1 CMPP PREPARATION EXAM 2024: QUESTIONS WITH 100% CORRECT ANSWERS ISMPP - Correct Answer - International Society of Medical Publication Professionals AMWA - Correct Answer - American Medical Writers Association EMWA - Correct Answer - European Medical Writers Association According to Jan 2017 statement from ISMPP, AMWA, and EMWA, what are the two major responsibilities of medical writers? - Correct Answer - 1) Helps authors and sponsors to disclose their research in peer -reviewed journals and at scientific congresses in an ethical, accurate and timely manner, with ultimate aim of advancing patient care 2) To have an extensive knowledge of ethical publication guidelines According to Jan 2017 statemen t from ISMPP, AMWA, and EMWA, when assisting authors with communication of the results of company -sponsored research, medical writers must (4 items): - Correct Answer - 1) Follow Good Publication Practice (GPP3) Guidelines and ICMJE recommendations 2) Consult appropriate reporting guidelines (ie, COSORT and others collated by the EQUATOR network) 3) Ensure that the authors and sponsors are aware of their obligations under these guidelines 4) Keep up to date with advances in medical communications ethics and best practices Good Publication Practice (GPP3) Guidelines - Correct Answer - The GPP3 guideline emphasizes on full access to relevant study data including study protocol, statistical analysis plan, statistical report, clinical study report or any additional reasonable analysis, and anonymized patient -level data, to the authors. This must be done while respecting patient confidentiality. Evolution of GPP - Correct Answer - -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 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 What is EQUATOR, and how do you define the Reporting Guidelines? - Correct Answer - EQUATOR: Enhancing the Quality and Transparency of Health Research 2 "A checklist, flow diagram, or structured text to guide authors in reporting a specific type of research, developed using explicit methodology." What are responsibilit ies of authors who collaborate with professional medical writers? (6) - Correct Answer - -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 -ensure that the final text fully reflects the views of, and is approved by, all authors -Affim the appropriateness of the final choice of journal or congress -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) - Correct Answer - Social media based metrics Who was the first publisher to implement a system of altmetrics, and in what year? - Correct Answer - PLoS was the first publisher to implement a system, in 2010 called Article -Level metrics, based on integrating communication in an aggregate of blog coverage, social bookmarking, citations, etc. What is the Altmetrics Manifesto? - Correct Answer - issued in 2010, describes the phenomena of integrating a composite novel set of indicato rs to complement citation analysis What is the San Francisco Declaration on Research Assessment (DORA) - Correct Answer - Issued in 2012, it was a statement to call for the need to improve the ways in which scientific research output is evaluated Why was the Authors' Submission Toolkit designed? (3 main reasons) - Correct Answer - 1) increase efficiency in the submission process to accommodate the rising manuscript volume 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 designed the Authors' Submission Toolkit? Who are main entities of this organization? - Correct Answer - Medical Publishing Insights and Practices Initiative (MPIP) ISMPP and pharmaceutical companies What is the Authors' Submission Toolkit? - Correct Answer - A compilation of :best practices" in manuscript preparation and submission, which maintains a focus on research sponsored by the pharmaceutical industry. Intended to elevate transparency and integrity in medical publishing while improving efficiency 3 When is the optimal time to agree upon who will be listed as an author? - Correct Answer - The optimal time to agree upon who will be listed as an author, contributor, or sponsor on the article and who will be acknowledged (if the journal allows acknowledgments) is before study initiation If a study investigator is a high volume enroller, do they automatically qualify for autho rship? Why or why not? - Correct Answer - While a study investigator might be a high volume enroller for a clinical trial, s/he may not meet all ICMJE requirements for authorship. Moreover, collection of data alone does not constitute authorship under ICMJE criteria (nor does acquisition of funding, or general supervision of the research group). Where is an appropriate place to list an investigator who was a supervisor, provided acquisition of funding alone, or collected data alone? - Correct Answer - The acknowledgments Should medical writers be considered for ICMJE authorship criteria? - Correct Answer - The World Association of Medical Editors states, "Editors should make clear in their journal's information for authors that medical writers can be l egitimate contributors." If the contributions of a professional medical writer do not meet 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 publications acceptable? - Correct Answer - The practice of ghostwriting (the unacknowledged use of writing assistance) for medical publications is deemed unacceptable What is the function of a corresponding author? - Correct Answer - Most journals recommend designating one author to submit the manuscript and function as primary contact between the journal and other authors/contributors. Should be designated early to streamline the eventual preparation and submission of materials Does not need to be lead or first author, but SHOULD have access to study data to ensure accuracy and completeness of the manuscript and its contents What is a publication charter? - Correct Answer - Tool for prospectively defining who is going to be involved in the process and delineating clear roles for each author. What are some of the most used altmetrics tools? - Correct Answer - Altmetric.com, ImpactStory, PlumX What is a limit that is included in Altmetrics.com? - Correct Answer - Mentions of articles published before July 11 may be missed, leading to an inaccurate score What are some opportunities/discussed positives of altmetrics? - Correct Answer - 1) Immediacy; data can be retrieved immediately (whereas citations take time to accumulate) 2) Coverage of many different types of research output, as they allow measurement of visibility of less conventional materials (such as slides, datasets, and conference presentations) 3) Measurement of impact on the general public, not just scholarly community 4) Harvesting of more reliable data than download statistics
