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Safety reporting is critical for protecting participant welfare. Carelane provides tools to capture and track safety information throughout the study.

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Safety Concepts

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Adverse Events (AEs)

Any untoward medical occurrence in a participant:
CategoryDescription
AEAny adverse event
SAESerious adverse event (per regulatory definition)
AESIAdverse event of special interest

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Reporting Requirements

Safety events may require reporting to:
  • IRB/Ethics Committee
  • Regulatory authorities
  • Sponsor safety department
  • Data Safety Monitoring Board

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Capturing Safety Data

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AE Questionnaires

Design questionnaires for AE capture:
FieldPurpose
Event DescriptionWhat happened
Start DateWhen it began
End DateWhen it resolved
SeverityMild, moderate, severe
Seriousness CriteriaSAE determination
RelatednessRelationship to study
OutcomeResolution status
Action TakenResponse to event

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SAE Identification

Include fields to identify SAEs:
CriterionTriggers SAE
DeathYes
Life-threateningYes
HospitalizationYes
DisabilityYes
Congenital anomalyYes
Important medical eventYes

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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.

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AE Form Design

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Essential Fields

Include in your AE questionnaire: 
Event Description (text)
Start Date (date)
End Date (date) - optional
Ongoing? (boolean)
Severity (choice: mild/moderate/severe)
Seriousness Criteria (multiple choice)
Relationship to Study (choice scale)
Action Taken (multiple choice)
Outcome (choice)

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Conditional Logic

Use conditions for follow-up:
  • If SAE → Show additional SAE fields
  • If ongoing → Hide end date
  • If related → Show additional assessment fields

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Tracking and Follow-up

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AE Log

Maintain a log of all AEs:
InformationPurpose
All AEsComplete safety record
Open AEsEvents requiring follow-up
SAEsExpedited reporting tracking

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Follow-up Documentation

Document AE follow-up:
  • Updates to event status
  • Resolution information
  • Outcomes
  • Actions taken

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Reporting Timelines

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Regulatory Timelines

Event TypeTypical Timeline
Fatal/Life-threatening SAE7 days
Other SAE15 days
Important Safety InformationAs required
Reporting timelines vary by jurisdiction and sponsor requirements. Consult your protocol for specific requirements.

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Internal Reporting

Establish internal reporting procedures:
  • Immediate notification for SAEs
  • Periodic safety reviews
  • Aggregate safety reporting

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Safety Review

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Ongoing Safety Review

Conduct regular safety reviews:
FrequencyActivity
As occursIndividual SAE review
WeeklyReview new AEs
MonthlySafety summary review
PeriodicDSMB/DMC reviews

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Safety Signals

Monitor for safety signals:
  • Unexpected AE patterns
  • Increased frequency
  • New types of events
  • Severity trends

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Data Quality for Safety

Ensure safety data quality:
AspectApproach
CompletenessAll fields required
TimelinessPrompt data entry
AccuracyVerification review
ConsistencyStandardized coding

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Best Practices

Ensure all site staff understand safety reporting requirements.
Enter safety data as soon as events are known.
Track events until resolution.
Conduct regular safety data reviews.

Protocol Compliance

Protocol requirements for safety.

Questionnaire Templates

Design safety questionnaires.