CureGN Ancillary Study Proposal Application
To submit a CureGN Ancillary Study proposal for review, complete this form and any additional required documents (e.g.
consent form, study questionnaires, data sharing plan). Click here for further instructions.
Ancillary studies may involve collection of additional data and/or samples from study participants, or use of existing data
and/or samples for analyses or laboratory assessments that are not directly related to the specific objectives of the
relevant CureGN study as defined in the protocol document. CureGN Ancillary Study policies are found in a separate
document.
Part A: Ancillary Study Face Page
Study Title
Principal Investigator
PI Affiliation (Institution)
PI Contact Information:
E-Mail
Mailing Address
Phone / Fax
CureGN Sponsor
(Required)
Co-Investigators
(Name, Affiliation, e-mail )
Expected Start Date
Expected End Date
Proposed Funding Source
and Mechanism
Estimated Total Budget
(Specify Direct or Total
Costs)
Do you think this is a
“Core Study” and/or will
produce “Core Data”?
Is this a training proposal?
(Check one)
Abstract (one paragraph):
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Yes - Core Study
Yes - Core Data
Neither
Yes. If yes, please include with the application a paragraph from the
mentor(s) indicating relevant experience, as well as commitment to the
trainee.
No
Part B: CureGN Study Impact
Please use this section to fully describe the impact of the ancillary study proposal on the CureGN study subjects,
biospecimens, Data Coordinating Center (DCC) and consortium. Insert additional lines as necessary to fully answer the
questions.
B1. Requirements
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All CureGN participants
OR
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B1a.
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Study Population
Study Resources
B1b.
(check all that
apply)
Select Population (check all that apply):
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Adult
Pediatrics
FSGS Cohort
MCD Cohort
MN Cohort
IGA Cohort
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Incident (first kidney biopsy within 6
months of enrollment)
Incident (first kidney biopsy at a
CureGN site after 1/1/2015)
Prevalent
Other: ______________
Use existing clinical data
Use existing procured samples
Use existing patient-reported data
Requires new clinical data
Requires additional sample procurement
Requires new patient-reported data
B2. Burden to Participants
B2a.
Does this ancillary study require additional study visits?
B2b.
Does this ancillary study require additional study procedures?
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Yes
No
Yes
No
If yes, use the table below to specify the proposed visit schedule and procedures (e.g. questionnaires,
intervention, and tests) to be performed. Provide a subject level time estimate of additional study procedures
(e.g. self-administered questionnaire x 10 minutes).
B2c.
B2d.
Procedure
Visit* (Time)
Procedure 1 <SPECIFY>
Procedure 2 <SPECIFY>
Procedure 3 <SPECIFY>
* Specify CureGN Visit # or additional visit time
Add rows as necessary
Visit* (Time)
Visit* (Time)
Does this ancillary study add new questionnaires/questions? If yes, provide a copy
of each proposed questionnaire/question with application.
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Yes
No
If yes, check all that apply:
B2e.
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Patient surveys
Clinical data (may be collected by patient interview)
Clinical data (chart review only)
Other (specify): _____________________________
B3. Biosamples
B3a.
Use of existing specimens. Does this ancillary study require use of biospecimens
collected in the core CureGN protocol?
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Yes
No
If yes, check box and provide volume for stored blood, urine, DNA, RNA samples requested
Please respect the limited nature of all biorepository specimens. Individual requests exceeding 10% of original
stored volume may be rejected. See https://curegn.org/publicdocuments/Biospecimens%20List.pdf for more
information.
Volume or
Amount
Type of Specimen
Requested
Visit(s)
Whole blood for genomic DNA - EDTA tube DNA
Extracted genomic DNA
Whole blood for genomic RNA - PAXGene tube RNA
Extracted genomic RNA
B3b.
EBV immortalized cell lines (PEDS ONLY)
Plasma - EDTA tube
Plasma - Sodium Citrate Tube
Plasma - Sodium Heparin (light protected)
Serum - Serum separator tube
Spot urine: supernatant and cell pellet harvested at site:
Spot urine cleared supernatant - with Sodium Azide (NaN3)
Spot urine cleared supernatant - with protease inhibitor (PI)
Spot urine cell pellet - Harvested in RNAlater stablizing Nucleic
acids at RT
24-hour urine - 24-hr urine collection container
B3c.
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New specimens: Does this ancillary study require additional specimen acquisition
beyond the core CureGN protocol? If no, skip to B3f.
Yes
No
If yes, please describe in table below:
B3d.
Specimen (Plasma, Serum,
Urine, Other - specify)
Sampling Times*:
Specimen 1 <SPECIFY>
Specimen 2 <SPECIFY>
Specimen 3 <SPECIFY>
* Specify CureGN Visit # or additional visit time
Add rows as necessary
Assay Proposed
Volume Requested
Will there be remaining biomaterials available for future use? If yes, where will
B3e. they be stored and what is the expected remaining volume?
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Yes
No
B3f.
Describe how testing of biologic samples (whether from stored CureGN biosamples or de novo
sampling) will be performed.
B3g.
Will CureGN samples need to be shipped?
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Yes
No
B4. Data
What existing Core data (provided as Standard Analysis Files (SAFs) are needed: (check all that apply)
B4a.
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Demographics
Comorbidities
Family History
Birth History
Pregnancy History
Prior Disease Course
Medications
Laboratory values/Clinical Information
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Hospitalizations and ER Visits
Limited Physical Exam
Patient-reported data
o Quality of life
o Adherence
Access to DPR Imaging
Other (specify: ________________)
B4b.
Provide schedule for Standard Analysis File (SAF) delivery and updates. (e.g., 2017 with 2 annual
updates)
B4c.
Will this ancillary study require additional derived variables? If yes, list variables
requested.
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Yes
No
If this ancillary study will result in new data, how will data be transferred to CureGN following the
B4d. completion of your study? Note: genomic data will also need to be submitted to dbGAP.
B4e.
Describe your data sharing plan here
B5. PCC Burden
Describe any additional burden to PCCs or study sites. (e.g., study coordinator training, interface with
B5a. participants, sample kit creation and delivery or shipping, etc.)
B6. DCC Burden
Will the ancillary study require the DCC to perform study monitoring activities?
□ Yes
B6a. (e.g., study coordinator training, IRB and/or other regulatory assistance, label
□ No
creation and delivery, etc.)
Will any additional effort or personnel time be expected of the CureGN DCC? (Check all that apply.)
B6b.
If yes, describe in detail with timeline for proposed activities.
□ CureGNLink questionnaire changes
□ CureGN Link functionality changes
□ Custom SAF
□ Other (describe)
Please consult the CureGN DCC early in the phase of development. Contact [email protected] with
questions or to discuss your study idea. Note that the proposed study may require additional activities identified
during the review process.
Where will the data analyses be conducted?
B6c.
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The DCC will conduct all analyses, OR
The ancillary study investigator (ASI) team will design and conduct the analysis with quality review from
the DCC, OR
The DCC will conduct some analyses, and the ancillary study investigator (ASI) team will conduct others.
Please explain.
B6d.
For analyses conducted by DCC, will the resulting manuscript(s) be submitted by
the DCC or other institution?
B6e.
Estimated Number & Timing of Publications (e.g. # per project year)
B7
B8
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DCC
Other (name:
______)
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Describe your plan for obtaining IRB approval for this study. (Required prior to sample shipment/data
transfer or initiation of ancillary work.
Do you anticipate need for an amendment to the approved CureGN IRB package
at sites where subjects are participating? (This would apply to new surveys, new
biospecimens, etc.).
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Yes
No
Indicate if the study has an active Investigational New Drug (IND) or Investigational Device
Exemption (IDE) number:
Number
B9
Responsible Investigator(s) or Sponsor(s)
IND
IDE
B10
Does this research have the potential to be used when applying for an IND or IDE
to the FDA?
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Yes
No
Part C: Study Design (3 Pages Maximum Excluding References)
1. Background and Rationale:
2. Hypothesis, Objectives and Specific Aims:
3. Study Design and Procedures: (Summary)
4. Statistical Analysis:
5. Sample Size and Justification: (Including Power Analysis)
6. Anticipated Results and Project Timeline:
7. References: (15 Maximum)
Please submit completed Ancillary Study Proposal Applications with all supporting documents including NIHstyle biosketches of all PIs, as a single PDF document to [email protected]