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CMPP Exam Preparation
Jeremiah
Terms in this set (129)
ISMPP International Society of Medical Publication Professionals
AMWA American Medical Writers Association
EMWA European Medical Writers Association
According to Jan 2017 statement from 1) Helps authors and sponsors to disclose their research in peer-reviewed journals
ISMPP, AMWA, and EMWA, what are the and at scientific congresses in an ethical, accurate and timely manner, with ultimate
two major responsibilities of medical aim of advancing patient care
writers? 2) To have an extensive knowledge of ethical publication guidelines
1) Follow Good Publication Practice (GPP3) Guidelines and ICMJE recommendations
According to Jan 2017 statement from 2) Consult appropriate reporting guidelines (ie, COSORT and others collated by the
ISMPP, AMWA, and EMWA, when assisting EQUATOR network)
authors with communication of the results 3) Ensure that the authors and sponsors are aware of their obligations under these
of company-sponsored research, medical guidelines
writers must (4 items): 4) Keep up to date with advances in medical communications ethics and best
practices
The GPP3 guideline emphasizes on full access to relevant study data including study
Good Publication Practice (GPP3) protocol, statistical analysis plan, statistical report, clinical study report or any
Guidelines additional reasonable analysis, and anonymized patient-level data, to the authors.
This must be done while respecting patient confidentiality.
-GPP(Standards for publicatoins arising from Phase II and Phase III clinical trials;
includes company sponsored review articles and secondary papers; publicatoins
from independent investigators' studies not included)
-GPP2(more authority to authors in terms of data sharing and knowledge of
sponsor's publication policy, demarcatoin between authorship, contributorship, and
Evolution of GPP
acknowledgments, role of professional medical writers)
-GPP3 (public positng of clinical protocols and results, protocol and results to be
published for all clinical trials, timing of publications, publications should follow
applicable guidelines for FDA 2007, ICMJE, EQUATOR, Steps to avoid duplicate
publications and plagiarism
EQUATOR: Enhancing the Quality and Transparency of Health Research
What is EQUATOR, and how do you define
"A checklist, flow diagram, or structured text to guide authors in reporting a specific
the Reporting Guidelines?
CMPP Exam Preparation
-ensure that they, as authors, have access to all relevant information (ie, protocols,
statistic analyses, clinical study reports)
-provide intellectual input before writing commences and throghout content
development
What are responsibilities of authors who
-ensure that the final text fully reflects the views of, and is approved by, all authors
collaborate with professional medical
-Affim the appropriateness of the final choice of journal or congress
writers? (6)
-Acknowledge the provision of medical writing support, including the nature of the
support, the name, and highest qualifications, and affiliation
-Recognize as a co-author, all contributors (including a professional medical writer)
who meet ICMJE authorship criteria
Altmetrics (definition) Social media based metrics
type of research, developed using explicit methodology."
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PLoS was the first publisher to implement a system, in 2010 called Article-Level
Who was the first publisher to implement a
metrics, based on integrating communication in an aggregate of blog coverage,
system of altmetrics, and in what year?
social bookmarking, citations, etc.
issued in 2010, describes the phenomena of integrating a composite novel set of
What is the Altmetrics Manifesto?
indicators to complement citation analysis
What is the San Francisco Declaration on Issued in 2012, it was a statement to call for the need to improve the ways in which
Research Assessment (DORA) scientific research output is evaluated
1) increase efficiency in the submission process to accommodate the rising
Why was the Authors' Submission Toolkit manuscript volume
designed? (3 main reasons) 2) reduce the resource demands on journals, peer reviewers, and authors
3) identify suitable venues to publish this research
What is the name of the organization that Medical Publishing Insights and Practices Initiative (MPIP)
designed the Authors' Submission Toolkit?
Who are main entities of this organization? ISMPP and pharmaceutical companies
A compilation of :best practices" in manuscript preparation and submission, which
maintains a focus on research sponsored by the pharmaceutical industry.
What is the Authors' Submission Toolkit?
Intended to elevate transparency and integrity in medical publishing while improving
efficiency
The optimal time to agree upon who will be listed as an author, contributor, or
When is the optimal time to agree upon
sponsor on the article and who will be acknowledged (if the journal allows
who will be listed as an author?
acknowledgments) is before study initiation
While a study investigator might be a high volume enroller for a clinical trial, s/he
If a study investigator is a high volume
may not meet all ICMJE requirements for authorship. Moreover, collection of data
enroller, do they automatically qualify for
alone does not constitute authorship under ICMJE criteria (nor does acquisition of
authorship? Why or why not?
funding, or general supervision of the research group).
Where is an appropriate place to list an The acknowledgments
investigator who was a supervisor,
provided acquisition of funding alone, or
collected data alone?
The World Association of Medical Editors states, "Editors should make clear in their
journal's information for authors that medical writers can be legitimate contributors."
Should medical writers be considered for
If the contributions of a professional medical writer do not meet authorship criteria,
ICMJE authorship criteria?
these contributions must be disclosed, including the writer's name and any
associated third-party organization.
Is the practice of ghostwriting for medical The practice of ghostwriting (the unacknowledged use of writing assistance) for
publications acceptable? medical publications is deemed unacceptable
CMPP Exam Preparation
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