CMPP EXAM QUESTIONS WITH 100% CORRECT ANSWERS 2024 SUCCESS ASSURED, Exams of Nursing

Download CMPP EXAM QUESTIONS WITH 100% CORRECT ANSWERS 2024 SUCCESS ASSURED and more Exams Nursing in PDF only on Docsity! CMPP EXAM QUESTIONS WITH 100% CORRECT ANSWERS 2024 SUCCESS ASSURED Which guideline recommends a PSC be formed? - Correct Answer - GPP3 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 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 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 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) 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 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 ISMPP GPP3 - Correct Answer - provides comprehensive guidance on roles of authors and contributors as well as reimbursement and honoraria and use of professional medical writers also offers recommendations regarding publication planning and documentation 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 Sunshine Act - Correct Answer - A US law requiring all pharmaceutical, 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. included in the US Patient Protection and Affordable Health Care Act also required to describe how the recipient received the payment (i.e. case, stock options, etc) 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 should the abstract usually briefly describe? - Correct Answer - - objectives/aim of study - methods - pertinent findings (results) - conclusions Subheadings that are almost always presented in the Methods section - Correct Answer - - study population - study design - outcome measures - sample size - statistical methods Where should a description of the ethical guidelines for humans that were followed be listed in the manuscript? - Correct Answer - methods (mandatory) Subheadings that are usually always included in the Results section - Correct Answer - - demographics - subject disposition - primary and secondary outcomes - safety and tolerability Do you need to cite a large number of sources to support a single claim? - Correct Answer - this is rarely necessary What should be included in a manuscript according to ICMJE recommendations? - Correct Answer - 1. authors 2. contributors (including the funding source for these services) 3. description of the role of the study sponsor 4. COI FDAA requires reporting of summary results information by when? - Correct Answer - no later than 1 year after the completion date for registered applicable clinical trials When does the FDAA requires that all interventional clinical trials must be registered on their clinical trial registry site (ClincalTrials.gov)? - Correct Answer - before enrollment In the US, when does the FDA require investigational clinical trials to be registered to a clinical trial registry site by? - Correct Answer - before enrollment In the US, when does the FDA require the primary results of the trial to be posted to a clinical trial registry site by? - Correct Answer - after the last patient's visit for a product already approved for market OR within 12 months of when the product is approved When does the FDAA require the primary results of a trial be posted in the clinical trial database? - Correct Answer - within 12 months after the last patient's visit for a product already approved for market or within 12 months of when the product is approved What do the ICMJE guidelines say is required of authors? - Correct Answer - - they need to take responsibility for at least one component of the work - should be able to identify who is responsible for other components - must make substantive intellectual contributions Which guideline recommends that each manuscript include statements to acknowledge the contributions of authors, writing support, editors, researchers, and sponsors? - Correct Answer - GPP3 What do you need to do before reusing published material? - Correct Answer - permissions need to be request and granted before it can be reused the person reusing the work has an ethical and legal requirement to obtain permission for reuse How do you obtain permission from a copyright holder? - Correct Answer - - STM (International Association of Science Technical and Medical Publishers) agreement - Directly from a journal STM agreement - Correct Answer - all major STM publishers have signed this agreement, providing rights to use portions of text/figures, or up to 400 words, free of charge For open access publications, is copyright usually transferred to the journal? - Correct Answer - no, it is not transferred to the journal and its usually owned by the author or institution and permission may still need to be sought Examples of misconduct - Correct Answer - - unethical data collection - data fabrication - errors in experimental design or analysis - plagiarism/duplicate publication What should a journal editor do if there is clear evidence of misconduct associated with a publication? - Correct Answer - may retract a previously published paper What should an editor do if there is a small change that is required to be made to a publication? - Correct Answer - issue a correction What should an editor do if there is not enough evidence to determine misconduct or errors? - Correct Answer - issue an "expression of concern" According to COPE, what is the main purpose of retractions? - Correct Answer - to correct the literature and ensure the integrity rather than to punish authors who misbehave What is one way to potentially engage authors who have not yet provided critique of the publication? - Correct Answer - target questions to a specific author during draft revisions Should you always follow ICMJE authorship criteria? - Correct Answer - always adhere to the specific journal guidelines for authorship criteria, if the journal criteria has not yet been defined follow ICMJE criteria Why do many journals require written permission for acknowledgement? - Correct Answer - because acknowledgement may imply endorsement Would you be acknowledged if when a publication was being written an author had a lengthy discussion with you about a certain part of the publication and the discussion resulted in a significant retooling of the section - Correct Answer - no What is a guarantor? - Correct Answer - When one author takes overall responsibility for the integrity of the study and its report per journal requirements OASPA - Correct Answer - Open Access Scholarly Publishers Association posted guidelines on transparency What does a CMPP do? - Correct Answer - - promotes ethical standards - integrity - transparency - accepts responsibility for their actions - avoid situations which COI may arise and disclose any circumstance that may be construed as potential COI When should authors sign and authorship agreement? - Correct Answer - definitely before writing and ideally before research occurs GATE Principles - Correct Answer - medical writer should be qualified based on these principles: Guarantee: are the authors guarantors of the article? Advice: was the professional writer 'advised' by the author(s) before and after starting the assignment Transparency: the contribution of professional writers should be acknowledged Expertise: does the professional writer have sufficient knowledge in the relevant specific field? all examples of authorship conflicts - Correct Answer - - an author who becomes unengaged in a project mid-stream - addition of new author in the final draft - an author who is deceased before the final draft is submitted - author asks to withdraw their name from authorship after the manuscript was accepted for publication - author does not understand the language in which the manuscript is written How do you resolve authorship conflicts? - Correct Answer - if an AA that details the authorship criteria has been signed, resolution of the conflict should occur after pointing out the relevant sentence(s) of the agreement if not, an appropriate, ethical solution may be found during a discussion with the author, sponsor's pub team, medical writer, or journal editor How may you avoid potential authors conflicts? - Correct Answer - by identifying authorship criteria at the beginning of the project What should be confirmed with authors during the KO call? - Correct Answer - - the extent to which a medical writer will be assisting the authors - author order/corresponding author - target journal/congress What can help the publication team ask the questions that they need to identify the most effective target journals/congresses to reach the intended auidence? - Correct Answer - Authors' Submission Toolkit To adhere to ethical medical writing, what should the author do in regards to the medical writer? - Correct Answer - - provide direction to the medical writer at every stage of mss development ICMJE - Correct Answer - International Committee of Medical Journal Editors focusing on the quality of medical science and reporting "Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals" reviews best practices and ethical standards for authors, editors, and others involved in developing/distributing articles What guidance will most likely help an author with manuscript preparation? - Correct Answer - Authors' Submission Toolkit What does the FDAAA require? - Correct Answer - Food and Drug Administration Amendment Act requires the reporting of summary results information (including adverse events) no later than 1 year after the completion data for registered applicable clinical trials When does the FDAAA require all interventional clinical trials be registered by? - Correct Answer - before enrollment on ClinicalTrials.gov When does the FDAAA require primary results of the trial to be posted in the ClincalTrials.gov database? - Correct Answer - within 12 months after the last patient's visit for a product already approved for marketing or within 12 months of the product being approved What does the TEST act aim to do? - Correct Answer - Trial and Experimental Studies Transparency (TEST) Act Addresses how much data is to be shared. Emphasizes the need for transparency with negative results. Mandates the addition of Phase 1 studies Why do publications carry such a heavy burden of responsibility? - Correct Answer - they have the potential to change behaviors and attitudes publication ecosystem - Correct Answer - Diverse and multi-stakeholder community that is influence and shaped by a number of guidelines, standards, and practices as well as compliance mandates Who is widely regarded as the "gold standard" of recommendations? - Correct Answer - ICMJE "conduct, reporting, editing and publication of scholarly work in medical journals" Is there a universal guide that should be followed to rank authors? - Correct Answer - no, it varies from institution to institution and sponsor company to sponsor company - alphabetical listing - listing by highest number of patient enrollers in clinical trials - senior authors listed either first or last When should authorship guidelines and qualifications be determined? - Correct Answer - at the start of the study and should be governed by publication working group (sponsor guidelines and Standard Operating Procedures (SOP)) What do you need to plan for in publication planning? - Correct Answer - - what data will be generated/discussion - what audience will find the data important - when this data will be available for publication/presentation Why are publications needed if we need to include data from the trial on the clinical trial registry database? - Correct Answer - because in publications the results are put into context and vetted by other scientists/clinicians during the process of peer review at scientific medical journals where only the basic data from the trial is posted to the clinical trial registry database Who makes the first assessment of whether a particular manuscript contains content that is relevant to the focus of the journal and would be of interest to their readership? - Correct Answer - journal editors- if it does meet their criteria it will then be sent to 2/3 experts in the therapy area for a more in-depth review Why may it be good to submit your data to a congress? - Correct Answer - although presentations usually go into less detail than is found in a complete manuscripts, they do serve as an important function by bringing early awareness of the results to a target audience and building anticipation when a more thorough discussion of results will appear in the full manuscript What is a placeholder abstract? - Correct Answer - tells what data will be included once the analyses are complete, but which does not contain any of the data important to note not all congresses will allow placeholder abstracts Who created a clinical trials registry and results data base for trials conducted in European Union - Correct Answer - European Medicines Agency (EMA) What are the requirements for clinical trials? - Correct Answer - - register clinical trials to a registry site - post clinical trial results to a registry site - post summaries of of the clinical study reports briefly describing the results of the study on their publicly accessible company website around the same time as the basic results are posted to a clinical trial data base *would be ideal if the manuscript could just be published before any of the data is available on the public website to provide a full discussion on the results and what they mean Should a manuscript be published first or a summary of the clinical study report on the company's website? - Correct Answer - manuscript When does publication planning usually start? - Correct Answer - typically after successful initial testing in human subjects (Phase 1) What kind of publications can be developed in Phase 1? - Correct Answer - - primary analysis - clinical summary reports - congress abstracts - journal manuscripts - slide sets What kind of publications can be developed in Phase 2? - Correct Answer - - primary analysis - clinical summary reports - congress abstracts - journal manuscripts - slide sets What kind of publications can be developed in Phase 3? - Correct Answer - - primary analysis - analyses for specific at-risk populations - clinical summary reports - congress abstracts - journal manuscripts What kind of publications can be developed in Phase 4? - Correct Answer - - abstracts and manuscripts based on new studies or new analyses - patient education materials - systematic reviews and meta-analyses - audience specific publications Members of a PSC - Correct Answer - - investigators (PI) - Members of study steering committee & protocol development team - sponsor clinical team/internal study team - publication lead (pub prof/medical writer - statisticians - other experts in the field When should a PSC be formed? - Correct Answer - when the protocol is finalized or at the end of study/trial enrollment