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

Purposes of the Binder

The QI Virtual Regulatory Binder assists sites in achieving and maintaining regulatory compliance and ensuring the highest standards of human subject research. The binder also provides:

1. Guidance for organization and record keeping,
2. Assistance with proper study documentation and successful study management
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 Virtual Regulatory Binder is comprised of sections that apply to the range of human subject studies. To access sections, click on the tabs at the top of each page. On certain browsers you will have to click on the link at the top of the page that says, 'Click here to view full screen' to see the entire page.

Each binder section outlines the regulatory requirements, institutional policies and GCP guidelines for organization and recordkeeping. At the bottom of each section are QI tips and links to additional resources (e.g., federal regulations, HRC policies and forms, QI tools).

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. For additional guidance on establishing a regulatory binder refer to the Regulatory Binder Instruction Manual.

How to Print Binder Sections

Sections of the binder can be printed from the browser by clicking 'Print this page' link located at the top right-hand corner of each tab. This will send a copy of the current section that you are viewing to your local/network printer.

If you would like to print all sections, click on the link below to access the complete set of binder tabs. You can print tabs on any compatible set of binder dividers.

Virtual Binder Tabs - printed version

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 schedule a binder consultation and/or request a printed copy of the Regulatory Binder, complete the QI service request form (PHS internal only) or email the QI program at humanresearchqi@partners.org.