Investigational Drug Case Report Form (Data Collection Form) Template
Using the template below, items to be documented on the case report form can be modified, added or omitted based on the data to be collected as specified in the actual study protocol.
Identifier (Must be included on every page)
Subject identifier
Study identifier
Visit type
Visit date
Investigator signature and date
Subject Enrollment Form(Data must be relevant to the study protocol)
Date of birth
Gender
Race
Weight & height
Subject number
Date informed consent signed
Date subject started the study
Eligibility Form
Inclusion criteria list – all answers must be YES
Exclusion criteria list – all answers must be NO
Subject Randomization Form
Date subject randomized
Subject randomization code
Medical History(Data must be relevant to the study protocol)
Medical history of the subject
Physical Examination(Data must be relevant to the study protocol)
Vital signs
Body systems
Clinical Laboratory Data(Those elements defined in the study protocol)
Prior
Baseline
During
End
After
Compliance
Pill count at each protocol interval
Concomitant Medication
Document all subjects’ medications taken during the study at each protocol interval
Adverse Events
Document ALL adverse events during the study including any run-in and follow-up periods
Date reported
Date of onset
Date ended
Severity
Description of adverse event
Event recovery status – resolved, not resolved, continuing
Relationship to study drug
Serious Adverse Events
Document ALL serious adverse events during the study including any run-in and follow-up periods
Date reported
Date of onset
Date ended
Description of serious adverse event
Event recovery status – resolved, not resolved, continuing
Relationship to study drug
Off Study Form
Document subject completion, removal from or drop-out from the study
Date
Reason
Death Report Form
Document ALL deaths during the study including any run-in and follow-up periods
Date
Description of cause of death
Relationship to study drug
Other Information or Data as Required in the Study Protocol