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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

    Adverse Events & Serious Adverse Events
    Bioavailability and Bioequivalence
    Clinical Trial Supplies/IMP
    Computer Questions and Internet
    Consent of Investigator/1572 and CVs
    GCP Essential Documents | gcp investigator brochure - GCPHelpdesk
    Generic Drugs
    Herbal Products
    Informed Consent and Patient Information Sheet
    Insurance and Liability
    Investigator and Investigator Site
    Phases of Trial
    Protocol and Study Design
    Quality Assurance and Audits
    Source Document Verification

    Opinion Poll

    Which one of the following do you think is the most common reason for participating in clinical trials?
    This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.
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