Step 1.
Create Your Registry Plan

1.1 Set Your Goals

Before creating a registry and setting your goals, determine whether a registry has already been created for your rare disease. Partnering with an existing registry allows for you to combine efforts, avoid “reinventing the wheel,” and reduce redundancy. There are many ways to find out whether a registry currently exists for your rare disease.

• Search ClinicalTrials.gov using the term “registry” and the name of your rare disease
• Conduct a general internet search
• Contact patient advocacy groups for the disease
• Contact the Rare Disease Patient Registry Coordinators
• Search the RD-Connect Registry & Biobank Finder
• Reach out to the Genetic and Rare Diseases Information Center (GARD)

After confirming that no other registry exists for your disease, you can start creating your registry.

Be specific, detailed, and realistic about the goals for your registry and clear about what you plan to do with the information you collect. Focus on how you can use your registry to organize your patient community and connect patients and researchers. Have a long-term vision for capturing detailed participant medical information to support the development of new treatments. Below are some goals to consider. Use the RaDar Tool: Registry Plan Template for help getting started.

Short-term registry goals:

• Identify patients who are interested in participating in research studies.
• Describe the personal characteristics of participants in your registry.
• Contact participants to inform them about new studies.

Long-term registry goals:

• Document patient medical history.
• Discover trends and common needs of participants.
• Improve scientific understanding of the disease.

Visit the Resources section of this step for resources that provide additional information for setting up your registry.

1.2 Consider Your Constraints

Budget
When first building your registry, start with volunteers and free or low-cost methods for collecting information. At this early stage, your registry is similar to a contact list or member database. If your patient advocacy group has more financial resources, consider the option of setting a higher budget to cover more sophisticated data collection methods or staff. Over time, you will build your registry to include medical information, at which point most patient advocacy groups pay for a service, or link with a research center or vendor to operate their registry.

Knowledge, Skills, and Time
You may need additional skills or experience to collect contact and demographic (e.g., age, race, ethnicity, sex) information. Many patient groups spent a few hours a week getting their registry up and running. Consider how much time you have available and look for one or more partners to join you if your time is limited. Consider the importance of obtaining Institutional Review Board (IRB) approval before collecting participant information. Without prior IRB approval, researchers may not be able to use your registry’s data to publish the results of their study.

1.3 Plan for Roadblocks

Any project is bound to face some roadblocks along the way. Create a list of things that might slow down your progress and include some ideas to move past the obstacles.

Potential Roadblocks:

• Lack of time
• Lack of interest within the patient community
• Competing ideas over the direction of the registry
• Difficulty making decisions
• Existence of other registries for the disease
• Difficulties of working alongside a research group versus doing it by yourself
• Too many “cooks in the kitchen”

Possible Solutions:

• Find others in your patient advocacy group to help share the workload.
• Use social media to create buzz by sharing stories, videos, infographics, and articles. Focus on the needs of the community and how your registry can address them.
• Work to stay unified by compromising and focusing on shared goals.
• Get the advice of other patient advocacy groups that have established similar registries.
• Define roles and responsibilities of registry staff.

1.4 Create Milestones to Track Progress

Draft a timeline for achieving registry milestones and for staying motivated. The timeline may change, but it will help you track your progress. For example:

• Registry will be set up and ready to collect information by [Date].
• Complete first recruitment push within [#] months.

1.5 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 Step 7.3 Manage Data Requests to learn about issues pertaining to data access, security, and privacy.

Resources