STATUS OF TREATMENT BLIND
If Yes, complete the Adverse Event Form and/or Investigational Product forms as appropriate
boolean
Date Blind Broken
date
Reason Blind Broken
text
Specify Other
text
STUDY CONCLUSION
Date of completion or withdrawal
date
subject withdrawal
boolean
Mark primary reason only
text
Investigator discretion, specify
text
PREGNANCY INFORMATION
Adverse Event/Concomitant Medications/Repeat Assessment (Check Questions)
Concomitant Medication
boolean
Non-Serious Adverse Events
boolean
Serious Adverse Events
boolean
Clinically Significant ECG Measurements
boolean
Repeat Hematology/ Clinical Chemistry
boolean
Repeat ECGs
boolean
Repeat Vital Signs / Temperature
boolean
Repeat PK Blood Samples
boolean
Repeat Peak Nasal Inspiratory Flow Tests
boolean
NON-SERIOUS ADVERSE EVENTS
Event Number
integer
Diagnosis or Signs/Symptoms
text
Start Date and Time
datetime
End Date and Time
datetime
Outcome
text
Frequency
text
Maximum Intensity
text
Action Taken
text
Subject Withdrawal
boolean
Causality
boolean
SERIOUS ADVERSE EVENTS
SAE Number
integer
Diagnosis or Sighs/Symptoms
text
Start Date and Time
datetime
End Date and Time
datetime
Outcome
text
Maximum Intensity
text
Action Taken
text
Subject Withdrawn
boolean
Causality
boolean
Was SAE study related?
boolean
Seriousness of Event
boolean
SAE Seriousness Level
text
Specify Other
text
SAE Occurrence after study initiation
boolean
Type of Report
text
RELEVANT CONCOMITANT/TREATMENT MEDICATIONS
Drug/Medication sequence number
integer
Trade name preferred
text
Dose
text
Unit
text
Frequency
text
Route
text
Start Date
date
Ongoing?
boolean
Primary Indication
text
RELEVANT MEDICAL CONDITION/RISK FACTORS
Condition number
integer
Specific Condition Name
text
Start Date
date
Ongoing?
text
End Date
date
Medical History
text
RELEVANT DIAGNOSTIC RESULTS
Lab sequence number
integer
Test Name
text
Test Date
date
Test Result
text
Test Unit
date
Comment
text
INVESTIGATIONAL PRODUCTS
GENERAL NARRATIVE COMMENTS
General narrative comments
text
General Narrative Comments
text