Create Your Registry Plan

Develop a Governance Plan

Registries should also create and follow a written governance plan. A good governance plan will provide guidance for making decisions about how the registry is run and how and with whom data will be shared and includes the following:

Defining objectives
Identifying stakeholders
Building your registry team
Establishing Ethical Legal and Societal Issue (ELSI) privacy and sustainability guidelines

You can read more about governance plans by referring to the paper “Recommendations for Improving the Quality of Rare Disease Registries.”

Visit RaDaR Manage and Share Data to learn about issues pertaining to data access, security, and privacy.

Resources

Set Goals

Section I: Creating Registries in Registries for Evaluating Patient Outcomes: A User’s Guide, [internet]. 4th Edition Agency for Healthcare Research Quality (AHRQ) (link)

The FAIR Guiding Principles for scientific data management and stewardship 2016 Article in Nature: Scientific Data (link)

RaDaR Tool: Registry_Plan_Template RaDaR

Frequently Asked Questions - Registries NIH Clinical Research Trials and You (link)

RARE Webinar: Collaboration Among Foundations Global Genes (link)

Rare disease registries: potential applications towards impact on development of new drug treatments 2018 Article in Orphanet Journal of Rare Diseases (link)

Rare Toolkit: Rare Disease Registries: Advancing Disease Understanding, Treatments, and Cures Global Genes (link)

PCORI Training: A Program for Rare Disease Patient Advocates Patient-Centered Outcomes Research Institute (PCORI) (link)

World Federation of Hemophilia Guide to Developing a National Patient Registry World Federation of Hemophilia (WFH) (link)

Registries Tool Kit TREAT-NMD Neuromuscular Network (link)

2013 Policy Fact Sheet - Rare Disease Patient Registries EURORDIS Rare Diseases Europe (link)

Developing a Patient Registry: A Practical Guide Health Research Charities Ireland (link)

Consider Constraints

Video: Institutional Review Boards (IRBs) U.S. Department of Health and Human Services (HHS) (link)

Develop a Governance Plan

Recommendations for Improving the Quality of Rare Disease Registries 2018 Published Article

Section II: Legal and Ethical Considerations for Registries in Registries for Evaluating Patient Outcomes: A User’s Guide, [internet]. 4th Edition Agency for Healthcare Research Quality (AHRQ) (link)