Responding to the RFI

Where can I find the notice of the GRDR RFI?

The GRDR RFI is available on Office of the Federal Register website at: http://www.ofr.gov/OFRUpload/OFRData/2012-03155_PI.pdf

When does the response period close?

Responses to the RFI must be entered by March 10, 2012 at 5:00pm EDT. At this time, the response forms will be closed and considered final.

Are only large or well-established patient organizations eligible to participate in the GRDR pilot program?

Patient organizations of any size will be considered for participation in the GRDR pilot program, regardless the disease or the prevalence of the disease. Interested parties are encouraged to contact us at This e-mail address is being protected from spambots. You need JavaScript enabled to view it with any questions about eligibility. Groups that are not chosen for the pilot program or are not ready to participate at this time will be provided guidance addressing how to prepare their communities for future participation.

Can international groups apply and participate in the GRDR?

International groups can apply, however, US based foundations that partner with an international foundation are preferred and encouraged.

What does it mean to be an existing registry or database?

Existing registries or databases are organized programs that already collect patient data in an ongoing manner. Collected data may include, but is not limited to patient contact, medical, health or diagnostic information.
Such programs should include a structured consent process, which may need to be updated and reviewed by an IRB or appropriate ethics committee in compliance with GRDR program requirements. Existing registries and databases should have a plan to sustain operations beyond the GRDR pilot program.

H ow do I update my RFI response?

RFI responses may be updated at any time before March 10, 2012 at 5:00pm EDT. To edit your response, log into your account with your username and password to enter your changes. Click the My RFI button at the top of the browser, if you are not automatically directed there. Click the blue Manage RFI Response button to open the form and enter your changes. Click Save to save your changes or click Cancel to close the form without saving your changes. Entered responses will be considered final at the close of the notification period.

How do I withdraw my RFI response?

Email Yaffa Rubinstein, Ph.D. at This e-mail address is being protected from spambots. You need JavaScript enabled to view it to withdraw an RFI response before March 10, 2012 at 5:00pm EDT. After this time, the RFI response will be considered final.

When will we learn who is selected to participate in the pilot program?

Selections will be announced approximately 4 weeks after the close of the response period, approximately on or around April 10, 2012. All submitters will be notified by email with the outcome of their RFI submission.

How will GRDR contact me?

GRDR will send account holders periodic email messages to remind interested parties about the RFI deadline. Please be sure to add This e-mail address is being protected from spambots. You need JavaScript enabled to view it to your safe senders list.

What costs should be budgeted for newly established registries to sustain their registry beyond the pilot program?

Ongoing costs for operating a GRDR registry may be considered in three areas: infrastructure to collect and maintain the data, curation of the data, and staff to operate the registry and liaise with the community. In general, ongoing costs to maintain the data and keep a registry operational are roughly $15-20k per year. Costs for data curation are roughly $20-50k per year (depending on the amount of curation planned). The effort required from registry staff may range from 0.25FTE to 1-2 full-time staff, depending on the registry size and resources available. The registry maintenance and curation estimates provided are applicable only to registries in the GRDR program, as they reflect the scope and scale of the template GRDR registries for services provided by PatientCrossroads.RFI participants who choose to expand their registry beyond the GRDR template may incur additional costs. RFI participants may choose to use other registry service providers and are not required to use the services of PatientCrossroads. A description of the plan to sustain the registry is requested in the Selection Criteria of the RFI.

What does the selection criteria #8 “Have, or plan for, support to navigate both future registry activities and community outreach” mean?

This is related to the whether the organization has the internal resources available to assist with the implementation and ongoing operation the registry (for instance a registry manager) including help in outreach, communication programs, collaborative projects or other activities. Responses may include a description of the technical/IT support and/or other expertise available to your organization.

What is required from existing registries and databases to export their data into GRDR?

Data may be contributed from any rare disease group willing to share their collected de-identified patient information. Only those elements mapped to the GRDR CDEs will be accepted. An API (application programming interface) will be created to accept de-identified patient registry data from approved external registries using a unique patient identifier. Programming to format data properly may be required by groups wishing to contribute their data (ie Webservices, XML, CSV), and is not provided in the GRDR pilot program. Participating groups will retain ownership of the data and control of their registry data.

What are the benefits for patient organizations to establish a registry through the GRDR pilot program?

By participating in GRDR, patient groups can establish a registry for their rare disease(s) to collect patient data to fuel research and locate clinical trial candidates. The GRDR template registry and contribution to the common repository will enable small patient registries to gain exposure and realize economies of scale. Benefits include:

• Organize patients for clinical trials & research studies
• Increase visibility to patients and researchers
• Allow patients to learn from each other through registry results
• Offer registry questionnaires in multiple language(s)

What are the benefits to existing registries to participate in GRDR?

Participating in GRDR will benefit existing registries by:

• Raising awareness of rare diseases by creating an aggregated data asset for people with any rare disorder, regardless of prevalence or organization size
• Supporting the creation of a rare disease registry public utility to support research, healthcare improvement, and patient engagement
• Contributing to the formation of a database that enables pan-disease research and knowledge will facilitate multi-disease clinical trials and secondary research
• Promoting the availability of your registry data to the broader research community through the aggregated GRDR