Congratulations!

You have successfully accessed the Partners Human Research Quality Improvement (QI) Program's Virtual Regulatory Binder. This invaluable resource was developed for the research community at Partners' HealthCare System.

Purposes of the Binder

The Virtual Regulatory Binder was developed to help study sites to achieve and maintain regulatory compliance and adhere to high standards of practice in the conduct of research involving human subjects. It provides:

1. Guidance for organization and record keeping,
2. On-line access to all materials and forms required/recommended for a complete regulatory binder, and
3. Readily accessible links to on-line resources, such as Partners Human Research Committee (HRC) policies, guidelines, and forms, as well as Federal Regulations.

How to Use the Binder

The binder is divided into 15 sections. To access these sections, click on the tabs at the top of each page. When a section has subsections, a drop-down menu will appear that allows you to quickly scan the contents and go directly to a specific topic.

On the first page of each section you will find a list of study materials that investigators are required to maintain for regulatory purposes, as well as answers to frequently asked questions. Links to useful resources (e.g., federal regulations, HRC policies and forms) applicable to each section have also been included for your reference.

Whom to Contact for Help

The QI Program provides individual consultation and educational offerings to both new and experienced members of the research community, including investigators and study staff. To learn more about the variety of services offered by the QI Program, visit our website at: http://www.partners.org/phsqi/ or call Stanley Estime, Senior QI/QA Specialist, at (617) 424-4136.

Please contact the QI Program if you would like a hard copy of the Regulatory Binder, and if you would like any additional information.