Board Certified Medical Affairs Specialist (BCMAS) Practice Exam

These questions are part of the practice quiz. Start practicing

• Which resource is highlighted as a guide for locating guidelines?
• In grant management, which stage is focused on reviewing, assessing, and auditing information?
• What is the first step of practicing evidence-based medicine (EBM)?
• The key to maintaining the integrity of and trust in medical communication is _________?
• What is a constraint on the manufacturing and selling of new medical devices?
• Which product was used as an obesity treatment and advertised on the radio without including adverse effects of tachycardia and insomnia?
• Which statement accurately reflects company policy on promotional materials for MSLs?
• Medical Information usually provides data-driven, targeted, and fair-balanced drug information for HCPs in which phase?
• After sufficient safety and efficacy data exist for a new COVID-19 vaccine, which application is required to launch?
• Under which condition may a company use prescriber data? (NOT permissible use)
• IND stands for which of the following?
• Who should medication guides primarily communicate warnings or contraindications to?
• REMS are designed to address the ______ for different drugs and classes of drugs.
• Which question best captures the aim of practicing evidence-based medicine?
• Which phase typically follows the discovery phase?
• Which limitation is commonly associated with systematic reviews?
• Pre-test and post-test studies determine the changes before and after the intervention.
• In the 5-step process to respond to a medical information question, which step is the final step?
• Which statement would best describe the purpose of a health status assessment instrument?
• Which data type is most directly used to identify safety signals for regulatory action?
• As an MSL, if asked to influence grant planning content, what is the appropriate response?
• Which of the following best defines the PICO constituents?
• REMS are designed to address the ______ for different drugs and classes of drugs.
• An MSL on your team provides a speaker honorarium in exchange for the healthcare provider to write at least 5 prescriptions per week of their newly approved drug. Which of the following is true?
• Prior to publication approval, which departments must approve abstracts, posters, oral presentations, and manuscripts?
• Which drug type has risks that may not be well understood?
• During which phase of the drug development process does testing in humans begin?
• What does REMS stand for?
• In the PICO approach to practicing evidence-based medicine, what does the 'I' stand for?
• Which section of a scientific manuscript should the inclusion/exclusion criteria fall under?
• Which advisory board has members with similar or relevant backgrounds?
• Which type of application do you need to file with the FDA to obtain approval to initiate clinical trials?
• In a parallel study design, how are participants allocated to interventions?
• Which statement is NOT a stated benefit of interactions between pharmaceutical companies and health care professionals?
• In health economics, which item is NOT a direct medical cost?
• Which type of economic analysis is used to compare costs and benefits by assigning a monetary value to all outcomes?
• How often is the Development Safety Update Report (DSUR) typically submitted?
• In pharmacoeconomic analyses, what does a sensitivity analysis examine?
• Health outcomes research encompasses pharmacoeconomic outcomes, therapeutic outcomes, nontherapeutic outcomes, and which other type?
• Which professional typically answers Medical Information questions by consulting drug references?
• Which groups were mandated by the NIH Revitalization Act of 1993 to be included in clinical research?
• Which statement about point-of-care diagnostics is false?
• Which of the following lists contains the three main literature classifications?
• Are published abstracts required to follow a defined structure or guidelines for publication purposes?
• Findings should be interpreted in the Results section.
• Which CFR Part is titled 'human subjects protection'?
• ETASU stands for which of the following?
• If a study does not require a mean and variance, what type of distribution is most likely indicated?
• In DOTS classification, an adverse effect occurring at supratherapeutic concentrations is described as:
• Which A/B classification is an augmented pharmacologic effect that is dose dependent and predictable?
• Which act is most closely associated with drug labeling and promotion compliance?
• 21 CFR Part 820 governs which area?
• Which statement about post-marketing data collection is true?
• Fundamental requirement for ongoing risk evaluations of REMS.
• What is an example of primary level of evidence?
• Which law requires manufacturers to demonstrate that drugs are safe and effective before marketing?
• European clinical trials conducted to support drug approval are generally similar to those conducted in the United States.
• In the 5-step process to respond to a Medical Information question, which step follows the initial assessment?
• T/F: Medical information responses must be specific, scientifically objective, balanced, truthful, transparent, and non-misleading.
• Which phase focuses on testing in humans?
• Combination product applicant(s).
• Which of the following is an FDA labeling requirement for in vitro diagnostic (IVD) products?
• Which statement best describes a requirement of promotional materials under the PhRMA code?
• Which statement best reflects policy on including off-label information in promotional materials?
• In regulatory terms, what does the phrase 'satisfactory balance' refer to?
• Jim's team plan with Key Opinion Leaders (KOLs) involves scheduling meetings. What type of product initiative is this?
• Which of the following is a secondary literature source?
• Practicing a presentation beforehand should be avoided because it can lead to an overly rehearsed tone.
• A meta-analysis is a type of study design that uses statistics to summarize results of several studies.
• When were the first Good Pharmaceutical Practice guidelines published?
• In the 5-step process to respond to a medical information question, which step comes first?
• Which of the following best describes an appropriate educational gift for HCPs?
• The EURD list pertains to the preparation of which type of report?
• Which statement best describes post-marketing trials?
• Which of the following is a tertiary source of evidence?
• Which element is NOT necessary for the REMS of the Abbreviated New Drug Application (ANDA)?
• Why would a pharma company consult an advisory board when starting development of a new drug?
• Which type of prescriber data includes information on how often a drug is prescribed?
• For marketing a biologic product in the United States, which regulatory submission is required?
• Diagnostic test data are characterized by which two properties?
• When looking for research opportunities, you can use some Internet resources, such as:
• In cost-effectiveness analysis, which outcome measure is illustrated by the example comparing two drugs?
• What is the first step in conducting a pharmacoeconomic analysis?
• Under 21 CFR Part 211 Subpart A, what best describes its purpose?
• In the clinical design stage, what is the most significant source of bias?
• NOT true about medical writers?
• Which of the following is not a component of the SMART paradigm for goals?
• Which characteristic best describes descriptive abstracts?
• Over a 10-year timeframe as of July 2020, approximately how many reports of potentially false or misleading promotion were submitted by healthcare professionals to the Bad Ad Program?
• What is an example of cost utility analysis (CUA)?
• Which statement about the PMA pathway for medical devices is true?
• Which of the following is a goal of pharmacogenomics?
• Which option is not typically part of post-market safety monitoring?
• CRAMS stands for which of the following expansions?
• In cost-effectiveness analysis, which type of outcome is used?
• External validity refers to the extent to which study results can be generalized beyond the study sample.
• What is the purpose of medication guides?
• A kick-off call is a call in which the pharma company brings in the KOL (physician, nurse practitioner, pharmacist, etc.) who will collaborate in developing the publication.
• Which statement about storytelling in MSL/HCP interactions is most consistent with best practice?
• What is considered the most challenging step when establishing an advisory board?
• Which law requires companies and manufacturers to publish their interactions with health care professionals?
• Which statement aligns with the regulatory definition of a mobile medical application?
• Which type of advertisement is required to provide a fair balance of drug risks compared with benefits?
• Which statement is true about the role of a KOL in publication development during a kick-off call?
• In Practice-Based Clinical Experience Studies (PESs), data are collected from which participants?
• In the context of medical information, which professional is most likely to use a drug manual to craft a formal response to a question?
• Which statement describes the purpose of the FDA's Bad Ad Program?
• Which REMS component is typically required to ensure safe use?
• Dr. Simpson, a neurologist, occasionally participates on an advisory board for Lightning Pharmaceuticals. Dr. Simpson has also just become a member of a national committee that makes recommendations for clinical guidelines and formulary decisions. Is Dr. Simpson required to disclose her relationship with Lightning Pharmaceuticals to the national committee she is a member of?
• Which statement best describes 21 CFR Part 58?
• Can unapproved drug uses be included in SRDs?
• Which statement best describes pharmacovigilance's role in drug safety?
• Under the third-tier compliance regulations, which statement best describes 21 CFR Part 7?
• Which phase focuses on post-marketing research after a drug has been approved?
• Which agency administers the Physician Payments Sunshine Act reporting requirement?
• Which item is NOT typically included in post-meeting follow-up communications?
• 21 CFR Part 56 covers which regulatory topic?
• Which study design assigns participants to two or more different treatment groups without randomization?
• True or False: The primary function of an advisory board is to offer trusted advice on the company's issues.
• Non-randomized comparative studies are best described as which design?
• Cost-minimization analysis (CMA) assumes that outcomes are equivalent.
• Which item is an example of a Class I medical device?
• Before market approval, testing for medical devices typically includes which set of attributes?
• Phase III trials are typically designed to assess effectiveness and safety in a larger patient population.
• Which phase involves post-approval studies and ongoing safety assessment?
• Under the first-tier compliance regulations, which statement best describes 21 CFR Part 211 (subparts A-K)?
• When would a New Drug Application (NDA) be submitted?
• Which economic challenge is commonly faced by medical device manufacturers?
• Which statement is true about public pharmaceutical companies?
• What is an example of secondary level of evidence?
• What best describes a health status assessment?
• Which study design is classified as retrospective?
• The European Union Reference Dates (EURD) is updated on an ongoing basis.
• What term describes the bias when the enrolled cohort differs from the general population?
• What type of educational gift would be considered appropriate for handing to a healthcare professional by a Medical Science Liaison?
• Which statement about abstracts is true?
• Indirect costs are best described as:
• What is the primary purpose of a Risk Evaluation and Mitigation Strategy (REMS) or Risk Management Plan (RMP)?
• Which acronym stands for International Conference of Drug Regulatory Authorities?
• Which statement about companion diagnostic labeling is true?
• When answering a medical information question, which step involves assessing the credibility and relevance of the information source?
• Which statement best describes a disease-specific Health-Related Quality of Life instrument?
• Individual board members are known as:
• What is the role of Medical Affairs in post-marketing studies?
• MSLs can aid in the design of corporate and investigator-initiated clinical trials.
• Which term describes the regulatory expectation that financial relationships with physicians be disclosed?
• Which statement about the Office of Prescription Drug Promotion (OPDP) is accurate?
• The publication plan is primarily used to do what?
• Triad between manufacturers, HCPs, and consumers refers to which model?
• What is the primary purpose of a communication plan in the context described?
• Which term is NOT a component of PICO?
• Which statement best describes informative abstracts?
• What is the primary goal of medical affairs?
• What is an example of cost-effectiveness analysis (CEA)?
• What is the correct order of the five major phases of drug development?
• Practice-Based Clinical Experience Studies (PESs) are designed to collect real-world data from which source?
• In a proactive interaction, who initiates the discussion about product information?
• The Prescription Drug Marketing Act allows drug samples to be provided for patient use.
• Which option indicates the 2012 Medical Device User Fees Amendment aims to improve the overall review process?
• Cost-benefit analysis (CBA) measures outcomes in what units?
• Which activity is typically described as part of the grant's pre-award phase?
• Cost-minimization analysis (CMA) is appropriate when which condition is met?
• In clinical trials, which phase enrolls the largest number of participants?
• What best describes cost-minimization analysis (CMA)?
• What term does the FDA use to describe a concern about an excess of adverse events compared to what would be expected with a product's use?
• Why is the diagnostic industry expanding its focus to rare diseases?
• CRAMS service mix includes both research and manufacturing capabilities. Which option best describes this?
• Which term describes an unpleasant and unintended response to any dose of a drug or biologic product where there is a possibility that the product caused the response?
• What ratio of content to interactivity should you strive to maintain in a presentation?
• At what point in the drug development process can a product launch occur?
• Which of the following is a recommendation from the GPP guidelines?
• Which factor considers the extent to which a reaction can cause harm?
• SRDs are prepared for which audiences?
• Quality of Life (QOL) outcomes refer to the impact on a patient's overall well-being and daily functioning.
• Which database is known for systematic reviews and meta-analyses in healthcare?
• HR-QOL stands for which term?
• Under the second-tier regulations, does the Institutional Review Board require a minimum of two members?
• Which are the most important types of validity?
• What would cause the FDA to require post-marketing studies or clinical trials at the time of approval or afterwards for a new product?
• Which description best aligns with compliant meals during representatives' interactions with healthcare professionals?
• The study of variations in DNA and RNA characteristics as related to drug response
• Which organization typically develops the communication plan?
• Which set of outcomes is included in health outcomes research?
• Which organization is responsible for harmonizing regulatory standards in the pharmaceutical industry?
• In the context of post-marketing studies, what is the team’s role when a potential label change is identified?
• Which step involves deciding on the best source to answer the question?
• Which statement best describes continuing education (CE) programs in medical writing?
• Not required by adverse drug reaction (ADR) reporting.
• Which statement best describes outcomes research focus?
• ADR reporting is best described as:
• Which of the following is a type of prescriber data a company may use?
• In Khaled's 5-step process for responding to a Medical Information question, what is the third step he should follow?
• In the described Phase III trial comparing osamarin to losartan, what type of study is it?
• Primary literature is original research.
• The regulatory requirements for drug products include much tighter controls over the manufacturing process than for medical devices.
• Which of the following is an essential compliance consideration for an advisory board on a new medical device?
• Which statement is accurate about the advisory board's function?
• An MSL delivers an educational program for cardiologists about a new cholesterol medication at a football game. Is this an appropriate interaction?
• Which statement about FDA clearance for medical devices is true?
• CRAMS service model emphasizes which of the following?
• In early drug development, what is the main purpose of consulting an advisory board?
• Which term describes the science that explains how inherited genetic differences influence individual responses to medications?
• When should companies start preparing for a product launch?
• Post-marketing trials involve fewer patients than Phase III studies.
• Practice-Based Clinical Experience Studies (PESs) are:
• Randomized controlled trials usually have more bias than non-randomized controlled trials.
• Which statement best describes primary literature?
• Which term in PICO describes the outcomes to be measured?
• What is the typical word limit for descriptive abstracts?
• A kick-off call in publication development is typically described as:
• IRB subpart addresses which element?
• An abbreviated new drug application is submitted to the FDA for which products?
• Which statement about post-marketing trials is correct?
• Which of the following is NOT typically included in the Drug Discovery Stage approaches?
• Which best describes retrospective data?
• What is a study's perspective?
• Among the four types of presenters in the context of MSL work, which should be the goal of an MSL professional?
• What is a mobile medical application?
• Which of the following describes the Investigators Brochure?
• Stephanie, a medical writer, is creating a descriptive abstract. Which of the following should she be sure to do so as to not confuse it with an informative abstract?
• The NIH Revitalization Act of 1993 directed the NIH to include which groups in clinical research?
• When first working on a publication, what should authors do to identify their rights, roles, and responsibilities?
• Which content does molecular diagnostics primarily detect to understand disease pathogenesis?
• Which description best fits a company that conducts research and manufactures drugs under licenses from other companies?
• Which statement describes challenges around impact measurements using scholarly big data?
• Which description best summarizes 21 CFR Part 211 (subparts A-K)?
• Which of the following best describes the purpose of an agenda and a meeting moderator for advisory board sessions?
• Which of the following is NOT a purpose of IIS?
• Which of the following meal policies is considered appropriate when representatives interact with healthcare professionals?
• The abbreviation BLA stands for what?
• At what point in a drug's lifecycle does the 20-years of patent protection begin?
• Approximately how many articles about COVID-19 were published in 2020?
• In research, which term describes distortion caused by other variables to both exposure and outcome?
• What is Pharmacoeconomics?
• Which option best completes this statement: The goal of evidence-based medicine is to integrate best research evidence with clinical expertise and patient values?
• Which scenario would most clearly violate the anti-kickback statute?
• FD&C Act is primarily associated with regulating which categories?
• What is a primary way molecular diagnostics help understand disease pathogenesis at the molecular level?
• Which statement best describes the investigator's responsibilities in a regulatory environment?
• What must the label of a companion diagnostic device contain information about?
• Direct medical costs are defined as which of the following?
• An advisory board moderator should develop which skill to keep meetings on track?
• What did the Medical Device User Fees Amendment of 2012 authorize the FDA to do?
• Why is it important to consider patient values in evidence-based practice?
• Which program requires companies to report certain payments to the federal government?
• Which describes discounting in financial forecasting?
• Statement: Medical writers should address the public's questions to prevent the spread of health misinformation.
• In what year was the American Medical Writers Association (AMWA) established?
• What forum, first hosted in the early 1980s by the WHO, is for global regulatory authorities to meet and discuss ways to strengthen collaboration?
• ETASU statement: 'Elements to Assure Safe Use' are required medical interventions taken by HCPs prior to using the drug.
• Who submits reports to the FDA's Bad Ad Program?
• Which scenario best describes a proactive interaction between a pharma company representative and a healthcare professional?
• What does the abbreviation CUA stand for in pharmacoeconomics?
• What percentage of communication meaning is derived from words?
• Which statement best describes a benefit of interactions between pharmaceutical companies and health care professionals?
• How have the Good Publication Practices (GPP) Guidelines for Sponsored Medical Research ensured industry standards?
• Is it true or false that IIS grants can be awarded by professional societies?
• Severe birth defects are not included in FDA mandated REMS.
• Under what conditions can a pharma company provide financial support for conferences and CME?
• The pharmaceutical industry's origins trace back to which country?
• What is the likely impact of outsourcing on workflow consistency?
• Which activity is a core function of pharmacovigilance?
• Which item is NOT commonly considered by the FDA when deciding on REMS?
• Which of the following is a potential disadvantage of IIS?
• Under the second-tier regulations, which statement best describes 21 CFR Part 58 (subparts A-K)?
• Post-Marketing Requirements (PMRs) typically address what aspect?
• A disadvantage of point-of-care diagnostics is training requirements.
• What is the last step of practicing evidence-based medicine (EBM)?
• 21 CFR Part 50 focuses on:
• The first step in initiating research funding involves which activity?
• Which CFR Part covers Institutional Review Boards (IRB)?
• A regulator's decision to approve a drug for marketing is based on it having a ______ of benefits and risks within the conditions specified in the product labeling.
• REMS may be required during which part of the product life cycle?
• Which statement about the FDA 510(k) clearance pathway is accurate?
• When would an Investigational New Drug Application (IND) be submitted?
• Which statement accurately reflects the PICO framework structure?
• Which sequence correctly describes the typical regulatory submission flow for a drug in the United States?
• Which statement best describes the predicate device concept in device regulation?
• Which study design is most commonly used in comparative research?
• EBM databases are exemplified by which of the following?
• Which of the following helps ensure that prescription drug promotion is truthful, balanced, and accurate?
• In research investigations where the investigational product may offer a valuable treatment alternative, which trial designs can be used?
• Which statement about REMS design is correct?
• New drug indications, new product combinations, new routes of administration, new drug delivery formulations, and testing of new excipients can all be:
• The third-tier compliance regulation 21 CFR Part 7 addresses what?
• Amber is an MSL and receives a physician question about a medication indication that is not FDA approved. Which statement is true?
• When considering interactions with healthcare professionals, the primary consideration should be the needs of whom?
• Which of the following is NOT a purpose of IIS?
• MSL teams can be as small as 1 or larger than 100 people.
• 21 CFR Part 50 Subpart B addresses detailed requirements for which topic?
• In project management, the SMART paradigm stands for which elements?
• Which of the following regulates prescription drug promotional labeling?
• Who is required to submit a periodic safety update report?
• Which advisory board is composed of up to 15 members with different backgrounds for a large-sized company?
• Which statement best describes descriptive abstracts?
• The medical affairs team contributes to the product launch by educating the medical community and customer groups.
• How are REMS designed to help drug sponsors?
• What is the purpose of the Investigators Brochure?
• SADR reporting triggers post-marketing safety actions by the FDA.
• What IVD market segment would Molecular Diagnostics belong to?
• Which of the following is a reason for conducting Post-Marketing studies?
• Molecular Diagnostics belongs to which IVD market segment?
• Post-Marketing Trials may be more complicated and time consuming than Phase III Clinical Trials. Which option is correct?
• In preparing a grant proposal, which item is NOT typically included?
• To what agency/organization must companies and manufacturers report payments to physicians, investment interests held by physicians, and transfers of value made to physician owners?
• Which description best describes 21 CFR Part 211?
• Which of the following statements about Post-Marketing Research is NOT true?
• Which trait is commonly associated with high emotional intelligence?
• In the United States, which organization established voluntary codes and standards regarding ethical interactions between HCPs and pharmaceutical companies?
• Which CFR Part corresponds to Quality and system regulations?
• In cost-effectiveness analysis, which is a common outcome measure?
• Which of the following is the first step in Ryan's grant process?
• CRAMS service expansion: which option correctly identifies the full expansion?
• What is the type of combination product in which the drug and device come in the same package as two different parts (e.g., a drug that comes with an empty syringe in the same package)?
• In vitro diagnostic test — example.
• Which drug description would be most likely to meet approval as a generic drug?
• In an equivalence trial, which hypothesis states that a difference of at least Δ exists?
• Which testing can take place at the Pre-Clinical Research phase?
• Which PMCs study type is commonly used to observe real-world drug utilization patterns?
• Which statement best describes the relationship between European and United States clinical trial processes?
• Bias is defined as which of the following?
• What is a typical discount rate range used in pharmacoeconomic analyses?
• Presentation skills are essential for maintaining a position with MA.
• An example of a marketed product SRD is:
• Which act covers labeling and advertising of drugs in the United States?
• CRAMS providers can best be described as entities that:
• In promotional content, the term 'off-label indications' refers to uses not approved by the FDA.
• Using a drug manual to answer a Medical Information question represents which level of evidence?
• Which term describes an advisory board where members share similar backgrounds?
• What does the 'P' in PICO stand for?
• What type of measurements do diagnostic tests provide to ensure accurate and reliable delivery of information?
• CRAMS stands for which of the following?
• Product Lifecycle Management (PLM) is described as the process of managing the lifecycle of a product (a drug) from innovation, development, and introduction to withdrawal from the market.
• Best practice and ethical standards for reporting research published in medical journals.
• Which agency is a primary regulator of pharmaceuticals in the United States?
• The medical director analyzes the data and determines whether there are informational gaps.
• Which option best represents an example of creating a healthcare policy document?
• Which statement describes an in vitro test environment?
• Which statement about FDA approvals for medical devices is true?
• Audience members come to a presentation with the primary focus of, "what's in it for me"?
• Which principle underpins truthful and balanced medical information communications?
• Which is the chief consumer watchdog which assesses new drugs before they hit the market and continues to monitor safety after they are marketed?
• Are surveys classified as cross-sectional studies?
• Which are considered key items the FDA will contemplate when deciding on whether REMS is needed?
• In the described market model, who functions as the important middlemen between manufacturers and consumers?
• Are IIS grant applications the same for all companies?
• What is another name for a group allocation design?
• Which technology or approach enables the identification of patient responders in rare diseases, supporting diagnostic expansion?
• Which of the following is regulated by the Office of Prescription Drug Promotion (OPDP)?
• To ensure accurate data for a potential label change, the Medical Affairs team should:
• What science is involved in the detection, assessment, and prevention of adverse effects in medicine?
• Which reason explains why Medical Science Liaisons (MSLs) may gain access to a physician's time more readily than traditional drug sales representatives?
• Which resource is an example of a place to locate clinical guidelines?
• What is the recommended timeframe for meeting follow-ups after the meeting?
• Which statement best describes a sensitivity analysis in pharmacoeconomic evaluations?
• Compared with generic HR-QOL instruments, disease-specific instruments are more likely to
• Which statement is not true about promotional materials?
• The statement 'Under the second-tier compliance regulations, 21 CFR Part 50 Subpart B addresses detailed requirements for informed consent' is true.
• Which type of advertisement is used to describe a disease without naming a drug?
• Which statement correctly describes when patent protection for a drug begins?
• In pharmacovigilance, safety signals are identified against a background of what?
• A group allocation design is also known as cluster randomization.
• What term describes the packaging arrangement where a drug and a device come in the same package as two separate parts?
• A newly approved pacemaker is undergoing ongoing surveillance for concerns. Which step of device development does this represent?
• Which term describes the ongoing collection of data on the safety of medicines after they've been marketed?
• Which of the following best describes the content of systematic reviews?
• Which regulatory concept describes the process that starts with an IND submission and ends with an NDA submission?
• In a setting with a standard of care for a serious illness, is it ethical to conduct a trial designed to demonstrate superiority over placebo?
• Which section of the Code of Federal Regulations (21 CFR) covers the procedures for performance standards development?
• Which description best describes 21 CFR Part 210?
• Which of the following is not typically part of PMCs?
• What is the integration of the best research evidence with clinical expertise and patient values called?
• Which medication prompted the Kefauver-Harris Amendments?
• Which element is required in FDA labeling for in vitro diagnostic products?
• What is the scientific platform?
• 21 CFR Part 58 governs what?
• Which CFR Part governs Good manufacturing practices for finished pharmaceuticals?
• Which regulatory classification applies to high-risk in vitro diagnostic devices requiring premarket approval?
• Which statement describes the content typically found in an informative abstract?
• According to the PhRMA code, promotional materials provided to healthcare professionals by, or on behalf of a company should: Which statement is NOT a requirement?
• The Medical Dictionary for Regulatory Activities (MedDRA) and the Common Technical Document (CTD) were developed through the work of which organization?
• Manufacturers are not required to report serious adverse events to the FDA.
• What is the main purpose of an Investigational New Drug (IND) application?
• Fellowship funding is best described as what type of grant?
• Which element is included in REMS to ensure safe use?
• First step of the process for device development?
• Which of the following is not one of the essential points to first consider when developing a medical affairs strategy?
• Who develops the clinical protocol for a study in a pharmaceutical company?
• How long does it typically take for a person to form a first impression during an initial interaction?
• What does the acronym PMR stand for?
• During which phase of the research process do MSLs typically begin surveillance of a specific therapeutic area or compound?
• Which type of drug advertisement describes a disease but does not discuss a specific medication?
• Which distribution channels are regulated by the FDA?
• Which of the following studies is NOT typically included as part of Post-Marketing Commitments (PMCs)?
• Goals of pharmacogenomics include which of the following?
• Which analysis considers patient preferences in its outcome measures?
• Which statement best describes evidence-based medicine?
• True or False: The use of storytelling in MSL/HCP interactions is outdated and should be avoided.
• For an advisory board developing a new medical device, which statement best captures its compliance focus?
• What is a common cause of export challenges for a medical device company?
• What is a disadvantage of outsourcing in medical affairs?
• A medical device company has completed form, fit, function, and safety testing but the device has no predicate device on the market and is presumed safe. Which FDA device class should be used to determine the appropriate approval process?
• Post-Marketing Commitments (PMCs) include study designs not mandated by the FDA.
• Which factor primarily determines the appropriate FDA approval pathway for a new medical device?
• In vitro describes something in glass such as a test tube or petri dish.
• A medical science liaison is tasked with creating a slide deck for a medical conference for physicians. The target audience is physicians.
• Which statement correctly contrasts CMA and CBA?
• Approximately how many slides should a 15 minute presentation include?
• Which step of the device development process involves the product launch and post-market safety monitoring?
• Which statement best reflects the purpose of post-marketing commitments?
• The process of internal cooperation, coordination, and common standards across the global pharmaceutical industry is referred to as:
• Retrospective data are used to estimate costs for which period?
• What can be both a challenge for advisory boards and a key element to a board's success?
• What are bibliometrics designed to provide?
• In clinical research, which term best represents the ratio of the odds of developing the outcome in the exposed group to the odds in the unexposed group?
• What fraction of communication is typically conveyed by tone of voice in professional interactions?
• Which of the following is NOT a typical reason for applying for a grant?
• Off-label information solicited by a drug manufacturer violates which US federal act?
• Which role is primarily responsible for ongoing pharmacovigilance and adverse event reporting within a pharmaceutical company?
• What are some of the ways that companies can benefit from non-mandated Post-Marketing studies?
• What is the ethical obligation for a clinician who has financial ties to a pharmaceutical company and serves on a clinical guidelines committee?
• What safety measure should be put in place to avoid serious infection associated with a drug?
• A company modified a device that has FDA-established performance standards for the device and the modification already in place. Which FDA filing type should the company submit?
• What type of study best provides real-life feedback from practitioners who have exposed a drug to a large number of patients?
• Which statement best describes the purpose of post-marketing studies?
• Which type of medical writing involves creating continuing education programs for healthcare professionals?
• What is outcomes research?
• Which of the following statements about PMCs is true?
• What is the Medical Device User Fees Amendment of 2012?
• Which statement about abstracts presented at professional meetings is true?
• In cost-utility analysis, which outcome measure is typically used?
• What is the first step to initiate the grant process?
• Prior to publication approval, which departments typically approve abstracts, posters, oral presentations, and manuscripts?
• In a randomized trial, which statement best describes the role of randomization?