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What are expected or possible consequences of over-estimation of recruitment potential? - Answer- - The trial will overrun its projected timeline - The recruitment period will be prolonged and more sites may be needed - The study will not have sufficient data within the required timeframe and will...

Clinical Trial - Answer- process of studying human subjects to assess the effect of a particular intervention (Drug, biologic, device, procedure or behavior change) on a pre specified set of measurable events. Endpoint or Outcome - Answer- Clinical event, measurable indicator, subject reported re...

What is an Adverse Event (AE) ? - Answer- Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. (ICH GCP E6 1.2) What is an Adverse Drug Reaction (ADR)? - ...

What is the purpose of the ICH's Good Clinical Practice: consolidated Guideline? - Answer- To define Good clinical practice and provide a unified standard for designing, conduction, recording and reporting trials that involve participation of human subjects. What guideline's purpose is to defin...

ADR - Answer- Adverse Drug Reaction Audit - Answer- Reviews how the research was conducted; takes into account SOPs, IRB requirements & GCP (ensures compliance) Audit Certificate - Answer- Confirmation audit took place Audit Report - Answer- Written Evaluation - not regularly made available...

Protocols - Answer- 1) General Information 2) Background info 3) Trial objectives and purpose 4) Trial design 5) Selection and withdrawal of subjects 6) Treatment of Subjects 7) Assessment of Efficacy 8) Assessment of Safety 9) Statistics 10) Source Data/Docs 11) Quality control/assurance ...

Which foundation of ethical research summarized the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research? - Answer- The Belmont Report T/ F. In defining the boundaries between research and practice, practice perm...

Assistive Technology - Answer- any item, piece of equipment, or product system, whether acquired commercially off the shelf, modified, or customized that is used to increase, maintain, or improve functional capabilities of individuals with disabilities Augmentative and Alternate Communication - A...