Traduction de «protocol inspection » (Anglais → Français) :

a statement from the sponsor (either in the protocol or in a separate document) confirming that the investigators and institutions involved in the clinical trial are to permit clinical trial-related monitoring, audits and regulatory inspections, including provision of direct access to source data and documents.

In order to be able to demonstrate compliance with the protocol and with this Regulation, a clinical trial master file, containing relevant documentation to allow effective supervision (monitoring by the sponsor and inspection by Member States), should be kept by the sponsor and by the investigator.

(Return tabled) Question No. 20 Mr. Alex Atamanenko: With regard to the horse slaughter industry in Canada: (a) what was the reason for the temporary halt, initiated by European Union (EU) officials, to horse meat imports from Canada on October 12, 2012; (b) has Canada participated in talks with EU officials regarding the safety of horse meat from Canada since that time, (i) if so, what topics were discussed, (ii) what conclusions were reached; (c) what restrictions effective in 2013 will be imposed upon the Canadian horse meat industry by the EU, (i) what is the anticipated impact of these restrictions on the frequency and type of drug residue testing on horse meat in Canada as well as on the data required on Equine Information Documents ...[+++] (EIDs), (ii) will the restrictions on prohibited/non-permitted drugs be further tightened; (d) is there any oversight by the Canadian Food Inspection Agency (CFIA) on transport drivers and horse meat dealers listed on EIDs as current owners to check for a history of violations of the United States Department of Agriculture, Ministry of Transport, or CFIA transport regulations, (i) does the CFIA enhance its scrutiny of such violators or conduct follow-up investigations on those who have been flagged for violations, (ii) is this information shared with any other inter-connected government agency either in Canada or in the United States; (e) how often do CFIA inspectors do a visual inspection of the transports that arrive at the slaughter plants to ensure that the horses have been transported safely; (f) how many transport violations concerning horse slaughter transportation have been issued to transport drivers within the last five years, (i) how many warnings of violations have been issued, (ii) if the warnings have been ignored, how does the CFIA restrict or prohibit those transport drivers from conducting business in Canada; (g) how often does the CFIA conduct inspections of feedlots and how many warnings or violations were ...

6. Member States shall ensure that Commission inspectors are authorised to carry items to be used for testing purposes, including those that are, or have the appearance of, prohibited articles, in any area to which access is required during the course of an inspection and when in transit to or from an inspection, in accordance with any agreed protocols.

The CFIA currently makes public its inspection manuals and procedures for example, the meat hygiene manual of procedures and protocol, the fish, seafood, and production visual inspection protocol, and I could go on with quite a list.

When providing the Agency with the information referred to in Article 2 of this Protocol, the Community shall also transmit information on the inspection methods which it proposes to use and the complete proposals, including estimates of inspection efforts for the routine inspection activities, for attachments to the subsidiary arrangements for facilities and material balance areas outside facilities.