Case Report Forms

Clinical studies use a series of case report forms to collect data in a consistent manner. The forms below are commonly used in clinical studies and can be customized to meet the needs of the specific clinical study. Investigators may need to create additional forms to capture all data elements required in the clinical study.

Administrative Forms

• Site Signature Log/Delegation of Authority Log [35KB Word file]

Baseline Visit Forms

• Visit Checklist [32KB Word file]
• Inclusion/Exclusion Criteria [34KB Word file]
• Demographics [33KB Word file]
• Medical History (a)
  • Word version [34KB Word file]
  • PDF version [80KB PDF] (not editable)
• Medical History (b)
  • Word version [33KB Word file]
  • PDF version [76KB PDF] (not editable)
• Vital Signs [33KB Word file]
• Physical Exam
  • Word version [38KB Word file]
  • PDF version [98KB PDF] (not editable)
• Randomization and Enrollment [35KB Word file]

Study-Wide Forms

• Adverse Events Form
  • Word version [34KB Word file]
  • PDF version [92KB PDF] (not editable)
• Serious Adverse Events Form [34KB Word file]
• Prior and Concomitant Medications
  • Word version [32KB Word file]
  • PDF version [79KB PDF] (not editable)
• Protocol Deviations Log [34KB Word file]
• Study Completion [33KB Word file]