Clinical Trial Agreement Canada

5 Dec

According to CanadaFDR, an application for authorization to sell or import a drug must be submitted to HC by a sponsor for a clinical trial. The application must be signed and dated by the sponsor`s senior medical or scientific director in Canada and an officer. The following information and documents must be included: According to CanadaFDR, G-TCPS2 and CA-ICH-GCPs, the Informed Consent Form (ICF) is considered an essential document, which must be reviewed and approved by an Institutional Ethics Committee (EC) (known as the Research Ethics Board in Canada) and provided to HC with the Clinical Trials Application (CTA). (For more information on what should be included in the form, see the theme “Enlightened Consent,” sub-theme Elements Required.) As defined in the CA-ICH GSCs, the clinical protocol should contain the following: A clinical trial site is the location where study-related activities are conducted, for example. B the place where the drug is rehabilitated or dispensed on trial (directly or prescription) and where the subject returns to subsequent assessment. Sites where ancillary medical techniques are performed, such as x-rays, magnetic resonance imaging (MRI) or blood drives, do not require CTSI forms. In accordance with g-TCPS2 and CA-ICH-GCPs, the CFI must include a statement describing the expected proportional payment to participants that is reasonably expected to participate in the study. Any compensation or inducement to participants should not be so excessive as to unduly influence participants or induce them to ignore important facts and risks. If the qualified investigator conducts the clinical trial at several sites controlled by the same REB, all sites can be identified by doubling Part 3 of the CTSI form as often as necessary. Additional pages that list multiple clinical trial sites should be attached to Parts 1 and 2 and the full document should be paged (for example.

B 1 in 5, 2 out of 5, etc.). If the REB authorizes clinical trials for several sites, it is possible to identify the sites by doubling Part 3 of the REB certification as often as necessary to identify all the location addresses authorized by the same REB. Only the last page of the REB certificate would have the signature of the REB representative. Additional pages that list several sites in the clinical trial are attached to Parts 1 and 2 and the full document must be paged (for example. B 1 in 5, 2 out of 5, etc.).