Toolkits

CoRDS  partners with Global Genes to provide RARE Toolkits to patients, families, and patient advocacy groups. The resources found at RARE Toolkits provide valuable information on a variety of topics related to living with and/or advocating for rare disease patients. RARE Toolkits are interactive and continue to evolve as rare disease stakeholders share best practices.

Your Partnership

 

Data Collection and Management

 

Access to CoRDS

 
 

 Your Partnership

Can my organization become a CoRDS partner? What is involved in being a CoRDS Partner?

If your organization represents a rare disease, or individuals affected by rare disease, you can become a CoRDS partner. As a CoRDS Partner, Rare disease organizations are invited to inform their membership about the opportunity to enroll in CoRDS.

Here is a list of some ways to share information that have been proven effective by current CoRDS partners.

  1. Sending a mailing to membership & Posting information to website: CoRDS will provide the necessary mailing materials or information and information needed. A high-resolution image of the CoRDS logo as well as other materials which you can post to your website are available in the “Partner Toolkit".
  2. Connecting with CoRDS on Social Media: Find us Twitter, Facebook, Pinterest, and Tumblr to stay up-to-date on the latest CoRDS news and events. Like, Follow, and Share!
  3. Annual Conference attendance: CoRDS can attend your annual conference to present information on CoRDS to your membership and host a booth to answer questions and help with enrollment.
  4. Sharing information about CoRDS: Tell other rare disease organizations, research institutions, healthcare providers, and advocacy groups about CoRDS and how they might benefit by initiating a patient registry with CoRDS, referring patients to CoRDS, or accessing information in CoRDS.  

Is there a cost to enroll in CoRDS? 

No, there is no cost to participants to enroll in CoRDS, researchers to access data in CoRDS, or patient advocacy groups to become a CoRDS Partner and create a registry for a specific disease within CoRDS.

How is CoRDS funded?

CoRDS is funded internally through the Sanford Children’s Health Research Center at Sanford Research and through a Sanford Health Foundation grant.

Is an Institutional Review Board (IRB) involved?

Yes, the CoRDS Registry is approved by the Sanford Health IRB. An IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy. 

What does IRB approval mean for partners, participants, and researchers?

IRB approval means that CoRDS activities are monitored by the Sanford Health IRB to ensure that the CoRDS Registry is executed in an ethical manner. This applies to all direct CoRDS communication to participants and affected individuals, and includes the CoRDS web content. This can make it easier for researchers to maintain their own IRB approval when using CoRDS as a resource for study recruitment, and makes CoRDS a uniquely valuable tool for rare disease researchers. 

Is CoRDS a national registry, or can individuals from around the world participate?

CoRDS is an international patient registry based at Sanford Research in Sioux Falls, South Dakota. Because the CoRDS study forms are in English, most participants are from the United States, Canada, the United Kingdom or Australia. The CoRDS database software can support other languages. CoRDS personnel will work one-on-one with patient advocacy groups that would like to translate documents into other languages.


Data Collection and Management

Who is eligible to enroll in CoRDS?

Any individual with a diagnosis of a rare disease, a disease with unknown prevalence, or who has not yet been diagnosed can enroll in the CoRDS Registry. 

What type of information does CoRDS collect?

The CoRDS Questionnaire is very brief and includes questions about contact information, demographic information, clinical diagnosis, when and how the diagnosis was confirmed, and if the participant has interest in participating in future research studies and/or clinical trials. 

Does CoRDS utilize Common Data Elements (CDEs)?

Yes, the CoRDS Registry utilizes the Common Data Elements (CDEs) recommended by the Office of Rare Disease Research (ORDR) of the National Institutes of Health. CoRDS implements these CDEs because we realize and value the importance of data harmonization in the future. CoRDS hopes to collaborate with the other patient registry efforts that are being developed or may develop in the future.

Can a disease specific Questionnaire be created through CoRDS?

Yes, if a PAG is interested in collecting more information, CoRDS will work with that PAG to develop a form that is suitable.  

Who manages the data? 

CoRDS personnel are responsible for collecting and managing the data in the CoRDS Registry. CoRDS personnel contact participants annually to remind them to update their information, and also contact participants if they qualify for a research study or clinical trial. Finally, CoRDS personnel are responsible for issuing a username and password to researchers who qualify for access to CoRDS.

What kind of software is used to manage CoRDS?

CoRDS utilizes a Velos eResearch system for its registry platform. The Velos eResearch suite is a web-based portal that is used to enter and maintain the CoRDS Registry data. Velos eResearch provides a mechanism to securely collect and manage collected participant information. Velos eResearch features powerful user security, HIPAA and 21 CRF compliance, easy navigation, extensive customization options, and 24/7 customer support.

How is the data curated? 

The information is all patient-reported. Documents such as test results can be uploaded to the registry by CoRDS personnel.

What happens to the information after a participant enrolls?

Patient-reported information will be stored in the CoRDS Registry at Sanford Research. Each participant will be assigned a unique participant identification number for confidentiality purposes. Researchers who have IRB approval for their research may apply for access to CoRDS and, if they are approved by the CoRDS Scientific Advisory Board (SAB), they will have access to de-identified information in the CoRDS Registry. 

Will confidentiality of the patient data be maintained?

Yes. The CoRDS Registry follows strict guidelines to ensure participant information is protected. Federal and state laws also protect the participant’s privacy. All confidential electronic information will be stored in our Velos eResearch Clinical Research Management System. Any confidential hard copies of Informed Consent Forms or Questionnaires will be stored in a secure, fireproof cabinet. Every possible effort will be made to maintain confidentiality. In the unlikely event that there is a breach in the database, all participants will be notified.

Who owns the data in CoRDS?

CoRDS is responsible for storing and managing the information as required by the Sanford IRB and as outlined in the CoRDS Informed Consent Form which is signed by the participant. The participant is the primary owner of the information in the CoRDS Registry. Participants have the option to decide how they would like their information shared. After a participant enrolls in the CoRDS Registry, their patient-reported information is housed in the CoRDS Registry. Participants can withdraw from CoRDS at any time and their information will be removed from CoRDS upon their request. If a participant withdraws from CoRDS, researchers will no longer have access to their de-identified information.


Access to CoRDS

Who has access to the data in CoRDS?

There are three different entities that may request access to the data in CoRDS.

  • Researchers: Any rare disease researcher with IRB-approval from their own institution can request access to the CoRDS Registry. Their application must be submitted for review to the CoRDS Scientific Advisory Board, convened by Dr. David Pearce (Principal Investigator of CoRDS). If approved, they will have access to de-identified information, meaning that all names, addresses, and other identifiable participant details will remain hidden and confidential.
  • Other patient registries: CoRDS participants may elect in their Informed Consent Form to have their information shared with other patient registries. A subset of de-identified information collected from each profile may be shared with these databases. This is done in order to help improve understanding of rare diseases, to avoid the duplication of efforts, and to collaborate with existing research efforts and PAGs dedicated to rare diseases
  • Patient Advocacy Groups (PAGs): Organizations representing individuals with rare or uncommon diseases who have partnered with CoRDS may also request access to information in CoRDS. CoRDS participants may elect in their Informed Consent Form to have their information shared with a specific CoRDS Partner. The PAG will sign an agreement stating that they will not use the information for research purposes. 

How does a researcher access CoRDS? 

Researchers are invited to complete a brief application that requests basic information as well as documentation of IRB-approval for the study. The application is reviewed by the CoRDS Scientific Advisory Board, convened by Dr. David Pearce (Principal Investigator of CoRDS). 

Can participants authorize others to access CoRDS?

At the end of the Informed Consent Form, CoRDS participants have the opportunity to indicate how they would like their information shared. Participants can choose whether or not they would like to be contacted in the future about research opportunities, if they would like a subset of their de-identified information shared with an existing IRB approved registry, or if they would like their information shared with a patient advocacy group. CoRDS can only share information with other entities if the patient authorizes CoRDS to share the information on the Informed Consent Form

Will CoRDS be paid by entities for access to the Registry?

No, the CoRDS Registry will not be paid by researchers, other patient registries, or patient advocacy groups for access to information in CoRDS.

Can biotechnology or pharmaceutical companies access the CoRDS Registry?

The CoRDS Informed Consent Form does not state that biotechnology or pharmaceutical companies can have access to CoRDS. CoRDS would consider these situations on a case-by-base basis and consult with the patient advocacy groups that may be involved. Allowing these entities access to CoRDS would require a re-consent process so that the participant could provide their consent to authorize these companies to access their de-identified information as approved researchers do.