Standard Operating Procedures - SOP-07
Standard Operating Procedures - SOP-07
Standard Operating Procedures - SOP-07
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<strong>Standard</strong> <strong>Operating</strong> <strong>Procedures</strong> (<strong>SOP</strong>)<strong>SOP</strong>-<strong>07</strong>Conducting a Study in the Context of aClinical Trial Application (CTA) inCanada
<strong>SOP</strong>-<strong>07</strong>Conducting a Study in the Context of a Clinical Trial Application (CTA) in Canada• Objective– Guide the sponsor-investigator in the conduct of a clinical trialwhen the trial is the subject of a Clinical Trial Application(CTA) to Health Canada.
<strong>SOP</strong>-<strong>07</strong>Conducting a Study in the Context of a Clinical Trial Application (CTA) in Canada• Information– Sponsors-investigators who want to conduct clinical drug trialsin humans
<strong>SOP</strong>-<strong>07</strong>Conducting a Study in the Context of a Clinical Trial Application (CTA) in Canada• Requirements– Before initiating a clinical trial in Canada:• Fill a Clinical Trial Application (CTA)– CTA are required from sponsors-investigators for :• All Phase I to III studies on drug development• Bioavailability comparison studies• Clinical trials of marketed drugs whose use exceeds theparameters of the notice of compliance (NC) or the drugidentification number (DIN)
<strong>SOP</strong>-<strong>07</strong>Conducting a Study in the Context of a Clinical Trial Application (CTA) in Canada• CTA Amendment (CTAM)– Amendments can be on the following modifications :• Drug manufacturing process modification• Approved protocol, altering the risk to the health ofa subject• Selection criteria• Duration of the clinical trial– To modify a CTA under review, withdraw the active CTAand submit another one
<strong>SOP</strong>-<strong>07</strong>Conducting a Study in the Context of a Clinical Trial Application (CTA) in Canada• Notification to Health Canada– Amendments to an already approved CTA and CTAM• Evaluation of a CTA Follow-up or Discontinuation– The sponsor-investigator should:• In the case of discontinuation, complete a notification
<strong>SOP</strong>-<strong>07</strong>Conducting a Study in the Context of a Clinical Trial Application (CTA) in Canada• Records Related to the CTA or CTAM– The sponsor-investigator should :• Keep complete and accurate record for a period of 25years, available to Health Canada upon request
<strong>SOP</strong>-<strong>07</strong>Conducting a Study in the Context of a Clinical Trial Application (CTA) in Canada• Research Ethics Board– The proposed protocol and the Informed Consent Formshould be reviewed and approved– The sponsor-investigator should :• Submit to Health Canada the name of the REB• Complete the section C of the Clinical Trial SiteInformation form
<strong>SOP</strong>-<strong>07</strong>Conducting a Study in the Context of a Clinical Trial Application (CTA) in Canada• Qualified Investigators (only one qualified investigator persite)– The Qualified Investigator Undertaking form is to be providedto Health Canada only upon their request– To summarize, prior to each clinical study in Canada, thesponsor-investigator should complete:• The Clinical Trial Site Information form• The Research Ethics Board Attestation form• The Qualified Investigator Undertaking form
<strong>SOP</strong>-<strong>07</strong>Conducting a Study in the Context of a Clinical Trial Application (CTA) in CanadaQuestions ?
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