ISMPP CMPP EXAM 2024: QUESTIONS WITH 100% CORRECT ANSWERS GRADED A+

1 ISMPP CMPP EXAM 2024: QUESTIONS WITH 100% CORRECT ANSWERS Why was the ISMPP Publication Primer developed? - Correct Answer - there was no single location where an interested party could obtain a solid overview of medical publications and publication planning A brief summary of a publication or conference presentation. In a publication, the abstract appears at the beginning of a manuscript (some journals may use other terms, e.g. Summary, Synopsis or Précis). usually submitted to the organizer ahead of the meeting and there is often a peer review process to select the abstracts that will be presented. - Correct Answer - abstract A member of an institution or association for advancement of sciences, arts or literature. The term is generally used to refer to a scholar or teacher/lecturer/professor at a college/university. - Correct Answer - Academician An expression of appreciation (by authors) for a person or body that has added value to a publication. For example, a professional medical writer (if used) or a company or institution that has provided financial or other type of support. - Correct Answer - Acknowledgment A publicly accessible catalog for registering a clinical trial(s) includes posting of: - summary results - patient recruitment - trials in progress or completed - Correct Answer - Clinical Trial Registry Conformity in fulfilling official requirements. In the area of medical publications these may include external mandates, such as laws and guidelines, as well as interna l guidance, in the form of standard operating procedures (SOPs) and policies - Correct Answer - compliance A document outlining the obligations agreed to by a pharmaceutical company as part of a civil settlement often mean that guidelines relating to publications become legal requirements - Correct Answer - Corporate Integrity Agreement (CIA) Summarized as a code of standards and principles for professional conduct and business practice that is appropriate for an individual or a group - Correct Answer - ethics "...the integration of clinical expertise, patient values, and the best evidence into the decision making process for patient care...The best evidence is usually found in clinically relevant 2 research that has been conducted using sound methodology" - Correct Answer - evidence -based medicine The management of the most appropriate timing for presentation/publication of the data from each phase of the development of a treatment, therapy or device - Correct Answer - life cycle management professional writers who assist with the preparation of manuscripts in an ethical and transparent manner - Correct Answer - medical writer a statistical analysis of results from a comprehensive set of studies meeting specific design and quality criteria, in order to produce an estimate of the magnitude of effect of a given treatment; as well as an assessment of the consistency of effect amongst studies - Correct Answer - Meta - analysis give unrestricted access to their articles based on the payment of publication fees by the submitters of the article - Correct Answer - Open Access Journals critical assessment of manuscripts or other forms of medical communication by professional peers for the purposes of evaluating suitability for publication and improving the quality of the work - Correct Answer - Peer review Before anyone can legally publish or distribute another person's copyrighted work, or even extracts or samples of that work (such as a figure or photograph in a published paper), must be requested from, and granted by, the copyright holder. The person reusing the work has an ethical and legal requirement to obtain permission for reuse. - Correct Answer - permission The practice of taking someone else's work or ideas and passing them off as one's own - Correct Answer - plagerism A type of conference presentation, comprising a large printed piece that is displayed for viewing by delegates. The conference organizer will advise presenters of any specific requirements for format/style, dimensions and content of the presentation - Correct Answer - poster a process, involving many steps, that aims to ensure accuracy and timeliness of the dissemination of clinical or scientific data. The ultimate goal of is to ensure that there is a complete profile of the treatment in the peer -reviewed scientific literature. - Correct Answer - publication planning A committee consisting of investigators, study sponsors, statisticians, and other experts whose responsibility is to plan and oversee the production of publications for a study - Correct Answer - PSC 3 Sets of guidelines created by various key stakeholders (such as editorial groups, publishers, government bodies and medical writing organizations) designed to ensure ethical, transparent, and accurate reporting of health research - Correct Answer - researc h guidelines If there is clear evidence of misconduct associated with a publication, such as unethical data collection, data fabrication, or errors in experimental design or analysis, plagiarism or duplicate publication, a journal editor may a previously published paper. Committee on Publication Ethics (COPE) states that the main purpose of is to correct the literature and ensure its integrity rather than to punish authors who misbehave - Correct Answer - retractions A US law requiring all pharmaceutic al, medical device, biological, and medical supply manufacturers that participate in US federal health programs to collect, track, and report any payment or other transfer of value greater than $10 made directly to physicians and teaching hospitals. - Correct Answer - Sunshine Act Communication of information to the public - Correct Answer - publications What distinguishes medical publications from news paper articles, society newsletters, TV, and radio stories - Correct Answer - peer-review Is peer-review designated to detect fraud, plagiarism, or other forms of publication malpractice? - Correct Answer - no, this responsibility rests with the author and indirectly with a professional medical writer What is the overarching reason for medical publications? - Correct Answer - they are the building blocks of evidence -based medicine (EBM) Acts as a preview/summary of the article and allows the reader to decide if they are interested in reading further - Correct Answer - abstract The most visible part of the article because it is freely available on the journal website and PubMed - Correct Answer - abstract What should the abstract usually briefly describe? - Correct Answer - - objectives/aim of study - methods - pertinent findings (results) - conclusions What should present a balanced overview of major findings in the topic area relevant to that publication and identify what question(s) this led the authors to investigate - Correct Answer - introduction Subheadings that are almost always presented in the Methods section - Correct Answer - - study population