Clinical Research Application

OVERVIEW

 

 

On this page, you will find links to the Clinical Research Application, Science and Merit form, appendices related to this application, and resources to assist you.  If you have further questions, please call the Office of Research Subjects at 651-254-3391.

 

Clinical Research Application Form

 

Science and Merit Form

 

Appendices To Be Submitted With Clinical Research Applications

Submission Resources

·                     Appendix A – Unapproved Drug

·       Reporting Adverse Events

·                     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 – Declaration of NO Financial Interest Form

OR

·                     Appendix I – Declaration of Financial Interest Form

 

·                     Appendix J – Data Use Agreement

Budget templates

 

Regulatory Resources

 

·         Regions Investigational Drug/Device Use Policy

 

 

 

 

 

Grant application information contacts

 

 

For general instructions and budget issues    

Sr. Manager, Planning & Development

Kate Rardin, MPH

952-967-5035

For scientific/statistical assistance

Manager, Statistical Services

Lauren Crain, PhD

952-967-5354

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

 

Applications are due the 3rd Friday of the month; reviews will be completed by the 3rd week of the following month.

 

Send or bring the original and 20 additional copies of this application, appendices and materials.  If appropriate (e.g., clinical trial), include 8 protocols and 2 investigator brochures.  Send all to:

 

HealthPartners Research Foundation

8170 Building

Mail Stop 21111R

 

Questions? Call 651-254-2928

 

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