Online survey seeks normal info from public on pure well being product utilization. A accomplished REB Attestation type (Appendix 3b) or the same document containing the same information if obtainable at the time of application. Evidence necessities for combination merchandise are described in part 12 of the Evidence for Security and Efficacy of Completed NHPs Steerage Document.
Sponsors could invite the qualified investigator(s) and different individuals who will be involved within the proposed trial(s) to attend the meeting. Compliance with ICH, Good Clinical Observe (GCP) and federal and provincial laws. This will likely embody a protracted historical past of use by people, wherein case, the normal pre-scientific info (e.g. pharmacological properties) could also be waived.
If the product licence of an NHP being used in a section IV clinical trial is suspended or cancelled Sections 18-21 of the NHP Rules, the sponsor must discontinue the CT and make contact with the NHPD for advice. The e-mail should embody 1) an in depth description of the investigational product and 2) a abstract of the protocol.
All these research do not require authorization from Well being Canada but require REB approval (see section 1.1 of this document). The security, efficacy and high quality of both the CT protocol and the investigational product(s) and placebo/comparator given in the course of the examine.
Normal chemistry and manufacturing data, corresponding to a summary of the manufacturing course of, impurity profile, stability data and completed product specs. A request for a pre-CTA consultation must be offered to the NHPD no less than 30 days previous to the assembly date.