Clinical research

Samples, Forms, and Worksheets





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








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



organizzazione di ricerca a contratto

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