Clinical research Samples, Forms, and Worksheets

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

 

 

 

 

 

 

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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

 

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