CARRA Data and Sample Share Request Form 

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Before submitting, review the Data and Sample Requests section of the CARRA Research Portal for guidance on required information and documentation. 

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Request Details


Note: The standard datasets do not currently include PROs, Long-term Follow-up program data, cohort-specific datasets, and SAE/ESI data. For more information about what is included in a standard dataset, please visit the CARRA Research Portal.
Requestor Information
Principal Investigator (PI) Information
The PI holds primary responsibility for the use of CARRA data and/or samples. The PI must be a CARRA member and a faculty-level investigator, such as an attending pediatric rheumatologist. Trainees—including students, residents, and fellows—may not serve as PI. If the proposed PI is not a CARRA member, the request will undergo additional review to ensure alignment with CARRA’s mission. 

The information you provide will be securely stored and may be edited at any time through the member portal for future reference. 
An EARLY INVESTIGATOR (EI) is a New Investigator who has completed their terminal research degree or end of post-graduate clinical training, whichever is later, within the past 10 years and who has not previously competed successfully as a PI for a substantial NIH independent research award.
Project Lead (PL) Information 
The PL is the individual leading the day-to-day execution of the project. This person may also serve as the PI or may be another member of the research team, such as a student, resident, fellow, research coordinator, or non-CARRA investigator working under the guidance of a CARRA member PI. Both the PI and PL will be copied on all communications related to the request. 
An EARLY INVESTIGATOR (EI) is a New Investigator who has completed their terminal research degree or end of post-graduate clinical training, whichever is later, within the past 10 years and who has not previously competed successfully as a PI for a substantial NIH independent research award.
Additional Investigators


Yo  You may include up to three additional investigators. Please list those who will actively work with the requested data or receive a portion of the samples. The full authorship plan will be requested separately. There is no need to list all authors here. 

Study Details
Limit your responses to information directly relevant to this application.


Methods:
Describe how the requested data and/or samples will be used. Include the following, as applicable: 
  • Study design and objectives 
  • Population, inclusion and exclusion criteria, and sample size, including power calculations 
  • Data analysis and statistical methods 
  • Timeline and feasibility considerations 

Outcomes of Interest: 

List the primary and secondary outcomes of interest, any covariates of interest and/or and main variables that may need to be considered (e.g. for adjustment) in the analysis.  
  • Primary Outcome 
  • Secondary Outcome 
  • Covariates 
  • Other Key Variables

Cohort Details
Describe in detail the count data you are requesting, including variable names (e.g. of those who have transitioned (RSNINACT), count of each rheumatic disease (PRRHEUMA), etc.
  • Refer to the data dictionary on the CARRA Research Portal for variable names and guidance. Please ensure you are using the most current version. For questions, contact research@carragroup.org.


ABC Grant Details
Data Request Details

An appropriate IRB approval letter is required when requesting full 5-digit ZIP codes, which constitute a limited data set. Select the type of zip codes you are requesting.
Upload a file highlighting the data points you are requesting.  
  • Refer to the data dictionary on the CARRA Research Portal for variable names and guidance. 
  • Please ensure you are using the most current version. For questions, contact research@carragroup.org.

Sample Request Detail

Please provide more detailed specifications related to this sample request. If the request is approved, further details including shipping addresses, patient global IDs, and other information will be requested through a Sample Order Form which will be submitted to the CARRA Biobank.

Sample Types
Type Estimated quantity/volume (units) Justification
Please specify sample type Estimated quantity/volume (units) Justification
Other Sample Types
(age, sex, ethnicity)

Invoice Details

CARRA will provide a budget estimate for any applicable expenses once your request is approved. Please confirm your invoice details below for any costs associated with data sharing or custom data count reports. 









Regulatory Approvals and Attachments
 Please attach IRB/REB approval and other relevant materials. 
  • IRB approvals from each institution that will receive/analyze data are required. Please scan all IRB approvals into one document before uploading. If your project does not require IRB approval, please provide your IRB exemption letter.
  • If a LOS was requested, please include a draft letter which CARRA will review and format on letterhead if approved

  • ·     If you do not have project funding, you have the option to submit a letter requesting a data access fee waiver for any data access fees. If you would like to request a fee waiver, please upload a letter from your department head under other supporting materials.

  • If this project is a committee-prioritized project that may qualify you for a data access fee waiver, please upload confirmation from the committee chairs under other supporting materials
  • You may choose to upload additional supporting materials. These materials can include, but are not limited to, additional investigator bio sketches, study protocols, project timelines, related publications, or any other documents you believe would be valuable for our reviewers to consider during the application review process.  Please limit these documents to information directly related to the data and/or samples being requested

Terms of Use Conditions Acknowledgement

To receive and continue using CARRA Data and Biospecimens, investigators must attest to their understanding of and compliance with the CARRA Data and Sample Sharing Policy, which is summarized below and available in full at https://carragroup.org/membership/policies/.

General Terms of Use

  1. The investigator agrees to use the data count reports, data, and biospecimens only for the approved research project as proposed in the Data and Sample Share application. If the investigator desires additional data or biospecimens or plans to use the data count reports, data, and biospecimens for any use other than the approved study focus/question, either a new application must be submitted or, at the discretion of CARRA in cases of minor changes in project scope, a revised request may be considered. Usage of data or biospecimens for purposes not expressly authorized by the approved research project constitutes a breach of agreement. Depending upon the severity of the infraction, CARRA may sanction the PI or other responsible investigators, including but not limited to imposition of restrictions on usage or publication of project work products, rescinding access and requiring immediate return or destruction of data count reports, data, or samples, and/or restrictions on submission and performance of other CARRA data and sample requests and projects.
  2. Data count reports, data, and biospecimens will not be shared with other co-investigators except those individuals on the application for use of the data and biospecimens. If there are additional co-investigators, a revision of the request should be submitted (see instructions for doing so here) and will require approval by CARRA.
  3. Use of data and biospecimens must follow HIPAA (Health Insurance Portability and Accountability Act) rules and local research compliance rules and be approved by the investigator’s local IRB. IRB documentation of review (approval, exemption, or waiver) that CARRA deems acceptable must be provided to CARRA prior to release of any data and/or biospecimens.

Investigator Cost Responsibilities

  1. Investigators are responsible for any data access fees, as outlined on the CARRA Research Portal (https://research.carragroup.org/en/requests/data-and-sample-share)
  2. Investigators are responsible for the costs related to shipment of biospecimens to his/her laboratory facility for study analyses, if applicable. Investigators will be asked to provide invoice information prior to shipment.
  3. Investigators are accountable for the expense of any equipment not returned to CARRA upon request. This encompasses super shippers, which may be utilized for specific sample shipments. Failure to return equipment as requested will result in CARRA invoicing the investigator to cover the equipment replacement cost.
  4. Investigators are responsible for costs related to certain biospecimen processing methods, including RNA extraction and for bioanalyzer quantification and quality reading, if applicable. The CARRA Biobank will provide an estimate of costs during the sample request review process to ensure project feasibility and a detailed estimate will be provided for approved requests. CARRA will invoice investigators for applicable expenses upon processing.
  5. Investigators are responsible for the costs of resultant abstracts, papers, publications, posters and presentations.

Results Sharing Requirements

  1. Progress reports must be submitted annually on July 31st until project completion to the CARRA Data, Sample, and Publications Committee (DSPC) for review of progress (abstracts, papers, publications, presentations, project status). All final progress reports must be submitted within 45 days of the final publication. The CARRA DSPC will review the progress reports for adherence to project scope and timeline. If investigators do not keep to their stated timeline and a request is made for similar data by other investigator(s), the data use permission may be withdrawn from the original investigator and issued to the next investigator in line. If progress reports are delinquent for existing requests, the investigator will not be granted access to additional data or samples until the report is submitted. Additionally, progress reports delinquent more than 6 months may result in a membership administrative hold, as outlined in the CARRA Membership Policy (https://carragroup.org/membership/policies/). Progress reports can be submitted to CARRA at the following link: https://carra.tfaforms.net/38.
  2. Resultant abstracts, papers, publications, posters and presentations arising from these collaborations are subject to CARRA Publication and Presentation Guidelines which are available on the CARRA Research Portal at https://carragroup.org/membership/policies/:
    • Submission of publication or presentations to the CARRA Data, Sample, and Publications Committee for review of authorship and CARRA acknowledgement should be made prior to journal/conference submission. Please reference the guidelines to ensure sufficient time for CARRA review prior to a submission deadlines. The submission will be maintained in confidence by CARRA prior to its publication.
    • Inclusion of the relevant acknowledgements and disclaimers
    • All CARRA-related publications should include the following:
      The authors wish to acknowledge CARRA and the ongoing Arthritis Foundation financial support of CARRA. This work could not have been accomplished without the aid of the following organizations: The NIH’s National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) & the Arthritis Foundation.
    • Submissions utilizing CARRA Registry data and samples should include the following:
      • Inclusion of ‘for the CARRA Registry Investigators’ in authorship byline
      • We would also like to thank all participants and hospital sites that recruited patients for the CARRA Registry. The authors thank the following CARRA Registry site principal investigators, sub-investigators and research coordinators: [insert Registry personnel list, updated bi-annually, found on https://carragroup.org/membership/policies/]
      • This study utilized data (and biospecimens) collected in the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry. The views expressed are the authors’ and do not necessarily represent the view of CARRA.
    • Copies of all accepted abstracts, papers, and/or presentations, published manuscripts, and any other publications arising from the project must be provided to CARRA promptly via email to research@carragroup.org. Publications will be made available publicly on the CARRA website if permission is provided by the investigator. CARRA will honor embargo periods for public listings when so advised by the investigator.
    • Investigator will arrange for all published manuscripts to be made publicly available via PubMed Central® (PMC): http://www.ncbi.nlm.nih.gov/pmc/ as per the NIH Public Access Policy (see https://www.nih.gov/health-information/nih-clinical-research-trials-you/what-is-nih-public-access-policy ) regardless of whether the investigator received funding from NIH for the research purpose.
By checking the following boxes and my signature below, I acknowledge that I have read and agree to all listed conditions above. Further, I understand that non-compliance may result in sanctions by CARRA, including but not limited to denial of participation in future Data and Sample requests:  
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Questions? Contact research@carragroup.org