Understand Data Principles

Overview

It is critical to fully understand what data are, and the best practices and guiding principles that a registry should follow when collecting, maintaining, and sharing data. Having entrusted you with information about themselves and their rare disease, registry participants expect you to act in their best interest with respect to being transparent and open. Researchers need to have confidence in the quality of your registry's data.

Understand What is Data

Data can be defined as a collection of information. Data usually include quantitative and qualitative information. Quantitative data include measurable information, such as height and weight. Qualitative data is descriptive information, such as gender and ethnicity. The goals of registry determine what kinds of data are collected. Registries typically collect both quantitative and qualitative.

Determining what kinds of data and how much of it needs to be collected requires thoughtful consideration. Because little is known about many rare diseases, you may be tempted to collect as much information as you can. But it's important that you do not overwhelm the people providing the information to your registry. You must take care to balance what you need to know (essential data) with what you would like to know (nonessential data). It is especially important that the information you collect is of high quality. Low-quality data cannot be used for research. High-quality data are verifiable, accurate, and are an exact fit for the registry's intended use. The data you collect must be capable of delivering the insight you hope to gain.

Data quality is determined by the following:

  1. Accessibility – Are the data available? Are the data easily and quickly obtained?
  2. Completeness – Is the data complete? Are the necessary questions included on your registry data collection forms? Were all the questions answered?
  3. Accuracy – Are the data correct and reliable?
  4. Objectivity – Are the data free of bias?
  5. Relevancy – Do the data address the questions your registry is attempting to answer?

Make sure you collect only high-quality data for your registry by following the FAIR Guiding Principles for scientific data management:

Findability – Data should be easily found.
Accessibility – Once the data is found, it should be accessible.
Interoperability – Data needs to be integrated with other data and to be able to work with various different applications.
Reusable – Data should be able to be re-used for different research and/or purposes.

We created the RaDaR Tool: Data Quality Control Checklist to assist you in evaluating the quality of data.

Be a Good Data Steward

When you decide to collect data, you take on the role of being a data steward. You need to protect the rights and interests of the people who have provided the information. You build trust by being purposeful, open, and transparent.

Be purposeful

  • Avoid biases when gathering data (e.g., do not only gather from people who have a specific symptom).
  • Recruit a balanced sample (e.g., all genders, races/ethnic groups, ages, and socioeconomic classes).
  • Identify possible barriers to participating and attempt to minimize or remove them (e.g., give people time to ask questions, accommodate various modes of participating such as via computer, paper, phone).

Be open

  • Have an informed consent that clearly states how, what, why, when, and where the data is being gathered.
  • Share the known benefits and risks of providing the information to the registry.
  • State the hoped outcomes or goals of the registry.
  • Indicate who will own the data.

Be transparent

  • Team with an Institutional Review Board (IRB).
  • Comply with rules and regulations of data collection.
  • Write a data governance plan and create agreements for data sharing.
  • Protect your participants.

Data stewardship applies to everyone interacting with the registry’s data. Some registries have a designated person responsible for proper data management, whereas others have an entire team dedicated to this role. Regardless of the number of people assigned to this role, the registry should have a governance plan that provides guidance for making decisions about how the registry will be managed and how and with whom the data will be shared. It is the responsibility of these individuals to ensure the data are used appropriately and kept safe and secure. One way to ensure this protection is to enter in data-use agreements with the researchers or other individuals who want to access your registry’s data. Data-use agreements clearly state the permitted uses of the participants' information and protects the privacy of the registry participants.

Know About Data Privacy & Security

As a good data steward, you need to understand the importance of protecting the privacy of your registry members and securing their data. Data privacy protects the use of the data and puts policies in place to ensure that patient information is being collected, shared, and used in appropriate ways. Data security refers to protecting data and to having safeguards in place to prevent malicious computer attacks and unauthorized access to data.

RaDaR Step 6 Clean Up Your Data: 6.3 Protect Your Data provides information about protecting your registry's data.

Rules have been created to protect people who share their personal and rare disease information. As a registry owner, you should become familiar with the rules, regulations, and/or laws that have been created to protect data. The “Learn About Ethical and Legal Aspects“ section provides information about other rules and regulations you should be familiar with.

You can read more about these rules and how they might pertain to registries.
7. Principles of Registry Ethics, Data Ownership, and Privacy. Registries for Evaluating Patient Outcomes: A User’s Guide [Internet]. 3rd edition.

Learn About Data Ownership

Before joining a registry, people may want to know who will own the data they share. Data ownership refers to having legal rights and complete control over the data. Ownership of this information should be clearly communicated to participants, stakeholders, and sponsors of the registry. In many cases, the sponsors are the owners of the data. When there is more than one sponsor, it is important to determine which sponsors own the data. Your registry should also decide who will own any intellectual property resulting from the registry (e.g., tools, forms, reports, analyses, and biosamples). Participants will need to trust that your registry is acting in their best interest.

Data owners need to remember the FAIR principles when determining how they plan to handle the sharing of their registry’s data. They should also appreciate that data sharing is critical for learning more about their rare disease and advancing research. In an effort to facilitate data sharing, they should create a data management plan and data-sharing agreement. Some considerations include the following:

  • Who will access the data?
  • For how long can they access the data?
  • What is the process for granting access to the data?
  • What is the process for requesting access to the data?
  • Will results/findings be communicated to registry participants?

It is critical to fully understand what data are, and the best practices and guiding principles that a registry should follow when collecting, maintaining, and sharing data. Having entrusted you with information about themselves and their rare disease, registry participants expect you to act in their best interest with respect to being transparent and open. Researchers need to have confidence in the quality of your registry's data.

Data can be defined as a collection of information. Data usually include quantitative and qualitative information. Quantitative data include measurable information, such as height and weight. Qualitative data is descriptive information, such as gender and ethnicity. The goals of registry determine what kinds of data are collected. Registries typically collect both quantitative and qualitative.

Determining what kinds of data and how much of it needs to be collected requires thoughtful consideration. Because little is known about many rare diseases, you may be tempted to collect as much information as you can. But it's important that you do not overwhelm the people providing the information to your registry. You must take care to balance what you need to know (essential data) with what you would like to know (nonessential data). It is especially important that the information you collect is of high quality. Low-quality data cannot be used for research. High-quality data are verifiable, accurate, and are an exact fit for the registry's intended use. The data you collect must be capable of delivering the insight you hope to gain.

Data quality is determined by the following:

  1. Accessibility – Are the data available? Are the data easily and quickly obtained?
  2. Completeness – Is the data complete? Are the necessary questions included on your registry data collection forms? Were all the questions answered?
  3. Accuracy – Are the data correct and reliable?
  4. Objectivity – Are the data free of bias?
  5. Relevancy – Do the data address the questions your registry is attempting to answer?

Make sure you collect only high-quality data for your registry by following the FAIR Guiding Principles for scientific data management:

Findability – Data should be easily found.
Accessibility – Once the data is found, it should be accessible.
Interoperability – Data needs to be integrated with other data and to be able to work with various different applications.
Reusable – Data should be able to be re-used for different research and/or purposes.

We created the RaDaR Tool: Data Quality Control Checklist to assist you in evaluating the quality of data.

When you decide to collect data, you take on the role of being a data steward. You need to protect the rights and interests of the people who have provided the information. You build trust by being purposeful, open, and transparent.

Be purposeful

  • Avoid biases when gathering data (e.g., do not only gather from people who have a specific symptom).
  • Recruit a balanced sample (e.g., all genders, races/ethnic groups, ages, and socioeconomic classes).
  • Identify possible barriers to participating and attempt to minimize or remove them (e.g., give people time to ask questions, accommodate various modes of participating such as via computer, paper, phone).

Be open

  • Have an informed consent that clearly states how, what, why, when, and where the data is being gathered.
  • Share the known benefits and risks of providing the information to the registry.
  • State the hoped outcomes or goals of the registry.
  • Indicate who will own the data.

Be transparent

  • Team with an Institutional Review Board (IRB).
  • Comply with rules and regulations of data collection.
  • Write a data governance plan and create agreements for data sharing.
  • Protect your participants.

Data stewardship applies to everyone interacting with the registry’s data. Some registries have a designated person responsible for proper data management, whereas others have an entire team dedicated to this role. Regardless of the number of people assigned to this role, the registry should have a governance plan that provides guidance for making decisions about how the registry will be managed and how and with whom the data will be shared. It is the responsibility of these individuals to ensure the data are used appropriately and kept safe and secure. One way to ensure this protection is to enter in data-use agreements with the researchers or other individuals who want to access your registry’s data. Data-use agreements clearly state the permitted uses of the participants' information and protects the privacy of the registry participants.

As a good data steward, you need to understand the importance of protecting the privacy of your registry members and securing their data. Data privacy protects the use of the data and puts policies in place to ensure that patient information is being collected, shared, and used in appropriate ways. Data security refers to protecting data and to having safeguards in place to prevent malicious computer attacks and unauthorized access to data.

RaDaR Step 6 Clean Up Your Data: 6.3 Protect Your Data provides information about protecting your registry's data.

Rules have been created to protect people who share their personal and rare disease information. As a registry owner, you should become familiar with the rules, regulations, and/or laws that have been created to protect data. The “Learn About Ethical and Legal Aspects“ section provides information about other rules and regulations you should be familiar with.

You can read more about these rules and how they might pertain to registries.
7. Principles of Registry Ethics, Data Ownership, and Privacy. Registries for Evaluating Patient Outcomes: A User’s Guide [Internet]. 3rd edition.

Before joining a registry, people may want to know who will own the data they share. Data ownership refers to having legal rights and complete control over the data. Ownership of this information should be clearly communicated to participants, stakeholders, and sponsors of the registry. In many cases, the sponsors are the owners of the data. When there is more than one sponsor, it is important to determine which sponsors own the data. Your registry should also decide who will own any intellectual property resulting from the registry (e.g., tools, forms, reports, analyses, and biosamples). Participants will need to trust that your registry is acting in their best interest.

Data owners need to remember the FAIR principles when determining how they plan to handle the sharing of their registry’s data. They should also appreciate that data sharing is critical for learning more about their rare disease and advancing research. In an effort to facilitate data sharing, they should create a data management plan and data-sharing agreement. Some considerations include the following:

  • Who will access the data?
  • For how long can they access the data?
  • What is the process for granting access to the data?
  • What is the process for requesting access to the data?
  • Will results/findings be communicated to registry participants?