The programs and data should be labeled table1 by v84g8v

VIEWS: 6 PAGES: 11

									 MULTICENTER AIDS COHORT STUDY / WOMEN'S INTERAGENCY HIV STUDY
                  Collaboration Concept Sheet Submission Form & Guidelines
                            This form is intended for all MACS and/or WIHS collaborations,
                           whether using data from both studies or from just one of the studies.

Please fill out all the lettered and numbered sections below:
              (THIS FORM WILL NOT BE ACCEPTED UNLESS ALL OF THE FIELDS ARE COMPLETED)

A. GENERAL INFORMATION
   1. Date of submission:

   2. Lead Investigator(s):

   3. Study Title:

   4. Contact Person:
        (if different from lead investigator)

   5. Submission type:             ☐ Initial ☐ Revised
                                   ☐ Addendum/Expansion of previously approved Concept (Readme# _______)

   6. Proposal includes:           ☐ MACS & WIHS             ☐ MACS only            ☐ WIHS only
                                   ☐ MACS local study only
                                   ☐ Other cohorts (identify): ____________________


   7. Guidelines (pages 8-11) have been reviewed:                  ☐ Yes        ☐ No



                                                                                             Continue on next page ➔

                                  Internal Use Only - DO NOT REMOVE
                                                 CAMACS Use Only
MACS EC Date: __________________________________                                           MACS Readme#: r________
 ____ Approved                          ____ Approved for grant submission                 ____ Approved w/comment
 ____ Revision Requested                                                                   ____ Rejected
 ____ Approved by _____________________ Working Group                                      ____ Deferred
                                                 WDMAC Use Only
SUB date:                                                    LLS?:
REV & PDR end:                                               DIST date:

PIR:                           PDR:                          PIR end:
LAB:                           GEN:                          OTCM: 1        2   3    4

Concept.doc                               1                                April 3, 2012
MACS/WIHS Concept Sheet                                                             ____________________________
                                                                                                            Lead Investigator

A. GENERAL INFORMATION (cont)
    8. Institution:

    9. Address:

    10. Telephone Number:

    11. FAX Number:

    12. Email:

    13. Topic:
        Topics include: Behavioral, Cancer/Pathology, Cardiovascular, Epidemiology, Genomics/Genetics, Hepatitis/Liver, HPV,
        Metabolics, Neurocognition, Pathogenesis/Immunology
    14. Sites involved in the proposed study :             ☐ All MACS & WIHS sites

        ☐ All MACS sites:                                             ☐ All WIHS sites:
          ☐ Baltimore/District of Columbia                                ☐ Bronx
             ☐ Chicago                                                    ☐ Brooklyn
             ☐ Los Angeles                                                ☐ District of Columbia
             ☐ Pittsburgh                                                 ☐ Los Angeles
                                                                          ☐ San Francisco
                                                                          ☐ Chicago


    15. Grant Information:
        a. Proposed study is related to an existing grant?
             ☐ Yes (Please indicate the sponsor and if NIH-supported indicate the grant number)
                      NIH Grant Number:
             ☐ No


        b. Proposed study is related to a grant submission?
             ☐ Yes (If yes, complete 1 - 3 below)       ☐ No
             1) ☐ NIH (Please specify solicitation number below)
                      NIH Solicitation Number: ________________________________________
             2) ☐ Other sponsor (please specify): _____________________________________________
             3) Your grant submission deadline __________________




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MACS/WIHS Concept Sheet                                                        ____________________________
                                                                                                              Lead Investigator

16. IRB & Human Subjects Issues:
        a. Does this project have local IRB approval?                  ☐ Yes     ☐ No
        b. Time period of IRB approval:                        /   /      to      /      /
        c. Local IRB reference #:
        d. This project will require collection of new: ☐ Data                   ☐ Specimens                    ☐ N/A
        e. If “N/A,” does your study require a new informed consent?             ☐ Yes               ☐ No
        f.   Do you have or will you be obtaining a Certificate of Confidentiality from NIH?
                    ☐ Yes ☐ No

    17. Will this project require the withdrawal of specimens
        from the DAIDS Central Repository?                               ☐ Yes        ☐ No
        a. If “Yes,” the deadline date you will require specimens (MM/DD/YY):                    /        /
        b. FOR MACS-RELATED PROPOSALS ONLY: At the time of concept approval,
           you will need to complete the MACS Materials Transfer Agreement (MTA) to be located at
           http://www.statepi.jhsph.edu/macs/forms.html.
        c. To protect the most valuable and irreplaceable specimens in WIHS, Central Repository requests for
           specimens from certain groups of WIHS participants (HIV-seroconverter, ART-naïve HAART initiator,
           long-term non-progressor, elite non-progressor, incident cancer case, etc.) will trigger additional review.

    18. FOR WIHS-RELATED PROPOSALS ONLY: Will this project require the withdrawal of host
        DNA from the WIHS DNA biorepository?      ☐ Yes        ☐ No
        a. If “Yes,” the deadline date you will require specimens (MM/DD/YY):                /        /
        b. If “Yes,” please complete the WIHS DNA Biorepository Sample Request Form; the link to this form
           is located at: https://statepiaps.jhsph.edu/wihs/index-invest-info.htm.


BEFORE SUBMISSION:

▸   Internal investigators should have the completed Concept Sheet (CS) reviewed by the site PI
▸   External investigators should have the completed CS reviewed by their co-investigator liaison (as indicated
    on page 7 of this form) from the studies to determine that this concept sheet is appropriate.
▸   If no liaison exists:
    ∙   MACS-related CS should be sent to Ms. Joana Roe at NIH, Division of AIDS
    ∙   WIHS-related CS should be emailed to wdmac@jhsph.edu




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MACS/WIHS Concept Sheet                                                          ____________________________
                                                                                                        Lead Investigator

B. STUDY DESIGN (Use the following organization to present your study plan.              Take whatever space is necessary
   to respond completely to each section. Complete in 12 point font only. Please submit electronic copies in MS Word,
   RTF, PDF, or Word Perfect format.)

   1. Lay Language Summary (provide a one paragraph summary of the study and its impact on participants,
       written for a 10th grade reading level)




       a. Does this project involve additional participant burden?
             ☐ New specimens
             ☐ New questionnaire
             ☐ Both


   2. Background (a brief description of the rationale for the substudy, including references)



   3. Specific Aims and Hypotheses IMPORTANT: Specimens and data provided by MACS and WIHS may only be
       used to complete the aims described in Section B3 below. Additional testing and use of data, including transfer to
       another investigator, outside the scope of the stated aims and not explicitly stated in the concept are not allowed.
       Additional testing and data use require review and approval from the study-specific Executive Committee. In
       addition, upon approval of the proposed CS a Data Use Agreement form will be sent by the MACS Data
       Coordinating Center (CAMACS) and must be completed by the Lead Investigator.

   4. Study Design (summarize the type of study, inclusion criteria, and sample size)



   5. Laboratory Methods (if applicable, summary of how new studies will generate data, etc.)



   6. Test Results:
       a. Will test results be returned to participants? ☐ Yes                  ☐ No         ☐ NA
       b. If yes, when and how?
       c. If no, why not?


   7. QA/QC Procedures (for studies generating new laboratory data: summarize laboratory QA/QC procedures,
       participation in recognized program, past publication, etc., relevant to the proposed investigations or testing)




   8. Data Analysis and Sample Size Calculations (Where appropriate, indicate which variables are needed from
       the MACS and WIHS database [MACS questionnaires with variables are available on line at
       http://www.statepi.jhsph.edu/macs/forms.html; for WIHS variables contact WDMAC at wdmac@jhsph.edu], and
       anticipated support needed from CAMACS and/or WDMAC. Include how data will be reported: on paper, what
       database, what file structure.)
                                                             4
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MACS/WIHS Concept Sheet                                                         ____________________________
                                                                                                      Lead Investigator



   9. Manuscript Will Be Completed by (anticipated month and year in which the manuscript will be ready for
      submission to the EC):
                                     ________________ _________
                                                     Month                     Year




C. SAMPLE SPECIFICATIONS (Specimens obtained may not be used for anything other than the
   approved project without prior consultation and permission from the study-specific EC.)

   To protect the most valuable and irreplaceable specimens in WIHS, Central Repository requests for
   specimens from certain groups of WIHS participants (HIV-seroconverter, ART-naïve HAART initiator, long-term
   non-progressor, elite non-progressor, incident cancer case, etc.) will trigger additional review.

   1. Epidemiologic Specifications

       a. Subgroup:               HIV (+)      HIV (-)       High Risk HIV(-)           Seroconverter
           No./Subgroup           ______       ______            ______            ______

       b. Disease Progression:                  Rapid               Intermediate          Slow
           Immunologically defined             ______                      ______           ______
           Clinically defined                  ______                      ______           ______

       c. Serial specimens with explicitly stated comparisons:

       d. Other:

   2. Sample Type:* ☐ Serum                 ☐ Plasma         ☐ PBMCs (viable)           ☐ PBMC pellet (not viable)
                                  ☐ Cervical Vaginal Lavage**              ☐ B cells        ☐ Host DNA**
                                  ☐ Other (specify):

       * Specimens previously thawed for other initiatives will most likely be shipped. If unacceptable, give a reason below
       for requiring specimens not previously thawed. Leftover material cannot be returned to the National Repository
       without prior approval from study-specific EC.
       ** Available only in the WIHS. If Host DNA is requested, please complete the DNA biorepository sample request
       form and ensure you have addressed all of the WIHS quality control requirements in your concept sheet.

   3. Sample Quantity:       Minimum:

                             Optimum:

   4. Expected number of Person-Visits to be studied:             ______

   5. Expected number of unique participants to be studied:           _____



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MACS/WIHS Concept Sheet                                                          ____________________________
                                                                                                          Lead Investigator

D. STATEMENT OF AGREEMENT

    I hereby acknowledge and agree that:
        ∙   All information that I provide in this Concept Sheet is complete and correct as submitted.
        ∙   Use of specimens and/or data is restricted to the aims outlined in Section B3.
        ∙   IRB approval has been, or will be, obtained before any data and/or specimens are received.
        ∙   I will complete a MACS Data Use Agreement if this proposal receives approval.
        ∙   I will submit a MACS MTA if this proposal receives approval.
        ∙   Under no circumstances will I make the MACS study subject 5 digit ID number public whether in
            documents or presentations, e.g., journal articles, abstracts, oral or poster presentations, or on any
            website.
        ∙   My signature below indicates a complete review, acceptance, and adherence to the Guidelines for
            collaboration, publication, and acknowledgment as outlined in the attached Concept Sheet Appendix:
            Guidelines.

Investigator Signature
                            NOTE: After your Concept Sheet has been submitted electronically, please sign and FAX this signature
                            page and page one of the Concept Sheet to 410-955-7587 for MACS and 410-223-1666 for WIHS.



E. ADDITIONAL SPECIMEN AND DATA REQUIREMENTS
    1. If you are requesting lymphoblastic cell lines, the NIH AIDS Research and Reference Reagent Program
       requires all investigators to be registered prior to receiving samples. Registration materials and
       instructions can be found on the Reagent Program web site located at www.aidsreagent.org
    2. A data file containing lab results and a codebook of specimens received must be submitted to the
       appropriate Data Center (CAMACS or WDMAC) prior to the release of visit data to you for analysis.
       There are absolutely NO EXCEPTIONS to this requirement.


F. MACS-RELATED PROPOSALS ONLY
    1. Use of MACS specimens requires submission of a signed MACS Materials Transfer Agreement.
    2. Conservation of specimens is very important. Please save all leftover samples. Please add 2 columns to
       the data file. The first column should be the number of thaw/freeze cycles. The 2nd column should have
       the amount in µL of specimen used.
    3. Once the specimen is thawed so that samples can be taken for testing, please freeze remaining specimen.
    4. Ship remaining specimens to:

            Kevin Kunstman                                       Phone: (312) 908-2538
            Northwestern University Medical                      Fax: (312) 908-2528
            School
            303 E. Superior
            Lurie 9-220
            Chicago, IL 60611

G. INTERNAL COLLABORATIONS ONLY
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MACS/WIHS Concept Sheet                                                            ____________________________
                                                                                                  Lead Investigator


   1. NEW SUBSTUDIES (detail any anticipated additional participant and MACS/WIHS staff burden (in terms of
        amount of time required, additional visits, specimens to be collected, etc.))


   2. RELEVANCE (to overall MACS and/or WIHS aims and justification for use of MACS/WIHS specimens)


   3. CORE GOALS (Discussion of consistency with MACS/WIHS core goals and scope. Proponents of
      Concepts are encouraged to link with MACS/WIHS investigators to avoid overlap with ongoing
      initiatives. Please review the files listed at http://statepiaps.jhsph.edu/wihs/admin/concept-sheet-
      info/concept-sheet-info.htm to see active concept sheets by research topic in the WIHS.)




H. MACS / WIHS INFORMATION
   1. MACS and/or WIHS Liaison:
   2. Institution:
   3. FAX Number:
   4. E-mail Address:
   5. Mailing Address:

   6. CAMACS / WDMAC Point Person:
      Telephone Number:                               (410) 955-4320
      FAX Number:                                     (410) 955-7587
      Mailing Address:                                Johns Hopkins University
                                                      Bloomberg School of Public Health
                                                      Department of Epidemiology
                                                      615 North Wolfe Street, Room E7644
                                                      Baltimore, MD 21205-1999


NOTE:       Email completed Concept Sheet in a Word, Word Perfect, PDF or RTF file to Joana Roe at NIH
            (jroe@niaid.nih.gov) for MACS and to WDMAC (wdmac@jhsph.edu) for WIHS. If a joint
            collaboration is proposed, the Concept Sheet must be sent to both email addresses.




                                      Please read the Guidelines in the following Appendix ➔




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                                        APPENDIX: Guidelines

A. General Instructions

The MACS/WIHS Collaboration Concept Sheet (CS) is intended for use for all collaborations, whether the
initiative is to combine data from both studies or for just one of the studies. Sections B and C are study-specific
protocols for the concept submission and processing.

                 Intended Study                                    Read Sections
                 MACS                                                 B and D
                 WIHS                                                 C and D
                 MACS and WIHS                                       B, C, and D



B. For research to be performed with the MACS:
    1. Investigators wishing to access MACS data or biologic samples are encouraged to review their proposed
       research with the MACS. If you do not have a MACS liaison, contact the NIH Project Officer, Joana
       Roe at 301-435-3759 or jroe@niaid.nih.gov for possible recommendations. It is recommended that the
       Lead Investigator review the MACS publication policy
       (http://www.statepi.jhsph.edu/macs/MACSpubpolicy.pdf ) prior to CS submission.
    2. Internal MACS investigators: review CS with site PI. External non-MACS investigators: review CS with
       MACS liaison and enter liaison’s contact information on page 7.
    3. Submit completed CS to Joana Roe (see Section D3) at NIAID.
    4. Proposal is assigned to appropriate MACS Working Group for review within 2 weeks. Working Group
       may contact investigator for further clarification or suggestions. The Working Group Chair notifies the
       Executive Committee (EC) of the working group’s approval and/or comments.
    5. MACS EC reviews within 2 weeks of posting, after which time the investigator may be asked to
       participate in a conference call for further clarification.
    6. The investigator will be contacted by the EC Chair with information that the concept was approved,
       approved with comments, tabled for further clarification, needs to be revised and reviewed again, or was
       rejected.
    7. Investigators needing MACS data will need to complete a Data Use Agreement Form and will be
       contacted by CAMACS after the concept sheet has been approved.
    8. After your CS has been approved, please review the MACS publication policy in depth located at
       http://www.statepi.jhsph.edu/macs/MACSpubpolicy.pdf .


C. For research to be performed with the WIHS:
    1. ALL abstracts MUST be submitted to the WIHS EC for review and approval before they are submitted to
       a conference. Also, ALL manuscripts (including site-specific) MUST be submitted to the WIHS EC for
       review and approval before they are submitted to a journal.
    2. Please review the WIHS publication policy in depth after your CS has been approved, located at
       https://statepiaps.jhsph.edu/wihs/Invest-info/WIHS-PubPolicy.pdf
    3. Upon Concept Sheet approval, a WIHS Repository Request Checklist or WIHS DNA Biorepository
       Sample Request Form (available on https://statepiaps.jhsph.edu/wihs/index-invest-info.htm) must be

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      faxed to Christine Alden at 410-955-7587, if specimens are to be requested.

D. For research to be performed with all studies (MACS, WIHS, and MACS/WIHS) :
   1. POLICY ON APPROVED USE OF DATA AND SPECIMENS
      Specimens or data provided by the MACS and WIHS are intended for the express purpose of performing
      EC-approved research. These specimens and data must not be provided to other investigators or used for
      additional projects without the written consent of the MACs and/or WIHS Executive Committee (EC).
      Unauthorized use of data and/or specimens for work not specifically described in the aims of the concept
      sheet will be considered a breach of professional ethics and could result in such actions as withdrawal of
      abstracts or publications, as well as the prohibition of future use of cohort data and specimens.
   2. JOINT CO-AUTHORSHIP
      For joint MACS/WIHS publications, with the first author being a co-investigator of either study, the
      number of coauthors should be: 1 to 3 from the 1st author's center and the analytical
      (CAMACS/WDMAC) center combined; and a total of 2 to 3 from specific study sites combined (e.g.,
      Cole SR [CAMACS/WDMAC], Li R [CAMACS], Anastos K [WIHS], Detels R [MACS], Young M
      [WIHS], Chmiel JS [MACS], Muñoz A [CAMACS/WDMAC]. Stat Med 2003).

   3. MANUSCRIPTS

      ▸   Manuscripts resulting from collaborative studies must be reviewed by MACS and/or WIHS
          investigators who are co-authors. Sufficient time for revision should be allowed before submission
          to a journal. Final revisions also must be available to co-authors for review before resubmission.
      ▸   If data analysis for the manuscript has not been carried out at CAMACS and/or WDMAC, the first
          author of the manuscript is responsible for sending the computer programs, final data sets and
          codebooks that directly relate to tables and figures in the manuscript to CAMACS/WDMAC. The
          programs and data should be labeled table1.dat, table1.sas (if SAS was used), etc. and should be sent
          along with the reprints to Judy Konig at CAMACS/WDMAC. Data received from CAMACS and
          WDMAC may only be used for the specific aims of the approved analysis proposed in this concept.
          Additional research initiatives should be submitted to the EC via completion of a new Collaboration
          Concept Sheet Submission Form.
      ▸   Lead authors should notify CAMACS/WDMAC of any and all manuscripts accepted for publication.
      ▸   Lead authors are responsible for complying with the NIH Public Access Policy, that peer-reviewed
          manuscripts arising from NIH funding and accepted for publication on or after April 7, 2008 are
          deposited in PubMed Central (PMC). The PMCID or NIHMSID should be sent to Judy Konig
          (jkonig@jhsph.edu) at CAMACS and/or Eryka Wentz (ewentz@jhsph.edu) at WDMAC along with
          notification of accepted for publication or actual publication of a manuscript.
      ▸   An electronic copy of all published manuscripts should be sent to Ms. Judy Konig to provide an
          archival record of work resulting from the study. An additional copy should be sent
          electronically to Joana Roe at NIAID for the MACS and the WIHS.

          Joana Roe                                       Judy Konig
          Division of AIDS                                CAMACS / WDMAC
          National Institutes of Health, NIAID            Johns Hopkins University
          Room 4218, MSC 7626                             Bloomberg School of Public Health
          6700-B Rockledge Drive                          615 N. Wolfe Street, Room E7644
          Bethesda, MD 20892-7626                         Baltimore, MD 21205
          (301) 435-3759                                  (410) 955-4320


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   4. ACKNOWLEDGMENT

      All publications and presentations of studies utilizing samples and/or data supplied by the MACS and/or
      WIHS should acknowledge both the contributions of samples and the MACS and/or WIHS collaboration
      itself. The suggested form for acknowledgment is:

       Data in this manuscript were collected by the Multicenter AIDS Cohort Study (MACS) and the Women's
       Interagency HIV Study (WIHS) Collaborative Study Group with centers (Principal Investigators) located
       at:

       MACS centers: The Johns Hopkins Bloomberg School of Public Health (Joseph Margolick); Howard
       Brown Health Center and Northwestern University Medical School (John Phair, Steven Wolinsky);
       University of California, Los Angeles (Roger Detels, Oto Martinez-Maza); University of Pittsburgh
       (Charles Rinaldo); and Data Analysis Center (Lisa Jacobson). The MACS is funded by the National
       Institute of Allergy and Infectious Diseases, with additional supplemental funding from the National Cancer
       Institute; and the National Heart, Lung, and Blood Institute: UO1-AI-35042, UL1-RR025005, UO1-AI-
       35043, UO1-AI-35039, UO1-AI-35040, and UO1-AI-35041.
       WIHS centers: New York City/Bronx Consortium (Kathryn Anastos); Brooklyn, NY (Howard Minkoff);
       Washington DC Metropolitan Consortium (Mary Young); The Connie Wofsy Study Consortium of
       Northern California (Ruth Greenblatt); Los Angeles County/Southern California Consortium (Alexandra
       Levine); Chicago Consortium (Mardge Cohen); Data Analysis Center (Stephen Gange). The WIHS is
       funded by the National Institute of Allergy and Infectious Diseases (U01-AI-35004, UO1-AI-31834, UO1-
       AI-34994, UO1-AI-34989, UO1-AI-34993, and UO1-AI-42590) and by the Eunice Kennedy Shriver
       National Institute of Child Health and Human Development (UO1-HD-32632). The study is co-funded by
       the National Cancer Institute, the National Institute on Drug Abuse, and the National Institute on Deafness
       and Other Communication Disorders. Funding is also provided by the National Center for Research
       Resources (UCSF-CTSI Grant Number UL1 RR024131). The contents of this publication are solely the
       responsibility of the authors and do not necessarily represent the official views of the National Institutes of
       Health.

   5. PROGRESS BEYOND CONCEPT APPROVAL BY THE MACS AND/OR WIHS EC
      ▸   Externally funded investigators utilizing MACS and/or WIHS data are requested to send a copy of
          their annual Progress Report (minus budget information) to the respective study.
      ▸   Investigators who use MACS specimens or data in grant-related projects are requested to send a copy
          of their annual progress report (identifying the lead investigator and title of the original CS) to the
          CAMACS email account: camacsms@jhsph.edu.
      ▸   Investigators who use WIHS specimens or data in grant-related projects are requested to send a copy
          of their annual progress report (identifying the lead investigator and title of the original CS) to the
          WDMAC email account: wdmac@jhsph.edu.


   6. INTERNAL MACS AND/OR WIHS INVESTIGATORS ONLY
      ▸   Upon approval of a concept sheet, authors are expected to uphold the following time frame:
          ∙    Assembly of analytical data set should follow 0.5 to 1 month after receipt of request. A writing
               group will be assembled during this time and the lead investigator will be notified of the
               membership. One of the co-authors will be the designated co-author who should receive copies
               of all drafts and analytic data sets. That author should be prepared to stand in if you are unable to
               complete the work in a timely fashion.
          ∙    Preliminary statistics, data visualization, descriptions, and exploration should be complete 1 to 2
               months after CS approval.


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          ∙   A focused statistical analysis aimed at addressing research questions, including draft of figures
              and tables to be included in the paper, would follow within a month. At this point, co-authors
              should be solicited for input.
          ∙   Two to 3 months after CS approval, reworking of analyses and writing should be in process. The
              analyst will be responsible for helping to draft “Methods and Results” sections of manuscript.
              The lead author and co-authors are responsible for drafting other components. By the end of
              month 3, a fairly complete draft of manuscript should be circulating.
          ∙   Three to 4 months after CS approval the draft should be revised with input from co-authors in
              preparation of the final draft.
          ∙   By end of month 4 there should be a manuscript ready to submit for MACS and/or WIHS EC
              approval and publication.
      ▸   This time frame is dependent on many variables but it is a reasonable target. The clearer the concept
          sheet, the faster the process. Investigators should be willing to be continually engaged with the
          analyst. Lead investigators are expected to keep the CAMACS / WDMAC Point Person apprised of
          any delays in testing, analysis, writing, and manuscript submission.
      ▸   Your submission indicates that you agree with all the information on the previous pages (Internal
          Investigators only) and that you have received local IRB approval for testing to be performed at the
          time samples are requested from the repository. Both the MACS and WIHS EC will review your CS
          for MACS/WIHS collaborative studies. Study-specific collaborations will be reviewed by that study
          EC. You will be notified of the status of your CS via email after your CS has been approved,
          approved with comment, revision requested or rejected. Additionally, approved CS will be assigned
          a project number: rYY## (MACS) and/or wYY### (WIHS), where YY = year. You should use these
          project #s in all correspondence up to and including publication.




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