Review Data Protection Plan

If you have not already developed a plan for managing and protecting your participants’ data when you were setting up your registry, do so now. You need to ensure that your participants’ data are secure. Develop an action plan in case a security breach accesses participants’ personally identifiable information (PII). Maintaining the trust of your participants and guaranteeing data security is paramount in ensuring the success of your registry.

Your data security protocol could address these or similar questions:

• Who can handle and access data?
• Which data do you share with researchers; which do you not?
• How often should you update your data security protocol?
• How do you update your registry as data security best practices evolve?
• How do you lock down the system if there is a breach?
• How and when should participants be notified if there is a breach?
• Which stakeholders or strategic partners should you notify and what should you tell them?
• How do you recover from a security breach?

Decrease the likelihood of data breaches by taking steps to minimize risks. Here are some example measures you can customize to develop and implement a data security protocol that meets the unique needs of your registry.

• Establish secure access. Determine how to control access to the data to ensure your registry is secure and to minimize exposure to your participants’ sensitive data.
• Develop security guidelines. Clearly set guidelines and expectations for security measures in a written policy for anyone who works with the registry data.
• Set up automated detection systems. These can alert you when there is unusual activity involving sensitive data.
• Maintain software and security updates. To keep up with the increasingly sophisticated ways breaches occur, make sure that your team is keeping up with security patches to address new methods of attacks.
• Create a data breach response plan. Data breaches can happen regardless of how many precautions you have taken. Establishing a response plan will help you determine the steps to take in the event of a breach. This plan should include a strategy for alerting participants of any threats involving their personal information.

Clean Data Collected

After reviewing your registry data, you may find you need to contact participants to correct data entry errors. If data are missing, explore why the fields are not completed. It is important to determine whether the data entry error is a user error or an issue with a question or the data collection tool.

Questions to help identify the cause of data entry errors:  

• Did the participant feel uncomfortable completing the field? Why?
• Did the participant understand the question?
• Did the participant attempt to complete the field?
• Did technical difficulties arise? What were the technical difficulties?
• What other explanation might describe the data entry error?

If you identify problems in the data collection process, fix the issues and then contact the participants and ask them to enter the missing information. If many participants have the same issues with entering information (and it’s not a data collection problem you can resolve), develop a frequently asked questions (FAQ) page that clarifies the data input process, and make it easily accessible on the registry website. 

Overview

Check the data you have collected for any errors and identify any broader problems with the data collection process. Review your data management and security procedures to ensure protection of participants’ information.

Develop a Recruitment Strategy

When your registry ready to go, locate participants and encourage them to join. Determine how to find participants that meet your registry criteria and develop a strategy to recruit them.

Your recruitment strategy could include the following components:

Description: What is your registry?

• What are your registry’s goals and purpose?
• Why should participants join (what value does it provide to them?)
• How will the participants’ information be collected and stored?
• Who will have access to the participants’ information?
• How will you monitor and evaluate the success of your registry?

Timeline: When will key activities occur? 

• When will recruitment outreach materials be ready?
• When will you launch recruitment efforts?
• When will your registry be ready for recruiting?
• When will participants be contacted by researchers?
• How will your activities change over time (e.g., will initial recruitment differ from ongoing recruitment)?

Methods for Finding Participants: How will you locate participants?

• Where do participants get information and medical care?
• On what platforms are participants communicating with each other?
• How/where are new participants diagnosed?
• Are there key influencers who can help you reach more participants?
• Are there other ways to extend your reach?

Strategy for Recruiting Participants: What channels will you use to encourage participants to join your registry?

• Create social media accounts for your registry.
• Post information about your registry in strategic online locations:
  • Websites, social media platforms, blogs, and chat groups
  • Nonprofit organizations’ websites
  • Other existing patient advocacy groups’ websites
• Connect directly with specialists or clinical centers that are diagnosing and treating patients.
• Request to be included in registry databases:
  • Genetic and Rare Diseases Information Center – National Center for Advancing Translational Sciences (NCATS)
  • Orphanet  – French National Institute of Health and Medical Research (INSERM)

Visit the Resources section of this step to learn about additional relevant resources.

Use multiple approaches to reach as many participants as possible.

Overview

Develop a strategy for finding participants and a plan outlining how you’ll communicate with them after they join. Establish a high level of trust with participants to ensure their continued involvement in the registry.

Develop an Engagement Plan

Documenting how you plan to engage with your participants will help you meet the goals you have set for the registry. It is important to create and maintain open communication channels so that participants stay engaged with the registry.

Key things to address in your communication strategy:

• Who, how, and when: Who will communicate with participants? How and when will you communicate?
• Transparency: How will you convey new information about the disease to participants, media, and other groups?
• Internal and external communication: Distinguish between internal registry communication needs and communication with participants.
• Communication methods and materials: What platforms will you use to engage with participants (chat group, website, etc.)?

Information you may want to share with participants:

• New findings or information on the disease.
• Changes or updates to the registry.
• Upcoming research needs.
• Data and results from studies.

Participants may contact you with:

• Updates to their contact information or health status.
• Question about how their information will be used.
• Questions on research studies.

Create Communication Materials

After developing a plan for engaging with participants, draft communication materials to maintain their interest in staying active in the registry. 

Examples of communication materials:

• Welcome letter
• Communications about new study opportunities
• Regular newsletters/emails with registry updates
• Semi-annual requests for participants to update their information

Create Recruitment Materials

Develop material to help you effectively reach participants. All materials should explain what the registry is and why participants would want to join it. Also explain that participants’ information will be confidential and their data will be protected. Refer to the RaDaR Tool: Sample Recruitment & Outreach Material, as you develop these materials.

Examples of information to include in recruitment materials:

• Registry goals/purpose
• How to join the registry
• How data will be used and who will have access
• Participation is voluntary/withdrawal options
• Contact person
• General information about registries such as frequently asked questions (FAQs)

Examples of recruitment materials are:

• E-mail content
• Blog post content
• Chat group posts
• Pictures or graphics to post on social media platforms
• One-page printable handout (to distribute at conferences or display on bulletin boards in strategic locations)
• List of common questions and answers

Identify Registry Stakeholders

You can set your registry up for success by identifying stakeholders early in the registry development process. Involving these individuals can help ensure that you have brought together people who possess the necessary skills and expertise to create and manage a registry. Speaking with the different members of your community either online (e.g., through forums, social media, websites) or in person (e.g., through talks, conferences, events) can help you determine the current understanding of your disease. Determine the main objectives of each stakeholder and clearly define the expected contributions for each role.

Registry stakeholders may include the following:

• Patients and their families/caregivers, patient advocacy groups
• Academic researchers
• Healthcare professionals who specialize in your disease
• Professional societies
• Biopharmaceutical industry partners
• Government and/or regulatory agencies

Learn What is Known About Your Disease

You need to know what information has been published about your rare disease because it will help you identify any gaps in research, determine next steps, and prioritize your registry goals.

Explore these online resources:

• Genetic and Rare Diseases Information Center (GARD) provides easy-to-understand information about rare and genetic diseases. GARD is a program of the National Center for Advancing Translational Sciences (NCATS).
• Orphanet has a directory of ongoing research projects, clinical trials, registries, and biobanks.
• PubMed is a resource of the National Center for Biotechnology Information (NCBI), at the U.S. National Library of Medicine (NLM), located at the National Institutes of Health (NIH). PubMed has over 30 million citations for biomedical literature from MEDLINE, life science journals, and online books. It is not only a great resource for finding information about rare disease research and for finding researchers.
• GeneReviews is an online resource written for and by healthcare providers that offers diagnosis, management, and other information about genetic conditions.

Find answers to these questions

Below are questions you may want to explore to learn more about your disease. As you begin gathering information, you may discover additional relevant information. If you can’t find information on a topic, you can make a note to discuss it with researchers.

• Disease features
  • What are the disease features (both frequent and rare)?
  • What organ systems are affected?
  • Is there variability in presentation of disease features from person to person? Is this variability observed even within the same family?
  • Are certain disease features only present in a subset of people living with the rare disease (e.g., age group, sex, geographical location)?
  • How do disease features vary or progress over a person’s lifetime?
• Cause
  • What is the cause?
  • Is there a known or suspected genetic and/or molecular cause?
  • Have any causes been ruled out?
  • Is the physiological basis of the disease known?
  • If the cause is genetic, is it inherited? Is the mode of inheritance (e.g., autosomal dominant, autosomal recessive) known?
• Diagnosis
  • Is there a specific age or age range in which people get diagnosed?
  • How is the disease diagnosed?
  • If the disease is genetic, is genetic testing available?
  • Does there appear to be a delay in diagnosis?
  • Does an ICD (International Classification of Diseases) code exist for the disease?
• Life expectancy
  • What is the life expectancy of the disease?
  • Does the life expectancy vary? If so, have the factors that can affect life expectancy been identified?
• Prevalence
  • How many people have been diagnosed with this rare disease?
  • Is it more common in a geographical location, ethnic group, sex, and/or age group?
• Treatment
  • Is there treatment available?
  • How many people respond to the available treatment?
  • How safe is the treatment?
  • Does it interfere with other medications?
  • How expensive is the treatment?
  • How is disease progression affected by available therapies?
• Other diseases
  • Are there other diseases with similar symptoms?
  • Do these diseases have treatment? Could the same treatment potentially be used to treat your rare disease?
  • Are the gene(s) or biological pathway involved in your disease associated with any other diseases?