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Appendix 4: Clinical Trial Application and Attestation Form Instructions.3g) Designated Party Authorization Form.3e) Authorization form for Third Party to Import the NHP.3d) Research Ethics Board Attestation form.
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3c) Qualified Investigator Undertaking form.3b) Clinical Trial Site Information Form.3a) Clinical Trial Application and Attestation Form.12.0 Roles and Responsibilities of Those Involved in Clinical Trials.10.0 Labelling and Instructions For Use of an NHP.8.0 Discontinuation of a Clinical Trial.7.3 Other reports requiring accelerated reporting.7.1 Refusals by Research Ethics Board or Other Regulatory Authority.6.2 When Changes to an Approved Clinical Trial Require a New CTA.6.1.1 Implementing changes described in amendments.6.1 When Changes to an Approved Clinical Trial Require an Amendment.3.3 Module 2: Common Technical Document Summaries.3.2 Module 1: Administrative/Clinical Information.1.4 When a CTA Does Not Need to Be Submitted to Health Canada.1.3.2 NHP that contains a medicinal ingredient that requires a prescription.1.3 When a CTA Should Be Submitted to the Pharmaceutical Drugs Directorate and not the NNHPD.1.2.5 NHPs for conditions of use not appropriate for self care.1.2.4 Clinical trials involving both an NHP and a conventional pharmaceutical.1.2.1 Inadequate evidence to support safety and efficacy of an NHP in humans.1.2 When a CTA Should Be Submitted to the NNHPD.1.0 Clinical Trials For Natural Health Products (NHPs).
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