Traduction de «suite d'essai » (Français → Anglais) :

Persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision, cannot take part in clinical trials, and persons, who due to their age, disability or state of health are reliant on care and for that reason accommodated in residential care institutions, that is accommodations providing an uninterrupted assistance for persons who necessitate such assistance, are in a situation of subordination or factual dependency and therefore may require specific protective measures.

Following that report, there are fundamental issues to be taken into consideration for a second European and Developing Countries Clinical Trials Partnership Programme (''EDCTP2 Programme''): the current scope of EDCTP1 needs to be amended and extended; the capabilities in developing countries for the sound conduct and management of clinical trials should, where necessary, be further developed and strengthened, in particular the role and development of ethical review committees and the corresponding regulatory environment, the coordination, collaboration and, where appropriate, integration of European national programmes should be further improved; collabo ...[+++]ration with other major public and private partners , including the pharmaceutical industry, and public-private partnerships such as the Product Development Partnerships (‘PDPs’), civil society, non-governmental organisations and foundations, need to be strengthened and extended; there should be clear and transparent rules of governance; synergies with European external policy actions should be developed specifically with Union development assistance; co-funding rules should be clarified and simplified; and monitoring tools need to be strengthened.

2. Following an intervention pursuant to paragraph 1, informed consent in accordance with Article 29 shall be sought to continue the participation of the subject in the clinical trial , and information on the clinical trial shall be given, in accordance with the following requirements:

(35) Persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision, cannot take part in clinical trials, and persons, who due to their age, disability or state of health are reliant on care and for that reason accommodated in residential care institutions, that is accommodations providing an uninterrupted assistance for persons who necessitate such assistance, are in a situation of subordination or factual dependency and therefore may require specific protective measures.

2.6.3. Pre-test check A pre-test check shall be performed within 2 hours before the test run in the following way: The accuracy of the flow meters shall be checked by the same method as used for calibration for at least two points, including flow values of GDILW that correspond to dilution ratios between 5 and 15 for the G TOTW value used during the test.

2.2.1. Determination of the Diluted Exhaust Gas Flow PDP-CVS system The calculation of the mass flow over the cycle, if the temperature of the diluted exhaust is kept within ± 6 K over the cycle by using a heat exchanger, is as follows: M TOTW = 1,293 x V0 x NP x (pB - p1 ) x273 / (101,3 x T) where M TOTW = mass of the diluted exhaust gas on wet basis over the cycle V0 = volume of gas pumped per revolution under test conditions (m³/rev) NP = total revolutions of pump per test pB = atmospheric pressure in the test cell (kPa) p1 = pressure drop below atmospheric at the pump inlet (kPa) T = average temperature of the diluted exhaust gas at ...[+++]pump inlet over the cycle (K) If a system with flow compensation is used (i.e. without heat exchanger), the instantaneous mass emissions shall be calculated and integrated over the cycle.