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

Question No. 53 Ms. Kirsty Duncan: With respect to the chronic cerebrospinal venous insufficiency (CCSVI) clinical trial being undertaken by Dr. Traboulse: (a) what milestones are reportable to the government, (i) on what date(s) is reporting expected to occur, (ii) how will this information be communicated to patients, the medical community, and the general public; (b) on what date did each of the trial sites pass ethical review; (c) on what date did recruitment of patients begin for each of the trial sites; (d) how many patients with multiple sclerosis (MS) are being recruited for each site, and how is consistency in diagnosis and treatment being ensured across sites; (e) who is performing the diagnoses for CCSVI for each site, (i) ho ...[+++]w is the diagnosis being performed, including, but not limited to, ultrasound and venogram, (ii) how many diagnoses has each person undertaking the diagnosis at each site performed prior to the study, and by whom was each person trained; (f) who is performing the procedures for each site, (i) how is the procedure being performed, including, but not limited to, anesthetic, balloon size, (ii) how many procedures has each person undertaking the procedure at each site performed prior to the study, and by whom was each person trained; (g) what are the selection criteria for the trial, including, but not limited to, type of MS, Expanded Disability Status Scale (EDSS) score, venous abnormality/malformed valve/stenosis, mobility, (i) how do these criteria compare with the international literature, (ii) with how many international studies to date will the selection criteria be analytically comparable; (h) if both progressive and relapsing-remitting forms of MS are to be examined in the trial, how will statistical significance be ensured given that 50 of 100 patients will undergo a “sham” procedure, 25 patients will have a progressive form of the disease, and 25 will have a relapsing-remitting form of the disease, and will people with bo ...

(Return tabled) Question No. 1123 Ms. Kirsty Duncan: With respect to the government’s position on chronic cerebrospinal venous insufficiency (CCSVI): (a) does the government track clinical trials on CCSVI currently being undertaken by other countries and, if yes, what are all clinical trials, identified by phase, currently being undertaken worldwide, (i) which countries are undertaking Phase lll trials; (b) does the government question whether CCSVI exists and, if yes, (i) why does the government not question whether treating CCSVI actually improves quality of life for Canadians with multiple sclerosis (MS); (c) how many cases of " major complications associated with venous angioplasty" have occurred in Canada and, if it is not possible ...[+++]to give this number, why, (i) what are identified complications to CCSVI and, for each complication, how many cases versus the number of procedures undertaken have occurred; (d) what are all procedures that have been performed on veins in Canada, including, procedures for Budd-Chiari syndrome and May-Thurner syndrome; (e) what is the government's position on ballooning veins and why does it consider that ballooning veins even once could be unsafe on fragile veins, even though participants involved in the proposed clinical trial will experience two procedures-one real, one simulated-in a one-year period; (f) is the government consulting with Canadians with MS, if so, (i) provide a list of all CCSVI groups the Minister of Health has met with along with the dates of the meetings, (ii) provide a list of all MS groups the Minister of Health has met with along with the dates of the meetings, (iii) provide the number of Canadians with MS the Minister of Health has met and the dates of all meetings, and if the government is not consulting, (iv) why not; (g) how does inviting the investigators of the seven MS-funded CCSVI studies to participate in the consensus workshop on ultrasound imaging meet CIHR's conflict of interest g ...

In particular, the Commission should be empowered to establish the specific procedures, tests and requirements for the type-approval of motor vehicles, components and separate technical units; to define more precisely the characteristics a tyre must fulfil to be defined as ‘special use tyre’, ‘off-road professional tyre’, ‘reinforced tyre’, ‘extra load tyre’, ‘snow tyre’, ‘T-type temporary-use spare tyre’ or ‘traction tyre’; to set out specific safety requirements for vehicles intended for the transport of dangerous goods by road within or between Member States; to exempt certain vehicles or classes of vehicles of categories M, M, N a ...[+++]nd N from the obligation to install advanced emergency braking systems and/or lane departure warning systems; to amend the limit values on rolling resistance and rolling noise for tyres as a result of changes in test procedures without lowering the level of protection of the environment; to establish rules on the procedure for the determination of noise levels of tyres; to shorten the sell-off period for tyres not complying with the requirements set out in this Regulation and its implementing measures; and to amend Annex IV to include the Regulations of the United Nations Economic Commission for Europe (UNECE Regulations) which are mandatory under Council Decision 97/836/EC of 27 November 1997 with a view to accession by the European Community to the Agreement of the United Nations Economic Commission for Europe concerning the adoption of uniform technical prescriptions for wheeled vehicles, equipment and parts which can be fitted to and/or be used on wheeled vehicles and the conditions for reciprocal recognition of approvals granted on the basis of these prescriptions .

3. The Commission shall keep under review the procedures, tests and requirements referred to in Article 5(3) as well as the test cycles used to measure emissions.

3. The specific procedures, tests and requirements for type approval set out in this paragraph, as well as requirements for the implementation of paragraph 2, which are designed to amend non-essential elements of this Regulation, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3).

obtain a clinical trial authorization before conducting clinical trials on therapeutic products that do not have a market authorization (new section 10), and to conduct clinical trials in accordance with the regulations (new section 11) (The procedures relating to obtaining, amending, suspending or revoking clinical trial authorizations are set out in new sections 18.2 to 18.6, and regulations relating to clinical trials can be made under new paragraphs 30(1)(w) to 30(1)(z.1).);