IRB Submission Documentation
IRB Submission Documents
Certificates of Confidentiality
“Effective October 1, 2017 CoCs will be issued automatically for any NIH-funded project using identifiable, sensitive information that was on-going on/after December 13, 2016.” For more information about the Major Policy Changes for Certificates of Confidentiality (CoC), go to https://grants.nih.gov/policy/humansubjects.htm. Please refer to Communication Memo #275 for more information concerning how this NIH policy change impacts the CKiD study.
Also, the text included in the CKiD consent form template is the suggested language recommended by NIH. For more details, go to https://grants.nih.gov/policy/humansubjects.htm
OSMB Letters (formerly EEP)
- Letter from NIDDK Project Director, 05/29/24
- Letter from the NIDDK Project Director, 12/09/22
- Letter from the NIDDK Project Director, 10/29/21
- Letter from the NIDDK Project Director, 11/30/20
- Letter from the NIDDK Project Director, 10/02/19
- Letter from the NIDDK Project Director, 08/20/18
- Letter from the NIDDK Project Director, 08/15/17
- Letter from the NIDDK Project Director, 07/29/16
- Letter from the NIDDK Project Director, 07/23/15
- Letter from the NIDDK Project Director, 07/09/14
- Letter from the NIDDK Project Director, 09/10/13
- Letter from the NIDDK Project Director, 08/06/12
- Letter from the NIDDK Project Director, 08/01/11
- Letter from the EEP Chair, 01/25/11
Repository and CBL- Repository and Central Biochemisty Laboratories- Notice of Exemption from IRB Review
NIDDK Data Distribution Agreement
CBL Certificates
- CAP Certificate – ARDL University of Minnesota
- CLIA Certificate – ARDL University of Minnesota
- CAP Certificate – URMC Labs Strong Memorial Hospital
- Documentation regarding delayed CAP inspection due to COVID-19 pandemic
- CLIA_Strong – URMC Labs Strong Memorial Hospital
Affidavits of Translation Accuracy / Certificates of Accuracy (COA)
2023 Affidavits
2022 Affidavits
2021 Affidavits
- Summer 2021 CKiD Family Newsletter COA
- F21 – Coronavirus Questionnaire (03/15/21) COA
- F21 – Coronavirus Questionnaire (09/15/21) COA
- PFU01 – Phone/In-person Follow-up form (09/15/21) COA
- ePIP/WFU01 – Web-based Survey (09-15-21) COA
- Baseline GH & MH and F15 Forms (08/01/21) COA
- Follow-up Forms – F13, F13a, F14, RF13, RF14 (08/01/21) COA
2020 Affidavits
2019 Affidavits
- Affidavit of Accuracy for Spanish Health Literacy Form Instructions
- Affidavit of Accuracy for Spanish Translated Continued Follow-up Material (2019)
2018 Affidavits
2015 Affidavits
- F02/F12 – Smoking, Alcohol and Drug Use form
- GH/F13/F13s – General History
- MH/F14 – Medical History
- MAT – Medical Abstraction Tracking
- F17 – Overall Physical Activity
2013 Affidavits
Continued Follow Up Web Survey Documents
- PFU02b continued follow-up form for outside physician: In some cases, CKiD participants no longer receive care at a CKiD site. Therefore, the site coordinator may not have access to medical records. In these instances, the PFU02b form will be provided to the participant’s physician to be completed.
- Screen Captions of the Web-based Survey – May 2024 Protocol Amendment
- Screen Captions of the Web-based Survey (Spanish version) – May 2024 Protocol Amendment
- Web-based Survey Consent Page (Spanish version) – May 2024 Protocol Amendment (Tracked Changes)
- Site Email Template
- Site Email Template (Spanish)
- Security and Backup Information
Study Documentation
Reports of CKiD Adverse Events
Sample Responses for IRB
- FDA IND Exemption Letter for Omnipaque 240
- FDA IND Exemption Letter for Omnipaque 300 (Discontinued as of April 1, 2023)
- Response about Iohexol
- FDA 510K clearance letter for Zio Patch device
- The 501k letter indicates that the device is classified as Class II and provides documentation that the device is substantially equivalent to a legally marketed predicate device (i.e., a device that has already been approved/cleared by the FDA and legally available on the market).
IRB Forms
Participant Forms in REDCap for May 2024 Protocol Amendment
2024 Protocol Participant Forms
- BLERT_Bell_Lysaker_Emotion_Recognition_Task_Adult_06_15_24_IRB
- BLERT_Bell_Lysaker_Emotion_Recognition_Task_Child_06_15_24_IRB
- F01_Symptoms_List_01_01_06b_IRB
- F02_Smoking_Alcohol_Drugs_10_01_14_IRB
- F13_General_History_08_01_21_IRB
- F13a_General_History_Abbreviated_08_01_21_IRB
- F14_Medical_History_08_01_21_IRB
- F15_Nutritional_Assessment_08_01_21_IRB
- GH_General History_08_01_21_IRB
- MH_Medical_History_08_01_21_IRB
- PROKid_Questionnaire_06_15_24_IRB
- RF13_General_History_for_Post_KRT_08_01_21_IRB
- RF14_Medical_History_for_Post_KRT_08_01_21_IRB
- TRAQ_Transition_Readiness_Assessment_Questionnaire_Parent_Caregiver_06_15_24_IRB
- TRAQ_Transition_Readiness_Assessment_Questionnaire_Youth_and_Young_Adults_06_15_24_IRB
Accelerometry (ActiGraph) Form (F20)
Adverse Event Form (ADVR)
Behavioral Assessments
BASC
- BASC-PRS Preschool (Parent 2 to 5)
- BASC-PRS Child (Parent 6 to 11)
- BASC-PRS Adolescent (Parent 12 to 21)
- BASC-SRP College Version (Young Adult 21 to 25)
BASC – Spanish Versions
- BASC-PRS Preschool (Parent 2 to 5)
- BASC-PRS Child (Parent 6 to 11)
- BASC-PRS Adolescent (Parent 12 to 21)
PEDS QL
- PedsQL (Child 8 to 12)
- PedsQL (Child 13 to 18)
- PedsQL (Young Adult 18 to 25)
- PedsQL (Parent 2 to 4)
- PedsQL (Parent 5 to 7)
- PedsQL (Parent 8 to 12)
- PedsQL (Parent 13 to 18)
BRIEF
Cardiovascular Alert Forms
Census Block Group (CBG)
Cognitive Forms
- Mullen Scales: Mullen Scales of Early Learning
- WPPSI-III: Wechsler Preschool and Primary Scale of Intelligence Third Edition
- WASI II: Wechsler Abbreviated Scales of Intelligence Second Edition
- WISC-IV Integrated: Wechsler Intelligence Scale for Children-Integrated Spatial Span Subtest
- WISC-IV: Wechsler Intelligence Scale for Children Digit Span Subtest
- WAIS-IV: Wechsler Adult Intelligence Scale Fourth Edition Digit Span Subtest (Forward & Reverse Components ONLY)
- WMS-III: Wechsler Memory Scale for Children Third Edition Spatial Span Subtest
- D-KEFS: Delis-Kaplan Executive Function System Subtests
Contact Information Form (CIF)
COVID-19 Questionnaires (C19 & F21)
Disenrollment Form (DSEN)
Eligibility Form (EL)
Fitness Measurements Form (F18)
Hand Grip Form (F19)
Health Literacy Assessment (HLA01)
Laboratory Forms
- Specimen Collection Form for Visit 1a (L01)
- Specimen Collection Form for Even Follow-up Visits (L21)
- Specimen Collection Form for Odd Follow-up Visits (L31)
- Specimen Collection Form for Visit 1b (L02)
- Specimen Collection Form for Make-up GFR Visits (MUGFR01)
- Local Renal Panel Results Form (L03)
- CBC Results Form (L04)
- Local Urine Assay Results Form (L06)
- Shipment Tracking Form for Central Biochemistry Laboratory (ST01)
- Shipment Tracking Form for Serum/Plasma/Urine for NIDDK Biological Repository (ST03a)
- Shipment Tracking Form for Hair/Nail for NIDDK Biological Repository (ST03b)
- Shipment Tracking Form for Rutgers Cell and DNA Repository (ST04)
- Shipment Tracking Form for Cystatin C/iPTH/hsCRP/Vitamin D/FGF-23 for CBL Dry Ice Shipper (ST05))
Medical Abstraction Tracking Form (MAT)
Medical History Forms
Missed Visit Form (MV)
Neonatal Form (NH)
Nutritional Assessment and Steroid Use (F15)
Phone/In-Person Follow-up Forms
Physical Examination Form (PE)
Post Kidney Replacement Therapy (KRT) Forms
- Specimen Collection Form for Baseline Post-Dialysis Visit (DL01)
- Specimen Collection Form for Baseline Post-Dialysis Visit (DL02)
- Specimen Collection form for Even Follow-Up Post Dialysis Visit (DL21)
- Specimen Collection form for Odd Follow-Up Post Dialysis Visit (DL31)
REACH Data Collection Form (RDC)
Refusal Form (REF)
Symptoms List Form (F01)
Transfer Form (TRF)
Transitional Form (TRS03)
Visit Checklist Form (VCL)
