MAB Registration Exam key terms

A function within life-sciences companies that bridges clinical development and commercial activity by generating and communicating scientific evidence, supporting investigators, and ensuring balanced information reaches healthcare professionals and patients.

Communication of scientific or medical information between company personnel and external stakeholders, including proactive education and reactive responses to unsolicited questions, distinct from promotional messaging.

A document defining a product's evidence gaps, data-generation priorities, stakeholder engagement approach, and communication goals across its lifecycle, aligned with clinical and commercial plans.

An early clinical study, usually in a small number of participants, designed mainly to assess safety, tolerability, pharmacokinetics, and sometimes pharmacodynamics, and to identify a dose range for later testing.

A process that assigns trial participants to treatment groups by chance, reducing selection bias and helping ensure that known and unknown prognostic factors are balanced across comparison arms.

Concealment of treatment assignment from participants, investigators, assessors, or analysts, intended to reduce bias in reporting, measurement, and interpretation of study outcomes.

The comparison group in a clinical trial, which may receive placebo, an active comparator, or standard care, allowing researchers to estimate the effect of the investigational treatment relative to a reference.

A predefined variable measured in a trial to assess treatment effect, such as a biomarker, symptom score, survival time, or safety event, specified in the protocol before data collection begins.

The main outcome a trial is designed and statistically powered to evaluate, forming the basis for the primary efficacy conclusion in the study report and regulatory submission.

A laboratory or imaging measure, such as tumor shrinkage or cholesterol level, used as a substitute for a clinical outcome when it is reasonably likely to predict benefit.

The probability that a study will detect a true treatment effect of a specified size, determined by sample size, effect size, variability, and the chosen significance level.

A prospective determination of the number of participants needed to answer a trial's primary question with adequate power and acceptable type I error, accounting for expected dropout and effect size.

The voluntary agreement of a person to participate in research after receiving and understanding information about purpose, procedures, risks, benefits, alternatives, and rights, documented per regulations.

An independent committee that reviews and monitors research involving human participants to protect their rights and welfare, with authority to approve, require modification, or disapprove studies.

An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials involving human participants, ensuring data credibility and protection of participant rights.

A regulatory pathway allowing earlier approval of drugs for serious conditions based on a surrogate or intermediate endpoint reasonably likely to predict benefit, with confirmatory studies required afterward.

A status granted to therapies intended for rare diseases meeting defined prevalence thresholds, typically providing incentives such as market exclusivity and fee reductions to encourage development.

A formal cross-functional process, usually involving medical, regulatory, and legal reviewers, that assesses promotional materials for accuracy, balance, fair balance, and consistency with approved labeling before use.

The requirement that promotional materials present risks and benefits with comparable prominence and readability, so that safety information is not minimized relative to efficacy claims.

Prescribing or using an approved medicine for an indication, dose, population, or route not covered by its approved labeling; companies generally may not promote such use.

A function that responds to unsolicited inquiries from healthcare professionals and patients with accurate, balanced, referenced scientific information about a company's products and therapeutic areas.

A pre-approved, medically reviewed document used to answer frequently asked unsolicited questions consistently, containing balanced information and citations that are kept current.

A field-based scientific professional who engages healthcare professionals and researchers in non-promotional scientific exchange, gathers insights, and supports research and education within compliance boundaries.

A clinician or researcher recognized for expertise and influence in a therapeutic area, who may advise on study design, speak at scientific programs, or participate in advisory boards.

A structured meeting in which external experts provide advice on scientific, clinical, or strategic questions, governed by rules on fair-market-value compensation, documentation, and separation from promotion.

Structured observations gathered from external stakeholders during field interactions, analyzed to inform medical strategy, evidence generation, and internal understanding of clinical practice and unmet needs.

A research study proposed, designed, and conducted by an external investigator or institution, with company support typically limited to funding, drug supply, or both, under a written agreement.

Clinical evidence derived from analysis of data collected outside randomized controlled trials, such as registries, claims, and electronic health records, reflecting routine care and broader populations.

A study designed to test an intervention under conditions resembling routine practice, with broad eligibility and usual-care comparators, to support generalizability and decision-making.

A question important to clinical or access decisions for which existing data are insufficient, inadequate, or conflicting, and which may justify new studies or analyses.

The science and activities relating to detecting, assessing, understanding, and preventing adverse effects or other drug-related problems, spanning pre-approval and post-marketing phases.

Any untoward medical occurrence in a patient or trial participant administered a product, which does not necessarily have a causal relationship with the treatment.

An adverse event that results in death, is life-threatening, requires hospitalization or prolongs it, causes persistent disability, is a congenital anomaly, or is otherwise medically important.

The process of identifying new or changed safety information that suggests a possible causal association between a product and an event, warranting further assessment and possible regulatory action.

A document describing a product's known safety concerns and the pharmacovigilance and risk-minimization activities planned to monitor and reduce those risks in real-world use.

A systematic evaluation of the clinical, economic, and social effects of a health technology, used by payers and agencies to inform coverage and reimbursement decisions.

An economic evaluation comparing the incremental cost of an intervention with its incremental health benefit, often expressed as cost per quality-adjusted life-year gained.

A metric combining length of life with health-related quality of life, where one year in perfect health equals 1.0, used to compare health gains across interventions and conditions.

A strategic process that maps anticipated data disclosures to planned manuscripts, abstracts, and congress presentations, aligning timelines, authorship, and channels with evidence-generation milestones.

Standards, commonly the ICMJE recommendations, defining who qualifies as an author through substantial contribution, drafting or critical revision, final approval, and accountability for the work.

The professional preparation of scientific documents such as protocols, clinical study reports, manuscripts, and regulatory summaries, ensuring accuracy, clarity, and compliance with required guidelines.

The compensation rate for services such as consulting or speaking that would be paid in an arm's-length transaction, used to avoid improper inducement in interactions with healthcare professionals.

Public disclosure of transfers of value from companies to healthcare professionals and organizations, such as fees, meals, and grants, as required by law or industry codes.