Clinical Research Application

Appendices To Be Submitted With Clinical Research Applications

Submission Resources

• Appendix A – Unapproved Drug

• Guidelines for Reporting Unanticipated Problems
• Report Form for Unanticipated Problems

• Appendix B – Unapproved Device

• Assent Sample

• Appendix C – Blood Drawing/Tissue Sampling and Storage

• Authorization Form

• Appendix D – Deception and Debriefing Process

• Consent Template

• Appendix E – Waiver of Consent and/or Waiver of Documentation of Consent

• Writing your own consent form--packet

• Appendix F – Special Populations

• Sample Consent Statement (no signature)

• Appendix G – Data Access Request Form (programmer’s signature required)

• Sample Contact Letters

• Appendix H – Significant Financial Interests Disclosure Form

• Appendix I – Letter of Support For Research Conducted in a Department at HealthPartners

• Appendix J – Interdepartmental Letter of Support for Research Activities

Regulatory Resources

Budget templates

• Objectivity in Research Policy

• General Budget Form (click on Instructions)

• Expedited Review Categories

• Donated TimeBudget Form

• HP/GHI Investigational Drug/Device Use Policy

• Clinical Trials Budget Form (click on Instructions)

• Drug & Device Exemptions

• Closing a Research Project

Grant Application Information Contacts

For general instructions and budget issues    

Sr. Manager, Planning & Development

Kate RardinLeahy, MPH

952-967-5035

For scientific/statistical assistance

Manager, Statistical Services

Steve Asche

952-967-5018

For grant implementation and research management issues

Manager, Research Operations

Betty Jo Haggerty, MS, FNP

952-967-5078

For questions about research subject’s protection and review processes

Manager, Office of Research Subjects

Bobbi Godding, BA

651-254-3391