ISMPP Certified Medical Publication Professional (CMPP) Practice Exam

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• How are investigators for clinical trials primarily selected?
• What defines the clinical trials that companies commit to providing registration and results for?
• What is one of the standard data elements that must be posted for applicable clinical trials according to the FDAAA?
• Which of the following activities are considered acceptable for a sponsor/funder of a clinical trial?
• Should acknowledgments state the financial and material support received for a study?
• Can compensation for research participants in a clinical trial be contingent on their completion of the trial?
• Regarding the responsibilities of medical writers, which of the following is NOT an obligation?
• What is encouraged concerning authorship and contributions in medical writing?
• Which responsibility do editors have towards reviewers?
• What is the primary role of a corresponding author in medical publications?
• What is one of the benefits of communicating clinical trial results post-approval?
• How many core principles are outlined in the ICH-GCP?
• What does ICH-GCP stand for?
• Which of the following is used to indicate statistical significance?
• What is the primary way for patients to engage in the drug development process?
• What does the acronym GPP3 emphasize regarding authors' access to study data?
• What does the "timely" requirement refer to in the context of posting results for discontinued clinical trials?
• How many steps are included in a publication plan?
• Who must review proposed payment from a sponsor to a patient for participation in a clinical trial?
• What does EMWA stand for?
• Which of the following is a commonly used altmetrics tool?
• Why is it crucial for a corresponding author to have access to study data?
• What is the main purpose of the peer-review process in editorial work?
• What role does a publication working group play in research projects?
• Why is it important for companies to register and report results from clinical trials conducted in patients?
• What does the acronym ICMJE stand for?
• What is one of the main reasons the Authors' Submission Toolkit was designed?
• What is an editor's right concerning their position?
• What does the acronym PhRMA stand for?
• What is an essential component to attain after developing a publication plan?
• What is the main goal of the EQUATOR Network?
• Which of the following BEST identifies why permissions need to be obtained prior to using a table or figure from a published work within a manuscript under development?
• Acknowledgments may include which of the following?
• Should medical writers be considered for ICMJE authorship criteria?
• What is the role of a Data Safety Monitoring Board (DSMB) in clinical trials?
• According to PhRMA, what priority should be given during clinical research?
• What term describes a brief summary of scientific publications that conforms to plain-language principles?
• What does "timely" submission and posting of clinical trial results generally mean for approved products?
• Which publisher was the first to implement a system of altmetrics and in what year?
• Which of the following is NOT one of the main reasons for the development of the Authors' Submission Toolkit?
• Are editors solely responsible for the management of DURC?
• What is typically associated with joint authorship?
• On which platform are clinical trials and their results typically registered and posted?
• What should proposed payments to participants in a clinical trial reflect?
• What is the primary focus of the Data Safety Monitoring Board during trials?
• What does a steering committee do in the context of publications?
• What is one of the primary responsibilities of an IRB/IEC in clinical research?
• Can companies continue to develop an investigational product while publishing interim results?
• Which of the following is NOT a qualification for participation in an expanded access program?
• What must an author obtain when using a copyrighted image in a manuscript?
• Should staff who contributed to data analysis but do not meet authorship criteria be listed as coauthors?
• What term describes a collaboration where two or more organizations work together while maintaining their identities?
• Why is diversity important in clinical trials?
• Why might biological samples collected during clinical trials be stored for many years?
• How can the relationship between a company and an investigator affect clinical trial publication?
• What is the primary purpose for which clinical trials are conducted?
• When there are differences in interpretation of clinical trial results, what should both parties do?
• Which guideline does PhRMA follow for the standards of research?
• Is the practice of ghostwriting for medical publications considered acceptable?
• Can journals limit the number of authors listed on a manuscript?
• Which of the following is the best website to determine whether a journal endorses ICMJE's Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals?
• Under PhRMA principles, is it permissible for a clinical investigator to own stock in the company sponsoring their trial?
• Which of the following options is NOT a responsibility of editors towards reviewers?
• Are clinical investigators encouraged to communicate a summary of trial results with participants post-trial?
• What year was the San Francisco Declaration on Research Assessment (DORA) issued?
• What is one of the key enhancements in GPP2 compared to GPP?
• Who has the responsibility for protecting research participants during a clinical trial?
• What does "trials conducted 'in patients'" imply in Principle 4?
• What is the primary goal of the Council of Science Editors (CSE)?
• Does having general supervision of the research group justify authorship?
• When is the optimal time to agree on authorship for a manuscript?
• What does ISMPP stand for?
• What are two general exceptions allowing an editor to release manuscript content to others prior to publication?
• According to ICMJE, which of the following criteria are among those required to qualify an individual for authorship of an original article?
• Which guideline must medical writers follow when assisting authors with research communication?
• Should clinical investigators in a drug trial also serve on the Data Safety Monitoring Board (DSMB)?
• If a study investigator is a high volume enroller, do they automatically qualify for authorship?
• What does a publication charter define?
• What is the significance of RCTs in clinical practice?
• Which of the following types of article formats typically requires a more extensive word count than 250 words?
• Which of the following is one of the responsibilities of authors who work with professional medical writers?
• What is the purpose of an author agreement in publishing?
• What is the typical timeframe for submitting clinical trial registration information after the enrollment of the first patient?
• What signifies that a development program for an investigational product is considered "discontinued"?
• What action should reviewers take if they have a conflict of interest?
• What does the Impact Factor measure?
• What is one of the three standards for coauthorship proposed by ICMJE?
• What is the primary purpose of a plain-language summary?
• According to the January 2017 statement from ISMPP, AMWA, and EMWA, what is a major responsibility of medical writers?
• What does EQUATOR stand for in the context of reporting guidelines?
• What is a limitation associated with Altmetrics.com?
• What should be included in a journal's policies regarding conflicts of interest?
• What should be reviewed and approved prior to commencing a clinical trial regarding participant payment?
• Can a clinical investigator who owns stock in the sponsoring company conduct a trial for that company?
• Which organization designed the Authors' Submission Toolkit?
• Which type of content is typically included in presentations at conferences?
• Who are typically the contributors to a specific publication or closely related publications?
• What should companies do if a product's development program is discontinued?
• What is one of the responsibilities of investigators related to statistical data in a clinical trial?
• What is the term used when too many qualified authors exist to be listed on an author byline?
• What metric is described as social media-based in the context of publication evaluation?
• What category is NOT included in the core principles of ICH-GCP?
• What does the term investigator group refer to?
• What is one reason a manuscript could be released to the public prior to publication?
• What is the primary concern for editors when managing DURC submissions?
• How are research participants informed about the archival use of their tissues?
• What is the focus of the findings outlined in the Clinical Study Report (CSR)?
• What is a crucial criterion for selecting clinical trial investigators?
• What is meant by the term share of voice in publication?
• What is a potential treatment option for patients with serious diseases who cannot participate in clinical trials?
• Is it necessary for authors to declare assistance received in study design or manuscript preparation?
• Which jurisdictions are primarily governed by the ICH Guideline for Good Clinical Practice (GCP)?
• Who benefits from the guidelines established by the EQUATOR Network?
• What factor must be weighed when considering expanded access for a patient?
• Which organization is indicated by the acronym AMWA?
• What is one use of altmetrics in research?
• Which of the following is a purpose of the GPP3 guidelines?
• If a DSMB member has a significant financial conflict, should they participate in a DSMB?
• What must coauthors ensure for their inclusion according to ICMJE guidelines?
• Which of the following provides a comprehensive list of ongoing clinical research in a given therapeutic area?
• Who reviews clinical trial protocols under PhRMA guidelines?
• What does the term re-publication refer to?
• What is a potential downside of using altmetrics?
• What is meant by a kick-off in research team activities?
• In the case of a large, multi-center study, who should be listed as coauthors?
• Which aspect of a publication plan is supported by evaluating an audience's knowledge base and informational needs?
• Who is responsible for crafting the text, tables, and figures in individual publications?
• What is a charter in the context of a steering committee?
• Should researchers communicate the results of exploratory trials conducted in healthy adults?
• In the context of clinical trials, what does "relevant" data refer to?
• What is the purpose of an authorship adjudication group?
• What important input does a literature gap analysis provide to the publication strategy?
• What does CSE stand for?
• Where are clinical trials typically registered and results posted?
• What is the purpose of the CONSORT Statement?
• What is a requirement for conducting clinical trials or observational studies?
• Is it appropriate to include additional participants in a clinical trial solely for training purposes for investigators?
• Which of the following is the MOST appropriate and transparent approach to disclosure of potential author conflicts of interest?
• What does RCT stand for in clinical research?
• What is the standard timeframe for companies to submit registration information for clinical trials after patient enrollment?
• What term refers to the collective contributions and perspectives of individuals involved in a publication?
• Why is data quality important in the context of ICH-GCP?
• If a physician licenses a compound to a company, can they also act as a clinical investigator for that compound?
• What does the Altmetrics Manifesto describe?
• Which term encompasses peer-reviewed journal articles, abstracts, and presentations at scientific conferences?
• What is the role of publication professionals?
• What must be disclosed if a medical writer's contributions do not meet authorship criteria?
• What is one positive aspect of altmetrics?
• What are congresses and professional meetings primarily focused on?
• Where is the appropriate place to list an investigator who only collected data or provided funding?
• What is an expected outcome of including diverse populations in clinical trials?
• Who typically owns a scientific journal?
• What does an encore presentation refer to in academic settings?
• What is the role of sponsors regarding investigator access to study data?
• What primary benefit does the Authors' Submission Toolkit aim to achieve?
• Which of the following is NOT a responsibility typically associated with medical writers?
• Is confidentiality required in the manuscript submission process?
• What are long-form publications intended to appear in?
• Which practice is central to the integrity of medical publishing as emphasized in the Authors' Submission Toolkit?
• What does the acronym IRB/IEC stand for?
• If a participant withdraws from a study, what can they request regarding unused portions of their stored samples?
• How should journals approach the process of manuscript evaluation?
• How often should a publication plan be reviewed and revised?
• When designing a clinical trial, what balance must sponsors maintain?
• What are presentations commonly referred to in the context of conferences?
• What information do companies commit to providing when presenting results of a clinical trial?
• What is an abstract in the context of research publications?
• What should be developed after a literature review in a publication plan?
• Which of the following is NOT a responsibility of editors towards authors?
• What should authors do prior to manuscript submission?
• How should companies communicate significant findings from exploratory trials?
• Does a company have a commitment to communicate results if the investigational product is not approved for marketing?
• What is enhanced content in scientific publications?
• If significant new safety information arises after consent has been obtained, what should the sponsor do?
• What is the requirement for IRB/IEC approval regarding clinical trials?
• For which publication format is it advisable to keep the word count to 250 words or less?
• What is the purpose of the Authors' Submission Toolkit?
• In what circumstance can ghostwriting in medical publications be considered ethically acceptable?
• Does Company C have an obligation to communicate results of a trial if the product is still under development?
• What is the main conflict of interest for a physician acting as an investigator while having licensed a compound to a company?
• What defines dual use research of concern (DURC)?
• What is generally considered the format for disseminating information in peer-reviewed journals?
• What time frame defines the "timely" submission of clinical trial results for approved products?