Patient Safety Incident Report (Clinical Trials)
Reporter Details
Name
Role/Designation
Contact Information
Patient Information
Study/Patient ID
Date of Birth
Gender
Female
Male
Other
Incident Details
Date of Incident
Time of Incident
Location of Incident
Description of Incident
Type of Incident
Adverse Event
Protocol Deviation
Medication Error
Other
Immediate Actions Taken
Outcome and Follow-up
Patient Outcome
Follow-up Actions/Recommendations