected SAE
- Yes - Other unexpected SAE
- No - Expected event
Follow-up Information Required
Information Pending (if initial or follow-up report):
- Final outcome
- Laboratory results
- Pathology report
- Imaging results
- Autopsy results (if death)
- Consultant reports
- Medical records
- Dechallenge/rechallenge information
- Other: ______________
Expected Date for Follow-up Report: [MM/DD/YYYY]
Regulatory Reporting
Sponsor Safety Assessment: [To be completed by sponsor]
- Expectedness: [ ] Expected [ ] Unexpected
- Relationship: [ ] Related [ ] Not related
- Reportable to FDA/EMA: [ ] Yes [ ] No
- Timeline: [ ] 7-day [ ] 15-day [ ] Annual
IRB Notification:
- Reported to IRB: [ ] Yes [ ] No [ ] Not required
- Date reported: [MM/DD/YYYY]
- IRB determination: _______________
Signatures
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]
Attachments
- Relevant laboratory reports
- Imaging reports
- Pathology reports
- Discharge summary
- Death certificate (if applicable)
- Autopsy report (if applicable)
- Consultant notes
- Other: ______________
Distribution List
- Study Sponsor
- FDA (if applicable)
- IRB/IEC
- Data Safety Monitoring Board (if applicable)
- Site regulatory files
Notes
Regulatory Timeline Requirements:
- Fatal or life-threatening unexpected SAEs: 7 days for preliminary report, 15 days for complete
- Other serious unexpected events: 15 days
- IRB notification: Per institutional policy (typically 5-10 days)
Key Points:
- Complete all sections accurately
- Provide detailed narrative
- Include temporal relationships
- Document all sources of information
- Follow up until event resolved
- Maintain patient confidentiality
- Use only de-identified information