Know Features of the Data Collection Tool

When choosing a data collection method for your registry, consider the following factors: 

• Cost
  • Is cost a factor for you?
  • Does the data collection method require a fee? Is it a one-time fee, or is it ongoing (e.g., monthly, yearly)?
  • If there is a fee, what does the fee cover?
    

• Information technology (IT) knowledge
  • What level of IT knowledge is required to create, edit, maintain, and review the form?

• Form building
  • Is there a limit on the number of questions?
  • Does it offer different question types (e.g., multiple choice, checkbox, dropdown, file upload)?
  • Are you able to select questions from a library of questions?
  • Can questions be customized?
  • Can you create conditional questions that use answers provided to relevant previous questions?
  • Can some fields be required?
  • Does the service provide a validation function (e.g., an error message displays when an e-mail address does not use  standard format,or a telephone number is missing a digit)?
  • Is there a limit to the number of responses per form?

• Accessibility/Participant Experience
  • Is it mobile-friendly?
  • Does it provide help to participants?
    • To help explain how to complete the form.
    • To help understand the question.
    • To let participants know if they have not completed a required field.
  • Can you share it using a link? (through social media, email, or from a website)
  • Are different languages available?
  • Is the form easy to read and easy to complete?
  • Can participants save their progress and complete the form later?
  • Can participants update their own information once the form has been filled out and submitted?

• Data usability
  • Is the data accessible, usable, and manageable?
  • Does it provide/create charts/graphs depicting all collected data?
  • Can data be collected and organized in real time? (e.g., via a dashboard, into a spreadsheet or other document)
  • Can you set up notifications to let you know when a form is completed?
  • Can data be exported into forms, sheets, or other programs/applications for sharing?

• Sustainability
  • How stable is the tool/service? (for example, how long has the service been in existence or does the service have a long-term plan)
  • Who owns the data?

Use the RaDaR Tool: Compare Features of Data Collection Methods to compare the various data collection options to find the one that best meets your registry’s goals.

Overview

Create a private and secure form that invites participants to join your registry. Your registry goals will determine the data collection options and features you choose. After you create an online form, you will want to test it with colleagues and participants to ensure the form is focused and the questions are clear.

Create Your Data Collection Tool

After you’ve chosen the data collection method that best meets the goals of your registry, it’s time to create the fields that will enable you to gather the information you want from each participant.

Keep these things in mind as you develop the form:

• Include a title.
• Explain the purpose of the form.
• Provide an estimate of time needed to complete the form.
• Provide clear instructions.
• Ask only for information that’s needed.
• Select the appropriate question type (e.g., multiple-choice, drop down menu, checkbox).
• Use clear language. 
• Consider the order of your questions. More important questions are typically found at the beginning of the form.

You may want to review the RaDaR Tool: Standard Contact & Demographic Questions as well as the sample Google Form  and Survey Monkey  created using this tool.

Test Your Data Collection Tool

After you’ve created the data collection form, consider asking a variety of people to fill it out and give feedback on their experience. This step will help you discover any problems or changes you need to make to your registry before it is widely distributed.

• Find participants to pre-test the form who represent a range of experiences/backgrounds.
• Provide instructions and a due date to complete the form.
• If your intent is for the form to be accessible from a mobile device, ask the testers to try to access it from both their mobile device and their computer.
• Follow up with testers and have them respond to a series of predetermined questions, such as:
  • What is your impression of the form?
  • Was the form easy to use?
  • How long did it take you to complete the form?
  • Did you have difficulty answering any of the questions?
  • Are any of the questions confusing?
  • Were there any questions you were expecting to see but did not?
• Collect the responses to your pre-launch test and adjust the form as needed.

Pick a Data Collection Tool

Many data collection methods are available. Below are a few options to consider. 

Most online forms provide features like:

• Drag and drop questions
• Multiple choice, fill-in, multiple answers, checkbox, and other types of questions
• Question library (a collection of questions used by others who have created online forms using that data collection method)
• Conditional questions (previous answers can allow users to skip irrelevant questions)
• Required questions
• A function that imports answers into a spreadsheet or centralized database
• A feature that sends a notifications when a form is completed

Three types of services can help you create online forms and collect data: online forms, online surveys, and registry platforms. Your options narrow with increased customization and deeper data analysis. Performing internet research to learn more about the online form builders will help you choose the most appropriate options for your registry.

Online Form
Use this service to create custom forms to collect information online. The cost and features vary and you can often find free options that meet many of your needs.

Primary Use: Small- to medium-scale populations
Cost: Free/low-cost options

Online Survey
Use this service to build online questionnaires with more sophisticated features and ways to analyze and present your data. There are free options, but usually with limited features (e.g., limits on the number of questions, no data export capabilities).

Primary Use: Small- to medium-scale populations
Cost: Free/low-cost options

Registry Platform
This custom software is designed to capture and manage patient data, including features for clinical trials and collecting participant registry data. These tools tend to have a significant cost, however they also usually provide customized support. 

Primary Use: Large-scale populations
Cost: Medium to high

Many data collection tools are available. For examples of data collection tools, visit the Resources section of this step. You may also want to view the sample online forms we created using Google Forms and Survey Monkey  using the RaDaR Tool: Standard Contact & Demographic Questions. We encourage you to perform an internet search to find other data collection method options. Use our RaDaR Tool: Compare Features of Data Collection Methods to compare options and to determine which service best meets your registry’s goals.

Create Questions About Diagnosis

Consider what questions on diagnosis you need to include to verify that a participant meets requirements to join your registry. To avoid, “survey fatigue” and overwhelming the person answering the questions, it is important to be mindful about the number of questions included in this section. Be selective in the questions you include.

For example:

1.  How was the patient diagnosed? (Consider providing answer options (e.g., clinical evaluation, laboratory tests, imaging tests, or diagnostic procedures))
   
2.  At what age was the patient diagnosed? 
3. What is the name of the clinician who diagnosed the patient?
4. What is the medical specialty of the clinician who made the diagnosis?
5. What was the diagnosis?
6. Name of medical center, practice, or hospital where patient was diagnosed.

Collect Patient Information

The first required questions to include in your registry are the patient’s name and age. Collect the patient’s date of birth to know his or her exact age, to be able to track it over time, and for researchers who recruit patients from specific age groups. 

If you allow a caregiver to register on behalf of a patient, include a question to clarify that the patient is not filling out the registry form, and capture the caregiver’s name.

The next set of questions address participant contact information. Depending on how you intend to contact them, typical information to gather includes participants’ e-mail address, mailing address, and phone number. To reduce errors, confirm data entry, such as having participants enter their e-mail address twice or using postal address verification.

The Clinical Data Interchange Standards Consortium (CDISC) develops data standards that are used worldwide to streamline medical research. The United States Core Data for Interoperability (USCDI) is a standardized set of health data classes and data elements for nationwide, interoperable health information exchange and includes patient demographic standards. Examples of other data standards include Systematized Nomenclature of Medicine (SNOMED) and Unified Medical Language System (UMLS). There are also other data standards.  Which one you choose is less important than selecting one data standard and using it consistently.

Decide on Demographic Questions

Including demographic (e.g., age, sex, race/ethnicity) questions can help you learn more about the participants in your registry. The goals of your registry will determine whether these questions are optional. A best practice is to follow demographic standards, because this will allow you to compare your results with other data sources. Refer to RaDaR Tool: Standard Contact & Demographic Questions to view sample questions selected using data standards established by the Clinical Data Interchange Standards Consortium (CDISC)  and United States Core Data for Interoperability (USCDI) .

Document Permissions to Use Data

Include questions that clarify how you intend to use the information you collect for your registry, who will have access to the data, how the data will be shared and with whom, and decide if any uses will be optional. This will give participants the ability to opt out if they choose. Being clear and transparent will help build trust in your registry and data collection methods, and underscore your role as a data steward. To learn more about obtaining informed consent, you may want to read Global Gene’s Rare Toolkit: Informed Consent – Important for Treatment Decisions and Advancing Research .

If you’ve decided to recruit patients from other countries, it’s important to familiarize yourself with that country’s laws regarding data privacy and security (e.g., European Union (EU) General Data Protection Regulation (GDPR) for European countries).

Overview

Decide which questions to include in your registry and how the answers will be formatted. Data are most useful if they have been collected in a standardized way (that is, everyone is asked the same questions and answers are provided in the same format). Choose an established data standard for collecting patient information for your registry.