This section contains the following:
The policy for publication of both interim reports and final scientific
papers should be clarified and documented in the trial protocol.
No publications, either in writing or orally, should be made before the
definitive manuscript has been agreed and accepted for publication,
without the prior approval of the Trial Steering Group (see Trial Management).
It is common practice to set up a sub-group of the Trial Steering Group
as a ‘Writing Committee’. Both interim and final reports are then
reviewed/approved by the full Trial Steering Group.
Arrangements for authorship should be agreed and documented in the
protocol. Many large trials have group authorship with a list of
contributors at the end of the paper, giving details of who did what in
the stages of the trial, eg. the Trial Steering Group, collaborating
clinicians etc. and not forgetting the participants.
A common format for reporting randomised trials has now been widely
adopted. This is known as the CONSORT statement and provides a
checklist consisting of 21 items that relate mainly to the methods,
results and discussion of a Randomised Control Trial report and
includes key pieces of information necessary to evaluate the internal
and external validity of the trial.
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Things to consider when writing a protocol
- Describe the policies and guidelines governing the publication of
scientific and technical results from the trial.
- Be sure the policy is designed to promote the scientific and
technical accuracy of any publications and ensure that fair credit is
given to the authors and to other individuals who have contributed to
- Consider all types of publications including: papers submitted to
electronic archives and refereed journals; scientific or technical
books or book sections; conference presentations; conference
proceedings papers; and theses.
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Illustrative examples - CLAP
Publications and Presentations
The review process and authorship for publications and presentations
will follow the guidelines set forth in the Policy and Procedures
Manual of the Global Network for Women’s and Children’s Health
Research. Any submission for publication or for presentation at
professional conferences must adhere to these principles.
Prior to their submission or application for presentation, all
manuscripts, posters or oral presentations, or other reports of the
outcomes of this research effort must be approved by a majority of the
members of the Site 1 Steering Committee. This committee’s membership
includes (1) the Principal Investigator, (2) the Senior Foreign
Investigator, (3) the NIH Project Officer, (4) a Senior Research
Officer from the Data Center, (5) the Study Coordinator, and (6) the
Statistician and Data Manager.
The authorship of manuscripts, poster or oral presentations, or other
reports of the results of this study will be guided by the criteria for
authorship formulated by the International Committee of Medical Journal
Editors and published in its Uniform Requirements for Manuscripts
Submitted to Biomedical Journals (updated October, 2001; available at
http://www.icmje.org). According to these criteria, the authors should
meet the following criteria.
Each author should have participated sufficiently in the work to take
public responsibility for the content. Authorship credit should be
based only on substantial contributions to (a) conception and design,
or analysis and interpretation of data; and to (b) drafting the article
or revising it critically for important intellectual content; and on
(c) final approval of the version to be published. Conditions (a), (b),
and (c) must all be met.
As a multicenter study, up to 12 authors, as permitted by journals such
as the New England Journal of Medicine and the American Journal of
Obstetrics and Gynecology, may be identified for a given manuscript,
but only those authors fulfilling the criteria above are eligible. As a
general, but not absolute, rule, at least one individual from the NIH,
one individual from the Data Center, the U.S. Principal Investigator,
and the Senior Foreign Investigator will be authors for all
publications that result from this research.
All publications, posters, oral presentations at scientific meetings,
seminars, and any other forum in which results of this NICHD-supported
research are presented will include a formal acknowledgement of NICHD
support, citing the NIH grant number as identified on the award
document. (CLAP Trial - go to protocol)
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Illustrative examples - WHO pre-eclampsia
Authorship for publications
The Steering Committee has agreed to adopt the so-called "modified
conventional form" to be used for the publications of the trial.
This form includes attribution to the investigators that were primarily
responsible for the trial followed by the name of the corporate
research group: e.g. Ann A. Meyeis, Henry C. Brown, .....,
for the WHO Calcium Supplementation during Pregnancy Trial Research
The list of investigators primarily responsible for the study will be
prepared by the Steering Committee and should include only those
actively involved in the preparation, organization,
implementation of the trial as well as data analysis and manuscript
The order of authorship in individual papers will be decided by the
Group. Credit will be given to the other participants of the
trial such as associated staff at participating centers and key
committee membership and will be listed at the end of the
manuscript. Acknowledgements will be expressed in a footnote to
the title or in a section following the credits. A WHO/HRP/RHR
certificate of collaboration will be given to doctors, midwives,
nurses and local staff who contributed to the trial but whose names do
not appear in the main papers. This strategy has been used in
previous trials and is highly appreciated by collaborators.
There will be a Publications Sub-Committee of the Trial Steering
Committee. This Sub-Committee will be responsible for:
preparing a list of tentative publications
reviewing all papers sent for publication
reviewing and authorization of secondary analysis proposed
certifying authorship of individual papers
(WHO Multicentre Randomized Trial of
Calcium Supplementation for the Prevention of Pre-eclampsia - go to protocol)
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The CONSORT statement is an important research tool that takes an
evidence-based approach to improve the quality of reports of randomized
trials. The statement is available in six languages and has been
endorsed by prominent medical journals such as The Lancet, Annals of
Internal Medicine, and the Journal of the American Medical Association.
Its critical value to researchers, health care providers, peer
reviewers, and journal editors, and health policy makers is the
guarantee of integrity in the reported results of research.
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This checklist was developed by Dave Sackett, who prepared it for
3rd edition of Clinical Epidemiology; A Basic Science for Answering
about Health Care, to be published by Lippincott, Williams &
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How to write a paper in scientific
journal style and format
This guide has been compiled, edited, and revised by Greg Anderson
and is intended to provide general content, style, and format
guidelines for students learning to write papers in a standard,
scientific journal style and format that can be easily adapted to
specific journal requirements or disciplinary conventions
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International Committee of Medical Journal Editors. Uniform
Requirements for Manuscripts submitted to Biomedical Journals. Ann
Intern Med. 1997;126:36-47.
Huth EJ. Guidelines on authorship of medical papers. Annals
of Internal Medicine,1986;104: 269-274.
Glass RM. New information for authors and readers. Group
authorship, acknowledgements and rejected manuscripts. Journal of
the American Medical Association 1992;268: 99.
McMillan, V.E. 1997. Writing Papers in the Biological Sciences. 2nd Ed.
Bedford Books, Boston 197 pp.
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This page was last updated 19th October 2004.