Board Certified Clinical Trials Specialist (BCCTS)

The Board Certified Clinical Trials Specialist (BCCTS) credential is awarded to pharmacists who demonstrate advanced competence in clinical research methodology, biostatistics, and the generation, evaluation, and translation of therapeutic evidence. This certification reflects a pharmacist’s ability to design and evaluate clinical studies, interpret research data, apply evidence-based medicine principles, and support ethical, regulatory, and quality standards in clinical research and therapeutics. Board Certified Clinical Trials Specialists contribute to evidence generation, informed therapeutic decision-making, and the translation of research findings into clinical practice, policy, and healthcare improvement initiatives.

BCCTS Exam Outline
Domain 1: Foundations of Clinical Research and Evidence-Based Therapeutics (20%)

  • Principles of evidence-based medicine and therapeutic decision-making

  • Hierarchy of evidence and evidence appraisal frameworks

  • Roles and responsibilities of pharmacists in clinical research

  • Research ethics, informed consent, and protection of vulnerable populations

  • Regulatory and ethical standards governing clinical research

  • Patient safety, data privacy, and professional accountability

Domain 2: Clinical Trial Design and Research Methodology (25%)

  • Clinical trial phases and study designs

  • Interventional and observational research methods

  • Randomization, allocation concealment, and blinding

  • Bias, confounding, and methods to minimize systematic error

  • Selection of endpoints, comparators, and outcome measures

  • Superiority, non-inferiority, equivalence, adaptive, and pragmatic trials

  • Internal and external validity considerations

Domain 3: Biostatistics and Data Interpretation (20%)

  • Data types and descriptive statistics

  • Probability concepts and statistical distributions

  • Hypothesis testing, confidence intervals, and p-values

  • Parametric and non-parametric statistical tests

  • Correlation, regression, and multivariable analysis

  • Survival analysis and time-to-event data

  • Sample size determination, power analysis, and handling missing data

Domain 4: Research Operations, Regulatory Affairs, and Quality Systems (15%)

  • Protocol development, amendments, and documentation

  • Case report forms and source data verification

  • Clinical data management systems

  • Monitoring, auditing, and inspection readiness

  • Regulatory submissions and ethics committee processes

  • Quality assurance, quality control, and data integrity

Domain 5: Evidence Synthesis, Knowledge Translation, and Professional Practice (20%)

  • Systematic reviews and meta-analyses

  • Critical appraisal tools and evidence synthesis methods

  • Clinical guideline development and health technology assessment

  • Translation of research into clinical practice and policy

  • Scientific writing, publication, and dissemination

  • Implementation science principles

  • Research misconduct, publication ethics, and professional standards

Recommended Resources

The following resources are provided as examples of study materials that may support preparation for the Board Certified Clinical Trials Specialist (BCCTS) examination. This list is illustrative and not exhaustive. Candidates are encouraged to consult current methodological guidance, regulatory standards, and evidence-based literature relevant to clinical trials and research practice.

Core References

  • Fundamentals of Clinical Trials
    Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, et al.

    A foundational reference covering the design, conduct, analysis, and interpretation of clinical trials across therapeutic areas.

  • Textbook of Clinical Trials
    Stephen J. Machin, Simon Day, Stephen Green

    A comprehensive resource addressing clinical trial methodology, statistical considerations, and practical implementation of clinical research.

  • Introduction to Clinical Trials
    Diana Elbourne, Sarah Cook

    An accessible overview of key clinical trial concepts, emphasizing study design, conduct, and interpretation.

  • Principles of Research Design and Drug Literature Evaluation, 2nd Edition

    A focused reference addressing research methodology, critical appraisal of drug literature, and evaluation of clinical evidence.

  • Designing Clinical Research, Fifth Edition
    Stephen B. Hulley, Steven R. Cummings, Warren S. Browner, et al.

    A practical guide to developing research questions, selecting appropriate study designs, and conducting high-quality clinical research.

Supplemental Resources

Candidates may also consult current resources that support clinical trials design, conduct, and interpretation, including:

  • International guidelines and standards for clinical research conduct and ethics

  • Regulatory guidance related to clinical trials oversight and compliance

  • Peer-reviewed journals in clinical research, biostatistics, and therapeutics

  • Evidence-based medicine frameworks and methodological tools

  • Continuing education programs in clinical trials and research methodology

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