Clinical research
Samples, Forms, and Worksheets
Contents
Adverse Event/Intercurrent Illness Log
Advertisement SampleApproved
Budgeting by Activity Worksheet
Budgeting by Position Worksheet
Case Report Form
Concomitant Medications
Confidentiality Letter or Nondisclosure Agreement Contact Worksheet for Sponsor and Vendors Contract or Clinical Trial Agreement Critique of an Inappropriate Ad
Data Clarification or Query Form
Delegation of Responsibility Log
Drug Accountability or Dispensing Log
Drug Study Announcement Memo
Facilities Letter
FDA Warning Letter Regarding Advertising Claims Form FDA 1572
HIPAA Consent Template: Authorization Language for Research Use
HIPAA Highlights for Researchers
Indemnification Language
Informed Consent for IRB Membership
1
Samples, Forms, and Worksheets
Informed Consent Form Requirements Checklist
Informed Consent Form Template
IRB Communications Checklist
IRB Communications Log
IRB Submission Checklist
Orientation for New Employees Worksheet
Patent and Inventions Clause
Patient Instructions
Patient Outcome Log
Patient Problem List
Patient Wallet Card
Pregnancy and Contraceptive Clauses
Preparing for an FDA Audit Checklist
Prestudy Activities Worksheet
Regulatory Binder Contents Checklist
Research Experience Summary
Schedule of Activities Worksheet
Screening and Enrollment Log
Serious Adverse Event Report
Signs and Symptoms Worksheet
Site Qualification Survey
Site Qualification Visit Agenda
Specimen Collection and Preparation Worksheet
Specimen Shipping Log
Study Closeout Checklist
Study Closure Report to the IRB
Study Feasibility Checklist
Study Supply Checklist
Telephone Log
Understanding HIPAA and Research Handout
