Clinical Trial Management Quiz

Risk-Based Monitoring

• Loss of control and subjectivity are disadvantages of Risk-Based Monitoring.
• Cost-effectiveness is an advantage of Risk-Based Monitoring.

Clinical Trial Unit in Europe

• HECRIN is a Clinical Trial Unit in Europe.

Structured Question Formulation

• PICOST is a structured question.
• PICO stands for Patient, Intervention, Comparison, Outcome.
• A structured question cannot mean Pin, which stands for Patient, Pain.
• Foreground questions are appropriate for structured question formulation.

Clinical Trials

• Phase II clinical trials aim to investigate the efficacy of a drug.
• The success rate of drug development is 1 FDA-approved drug from 10,000 compounds.

Translational Medicine

• The dimensions of the 5R framework for translational medicine include Right target and Right patients.
• The main pillars of translational medicine according to the European definition include bedside, community, and benchside.

Precision Medicine

• Decision-making in precision medicine is algorithm-based.

Systematic Reviews

• The goal of a literature search is to find all relevant documents.
• The OPTIMAL search strategy involves a combination of standardized subject headings and keyword search.
• A literature search aims to include the most recent, incompletely processed publications in the results.

Literature Search

• Compact, up-to-date summaries from a reliable source, based on evidence of the highest possible level, are the best sources for clinical decision-making.
• Professional guidelines, collections of systematic reviews and meta-analyses, and clinical decision support systems are strong sources for this task.
• PubMed is among the largest databases of life science literature, and it contains publications in multiple languages.

Bibliographic Databases

• Bibliographic databases, such as Scopus and Web of Science, contain descriptive data, citations, and details of citing publications, but do not include full texts or links to locations and contact details.

PICO Question Formulation

• The PICO question formulation methodology involves combining search terms with the AND operator to yield a common intersection of the result sets.
• The search strategy resulting from the formalized PICO question should be presented when describing the methodology.

Critical Appraisal

• STROBE, Newcastle-Ottawa Scale, Cochrane Risk of Bias Tool, and CASP are standard checklists for critical appraisal.
• CASP evaluates qualitatively and focuses on a standardized questionnaire.
• Newcastle-Ottawa Scale is used for critical appraisal of observational studies.

Reporting Guidelines

• CONSORT is a reporting guideline for RCTs.
• PRISMA is a reporting guideline for meta-analyses.

Clinical Guidelines

• Agency for Healthcare Research and Quality and U.S. Preventive Services Task are sources of clinical guidelines.
• EBM involves applying the best quality evidence available to patient care.
• Advantages of EBM include improving the quality of patient care, reducing the cost of treatment, minimizing errors during patient care, and updating knowledge and following the literature.

Guideline Development

• The AGREE instrument is used to assess the methodological quality of guidelines.
• Guidelines should include individuals from all relevant professional groups and patients' views and preferences.
• Guidelines can be developed through adaptation or de novo development.

Test your knowledge of clinical trial management, including risk-based monitoring, data quality, and European clinical trial units. Evaluate your understanding of the advantages and disadvantages of risk-based monitoring and more.