Transcript

Canadian Centralized Research Ethics Board - Submission Process

CANADIAN CENTRALIZED RESEARCH ETHICS BOARD SUBMISSION PROCESS The sponsor or its designee must be armed with the critical information necessary to select the Lead Provincial Applicant SELECT LEAD PROVINCIAL PROVINCIAL APPLICATION INCLUDES: APPLICANT • Complete, signed submission package (electronic & paper) • Health Canada No Objection Letter (NOL Sponsor or CRO selects one site to act as the Lead Provincial Applicant SUBMIT PROVINCIAL 2 APPLICATION 2 weeks prior to meeting REB MEETING – REVIEW LETTER ISSUED TO 3 4 APPLICATION REVIEW PROVINCIAL APPLICANT TO AVOID DELAYS YOU NEED: Frequency (average twice per month) non-negotiable informed consent clauses sponsor documents submission package. This step continues to be the biggest bottleneck in FINAL RESPONSECS) the approval process but it should not take more FROM LEAD PROVIN CIAL APPLICANT than 10 BUSINESS DAYS if your CRO is prepared and knows what to expect. AVERAGE OVERALL TIME TO APPROVAL (DAYS) 11 6 46 2014 10 5 33 15 2005 10 20 30 40 50 60 70 Submission to meet ing SCIMEGA'S OVERALL TIME TO APPROVAL (DAYS) Meeting to Review Letter 11 6 10 2 Review Letter to Final PL Response 2008-2015 PIResponse to Approval 10 20 30 40 50 60 70 PROVINCIAL APPROVAL – PARTICIPATING SITE EXPEDITED REVIEW APPLICATIONS This step does not require a Final REB approval along with TWO DAYS formal REB meeting and final the approved provincial ICF is decisions are issued within then transferred to the other ... two days of receiving the final participating sites. ..... response to the review letter. SITE APPLICATION INCLUDES: • Complete, signed submission package (plus 1 copy of the signed application form) • Signed Board of Record Study 8. Agreement SITE APPLICANT Additional PARTICIPATING Participating Sites SITE Submit only after provincial approval is isued. APPROVALS CO

Canadian Centralized Research Ethics Board - Submission Process

shared by AgentIllustrateur on Dec 22
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How the submission process work for a successful application to the Canadian Centralized Research Ethics Board.

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Agent Illustrateur

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Health
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