Regulations are generally consistent with the principles, definitions and standards of the International Conference on Harmonization (ICH) Guidance documents on clinical trials. Where there are inconsistencies, priority is given to regulations. If the drugs are to be imported from clinical trials, importers should be authorized by the sponsor. This information should be included in Appendix 1 of Form HC/SC 3011 and provided at the time of application. When drugs are shipped to individual clinical trial sites, Schedule 1 can be replicated as often as necessary to cover all sites. A copy of Schedule 1 should be included in the batch with the NOL. Before launching a clinical trial or modifying a clinical trial at a site, the sponsor must ensure that the REB Attestation and Qualified Investigator Undertaking forms have been completed and stored by the sponsor and that the clinical trial information form has been submitted to Health Canada. For all organic products, the BGTD requires that information on the release of lots be provided by the promoter/manufacturer of the CTA prior to its use in the study (see section 2.7.4). Sponsors must conduct all clinical trials, including Phase IV trials, in accordance with Division 5, including GSC principles, labelling requirements and REB approval. The Department of Health`s new model agreement raises questions about the NHS`s relationship with industry Despite the suspension, cancellation or closure of a clinical trial in Canada, a study as a whole is considered complete after the last subject in the world has completed the “end of study” visit within the meaning of the protocol. The “end of the visit” is the last visit for tests and procedures related to the study, including the detection of all potential adverse events related to the study, and usually occurs some time after the completion of the study drugs. The “end of the study visit” is usually a face-to-face visit, but for some studies it can also be done by phone. Some studies, such as oncology studies, include long-term monitoring of results (for example.
B survival) in which the person or family of the person concerned is contacted to determine the result in question. However, the study would not be considered incomplete if all subjects enrolled worldwide had stopped study-related therapies, tests and procedures and completed the “end of studies,” including possible safety monitoring. If additional drugs are introduced for clinical trial (for example. B Comparment, Accompanying and Rescue Drugs), a list of these drugs should be provided to Section 1.2.3 of the CTA using the Innas “Supplement Drug Summary” (SOAD) form in Appendix 4 of these guidelines.