Safety Concepts
Adverse Events (AEs)
Any untoward medical occurrence in a participant:Reporting Requirements
Safety events may require reporting to:- IRB/Ethics Committee
- Regulatory authorities
- Sponsor safety department
- Data Safety Monitoring Board
Capturing Safety Data
AE Questionnaires
Design questionnaires for AE capture:SAE Identification
Include fields to identify SAEs:Safety Workflow
1
Event Occurs
Site becomes aware of adverse event.
2
Initial Documentation
Site enters AE into Carelane questionnaire.
3
Severity Assessment
Site assesses severity and seriousness.
4
SAE Determination
If SAE, initiate expedited reporting.
5
Follow-up
Continue documenting until resolution.
6
Study Team Review
Study team reviews safety data.
AE Form Design
Essential Fields
Include in your AE questionnaire:Conditional Logic
Use conditions for follow-up:- If SAE → Show additional SAE fields
- If ongoing → Hide end date
- If related → Show additional assessment fields
Tracking and Follow-up
AE Log
Maintain a log of all AEs:Follow-up Documentation
Document AE follow-up:- Updates to event status
- Resolution information
- Outcomes
- Actions taken
Reporting Timelines
Regulatory Timelines
Internal Reporting
Establish internal reporting procedures:- Immediate notification for SAEs
- Periodic safety reviews
- Aggregate safety reporting
Safety Review
Ongoing Safety Review
Conduct regular safety reviews:Safety Signals
Monitor for safety signals:- Unexpected AE patterns
- Increased frequency
- New types of events
- Severity trends
Data Quality for Safety
Ensure safety data quality:Best Practices
Train on Safety
Train on Safety
Ensure all site staff understand safety reporting requirements.
Report Promptly
Report Promptly
Enter safety data as soon as events are known.
Follow Up Diligently
Follow Up Diligently
Track events until resolution.
Review Regularly
Review Regularly
Conduct regular safety data reviews.
Related
Protocol Compliance
Protocol requirements for safety.
Questionnaire Templates
Design safety questionnaires.