THE CORONARY ARTERY RISK DEVELOPMENT IN YOUNG by yUSU23

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									                                                          SECTION 9
XVI.               THE CORONARY ARTERY RISK DEVELOPMENT IN YOUNG
                                ADULTS (CARDIA) STUDY
                             DATA ANALYSIS AND PUBLICATIONS POLICIES


I.       Overview ....................................................................................................................... 1
*II.     Documents and Forms Access via CARDIA Public Web site ....................................... 2
III.     Publications and Presentations (P&P) Committee ........................................................ 3
         A. Role of P&P Committee ............................................................................................ 3
         B. Composition of P&P Committee ............................................................................... 3
         C. P&P Committee Meetings ......................................................................................... 3
IV.      Proposing Manuscripts and Abstracts (Mainstream and Ancillary Study) ..................... 4
*        A. Early Career /Junior Investigators ........................................................................... 4
*        B. Steering Committee approved CARDIA Investigators ............................................. 4
         C. Timeframe for Submitting Manuscript Proposals and Abstracts to P&P .................. 5
         D. Ancillary Study Manuscript Proposals ..................................................................... 5
*        E. Genetic Consortia Manuscript Proposals ................................................................ 5
         F. Abstract Format ....................................................................................................... 6
*V.      Distributed Materials and Data Agreement ................................................................... 6
*VI.     Confidentiality Certification (C-Cert) Form .................................................................... 6
*VII.    Data Set Request and Notice of Intent to Analyze Form .............................................. 6
*VIII. Analytic Data Set Requests .......................................................................................... 7
*        A. Original data requests ............................................................................................. 7
*        B. Two Types of Additional Data Set Requests ........................................................... 7
              1. Additional data requests for data approved in manuscript proposal ................. 7
*             2. Additional requests for data "NOT" approved in manuscript proposal .............. 8
*        C. Communications with Collaborating CARDIA Investigator ...................................... 8
         D. Secondary Data Analyses ....................................................................................... 8
IX.      Submission of Abstracts/Manuscripts ........................................................................... 8
X.       Authorship..................................................................................................................... 8
         A. First Authorship ....................................................................................................... 8
         B. Co-Authorship ......................................................................................................... 9
XI.      Three Manuscript Limit for First Authors ..................................................................... 10
*XII.    Nine-Author Rule ........................................................................................................ 10
CARDIA Data Analysis & Publications and Presentations Policies                                             Revised 2011-08-26
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                                                             SECTION 9
XIII.    Manuscript Completion Process ................................................................................. 10
         A. Timeline for Manuscript Completion and High Priority Manuscripts ............................ 11
         B. Expectation from Co-authors ................................................................................. 11
*        C. Declaration of Dormant and Withdrawn Manuscripts ............................................ 11
*        D. Designation of a Manuscript as High Priority ......................................................... 12
*             1. High Priority Timelines ..................................................................................... 12
*             2. Operational Implication of High Priority Designation ........................................ 12
         E. Manuscript Initiation and Completion Process ....................................................... 12
         F. Notifying the CC of all Journal Submissions ......................................................... 14
         G. Entities Involved in P&P Review/Approval Process ............................................... 16
         H. Responsibilities of Entities Involved in the P&P Process ........................................ 17
*XIV. Verification Process .................................................................................................... 18
*        A. Data Set Verification .............................................................................................. 18
         B. Re-Verification and Re-review of a Manuscript ..................................................... 18
XV.      P&P Committee Review of Manuscripts (mainstream and ancillary) .......................... 20
         A. Assignment of Chief Reviewer .............................................................................. 20
*        B. Assignment of Statistical Reviewer........................................................................ 21
         C. Statement of Authors Form ................................................................................... 21
XVI.     NHLBI Review for Abstracts and Manuscripts ............................................................ 22
         Requests for NHLBI Review use Email address: ebpdocs@nhlbi.nih.gov
XVII. Acknowledgment of NHLBI Role and CARDIA review ................................................ 23
XVIII. NIH Public Access Policy ............................................................................................ 24
XIX.     Other Publication Policies and Considerations .................................................................. 24
         A. Causality Statement .............................................................................................................. 24
         B. Industry Funding .................................................................................................... 25
         C. Graduate Student Dissertation .............................................................................. 25
         D. Data Distribution Policy and Agreement in Relation to Student Dissertations ....... 26
XX.      Review Process for Abstracts and Presentations ....................................................... 26
XXI.     Invited Manuscripts and Presentations ....................................................................... 26
Appendix 1: Manuscript Proposal Form ................................................................................ 1-2
Appendix 2: Verification Instructions .................................................................................. 3-13



CARDIA Data Analysis & Publications and Presentations Policies                                                  Revised 2011-08-26
S:\swap\cardia\pubs\policies\CARDIA Pubs Policy-revision                                                        * = Revisions
I.      Overview
        The Coronary Artery Risk Development in Young Adults (CARDIA) Study is a
longitudinal epidemiologic study of an initial cohort of 5115 participants from four clinical
centers. As a multi-center study, it involves Investigators from each of the clinical centers, the
National Heart, Lung, and Blood Institute (NHLBI) which is the funding agency, the CARDIA
Coordinating Center, and several consultants to the study. Each of the clinical centers, the
Coordinating Center, the NHLBI, and the chair of the CARDIA Steering Committee has
complete copies of the CARDIA data set. The official CARDIA data set is maintained at the
Coordinating Center.
        CARDIA requests that individuals working on projects involving CARDIA data work
closely with at least one of the CARDIA Investigators and follow the policies of the study. This
is to ensure that you have access to all information pertinent to your analysis venture. This
important information includes the documentation notebook which is distributed by the
Coordinating Center with the data; this notebook gives detailed information on the data set
including the edits which have been performed, any problems in the data set, and lists of
calculated variables and their algorithms. This documentation also includes the distributed
data forms that are used in the research process by the Investigators. We also encourage
you to obtain access to the manual of operations that describes the data collection process
and quality control procedures used by the study.
        CARDIA has implemented policies involving the use of its data, (1) to ensure that
Investigators know of ongoing research efforts and have the opportunity to participate in the
efforts if they so desire; (2) to ensure that duplication of analyses is kept to a minimum; (3) to
permit the Coordinating Center to maintain control of the official CARDIA data base includes
being informed of any problem areas in the data base; (4) to ensure that publication or
presentation of CARDIA data does not occur without the knowledge and approval of the
CARDIA P&P Committee and endorsement of the Steering Committee; and (5) to maintain
the integrity of study data longitudinally.
        The CARDIA Steering Committee has final say over all CARDIA publications and
presentations. In 1990 the CARDIA Steering Committee initiated a set of policies to
encourage the timely completion of manuscripts in the study and to recommend guidelines
for the effective functioning of writing groups. In 1996, The Steering Committee empanelled a
Publications Planning Committee to deal with long-range planning issues. Acknowledging the
continued growth of the study and the increasing scope and complexity of the scientific

CARDIA Data Analysis & Publications and Presentations Policies   *=Revisions                         1
collaborations that use CARDIA data, the CARDIA P&P Committee was created in October,
2003.




II.     *Documents Access via CARDIA Public Web site
        An advantageous change has occurred for the CARDIA Study in the Publications
Arena. This process will assist with expediting publications by having the necessary
documents and forms readily available to Investigators.
        Investigators may access the documents and forms noted in this policy at any time
from the CARDIA Public Web site at: http://www.cardia.dopm.uab.edu/publications.htm.
Once the web page is accessed, select the tab: Publications Documents. All posted
documents are word files and may be downloaded, completed and e-mailed to the CC for
processing.
      Direct these documents and forms to mgray@dopm.uab.edu and
lsellers@dopm.uab.edu. The documents and forms posted to CARDIA Public Web site are
as follows:

A.      CARDIA Data Analysis and Publications Policies

B.      Manuscript Proposal Form

C.      Confidentiality Certification Form

D.      Data and Materials Distribution Agreement

E.      How to Complete a Data and Materials Distribution Agreement for Publications (Writing
        Projects)

F.      Data Set Request & Notice of Intent to Analyze

G.      Manuscript Submission Instructions – to Publications & Presentations Committee

H.      Chief Reviewer’s Role

I.      Statement of Author’s Form

J.      Verification Submission Instructions

K.      CARDIA Investigators for Ancillary Studies and Publications_Areas of Interest

L.      CARDIA NHLBI Repository Data Set Slide with NHLBI E-mail Address

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M.      NHLBI Address for Submitting Abstracts and Manuscripts




CARDIA Data Analysis & Publications and Presentations Policies   *=Revisions   3
III.      P&P Committee
          The success of the CARDIA Study will be judged largely on the number and quality of
its scientific publications and presentations. The purpose of the policies established herein is
to encourage and facilitate important analyses while providing guidelines that assure
appropriate use of the CARDIA data, timely completion of projects, and adherence to the
principles of authorship.


A.        Role of the P&P Committee
          The P&P Committee oversees all CARDIA P&P activities, with final adjudication of
decisions by the Steering Committee. The P&P Committee approves the proposal of
publications and the submission of abstracts; as well as before they are submitted for
publication or presented in a public forum. The P&P Committee submits its decisions to the
Steering Committee for approval at the Steering Committee meeting that follows the P& P
Committee meeting, usually within one week of the P&P Committee meeting. Appeals of
P&P Committee decisions may be made to the Steering Committee. However, the
expectation is that only occasionally will decisions made by the P&P committee be discussed
at Steering Committee meetings in detail. Such occasions might be an appeal or another
exceptional circumstance.
       The P&P Committee may decide who assumes first responsibility for a manuscript if there
is more than one interested candidate. The P&P Committee also may re-assign first
responsibility if reasonable progress on completing an abstract or manuscript has not
occurred.


B.        Composition of P&P Committee
          The P&P Committee consists of one representative from each of the four CARDIA
Field Centers, one representative from the Coordinating Center, one representative from the
NHLBI Project Office, and the Chair of the Steering Committee. A Chair and Co-Chair for the
P&P Committee will be designated from the P&P Committee membership by the Steering
Committee. An additional member of the P&P Committee who is a CARDIA investigator and
a biostatistician will be added to the P&P Committee by the Steering Committee, if the seven
members of the P&P Committee do not include at least one biostatistician.


C.        P&P Committee Meetings

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        The P&P Committee meets on a biweekly basis by conference call, preferably during
weeks that alternate with standing Steering Committee calls. Decisions requiring a vote
will be made during these calls only by P&P Committee members. However, all Steering
Committee members are invited to attend. First authors of manuscripts, proposals, abstracts,
or presentations that are to be discussed during a P&P Committee call are invited to either
attend themselves or send a representative. Steering Committee members who are not
designated members of the P&P committee are welcome to contribute to deliberations of the
committee. It is expected that the great majority of discussion of manuscripts will be during the P&P
meeting, rather than the subsequent Steering Committee meeting. Thus, Steering Committee members
with a special interest in a given manuscript should attend the corresponding P&P meeting.
Coordinating Center staff (the Publications Coordinator or delegate) will arrange the calls and
take minutes, to be forwarded to the Steering Committee.


IV.     Proposing Manuscripts and Abstracts
        Manuscript proposals and abstracts may be initiated by any investigator, who is listed
as one of the authors on the proposal/abstract. CARDIA investigators include Principal
Investigators and Co-Investigators at any field center and the Coordinating Center,
participating NHLBI staff, CARDIA subcontractors and Investigators which have been
approved by the Steering Committee as CARDIA Investigators who may represent the Study
on manuscripts, abstracts and Ancillary Studies.


*A.     Early Career / Junior Investigators may initiate manuscript proposals and abstracts
with the collaboration of at least one CARDIA Investigator from the Steering Committee
approved CARDIA Investigator list posted on the CARDIA Public Web site,
http://www.cardia.dopm.uab.edu/publications.htm; see Section II for details on how to
access this document.)


*B.     Steering Committee approved CARDIA Investigators
        The CARDIA Study requires that all manuscripts or abstracts have participating
Steering Committee approved CARDIA Investigators serving as authors on the writing group.
        CARDIA values collegiality and across center collaborations very highly. In this spirit, it
is strongly recommended that co-authors from more than one center be included in each
Abstract or manuscript proposal. We also encourage that the number of authors be kept at 4

CARDIA Data Analysis & Publications and Presentations Policies   *=Revisions                            5
to 5 at time of submission of a manuscript proposal to the P&P committee. The purpose of
this is to allow additional CARDIA authors to join the writing group at the time of manuscript
proposal approval by the P&P committee. We recognize that occasionally it is not possible to
adhere to these recommendations. When this is the case, please include in the manuscript
proposal an explanation of why there are more than 4 to 5 authors or why all authors are from
the same Center.
C.      Timeframe for submitting manuscript proposals and abstracts to P&P
        After review by all initially named co-authors, manuscript proposals and abstracts
should be submitted to the P&P Committee one week prior to the regular biweekly P&P
Committee conference call. Abstracts should be submitted to the P&P Committee for
approval to assure that the Committee can discuss it on a conference call at least two weeks
prior to the deadline for submission. Investigators are encouraged to conduct limited
preliminary data analyses prior to submitting a formal manuscript proposal to test the
feasibility of pursuing a given topic. Each abstract must include a CARDIA investigator, as
designated by the Steering Committee.


D.      Ancillary Study Manuscript Proposals
        The CARDIA Steering Committee requires that ancillary study manuscripts follow the
same policies as the core study.

*E.     Genetic Consortia Manuscript Proposals
        CARDIA Study policy for involvement in and approval of presentations and publications arising from
genetics consortia that include data from CARDIA participants.
        For those consortia including CARDIA participation that have a Publications Committee or other entity
with the mandate to approve publication and presentation related activities based in part on data from CARDIA
participants, then the CARDIA Study delegates the approval for such manuscript proposals, abstracts,
presentations, and manuscripts that include CARDIA data to the Consortium Publications Committee or other
entity with this mandate, provided there is a CARDIA representative on this committee and this representative
approves the publication item. If the CARDIA representative does not agree with the publication item, the
Consortium will be so advised, and the CARDIA representative is to submit the item to the CARDIA P&P
Committee for review and approval. The expectation is that Consortium approval will thus be pending until the
item is processed by the CARDIA P&P Committee. Further, CARDIA policy also requires that all proposals,
abstracts, presentations, and manuscripts involving CARDIA data and approved by the Consortium will be
forwarded to the CARDIA P&P committee as an information item upon approval by the Consortium.


CARDIA Data Analysis & Publications and Presentations Policies   *=Revisions                                    6
        If the consortium does not have a Publications Committee or similar entity, then the expectation is that
there would be a writing group that would include a CARDIA representative if the results to be included are
based in any part on data from CARDIA participants. In this case, this representative would serve as a co-
author for the publication entity and the CARDIA Study would delegate approval to this representative. If this
representative does not approve, then the other members of the writing group will be so advised, and the
CARDIA representative is to submit the item to the CARDIA P&P Committee for review and approval. The
expectation is that approval will thus be pending until the item is processed by the CARDIA P&P Committee.
        Additional information on submitting manuscript proposals is in Section XI.
F.      Abstract Format
        The CARDIA Steering Committee strongly encourages the use of a structured abstract
format, even when this is not required by the meeting at which the abstract is to be
presented. We suggest that, at a minimum, each abstract should be written in four sections,
with the headings of Background/Objectives, Methods, Results, and Conclusions.
        We further suggest that, even if a journal does not require it, abstracts for completed
manuscripts also be presented in a structured format. In addition, we strongly recommend
that abstracts for completed manuscripts not exceed 250 words. MedLine will only accept
250 words in abstracts for published manuscripts, the text after 250 words will be omitted.

*V.     Distributed Materials and Data Agreement
        After a manuscript proposal or abstract is approved, the investigator(s) collaborating
with the CARDIA Study and/or investigators must review the CARDIA Distributed Materials
and Data Agreement (DMDA), complete and sign the DMDA and submit to the CC. An
analytic data set will not be released if the DMDA is not on file at the CC. The DMDA is
posted to the CARDIA Public Web site:
http://www.cardia.dopm.uab.edu/publications.htm


*VI.    Confidentiality Certification (C-Cert) Form
        This form is signed by the first author and the PI of the CARDIA Center for which the
first author is affiliated. If the Investigator is not affiliated with a CARDIA Center and plans to
request analytic data sets from the CC, the PI of the CC will sign the C-Cert as the Center PI.
The signed C-Cert should be submitted to the CC. If the CC PI should sign as the Center PI,
the CC will obtain this signature for the first author, file the C-Cert at the CC and e-mail the
signed C-Cert to the first author for their files. An analytic data set will not be released to the
first author if the completed C-Cert is not on file at the CC.

CARDIA Data Analysis & Publications and Presentations Policies     *=Revisions                                     7
*VII. Data Set Request and Notice of Intent to Analyze Form
       The investigator must complete a Data Set Request (DSR) and Notice of Intent to
Analyze form and Confidentiality Certification (C-Cert) to accompany the DMDA. The CC
will prepare an analytic dataset which will be sent to requesting investigator(s) or data
center(s). The CC will not release an analytic data set if the DMDA and DSR are not on file
at the CC. The DSR is posted to the Public Web site:
http://www.cardia.dopm.uab.edu/publications.htm
       The instructions, which is also a checklist for the DSR, (page one of the DSR), should
be reviewed, completed and returned to the CC with the DSR form (page 2) when the data
request is submitted. Following the instructions on the DSR and including all requested
materials will expedite the processing of your request.


*VIII. Analytic Data Set Requests


*A.    Original Data Requests
       The investigator must complete a Data Set Request (DSR) and Notice of Intent to
Analyze form and C-Cert to accompany the DMDA. The CC will prepare an analytic dataset
that will be sent to requesting investigator(s) or data center(s). The CC will not release an
analytic data set if the DSR is not on file at the CC.

*B.    Two Types of Additional Analytic Data Set Requests


       1. Additional data requests for data approved in manuscript proposal
          In addition to the original data set request for a specific manuscript, the first author
       may request additional data sets by completing a DSR, a memo (or e-mail) which
       describes the nature of the request, the original manuscript proposal and submit these
       to the CC. This request will be processed and submitted to the statistical unit. The
       CC will prepare an analytic data set that will be sent to requesting investigator(s) or
       data center(s).


       2. Additional requests for data "NOT" approved in manuscript proposal
          The first author may request data that was not included in the original manuscript proposal
      by submitting a completed DSR, a memo (or e-mail) which describes the nature of the request,
CARDIA Data Analysis & Publications and Presentations Policies *=Revisions                         8
        and the original manuscript proposal to the CC. The data set request is reviewed for approved
        by the P&P Committee via e-mail with a 3-day response default for P&P Members to the CC.
        After the 3-day period, the CC will complete the processing of the request by submitting it to
        the statistical unit for release of the data set. If the request is denied by P&P, the first author
        will be notified and given the opportunity to join a P&P call to discuss the decision.
        Occasionally, a data set request will be reviewed on a P&P Call. The first author or
        representative must be present on the call on which the request is considered.




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*C.     Communications with Collaborating CARDIA Investigator
        All first authors are encouraged to communicate with their collaborating CARDIA Investigator
when preparing the original data request and to consider requesting ALL data that may be useful to the
writing project in the original request.
        It is explicitly important for the New / Early Career Investigators to become fully apprised of
the CARDIA policies and available data. The communications with CARDIA Investigators will
provide valuable information in the early stages of their writing projects and assist with expediting the
completion of these projects.


*D.     Secondary Data Analysis
        Secondary analyses are defined as analyses using pre-existing CARDIA data, i.e., no additional
data are to be collected for the purposes of the study or manuscript(s). Investigators interested in
submitting a grant application for the purpose of obtaining funds to perform analyses should submit a
manuscript proposal (or proposals), a summary of the grant proposal and the intent of the overall
analyses to the P&P Committee for approval prior to the grant submission. If an investigator's student
will be using data from their specific ancillary study, a statement that the student will be mentored by
the investigator should be included.


IX.     Submission of Abstracts/Manuscripts
        *Each Principal Investigator has the right to publish data from his/her own clinic population
after approval of the P&P Committee and the approval is endorsed by the Steering Committee. Local
data presentations and publications will be limited to those data already presented from study-wide
results. See Section “XX. Review of Abstracts and Presentations” for guidelines on P&P Committee
review/approval of a presentation (page 26).”


X.      Authorship
A.      First Authorship
        The initiator generally assumes first authorship of the proposed manuscript. The
initiator is encouraged to contact other potentially interested individuals before the manuscript
or abstract is proposed. At the time of proposal, individuals at each of the clinical centers, the
Coordinating Center and the Project Office are given the opportunity to be co-authors. The
first author is encouraged to involve individuals with specific expertise or experience as



CARDIA Data Analysis & Publications and Presentations Policies   *=Revisions                               10
necessary. Each manuscript must include a CARDIA investigator, as designated by the
Steering Committee.
*         All first authors are encouraged to communicate with their collaborating CARDIA Investigator
on a regular basis throughout the writing of their manuscript. It is explicitly important for the New /
Early Career Investigators to become fully apprised of the CARDIA policies and available data. The
communications with CARDIA Investigators will provide valuable information in the early stages of
their writing projects and assist with expediting the completion of these projects.

B.        Co-Authorship – Dr. Kiefe: should this section be rewritten?
          The criteria for authorship will be those of the International Committee of Medical Journal
Editors (ICMJE, the "Vancouver Group"). [1] These criteria are similar to those of other major
organizations concerned with authorship, especially those written recently. Excerpts of these criteria
follow.
     “All persons designated as authors should qualify for authorship, and all those who qualify should
be listed. Each author should have participated sufficiently in the work to take public responsibility
for appropriate portions of the content. One or more authors should take responsibility for the
Integrity of the work as a whole, from inception to published article. Authorship credit should be
based only on the following:
     1) Substantial contributions to conception and design, or acquisition of data, or analysis and
interpretation of data,
     2) Drafting the article or revising it critically for important intellectual content, and
     3) Final approval of the version to be published
     Conditions 1, 2, and 3 must all be met. Acquisition of funding, the collection of data, or general
supervision of the research group, by themselves, do not justify authorship.” Co-authors should
become involved in manuscript development as early as possible.
     The first author should seek involvement by soliciting help early on, e.g., by circulating to co-
authors a manuscript outline with some table shells and/or a request for suggestions of additional table
and figure shells. Early drafts should be circulated to all co-authors, with a deadline for responses.
     Though the time allowed for co-author response will vary, it is suggested that two weeks is a
reasonable interval. The first author is expected to play a pro-active role in seeking co-author
involvement and in taking action if this involvement is not forthcoming. If during the completion of
the manuscript or presentation it becomes apparent that the contributions of one or more co-authors do
not merit authorship, the first author should discuss the possibility of removing the names of
individuals from the manuscript with the co-authors.
CARDIA Data Analysis & Publications and Presentations Policies    *=Revisions                             11
      Failure to respond in a timely manner to a request for comments, especially if unexplained or
repeated, should be grounds for considering the removal of a co-author. In addition, each co-author
should critically examine his/her role in the process and volunteer to remove his/her name, if
warranted. The first author should attempt to reconcile divergent views of the co-authors with his/her
own. However, sometimes a co-author may elect to remove his/her name because of disagreements in
the interpretation of the data or in the style of writing, even though substantial contributions were
made. [1] http://www.icmje.org


XI.      Three Manuscript Limit for First Authors
         Investigators are limited to first authorship on no more than three manuscripts in
progress (prior to submission to a journal). Exemptions from this policy may be made by the
P&P Committee and endorsed by the Steering Committee in the case of demonstrated
productivity of the investigator, invited manuscripts, or other special circumstances.


*XII. Nine-Author Rule – Dr. Kiefe to revise.
         Some medical journals, such as the Journal of the American Medical Association
(JAMA), limit the number of authors on a manuscript to six, and The National Library of
Medicine's online reference service includes only six names. Moreover, it is difficult to work
on a writing project with more than six people. Thus, CARDIA has established the policy of
attempting to limit the number of authors on a manuscript or presentation to no more than
nine. Exceptions to this rule are allowed in the case of manuscripts that legitimately require
additional expertise or mainstream results manuscripts that require the input and
acknowledgment of many Investigators. The New England Journal of Medicine allows 12
authors in a multi-center study, while Annals of Internal Medicine allows a maximum of 10
authors. Also, note that in Item III we encourage manuscript proposals to have no more that 4
authors at the time of submission of the proposal to the P&P committee. Again, the purpose
is to leave "room" for additional authors to join at the time of proposal approval, and thus
promote across-site collaborations.


XIII. Manuscript Completion and High Priority Manuscripts
         As for other multi-center studies, important CARDIA manuscripts must be written in a timely
fashion, yet most CARDIA Investigators are over-extended, budgets do not allow for adequate time for
manuscript preparation, and manuscripts may not be completed in an expeditious manner. This part of

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the CARDIA publications policies represents an effort to address this issue. Its purpose is to establish
procedures that will facilitate the timely completion of CARDIA manuscripts, with special emphasis
on high priority manuscripts.


A.      Timeline for manuscript completion
        A proposed timeline for completion is part of each CARDIA Manuscript Proposal (see
Appendix 1 for Manuscript Proposal Form and Instructions on submitting the proposal to the P&P
Committee). At the time of proposal approval, the P&P Committee approves the manuscript proposal
conditional on adherence to the timeline. It is the first author’s responsibility to oversee timeline
adherence. Non-adherence to timeline has specific implications if a manuscript has been designated as
high priority.
        Soon after the proposal is approved by P&P (we recommend no more than one month), the first
author should coordinate a conference call with all co-authors. At this time, the manuscript’s timeline
should be refined, and co-authorship expectations clarified. The goal for this call should be to provide
the first set of shell tables to the analyst(s).


B.      Expectation from co-authors:
        Frequently, a manuscript lingers because all co-authors do not respond to a draft in timely
fashion. Co-authors are expected to respond to any request from the first author regarding a manuscript
in progress within one week, preferably less, either by providing feedback or declaring that they will
be unable provide feedback at this time. Declaring one’s inability to respond to a single request does
not eliminate one from the co-authorship list. However, once the manuscript is ready to be submitted to
the P&P committee for approval, both first and co-authors should to ensure that each listed author has
satisfied scientific requirements for co-authorship, as outlined in “XIII. Manuscript Completion
Process” on page 10. For example, if a co-author has never provided input, in spite of repeated
requests from the first author, then the first author should drop the co-author form the authorship list
before sending the final draft to P&P.


*C.     Declaration of Dormant and withdrawn manuscripts
        The CARDIA Coordinating Center contacts the first authors of all manuscripts in progress at
least twice a year, to request an update on the status of the manuscript.
        If a first author does not respond to this request, he/she is re-contacted within a month, with a
warning that lack of response will result in the manuscript being classified as “dormant”. If the first

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author of a “dormant” manuscript does not respond to the status update request at the next semi-annual
contact, the P&P committee will review the authorship list and either reassigns first authorship to
another member of the writing group, who commits to expediting the writing of the manuscript, or
declares the manuscript “withdrawn”.
        Withdrawn status means that any other CARDIA investigator may propose to write this
manuscript or another one that seriously overlaps with it.

*D.     Designation of a Manuscript as High Priority
        The P&P Committee will review the list of all in progress manuscripts, at least biannually, with
special attention to high priority classification. Criteria for classifying a manuscript as high priority
include: 1) Scientific importance of potential findings, 2) Potential impact of publication on the future
of CARDIA, 3) Potential for high visibility in wide circulation scientific journals, and 4) Urgency in
making findings available to scientific community and/or public.


        *1. High Priority Timelines
              High priority manuscripts will be scrutinized closely at least biannually by the P&P
        committee regarding timeline adherence. If approval of the completed manuscript by the P&P
        committee is not obtained within three months of the initially approved timeline, the P&P
        committee will request a new timeline from the first author, which will be subject to P&P
        approval. If the first author and the P&P committee cannot agree on a new timeline, or if the
        new timeline is not adhered to either, the P&P committee will ask the first author to select
        another first author from the initial writing group, who will commit to an acceptable new
        timeline. Should no member of the initial writing group be willing to make this commitment,
        the P&P committee may select a new author to first the manuscript to completion in a timely
        fashion.


        *2.      Operational Implication of High Priority Designation
                 A high priority manuscript will receive priority by the Coordinating Center in the
        preparation of analytic data sets and data verification. High priority manuscripts will be
        scrutinized closely in terms of timeline adherence, as above.


*E.     Manuscript Initiation and Completion Process
        In general, manuscripts are initiated and completed as described below:


CARDIA Data Analysis & Publications and Presentations Policies   *=Revisions                                14
        1.   Investigator submits a manuscript proposal (one to two pages) for review by the
             P&P Committee.
             *The Manuscript Proposal form is attached to these policies as Appendix 1. The
        P&P Committee advises that all information requested on the Manuscript Proposal
        form be provided at the time of submission for review/approval.
             The proposal should include:
                  a.    Title and Abbreviated Title
                 *b.    Data to be used in analysis (Core, Ancillary or Both) and Ancillary Study
                        title
                 *c.    Keywords (must be included on proposal)
                 *d.    Identify exam years of the data to be used in proposal
                  e.    Writing group (list "first author" with lead responsibility first)
                  f.    List co-authors names
                 *g.    List co-authors names and complete contact information, including e-mail
                        addresses on page 2 (add additional pages, if necessary)

                 *h.    Representative (contact person): (person who will represent the paper or
                        serve as the contact person other than first author)

                  i.    Scientific background and rationale
                 *j.    Main study research questions and hypotheses
                 *k.    CARDIA data to be used (Required: CARDIA Exam year(s);
                        Recommended: variable types, names CARDIA source form)
                 *l.    Analytic plan (brief description of methods of analysis)
                 *m. Timeline

    2. Once the proposal is approved by the P&P Committee, the initiating author, in
    conjunction with the selected CARDIA Investigator and co-authors, should agree upon
    assignments for research, analysis and writing, as appropriate. If not included in sufficient
    detail in the proposal, the first author should work with their CARDIA Investigator and
    circulate a detailed plan for data analysis among the co-authors and solicit their input.
        *All first authors are encouraged to communicate with their collaborating CARDIA
    Investigator on a regular basis throughout the writing of their manuscript. It is explicitly important
    for the New / Early Career Investigators to become fully apprised of the CARDIA policies and
    available data. The communications with CARDIA Investigators will provide valuable

CARDIA Data Analysis & Publications and Presentations Policies   *=Revisions                            15
    information in the early stages of their writing projects and assist with expediting the completion of
    these projects.


    3. Early in the process, there should be at least one communication (phone, E-mail or
    regular mail) between the first author(s) and each co-author about research strategy;
    additional communications will be necessary. Response to communications from any
    author should be as quick as possible, typically less than two weeks. An e-mail response
    the same day is desirable, given the critical nature of collaborative feedback in the
    manuscript writing process. Failure to participate collaboratively may be taken by the first
    author(s) as a signal that the co-author no longer wishes to participate in the manuscript.
    4. Each stage of the manuscript writing process is monitored by the P&P Committee
    Chair, Co-Chair and the Publications Coordinator. The first author is encouraged to keep
    the Publications Coordinator informed of the manuscripts’ progress. Chronic failure to
    advance in the writing of a manuscript may result in the reassignment of the topic to
    another investigator.

    5. In the cover memo accompanying a manuscript draft, first authors should provide a
    time line to co-authors for returning the draft. The first authors may clearly state that the
    co-author will be removed from the manuscript if a response is not received by the
    specified date. Removal of a co-author will be at the discretion of the first author and not a
    requirement of the publication policies. However, the Publications & Presentations

    Committee, and endorsed by the Steering Committee, strongly encourages adherence to

    reasonable timelines.

    *6. The final version of the manuscript is submitted for review/approval by the P&P
    Committee (and NHLBI if a co-author is a staff member of NHLBI) prior to submission to a
    journal for publication. All co-authors must be willing to take public responsibility for the
    manuscript as submitted to the Publications & Presentations Committee, as is implied by
    signing the Statement of Authors form. See section XI. Publications & Presentations
    Committee Review for Manuscripts

    7. Authors should keep the Publications Coordinator informed of authorship
    additions/deletions, journal submission(s), (dates and journal name), results of reviews
    (acceptance, rejection or request for revision) and final acceptance by journal.
CARDIA Data Analysis & Publications and Presentations Policies   *=Revisions                            16
F. Notifying the CC of all Journal Submissions and Copies of Journal Submissions


Dr. Kiefe: Could we ask for an e-mail when the manuscript is submitted or resubmitted to a
Journal & the specific journal?
    Simultaneously with the submission of a manuscript to a journal (whether it be the first,
second, third, etc. submittal), the first author will send a copy of the submitted version as well
as a copy of the cover letter to the Publications Coordinator at the Coordinating Center. This
will allow the Coordinating Center to have on file the final copy of all submissions whether
accepted, rejected, or under revision and also to compile data on journal responses to
CARDIA manuscripts.
    If there are substantial changes to an approved manuscript prior to publication, whether
required by the journal or not, these changes must be discussed with the co-authors. Co-
authors should receive proposed re-submissions at least one week prior to journal re-
submission. Occasionally, a re-verification of a manuscript is necessary. Section XIV “Re-
verification of a manuscript”, Item B, page 18.




CARDIA Data Analysis & Publications and Presentations Policies   *=Revisions                     17
G.        Entities involved in the Publications and Presentations approval process

  Table 1. Entities involved in the P&P approval process with timing of approval, CARDIA
  Study
                         Manuscript
                                            Abstract         Presentation      Manuscript
                          Proposal
     Co-author                    1                     1                  1                    1
     Chief reviewer              N/A                   N/A               N/A                    2
     P&P Committee                2                     2                  2                    2
     NHLBI                       N/A                    3                N/A                    3

     1-    Approval required prior to date of scheduled P&P Committee discussion.

     2-    Approval required at time of P&P Committee discussion or subsequently, but prior to
           manuscript or abstract submission to journal or meeting, and prior to presentation.
           P&P Committee rarely delegates approval to chief reviewer or an ad hoc committee.

     3-    Review required at time of P&P Committee discussion or subsequently, but prior to
           manuscript or abstract submission to journal or meeting and prior to presentation.

     N/A- Not applicable

     NOTE: Approval of a manuscript proposal is not required prior to approval of an
           abstract/presentation.




CARDIA Data Analysis & Publications and Presentations Policies   *=Revisions                        18
H.       Responsibilities of Entities Involved in the Publications and Presentations Process

  Table 2. Responsibilities of entities involved in the P&P process, CARDIA Study
                                 Manuscript           Abstract      Presentation  Manuscript
                                     Proposal
     First author                        1,2                 1,2                   1,2    1,2
     Co-author                          3,4,5               3,4,5              3,4,5     3,4,5
     Chief reviewer                     N/A                 N/A                    N/A    6,7
     P&P Committee                       8,9                 8,9                   8,9    8,9
     NHLBI                              N/A                  14                    N/A    14
     CoC pubs coordinator                12                  12                    12    11,12
     PI of originating center             4                      4                  4     4
     CoC analysts                       N/A                 N/A                    N/A    13

  1 - First proposal/analyses/writing efforts, keeps co-authors informed and active as
  necessary.
  2 - Assures required approvals obtained.
  3 - Participates significantly in all scientific efforts.
  4 - Approves before submission to P&P Committee.
  5 - Is informed of minor changes and approves major changes after P&P Committee
  decision.
  6 - Approves final version of manuscript before submission to journal.
  7 - Provides feedback to first author, summarizes all comments in writing, makes
       recommendations to P&P Committee.
  8 - Approves manuscript proposal. Approves manuscript prior to journal submission or
       delegates this authority to chief reviewer. Approves abstract prior to submission or
       presentation prior to meeting or delegate responsibility to an appointed ad hoc
       committee.
  9 - Gives feedback to first author and chief reviewer prior to P&P Committee discussion.
  10 - Assigns chief reviewer.
  11 - Assures that all co-authors have approved manuscript in writing prior to Steering
       Committee submission.
  12 - Maintains data base and filing system, communicates with first authors regarding
       status of all publication items.
  13 - Verify results presented in manuscript prior to submission to journal.
  14 - Approves manuscript prior to journal submission or delegates this authority to chief
       reviewer. Approves abstract prior to submission or presentation prior to meeting or
       delegate responsibility to an appointed ad hoc committee.

  N/A- Not Applicable




CARDIA Data Analysis & Publications and Presentations Policies       *=Revisions                 19
XIV.   Verification Process
       When designing the distributed data analysis system, the Steering Committee
recognized the necessity to ensure consistency in analyzing and publishing data. To do this,
they instituted the verification process, in which the analyses for all submitted manuscripts
are duplicated at the Coordinating Center. During the process, staff verifies that the most
recent version of the database was used, that all exclusions are described accurately in the
manuscript, and that the results reported in the manuscript match those obtained from the
submitted code. When appropriate, a suggestion may be made to use a different statistical
method for analysis. Verifications are assigned to various Coordinating Center staff.
CARDIA guidelines state that manuscripts cannot be submitted for publication until the
verification described above is performed and resultant corrections applied.


*A.    Data Set Verification
       In March 1997, the Steering Committee approved an optional step in the verification
process. Prior to beginning analyses, authors may submit the materials used to create their
data sets to the Coordinating Center for review of any problems. This allows problems with
exclusions or created variables to be detected before analyses are completed. The materials
required for this type of verification are similar to those listed for Item #11. Analysis programs
will not be included and only a draft of the Methods section of the manuscript is required.
       After all necessary verification materials are received at the Coordinating Center; it will
take approximately two to three weeks to complete the verification. This timeline is extended
if further information is required from the first author. When the verification is completed, the
first author and the Chief Reviewer will be notified in writing of any notations or discrepancies
between reported findings and the Coordinating Center’s analyses. If the first author
disagrees, he/she may contact the Coordinating Center to resolve the discrepancy or work
with the Chief Reviewer to adjudicate any discrepancies. Otherwise, the corrections should
be made to the manuscript.
       At the time of manuscript proposal approval, first authors will receive a "Manuscript
Verification Submission Instructions" packet describing the materials required for
verification. These materials should be submitted to the Coordinating Center when the
manuscript is submitted to the P&P Committee for approval. For your convenience, these
instructions are in Appendix 2.

B.    Re-Verification and Re-review of a Manuscript
CARDIA Data Analysis & Publications and Presentations Policies *=Revisions                          20
        After a manuscript has been verified by the Coordinating Center, there often is
occasion for revision. This may happen because of changes suggested by the P&P
Committee or NHLBI or, perhaps most commonly, when a manuscript is resubmitted to a
Journal. These revisions may entail re-analyses including additional use of data. The first
author should request re-verification by the Coordinating Center when:

        1.    The information contained in a table or figure is changed other than by (1)
              deletions, or (2) corrections of simple typographical errors.

        2.    New statements in the text refer to analyses not previously verified.

        3.    The first author or a co-author believes that a re-verification is in order.
        In order to ensure that re-verifications may proceed as expeditiously as is desirable,
re-verification materials should be submitted that conform to the specifications outlined for
regular verification procedures. If the same data set was used for the new analyses, only the
programs that contain the new analyses should be sent. If the revisions involve a new data
set, (e.g., different exclusions, additional variables) all programs used for the manuscript
should be submitted.
        The Coordinating Center will confer high priority to re-verifications. Staff at the
Coordinating Center should be notified of any deadlines associated with the re-verification to
ensure the work can be done within that time frame.
        In addition to re-verification, the re-review of the manuscript should also be
considered. CARDIA investigators who are co-authors should decide whether the revised
manuscript is sufficiently different from the originally approved version to require re-review by
the P&P Committee. Examples of indications for re-review follow. This list is not exhaustive:

        1. Any major change in the results, e.g., changes in the direction of an association,
        significant changes in the magnitude of an association, newly significant associations,
        or loss of statistical significance of previously found associations.

        2.   Potential new overlap with other CARDIA publications.

        3. Use of new variables, not part of the dataset that yielded the original submission.
NOTE: Regardless of the necessity for re-verification by the Coordinating Center, each
revision which is sent to a Journal should also be approved by each co-author. The form of
this approval is up to the authors and may be verbal, if mutually agreed upon by the first
author.
CARDIA Data Analysis & Publications and Presentations Policies   *=Revisions                     21
CARDIA Data Analysis & Publications and Presentations Policies   *=Revisions   22
XV.     P&P Committee Review of Manuscripts (Mainstream and Ancillary)
        The purpose of the manuscript review is to evaluate the scientific merit, the clarity of
the writing, and the consistency with other CARDIA findings.

*A.     Assignment of Chief Reviewer
        Prior to submission of a manuscript to the P&P Committee, the first author should
contact the P&P Committee Chair to arrange assignment of a Chief Reviewer. The first
author and the Chief Reviewer agree on a mutually convenient conference call date for the
P&P Committee review of the manuscript and notify the CC of this date.
*       The CC will distribute the manuscript to the P&P Committee and other interested
investigators, with a request that comments be sent to the first author, Chief reviewer and
Chair, P&P Committee, at least three days before the P&P Committee conference call date.
The Chief Reviewer for the manuscript serves as the P&P Committee's representative in
communicating with the first author and expediting the review.

*       1. The Chief Reviewer assembles all comments and communicates these to the first
        author, Chair of P&P Committee and P&P Committee. The Chief Reviewer is
        encouraged to communicate with the first author prior to the manuscript review by the
        P&P Committee. If a written review is provided, the CC will post the review for the
        P&P Call on which the manuscript is scheduled for review. The Chief Reviewer will
        also receive the Statistical Review and take this into account when making their
        recommendation to the Committee.

        2. The Chief reviewer briefly summarizes his/her own major comments and those
        from other investigators to the P&P Committee during the conference call. The Chief
        Reviewer then makes a recommendation to the P&P Committee, in one of three
        categories: (1) unconditional approval; (2) approval with revisions, conditional only on
        chief reviewer approval; (3) suggested major revisions with re-review by entire P&P
        Committee. The Chief reviewer is strongly encouraged to discuss his/her planned
        recommendation to the P&P Committee before the P&P Committee call, unless the
        recommendation falls into category (1).

        3. The Chief Reviewer adjudicates any differences in opinion between the writing
        group and the CARDIA Steering Committee.


CARDIA Data Analysis & Publications and Presentations Policies   *=Revisions                       23
        4. The Chief Reviewer receives the results of the manuscript verification performed at
        the Coordinating Center and ensures that all issues have been resolved with the first
        author prior to journal submission.

        5. By accepting Chief Reviewer status, the Chief Reviewer commits to timely
        execution of Chief Reviewer’s tasks, including a rapid response to a revised
        manuscript conditionally approved by the P&P Committee and submitted to the Chief
        Reviewer for final approval. Typically, the last task should be carried out in less than
        two weeks.


*B.     Assignment of Statistical Reviewer
        The Statistical Review is performed by a Statistical Reviewer who is affiliated with and
assigned by the Coordinating Center. The purpose of this review is to evaluate the 1) appropriateness
of all data analyses reported in the manuscript, 2) validity of interpretation of findings, and 3) clarity of
presentation of findings.
        Upon receipt of a final manuscript, the CC will assign a Statistical Reviewer to a
manuscript prior to distribution to the P&P Committee. The Statistical Reviewer is allowed
two weeks (14 days) to complete the review which will be e-mailed to the first author, Chief
Reviewer, Chair of P&P Committee, CC assignee and the CC.                  The written review will be
posted for the P&P Call on which the manuscript is scheduled for review. The Chief
Reviewer for the manuscript serves as the Steering Committee's representative in
communicating with the first author and expediting the review.


C.      Statement of Authors Form
        The first author is responsible for having all co-authors sign-off on the Statement of
Authors Form prior to the manuscript being sent to the P&P Committee. Each coauthor
should state their involvement with the manuscript. The original of the Statement of Authors
Form is kept by the first author and a copy is sent to the Publications Co- Chair c/o of the
Publications Coordinator at the Coordinating Center. Completion of this form is required prior
to manuscripts being approved by the P&P Committee. A copy may be obtained by
contacting the Publications Coordinator at the Coordinating Center.
        The first author sends the final version of a manuscript to the Coordinating Center for
distribution to the Publications & Presentations Committee after approval by the Principal
Investigator of the responsible center. The manuscript should be accompanied by a memo
CARDIA Data Analysis & Publications and Presentations Policies   *=Revisions                               24
stating the CARDIA manuscript number, the title of the manuscript, the name and telephone
numbers of the first author and Chief Reviewer (as assigned by the Publications Co-Chair)
and the date of the conference call when it will be reviewed by the P&P Committee.
        Each member of the Publications & Presentations Committee and Steering Committee
has an opportunity to review and communicate approval or disapproval to the Chief Reviewer
and first author within two weeks of receipt (at least five working days prior to the conference
call when the manuscript will be reviewed). If all P&P Committee members agree that the
manuscript may be submitted for publication, the manuscript will be approved.
        Approval of a manuscript is documented in the minutes of the P&P Committee
conference call. The Principal Investigator of the originating center and the Chief Reviewer
are required to ensure that any small but required changes not requiring another full cycle of
review are made before the manuscript is submitted to a journal.


XVI. NHLBI Review for Abstracts and Manuscripts
        As of July 2008, NHLBI no longer routinely reviews manuscripts and abstracts that emanate
from NHLBI-sponsored contracts and cooperative agreements that do not include NHLBI staff as
authors.
        The NHLBI review will continue for manuscripts that include NHLBI staff as authors. The
abstracts will undergo review within five (5) business days. Manuscripts that are not considered High
Impact by the Project Officer will undergo expedited review within five (5) business days. Manuscripts
that are considered High Impact will undergo a detailed review within 10 working days.
        In order to minimize time delays, NHLBI review of CARDIA materials may take place
simultaneously with CARDIA P&P Committee review.
        As a courtesy, the NHLBI Project Officer for CARDIA should receive copies of manuscripts at
the time of journal acceptance or before, particularly for "high-profile" manuscripts such as those
published in high impact journals or those having potentially sensitive topics.
        Manuscripts or abstracts which require NHLBI review should be submitted to NHLBI for
approval @ ebpdocs@nhlbi.nih.gov. The first author will receive the comments and the approval
letter from NHLBI electronically. Please also provide your complete mailing address so that NHLBI
can include it on the approval letter. A CARDIA manuscript should not be submitted to a journal until
the NHLBI approval is received.




CARDIA Data Analysis & Publications and Presentations Policies   *=Revisions                            25
XII.    Acknowledgement of NHLBI Role and CARDIA Review
Dr. Kiefe: Below is the current acknowledgement; and below it are the acknowledgements from the
DMDA. Should the existing acknowledgement be deleted and the others used or possibly 7.1.a and
7.1.b. Please advise.

                All manuscripts using CARDIA’s distributed data set are required to acknowledge
        support. For example, this acknowledgment should read, “Work on this manuscript was
        supported (or partially supported) by contracts: University of Alabama at Birmingham,
        Coordinating Center, N01-HC-95095; University of Alabama at Birmingham, Field Center,
        N01-HC-48047; University of Minnesota, Field Center and Diet Reading Center (Year 20
        Exam), N01-HC-48048; Northwestern University, Field Center, N01-HC-48049; Kaiser
        Foundation Research Institute, N01-HC-48050; University of California, Irvine,
        Echocardiography Reading Center (Year 5 & 10), N01-HC-45134; Harbor-UCLA Research
        Education Institute, Computed Tomography Reading Center (Year 15 Exam), N01-HC-05187;
        Wake Forest University (Year 20 Exam), N01-HC-45205; New England Medical Center (Year
        20 Exam), N01-HC-45204 from the National Heart, Lung and Blood Institute.”
                In addition, some journals are requiring that the first author describe the role of the
        sponsor. In this case, it should be reported that NHLBI had input into the overall design and
        conduct of the CARDIA study. If there is an NHLBI co-author on a manuscript, then this co-
        author will provide further guidance in describing NHLBI’s role in more detail.
        ***********************************************************************
Acknowledgements from DMDA –(this section has not been renumbered for the pubs policies.)
7. Acknowledgments. Recipient and Recipient’s PI agree to acknowledge the contribution of CARDIA staff in
any and all oral and written presentations, disclosures, and publications resulting from any and all analyses of
Data or Materials.

        7.1 Collaborations. If a manuscript resulting from the Research Project has CARDIA co-investigators
        as co-authors, then the manuscript will be reviewed by CARDIA.

                7.1.a If the manuscript is approved by the CARDIA, the Recipient and Recipient’s PI will use
                the following acknowledgment.

                "The Coronary Artery Risk Development in Young Adults Study (CARDIA) is conducted and
                supported by the National Heart, Lung, and Blood Institute (NHLBI) in collaboration with the
                University of Alabama at Birmingham (N01-HC95095 & N01-HC48047), University of
                Minnesota (N01-HC48048), Northwestern University (N01-HC48049), and Kaiser Foundation
                Research Institute (N01-HC48050). This manuscript has been reviewed by CARDIA for
                scientific content and consistency of data interpretation with previous CARDIA publications.”

                7.1.b If the manuscript is not approved by CARDIA and the Recipient and Recipient’s PI wish
                to proceed to publish without inclusion of CARDIA investigators as co-authors, then the
                following statement must be included with the manuscript.

CARDIA Data Analysis & Publications and Presentations Policies    *=Revisions                                  26
                 “The Coronary Artery Risk Development in Young Adults Study (CARDIA) is conducted and
                 supported by the National Heart, Lung, and Blood Institute (NHLBI) in collaboration with the
                 University of Alabama at Birmingham (N01-HC95095 & N01-HC48047), University of
                 Minnesota (N01-HC48048), Northwestern University (N01-HC48049), and Kaiser Foundation
                 Research Institute (N01-HC48050). This manuscript was not approved by CARDIA. The
                 opinions and conclusions contained in this publication are solely those of the authors, and are
                 not endorsed by CARDIA or the NHLBI and should not be assumed to reflect the opinions or
                 conclusions of either.”

        7.2 Other Studies. If the Research Project does not involve collaboration with CARDIA co-
        investigators, then the Recipient and Recipient’s PI agree to include in any resultant manuscript the
        following acknowledgement.

                 " The Coronary Artery Risk Development in Young Adults Study (CARDIA) is conducted and
                 supported by the National Heart, Lung, and Blood Institute (NHLBI) in collaboration with the
                 University of Alabama at Birmingham (N01-HC95095 & N01-HC48047), University of
                 Minnesota (N01-HC48048), Northwestern University (N01-HC48049), and Kaiser Foundation
                 Research Institute (N01-HC48050). This manuscript was not prepared in collaboration with
                 investigators of CARDIA and does not necessarily reflect the opinions or conclusions of
                 CARDIA or the NHLBI.”

        7.3 Ancillary Study Investigator Acknowledgments. If Data include data provided to the CARDIA by
        ancillary study investigators, Recipient and Recipient’s PI also agree to acknowledge their contribution
        in any and all oral and written presentations, disclosures, and publications resulting from any and all
        analyses of such Data.
        ************************************************************************
XVIII. NIH Public Access Policy
        Because CARDIA publications are funded by NIH, the NIH Public Access Policy applies to
this manuscript (please see http://publicaccess.nih.gov/). Authors should note that, depending on the
journal, there may be costs involved in abiding by the NIH policy.


XIX. Other Publication Policies and Considerations
A.      Causality Statement
        1. CARDIA is an observational study, with inherent limitations on any causal inferences to be
        made from CARDIA analyses. Authors should generally frame CARDIA findings and
        conclusions in terms of association rather than causation. However, hypotheses involving
        etiological pathways can and should be generated by CARDIA analyses, and causal inferences
        are an appropriate topic for the discussion section of the manuscript.

        2. It is expected that some reference to CARDIA appear in the title of any mainstream
        manuscript. This helps in indexing and retrieval and in gaining recognition for the
        study.


CARDIA Data Analysis & Publications and Presentations Policies     *=Revisions                                  27
        3. When special databases are provided by the Coordinating Center to Investigators
        for special analyses, the Coordinating Center will keep copies of these. The
        Coordinating Center must maintain control of the master data file for each and all
        centers and not permit unauthorized changes to be incorporated in it.

        4. Each clinical center will have a copy of the complete set of its own data, which may
        be explored as desired. However, all publications stemming from center-specific
        analyses must be reviewed and approved just as is done for all other CARDIA
        publications.

        5. The P&P Committee will regularly review manuscript assignments to determine if
        they are sufficient. The questions to be answered are:
        a.      Are enough topics being covered?
        b.      Are selected topics of sufficient importance to justify continued support?


B.      Industry Funding
        The recipient agrees not to enter into any verbal or written agreement or contract with
industry or private individuals that will provide funding for analyses of CARDIA data without
prior review and written approval of the CARDIA Study Investigators. These proposals (or
requests) are approved by the CARDIA Executive Committee (EC). These may be submitted to Dr.
David Goff, Chair, EC, and Dr. Christie McCullum-Hill, via e-mail: dgoff@wfubmc.edu; cmccullum-
hill@mail.dopm.uab.edu.


C.      Graduate Student Dissertation
        The use of CARDIA data for doctoral or masters’ levels theses is encouraged although
some aspects of graduate student work with CARDIA data require special consideration. In
particular, students are generally new investigators who are usually unfamiliar with CARDIA
data. This section of the publication policies attempts to balance the opportunity to involve
promising new investigators with preserving the opportunity for established CARDIA
investigators to publish study findings.
        P&P resulting from theses are subject to all CARDIA publication policies, including the
requirement that the CARDIA P&P Committee approve all manuscript proposals, all
completed manuscripts before journal submission, and all presentations before they occur.
This includes seminars open to the public that are part of a thesis defense.

CARDIA Data Analysis & Publications and Presentations Policies   *=Revisions                    28
        The distinction between approval of a dissertation proposal and approval of specific
manuscript proposals resulting from a thesis is important. A specific request for thesis
approval should include not more than one manuscript proposal and the elements specified
below, with additional proposals to be entertained by the CARDIA P&P Committee later, as
the thesis matures. Although prompt submission of subsequent manuscript proposals is
strongly encouraged, the student should note that approval of the thesis does not constitute
approval of any manuscript proposal other than the one included in the thesis proposal.
The request to use CARDIA data in a graduate dissertation should include the following
elements:
        1. The name of at least one CARDIA investigator who has agreed to serve on the
        student’s dissertation committee and as a co-author of the first publication.

        2. Brief description of rationale, background, main hypotheses, analytic approach for
        the thesis.

        3. Proposal of one CARDIA manuscript to result from the thesis work, in the usual
        CARDIA manuscript proposal format. Like all other CARDIA manuscript proposals, this
        must include at least one CARDIA investigator as co-author.

        4. Acknowledgment of having read CARDIA publications policies and commitment to
        abide by them.

        5. Timeline for completion of analysis and proposed manuscript

        6.   Formal involvement of the thesis advisor, in the form of an e-mail or letter that (1)
        endorses the thesis and manuscript proposal; (2) states willingness and availability to
        discuss the work with CARDIA investigators; and (3) states commitment to abide by
        CARDIA publications policies.

D.      Distributed Materials and Data Agreement (DMDA) in Relation to Student
Dissertations
        After a thesis proposal is approved, both the student and the advisor must review the
CARDIA Distributed Materials and Data Agreement and complete and sign a CARDIA
Distributed Materials and Data Agreement, and only then will the CARDIA Coordinating
Center prepare an analytic dataset that will be sent to the advisor, for both the advisor and
the student’s use for approved thesis work.

CARDIA Data Analysis & Publications and Presentations Policies   *=Revisions                     29
XX.     Review Process for Abstracts and Presentations
        1.      Verification of the analyses for an abstract is not performed by the Coordinating
        Center unless the data appear questionable.

        2.      Abstracts must be reviewed by both P&P and NHLBI prior to submission. See
        Section XVI. NHLBI Review for Manuscripts and Abstracts


        3.    If a poster presentation is not submitted to the P&P Committee at least two weeks
        prior to the presentation date, the poster may be required to be withdrawn. If an oral
        presentation is not submitted for review in sufficient time, the presenter may be asked
        to withdraw from the program.

        4.      Review by the P&P Committee is required for all presentations of CARDIA
                findings atmeetings and conferences except:
        a.      Teaching conferences and classes for students and colleagues in a university
                setting, and that have no publicity involved, or
        b.      CARDIA findings, ALL of which have been previously published or approved for
                presentation.


XXI. Invited Manuscripts and Presentations
        It is anticipated that Investigators associated with CARDIA will be invited as individuals
to prepare manuscripts or give oral presentations concerning findings or other aspects of
CARDIA. When such invitations are received, the invitee should inform the inviter that
acceptance is contingent upon approval by the P&P Committee. The Committee will decide
whether such a manuscript or presentation is appropriate and who should give the
presentation or take the lead in writing the manuscript. (Manuscripts and the list of authors
will require final approval as described above.) Among other factors, these decisions take
into consideration possible conflicts with other planned data analyses or competition for use
of other CARDIA resources within the time allowed for completion of the invited manuscript or
talk.
        If an inviter has special reasons for choosing the particular invitee, (e.g., special
qualifications, previous or other involvements with the organization) these should be
submitted by the inviter or invitee to the P&P Committee to assist it with the decision.

CARDIA Data Analysis & Publications and Presentations Policies   *=Revisions                     30
CARDIA Data Analysis & Publications and Presentations Policies   *=Revisions   31
                                                     APPENDIX 1
                                      Manuscript Proposal, CARDIA Study
                                                (Date of request)
       (See page 2 for instructions on completing and submitting this proposal, then delete this sentence.)

 I.      Title:

 II.      Abbreviated Title:

 III.     Data: Core:          Ancillary:       Both:       Ancillary Study Title:

          Keywords:
          Reminder: Identify your keywords!

        Identify Exam Years to be used in proposal by typing an “X” in the box to the left of exam year.
                  Year 0     Year 2      Year 5      Year 7      Year 10     Year 15      Year 20    Year 25
Exam data:          Exam 1      Exam 2      Exam 3      Exam 4      Exam 5       Exam 6     Exam 7       Exam 8
                  1985-86    1987-88     1990-91     1992-93     1995-96     2000-01       2005-06     2010-11

IV.       Writing Group (list individual with lead responsibility first)

First author:
Phone:                                        Fax:                           E-mail:
Address:

Co-authors: List names here.
- On page 2, List co-authors, addresses, e-mail addresses, and phone numbers; additional pages may be added if
necessary. Submit all to the Coordinating Center to mgray@dopm.uab.edu and lsellers@dopm.uab.edu.

Representative (contact person):
E-mail address:

V.        Background

VI.       Main Study Questions and Hypotheses

VII.      CARDIA data to be used (Required: CARDIA exam year(s);
          Recommended: variable types, names CARDIA source form)

VIII. Analytic Plan

IX.   Timeline
References (if applicable)




                                                                                                                  1
                                                 APPENDIX 1 (cont.)

1. Complete the manuscript proposal; it may be returned as an attachment via e-mail. It is recommended that a
manuscript proposal be limited to two (2) pages.

2. a. Provide complete contact information for the first author and co-authors.
   b. If the representative (contact person) is the CARDIA investigator include this on the proposal.
   c.1. Type the contact information, including e-mail address, for the first author on the manuscript proposal.
   c.2. Type the contact information, including e-mail address, for co-authors at the bottom of this page.

3. Indicate if “Core or Ancillary Study” Data. Include the “Ancillary Study title”, “Keywords” and “Years data to be
used, and a “Timeline.” All of this information is required, if it is not provided, the proposal may not be reviewed and
could possibly be returned to you for completion.

4. The PI of the originating site or CARDIA investigator participating on the writing group must review and approve the
proposal prior to submission to the Publications (P&P) Committee.

5. Submit the proposal to the CARDIA P&P Committee with a request for approval via e-mail. Manuscript Proposals
are due to the Coordinating Center the Wednesday prior to Tuesday on which the proposal will be reviewed. You or a
representative must attend the call on which your proposal is reviewed.

6. Provide the conference call date on which the proposal will be considered and any other information associated with
the review of your proposal. The P&P Committee calls are the 1st. & 3rd. Tuesday of each month, 3:00 PM (CT). Dial in:
1-800-822-2255. Dr. Catarina Kiefe, Moderator.

7. E-mail proposal to Marie Gray and Linda Sellers for distribution to the P&P Committee and the CARDIA
investigators. mgray@dopm.uab.edu and lsellers@dopm.uab.edu.

8. Questions? Contact the Coordinating Center at (205) 934-0786

NOTE: Additional pages may be added, if necessary, to list the co-authors’ contact information.




                                                                                                                           2
                                             APPENDIX 2

                Manuscript Verification Submission Instructions, CARDIA Study



MEMORANDUM

TO:            CARDIA First Author

FROM:          Lucia Juarez, Director
               Data Analysis and Verification Unit
               CARDIA Coordinating Center
               ljaurez@dopm.uab.edu

RE:            Manuscript Verification Submission Instructions

         As part of the CARDIA manuscript approval process, the Coordinating Center reviews and
verifies the findings presented in each manuscript to ensure consistency and accuracy in CARDIA
publications. The purpose of the memorandum is to inform you of the current verification process
which was updated in June 2008. Please read this memo carefully, even if you have submitted a
manuscript for verification in the past. If the person who performs the statistical analyses is not you,
the first author, please share this memo with that person as it contains information that may influence
the analysis process as well as the preparation of the verification materials.

Verification Process Overview

       After the Coordinating Center has received a complete set of materials from you (see detail
below), we use the current version of the distributed data to confirm that the data set used for analyses
was created correctly. Elements we evaluate include the merging of the component data sets,
exclusions of participants from the analyses, definitions of new variables, and proper handling of
missing values. We also compare the data set creation programs to the text of the manuscript to ensure
the manuscript accurately describes the basis of the analyses.

        Once the data set is verified, we reproduce the analyses performed. As part of this step, we
confirm all values reported in tables, figures, and text. In addition to confirming specific numeric
values, we review the description of analyses performed and results obtained, including findings that
are discussed but for which values are not reported.

       When we have completed the verification of your manuscript, we will notify you in writing of
any discrepancies between your reported findings and our analyses. A copy will be sent to the chief
reviewer of your manuscript so that the information can be used to finalize your manuscript for
submission to a journal. CARDIA guidelines state that manuscripts should not be submitted for
publication until they are verified and the resultant corrections applied.




                                                                                                           3
Step 1: Instructions for Data Set Verification

a.     Data Set Verification Prior to Analyses

               Many of the problems encountered during verifications involve the data set rather
       than the analyses. Hence, you may handle your verification using two steps: (1) a data set
       verification prior to analyses and (2) a manuscript verification. After creating your data set
       (merging component data, making exclusions, and creating all necessary variables), but before
       performing your analyses, you may have the Coordinating Center verify your data set.
       The following materials should be submitted for the verification:

       1.      On a CD-Rom, labeled with first author and CARDIA manuscript number or by e-mail
               as attachments:

               a.     All programs used for data set creation, thoroughly documented. This includes
                      programs that make exclusions and create new variables;
               b.     A text file that lists and describes all files on the disc/attachment; and

       2.      A draft of the Methods section, including a description of exclusions and created
               variables. If the draft does not explicitly state how missing and ‘Don’t Know’
               responses are handled for variables, also include a description of those decisions.

       3.      The name, e-mail address and telephone number of the first author and the programmer.

               A checklist of these items is attached to this memo to facilitate your submission. Our
       experience is that many of the problems with verifications occur during this stage. Thus, early
       verification of the data set can eliminate the necessity to rerun analyses. Our intention is to
       make this a fast process that will ultimately lead to quick turnaround on final verification.
       While most analyses of CARDIA data will be done in SAS and result in programs to be used in
       SAS, other analysis packages may be used. Instructions regarding non-SAS analyses can be
       found on page 3. Other related files can be submitted in WORD and EXCEL, or other such
       packages.

b.     Data Set Verification as part of Manuscript Verification

       If you choose to wait until your manuscript is complete to have the data set verified, please
       follow the instructions outlined below.

Step 2: Instructions for Manuscript Verification

       When your manuscript is complete, but prior to submission to a journal, you should submit the
following materials to the Coordinating Center:

1.     On a CD-Rom, labeled with first author and CARDIA manuscript number, or as e-mail
       attachments:

       a.      All programs used for data set creation, thoroughly documented. This includes
               programs that make exclusions and create new variables;

                                                                                                        4
       b.      All programs used for analyses, thoroughly documented. This includes analyses that
               are discussed in text only; and

       c.      A text file that lists and describes all files on the CD.

2.     The manuscript, including all tables, figures, and appendices, annotated with program names
       for discussed analysis. In addition, please write on each figure the values used to create the
       figure or attach a page that clearly lists the values (e.g., a spreadsheet).

3.     A complete description of any analyses conducted by hand, including reference if possible.

4.     The name, telephone number, and e-mail address of the first author and the programmer.

5.     The verification checklist, signed and dated by you indicating that the packet is complete and
       ready for submission.

       Please note that, even if you have already had your data set verified, it is necessary to submit all
programs again in case changes were made to the data set during the analysis phase.

Analyses Using Programs Other than SAS

        While CARDIA data are distributed for use with SAS, other software packages are sometimes
used to perform part or all of the analyses for a manuscript. When this is the case, program code may
not be sufficient to allow us to duplicate your analyses. Please include the following:

1.    All documentation to describe how the data set was created (particularly important when the
      software is interactive). Please include information about how missing and ‘Don’t Know’
      responses were handled.

2.     A text file containing a list of all CARDIA variables used in the analyses, using the actual SAS
       variable names from the distributed data (e.g., A10SMOKE).

3.     A text file containing names and formulae for all created variables, including formats,
       reformats, and recodes. Again, please use the actual SAS variable names from the distributed
       data when noting these details.

4.     A text file containing exclusions in term of the SAS variable names from the distributed data
       (e.g., A22DURTN<500).

5.     All programs used for analyses. If the package does not generate programs for analyses, text
       files containing code-like statements that correspond to the analyses done and using CARDIA
       variable names.

6.     For calculations done in spreadsheets, please provide us with the formulae used.

Data from Ancillary Studies or Non-CARDIA Studies

       Manuscripts using data from ancillary studies should be verified. If the data for an ancillary
study are not already on file at the Coordinating Center, you should provide those data along with the
                                                                                                         5
other verification materials. If your manuscript presents data from another study, please contact the
Coordinating Center so that we may determine which portion of your analyses are to be verified and
which portion does not.

Other Useful Information

         Authors are encouraged to call or e-mail the Coordinating Center at any time to discuss issues
or questions regarding data set creation. While the documentation distributed with the data is intended
to be complete, questions often arise, particularly regarding some of the more complicated data sets
such as pregnancies or medications. In the Version 5.1 data documentation update, we will provide a
list of common mistakes made in CARDIA analyses. An important check you should perform is to
make sure that the programs you plan to submit do in fact run. Sometimes programs submitted to us
have been cut and pasted from larger programs and do not run on their own.

        Verifications are assigned to various Coordinating Center staff depending upon their current
task load. After we receive all necessary materials, it will take approximately three weeks for us to
complete your verification. This time line is extended if we require further information from you. The
verifications staff at the Coordinating Center vary in their experience, but all have had graduate
training in statistics. Thus, we may include suggestions and/or comments in the completed verification
that we think may help clarify your analyses and make your manuscript stronger.

Attached Materials

       Attached to this memo are additional materials which we trust you will find useful. First, we
have summarized the materials required for verifications in a checklist. Please use the checklist when
preparing the packet you will send to us and sign and date it once you assure the packet is complete.
When you are ready to send the files, please e-mail these as attachments to Lucia Juarez at
ljuarez@uab.edu. Use a descriptive e-mail subject line: “Verification request for manuscript # xxx.”

        Second, we have included sample SAS programs complete with the type of documentation we
would like to have in programs you submit. We have also included a couple of example manuscript
pages illustrating the type of required annotation. If you have any questions regarding the verification
process or this memorandum, please contact Lucia Juarez (lucia@uab.edu) at the Coordinating Center
at (205) 934-0786.




                                                                                                         6
                  CARDIA DATA SET VERIFICATION CHECKLIST

   1.    All data set creation programs merging distributed CARDIA data,
          thoroughly documented.

   2.    All programs that make exclusions, thoroughly documented.

   3.    All programs that create variables, thoroughly documented.

   4.    A text file that lists and describes all files enclosed.

   5.    A CD-Rom or e-mail message with text attachments
          containing Items 1-4, labeled with first author and CARDIA manuscript number.

   6.    Confirm that submitted programs run.

   7.    Draft of the Methods section, including description of exclusions and
          created variables. If the draft does not explicitly state how missing and
          ‘Don’t Know’ responses are handled for variables, also include a
          description of those decisions.

   8.     Name, e-mail address and telephone number of both the first author and the
    programmer.




                                                                                          7
                 CARDIA MANUSCRIPT VERIFICATION CHECKLIST

     1.    All data set creation programs merging distributed CARDIA data,
            thoroughly documented.

     2.    All programs that make exclusions, thoroughly documented.

     3.    All programs that create variables, thoroughly documented.

     4.    All programs that perform analyses, thoroughly documented, including
            documentation of the portion of the manuscript to which the analyses
            pertain.

     5.    A text file that lists and describes all files on the disc/attachment.

     6.    A CD-Rom or e-mail attachments containing Items 1-5, labeled with first author
                        and CARDIA manuscript number.

     7.    Confirm that submitted programs run.

     8.    Annotated manuscript, including values noted on figures or a separate
            sheet listings figure values.

     9.    Complete description of any analyses conducted by hand, including
            reference if available.

     10.   Completed Form DD-5.

     11.   Name, e-mail address and telephone number of both the first
            author and the programmer.




__________________________________                                  _________________
Signature of First Author                                           Date Signed




                                                                                             8
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                          SAMPLE ANNOTATED MANUSCRIPT PAGES


       Purpose: The purpose of this study was to examine dietary correlates of serum gamma
glutamyltransferase (CGT) level, motivated by the observation of a strong dose response relationship
of serum CGT level with incident diabetes.
       Methods: [P999 – A.SAS, Item 1] Study subjects were 3146 black and white men and women
aged 18-30 years in 1985-1986. Diet was measured at years 0 and 7 using an interviewer-
administered quantitative food frequency questionnaire. [P999 – A.SAS, Item 2] Food items were
classified into 14 food groups; alcohol, meat, poultry, fish, fresh or frozen vegetables, fried or
breaded/battered or canned vegetables, fruit, fruit juice, refined grain, whole grain, dairy, legumes,
nuts, and coffee.
       Results: [P999 – A.SAS, Item 6] After adjusting for non-dietary factors and other food
groups, serum CGT level was positively associated with alcohol consumption and meat intake. [P999 –
A.SAS, Item 8] Geometric means of year 10 CGT across categories of alcohol consumption (0g. 1-
9g/d, 10-19g/d, 20-29g/d, ≥30g/d) were 17.7, 18.8, 20.4, 21.8 and 24.8 U/L (P for trend <0.01);
corresponding means across quintiles of meat intake were 19.2, 20.2, 20.5, 21.8, and 21.2 (P for trend
<0.01). [P999 – B.SAS< Item 1] However, serum CGT level was inversely associated with various
plant foods, especially fruit, and fish intake. [P999 – B.SAS, Item 4] Among possible meat
constituents, dietary heme iron, but not saturated fat, was associated with serum CGT level. [P999 –
B.SAS, Item 5] Beneficial dietary constituents typical of plant foods, including beta-carotene, vitamin
C, and fiber showed an inverse association. [P999 – B.SAS, Item 6] In contrast, vitamin A, vitamin C,
and folate from supplements were positively associated with serum CGT level.
       Conclusion: Serum CGT level increased in a dose-response manner as alcohol and meat
consumption increased and fruit consumption decreased. Heme iron contained in meats and beneficial
dietary micronutrients contained in fruits may influence CGT metabolism. However, micronutrients
taken as supplements did not show a consistent relation with CGT level.




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