Investigator Resources

The Chronic Kidney Disease in Children (CKiD) study welcomes collaborations with investigators and with other cohorts. If you are an investigator interested in collaborating with CKiD, below is information on how to propose a new research proposal, request data and/or specimens, develop and submit a manuscript, and comply with CKiD publication requirements.

Please click here to see a list of approved, ongoing, and published CKiD projects.

The information below applies to concept sheets and data and specimen requests that will be submitted directly to CKiD for approval. If you are interested in using publicly available CKiD data, please visit the NIDDK Central Repository for more information about the public data request process.

New Research Proposal or Analysis

Step 1: Develop Research Proposal

Internal CKiD investigators should have their new research proposal reviewed by another CKiD investigator
Internal CKiD investigators should have their new research proposal reviewed by another CKiD investigator
External investigators should discuss research proposal with their CKiD liaison to determine feasibility. If you are not already working with a CKiD liaison, external investigators should contact Bradley Warady (bwarady@cmh.edu) and/or Susan Furth (furths@email.chop.edu).
A CKiD liaison is required for all external investigators
Investigators should review list of approved CKiD projects to avoid overlap:
- List of Approved CKiD Concept Sheets
- Guide to CKiD Concept Sheet Overview in Airtable
Investigators should review CKiD data codebooks and data collection forms to become familiar with the variables CKiD collects
Investigators should review the CKiD Publication Policy prior to submitting a new research proposal

Step 2: Complete the Concept Sheet Research Plan

Complete the concept sheet research plan template
Concept sheets should be reviewed by CKiD liaison or subcommittee before submission

Step 3: Submit Concept Sheet to CKiD for Review

Complete the online concept sheet submission form and upload your completed research plan
Investigator must submit concept sheet at least 12 weeks prior to grant application deadline

Step 4: Concept Sheet Review

Step 5: Concept Sheet Review Outcome

Based on the results of the concept sheet review, investigators will receive one of four responses:

Approved “as is”
Approved with comment
Revisions requested
- Investigator must address comments and submit the concept sheet submission form with revisions for further review. Investigator has 2 opportunities to resubmit the concept sheet.
Rejected (e.g., overlap with other CKiD projects, lacking scientific merit)

Step 6: README Number Assignment

Once a concept sheet is approved:

KIDMAC assigns a CKiD README number (used in all future communication regarding project)
If KIDMAC will be performing analysis, a KIDMAC contact will be assigned to the project

Submit a Revised Concept Sheet or Amendment

Revised Concept Sheets

Investigators may submit a revised concept sheet based on comments from the reviewers and Steering Committee. To submit a revision for review, please complete the following:

Indicate the submission type is “revised” on the Concept Sheet Research Plan (page 1)
Complete the “Summary of Changes” section on the concept sheet submission form (page 1)
Complete the concept sheet revision form using the individual form link that was provided via email

Amendments

Investigators may submit an addendum or amendment to a previously approved concept sheet if they are requesting additional data or specimens. The concept sheet will retain the same README number assigned to the initial project. To submit and amendment for review, please complete the following:

Indicate the submission type as “addendum/expansion of previously approved concept” and include the original README # on Research Plan (page 1)
Complete the “Summary of Changes” section on the Research Plan
Include a clean version and a tracked version of the addendum or amendment to the original concept sheet and email both documents to Judith Jerry Fluker (jjerry@jhu.edu)

Request Limited Dataset/Data Use Agreement

As indicated on the concept sheet submission form, an investigator can request the creation of a limited data set to complete the analysis independently.

Must complete a Data Use Agreement (DUA) between investigator’s institution and Johns Hopkins (on behalf of CKiD)
- Investigator submits the DUA to their own institution’s research administration to obtain the appropriate signatures
- Send partially executed DUA back to CKiD to submit to JHU Research Administration
After fully executed DUA is completed, KIDMAC will prepare the dataset and codebook for the variables included in investigator’s approved concept sheet

If an investigator is completing the analysis independently and wants to examine additional variables beyond those requested in their approved concept sheet, an addendum will need to be submitted and reviewed. To submit an addendum request, an investigator will need to complete the Concept Sheet Submission Form, list the additional variables requested and check “addendum” as the submission type and include the assigned README number.

Requesting Specimens

Before obtaining CKiD specimens from the NIDDK Central Repository, an investigator must complete these steps:

Obtain documented Institutional Review Board approval or exemption from your institution
Register for a user account on the NIDDK Central Repository website (www.niddkrepository.org)
Obtain a fully executed Sample and Data Use Certification (SDUC). This is an agreement between the investigator and the NIDDK Central Repository.
- NIDDK Central Repository Agreement forms – Click here.
- Requires authorized signatures from the study PI and institution. If collaborating with external investigators, an investigator from each institution is required to complete a separate SDUC
- All communication with NIDDK Central Repository is done through its website
- SDUC is valid for two years from the data of approval. Renewal of access may be granted by submitting a request to the NIDDK Central Repository
Once fully executed SDUC is obtained, KIDMAC will provide sample list to upload onto the NIDDK Central Repository website and the repository prepares request
If there are any issues with the request (i.e., date or visit discrepancies, less sample than expected), the repository communicates issues with KIDMAC to find resolution
Cost and shipment information is confirmed with investigator
Prior to shipment, final shipping manifest is reviewed by KIDMAC

Annual Progress Report for Approved Concept Sheets

All investigators with approved CKiD concept sheets are required to submit an annual progress report.

Investigators must show productivity within 6 months after Steering Committee approval
If no progress report is received after two reminders, CKiD can close the project

A link to the progress report will be available here when the progress report is due.

Publication Procedures

The lead author is responsible for following CKiD Study publication policies and procedures outlined below.

Include “for the CKiD study investigators” in the authorship list after the senior author.
Include a supplemental document with a list of site principal investigators with all manuscript submissions. The supplemental document can be downloaded as a Word document and may be formatted for the journal.
Include the CKiD study publication acknowledgement below:

“Data in this manuscript were collected by the Chronic Kidney Disease in children prospective cohort study (CKiD) with clinical coordinating centers (Principal Investigators) at Children’s Mercy Hospital and the University of Missouri – Kansas City (Bradley Warady, MD) and Children’s Hospital of Philadelphia (Susan Furth, MD, PhD), Central Biochemistry Laboratory (Jesse Seegmiller, PhD) at the University of Minnesota, and data coordinating center (Derek Ng, PhD) at the Johns Hopkins Bloomberg School of Public Health. The CKiD Study is supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases, with additional funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Heart, Lung, and Blood Institute (U01 DK066143, U01 DK066174, U24 DK137522, U24 DK066116). The CKiD website is located at https://statepi.jhsph.edu/ckid and a list of CKiD collaborators can be found at https://statepi.jhsph.edu/ckid/site-investigators/.”

PMCID Requirement

Investigators are required to ensure that any publication that uses CKiD data or samples has a PubMed Central Reference Number (PMCID) assigned to it. The PMCID is a unique reference number that is distinct from the PMID number assigned in PubMed. Some journals will submit manuscripts on behalf of authors to be deposited in PubMed Central (see list here).

It is the responsibility of the lead author to submit published manuscript to the NIHMS system to obtain a PMCID if the journal does not submit manuscripts directly. This process is outlined in more detail in the CKiD Publication Policy. Please contact KIDMAC with any questions about this process.

CKiD Grant Numbers

U01 DK066143 (grant number for CMH; PI: Bradley Warady)
U01 DK066174 (grant number for CHOP; PI: Susan Furth)
U24 DK13752 (grant number for CBL; PI: Jesse Seegmiller) Previously U01 DK082194; PI: George Schwartz
U24 DK066116 (grant number for DCC; PI: Derek Ng) Previously U01 DK066116; PIs: Alvaro Muñoz and Derek Ng