Betekenis van:
clinical trial

clinical trial
Zelfstandig naamwoord
    • a rigorously controlled test of a new drug or a new invasive medical device on human subjects; in the United States it is conducted under the direction of the FDA before being made available for general clinical use

    Synoniemen

    Hyperoniemen

    Hyponiemen


    Voorbeeldzinnen

    1. PART 4: PRE-CLINICAL AND CLINICAL TRIAL
    2. All veterinary clinical trials shall be conducted in accordance with a detailed trial protocol.
    3. The available non-clinical and clinical information on an investigational medicinal product shall be adequate to support the proposed clinical trial.
    4. In respect of each clinical trial, the clinical observations shall be summarised in a synopsis of the trials and the results thereof, indicating in particular:
    5. The investigator and sponsor shall consider all relevant guidance with respect to commencing and conducting a clinical trial.
    6. The content of the essential documents shall be in accordance with the specificities of each phase of the clinical trial.
    7. All clinical trial information shall be recorded, handled, and stored in such a way that it can be accurately reported, interpreted and verified, while the confidentiality of records of the trial subjects remains protected.
    8. The Ethics Committees shall, in every case, retain the essential documents relating to a clinical trial, as referred to in Article 15(5) of Directive 2001/20/EC, for at least three years after completion of that trial.
    9. precise identification of the formulation of the veterinary medicinal product used in the clinical trial and the physical and chemical test results for the relevant batch(es);
    10. Nevertheless, it should also aim at facilitating the evaluation of any future application for clinical trial and marketing authorisation based on the same data.
    11. a letter notifying the marketing authorisation holder that the study is a clinical trial falling under the scope of Directive 2001/20/EC.
    12. The sponsor and the investigator shall retain the essential documents relating to a clinical trial for at least five years after its completion.
    13. In conducting clinical trials on investigational medicinal products for human use, the safety and the protection of the rights of trial subjects should be ensured.
    14. They shall establish the legal and administrative framework within which their good clinical practice inspections operate, with definition of the powers of inspectors for entry into clinical trial sites and access to data.
    15. all results of the clinical trials, fully describing the results based on the efficacy criteria and end points specified in the clinical trial protocol and including the results of the statistical analyses, if appropriate;