Glossary

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  • CBG
    Dutch National Competent Authority (English: MEB). http://www.cbg-meb.nl/"
  • Clinical study
    A clinical study is a scientific investigation in which participants receive a health-related intervention, such as a medicine, in order to learn about (discover or verify) how it works and interacts with the body (clinical, pharmacological, pharmacodynamic, and pharmacokinetic effects), or to(...)
  • Clinical study report
    A clinical study report is a document containing extensive detail about the plan, methods and conduct of the study so that it is clear how the study was carried out. This report should provide a clear explanation of how the design features of the study were chosen and include results of the(...)
  • Clinical trial
    A clinical trial is a clinical study in which participants are assigned according to a pre-defined therapeutic strategy or plan (protocol) to receive a health-related intervention, such as a medicine, in order to investigate its effects on health outcomes, usually compared to another (or(...)
  • Clinical Trial Application
    Clinical Trial Application
  • Clinical trial authorisation
    Before a clinical trial can start, the sponsor must apply for and be given clinical trial authorisation (CTA). Each European country has its own regulatory authority that assesses applications for clinical trial authorisations. For clinical trials that will take place in more than one European(...)
  • Clinician-reported outcome
    A type of outcome assessment determined by a trained health-care professional after observation of a patient’s health condition.
  • ClinRO
    A type of outcome assessment determined by a trained health-care professional after observation of a patient’s health condition.
  • Cohort Studies
    Cohort studies are used to study how common diseases are, their causes, and their prognoses. Cohorts are groups of people who are selected on the basis of certain characteristics. For example, if exposure to a risk factor such as cigarette smoke is suspected to cause a disease, a cohort can be(...)
  • Cold-chain
    An uninterrupted series of production, storage, and distribution activities, along with associated equipment and logistics, which maintain a desired low temperature range. It is necessary to maintain the quality and efficacy of certain medicines and vaccines.
  • College ter Beoordeling van Geneesmiddelen
    Dutch National Competent Authority (English: MEB). http://www.cbg-meb.nl/"
  • Combined advanced-therapy medicines
    Combined advanced-therapy medicines are medical products based on the combination of genes (gene therapy), cell therapy (cell therapy) or tissues (tissue engineering) with one or more medical devices as an integral part of the medicine.
  • CSR
    A clinical study report is a document containing extensive detail about the plan, methods and conduct of the study so that it is clear how the study was carried out. This report should provide a clear explanation of how the design features of the study were chosen and include results of the(...)
  • CTA
    Before a clinical trial can start, the sponsor must apply for and be given clinical trial authorisation (CTA). Each European country has its own regulatory authority that assesses applications for clinical trial authorisations. For clinical trials that will take place in more than one European(...)

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