DBT NOC Package

DBT NOC Package

Appendix II
Appendix III
Appendix IV
summary sheet

Sumbittal Form for Internal Investigators

All form fields are compulsory. Enter NA if the field is Not Applicable. Please go through the entire contents of the form before you begin. The form cannot be saved halfway through the submission. If you prefer to fill the form offline, please download it and email the completed form to RePORT India Coordinator, U.S. Secretariat and Executive Committee Chairs at dgnanadason@crdfglobal.org

download submittal form

    GENERAL INFORMATION

    1. Lead Investigator

    2. Study Title / Concept Sheet Title

    3. Contact Person

    4. Submission Type

    InitialRevisedAmendment

    5. Summary of Changes

    If the submission is a revision (to a previously rejected) or an amendment (to a previously approved) existing concept sheet, please summarize all changes.

    NOTE: In addition, please highlight all changes to previously submitted concept sheet.

    6. Consortia involved in the proposed study

    RePORT IndiaRePORT BrazilRePORT South AfricaTRIPOD IndonesiaOthers

    7. RePORT India sites involved in the proposed study

    BJGMCBMMRCNIRTMVDRCJIPMERCMCHindujaOthers

    8. Proposal includes (Mark all that apply)

    RePORT India Common Protocol Cohort ARePORT India Common Protocol Cohort BOthers

    8a. Proposal activities (Mark all that apply)

    Request to analyze existing dataset(s)Request use of current repository specimens for further testingRequest additional new protocol procedures and/or participant visitsOthers

    9. RePORT India Liaison (if lead investigator is not a RePORT India investigator)

    Has the RePORT India liaison reviewed the completed Concept Sheet and approved the submission to the RePORT India EC?

    YesNo

    10. IRB/IEC& Human Subjects Issues

    Does this project have IRB or IEC approval?

    YesNo

    11. Grant Information

    a. Is the proposed study related to an existing grant?

    YesNo

    b. Is the proposed study related to a pending grant submission?

    YesNo

    c. Are RePORT India funds requested to support this proposed study?

    Yes, funds from the parent protocol budget will be used to support these effortsYes, fund from the Common Protocol budget will be used to support these effortsYes, discretionary funds from the RePORT Consortium will be requestedNo, a separate budget not related to RePORT will fund these efforts

    12. Conflicts of Interest Disclosure

    Do any of the investigators have any financial conflicts of interest to disclose?

    YesNo

    13. International Collaborations

    Regardless of whether or not a subcontract is arranged, will this collaboration involve an institution or company that is not located in the United States or India?

    YesNo

    NOTE: Please keep in mind that collaborations with non-US investigators proposing to use specimens and/or data from NIH-funded awards cannot be initiated without prior NIH approval. Should this Concept Sheet receive Executive Committee approval, the lead investigator at each primary awardee institution involved with the collaboration should immediately contact the NIAID Program Official (XX) in order to receive further details for obtaining such approval.

    14. Confidentiality

    Does this concept sheet include confidential or commercially sensitive information?

    YesNo

    NOTE: The RePORT India Coordinator will share a confidentiality agreement template to be signed by the lead investigator and each concept sheet reviewer.

    STUDY DESIGN

    Use the following organization to present your study plan.

    1. Summary

    2. Background

    3. Specific Aims and Hypotheses

    4. Does this project involve additional participant burden?

    YesNo

    Check all that apply

    New specimen collection neededNew questionnaire administeredNew procedure (e.g., MRI, biopsy)New or additional consent neededAdditional visit required

    5. Does this project involve additional RePORT India site staff burden

    (e.g., IRB submission, coordination of participant visits, administration of forms, data management, training etc.)?

    YesNo

    6. Are laboratory tests required?

    YesNo

    7. Test Results: If lab tests to be done, will test results be returned to participants?

    YesNoNA

    8. Data Analysis and Sample Size Calculations

    Where appropriate, indicate which variables are needed from the RePORT India Common Protocol database. For Common Protocol variables review Case report forms and data elements bank on the RePORT India website or contact RePORT India Administrative Coordinator, Daphne Martin-Gnanadason, dgnanadason@crdf.org.

    Will analytic support be requested from the RePORT Consortium?

    YesNo

    SAMPLE SPECIFICATIONS

    Specimens obtained may not be used for any purpose other than the approved project without prior consultation and permission from the Executive Committee.

    1. Repository Information

    a. Will this project require the withdrawal of specimens from the NIRT Central Biorepository?

    YesNoNot Sure

    b. Will this project require the withdrawal of whole blood DNA from the NIRT Central Biorepository?

    YesNoNot Sure

    NOTE: At the time of concept approval, you will need to complete the RePORT India Genetics Data Use Certification Agreement. In addition, once the concept is approved please complete the NIRT DNA Biorepository Sample Request Form.

    Sample Characteristics: To protect the most valuable and irreplaceable specimens in the RePORT India Common Protocol, Central Biorepository requests for specimens from certain groups of Common Protocol participants (e.g., Cohort B TB activation cases, Cohort B TB activation cases who enrolls in Cohort A, pediatric active TB cases, TB treatment failure or early relapse, etc.) may trigger additional review by the RePORT India Specimen Allocation Committee.

    A. Mark the types of participants whose specimens are targeted by this request

    Cohort A general

    Cohort B general

    Cohort A diabetic

    Cohort A non-diabetic

    Cohort B diabetic

    Cohort B non-diabetic

    Cohort A TB treatment failure

    Cohort A TB relapse

    Cohort B TB activation cases

    Cohort B TB activation cases who enroll in Cohort A

    Pediatric Cohort A (active TB) aged 5 years or younger

    Pediatric Cohort A (active TB) aged 6-14 years

    Pediatric Cohort B (HHCs) aged 5 years or younger

    Pediatric Cohort B (HHCs) aged 6-14 years

    HIV co-infected Cohort A

    HIV co-infected Cohort B

    Others

    Expected number of visits & participants

    Will this project require serial specimens with explicitly stated comparisons?

    YesNo

    B. Sample Type
    PBMCPlasmaPaxgene RNAMtb isolate subcultureSputumUrineSalivaWhole Blood (DNA)QuantiFERONOthers

    NOTE: Specimens previously thawed for other initiatives may be shipped. If unacceptable, give a reason below for requiring specimens not previously thawed. Leftover material cannot be returned to the NIRT Central Biorepository without prior approval from the Repository Program Officer and the RePORT EC.

    C. Common Protocol samples and storage specifications
    Please refer to the Appendix for a list of Common Protocol samples and storage specifications. Indicate the quantity of sample that is being requested in the table format available at this link - CS Appendix Sample Request Specifications

    D. Upload quantity of sample requested

     

    Please read the STATEMENT OF AGREEMENT

    I hereby acknowledge that I have read and agree with the Statement of Agreement

    Submittal Form For External Investigators

    submittal form for external investigators