Below are tools and guidance provided by the ORC to help you conduct and manage aspects of your study. Check back often as these documents will be regularly updated.

Guides for Investigators

•    A Practical Research Handbook 
•    Good Clinical Practice (GCP) E6 Guidelines  
•    Fundamental Elements of Research Documentation – ALCOA  
•    Specimen and Data Repository Guidance 
•    ePHI Security Guide 

Consent Process Guides

•    The “Let’s Talk” Approach - A Guide for Research Consent Discussion 
•    Strive for Excellence in Research Consent Guide  

If you’d like to receive printed consent guide cards please contact the ORC at orc@nshs.edu

Tools and Guidance for Multi-center Trials and Sponsor Investigators

•    Guidance for Investigator-initiated Multi-center Trials 
•    Site Selection Questionnaire 
•    Multi-Site Tracking and Monitoring Spreadsheet  
•    Regulatory Binder Tabs for Coordinating Centers and Sponsor Investigators 
•    Sponsor-Investigator IND Checklist  
•    Sponsor-Investigator IDE Checklist  
 

Other Guidance

•   Sunrise Medical Record Access for External Monitors 

The following forms are available on Health Port under Research Policies

•    Register of Archived Research Data & Records Form
•    Contact Tree and Audit Checklist in the event of an external audit (within the Good Clinical Practice Research Inspection at a Clinical Site Policy)
•    Core Lab Billing Request Form
•    Outpatient Research Subject Registration Form
•    Inpatient Research Subject Registration Form
•    Research Study Participant Payment Form