Reviewer Form –Initial Provincial Application (PIA) CTO Study ID # Reviewers may choose to: complete and upload this form under the Review Documents section at the bottom of the Documents tab in the PIA workspace; or use this form as a guideline/reference, documenting that each of the elements have been considered. Reviewer Conflict of Interest (COI): may include financial, professional, academic or other competing interests related to the study or to the study sponsor. If there are COI, do not proceed with the review. Discuss with the Chair or OCREB Research Ethics Officer. If there are no COI, complete the declaration below or log a similar note in a Form comment. Reviewer Declaration: I do not have a conflict relevant to this review: Summary: (optional) Review Criteria (refer to application, protocol and other submitted documents) If “No” is selected for any of the items, log a panel comment in the relevant section of the application. PIA Section 1.0 – General Information No issues have been noted in previous scientific or REB reviews: Yes No PIA Section 2.0 – Study Description The purpose/rationale for the research is acceptable: Yes No Social and scientific value is acceptable: Yes No Pediatric studies: the criteria for approving more than minimal risk research have been met and the research presents the prospect of direct benefit to the Yes No N/A individual participants The study design/methodology is acceptable: Yes No The justification for the sample size is appropriate: Yes No The selection of participants is equitable: Yes No The eligibility (inclusion/exclusion) criteria are acceptable Yes No The statistical/data analysis plans are acceptable: Yes No The stopping rules are appropriate: Yes No N/A (none) The collection, use and retention of biological samples is acceptable: Yes No N/A (none) The plan for the return of genetic testing results is acceptable: Yes No N/A (none) The use of the proposed surveys, questionnaires, interviews or focus groups is Yes No N/A (none) appropriate acceptable: PIA Section 3.0 – Clinical Trial Information (refer also to the protocol and relevant appended documents)
Reviewer Form –Initial Provincial Application (PIA) CTO Study ID # Reviewers may choose to: complete and upload this form under the Review Documents section at the bottom of the Documents tab in the PIA workspace; or use this form as a guideline/reference, documenting that each of the elements have been considered. Reviewer Conflict of Interest (COI): may include financial, professional, academic or other competing interests related to the study or to the study sponsor. If there are COI, do not proceed with the review. Discuss with the Chair or OCREB Research Ethics Officer. If there are no COI, complete the declaration below or log a similar note in a Form comment. Reviewer Declaration: I do not have a conflict relevant to this review: Summary: (optional) Review Criteria (refer to application, protocol and other submitted documents) If “No” is selected for any of the items, log a panel comment in the relevant section of the application. PIA Section 1.0 – General Information No issues have been noted in previous scientific or REB reviews: Yes No PIA Section 2.0 – Study Description The purpose/rationale for the research is acceptable: Yes No Social and scientific value is acceptable: Yes No Pediatric studies: the criteria for approving more than minimal risk research have been met and the research presents the prospect of direct benefit to the individual participants Yes No N/A The study design/methodology is acceptable: Yes No The justification for the sample size is appropriate: Yes No The selection of participants is equitable: Yes No The eligibility (inclusion/exclusion) criteria are acceptable Yes No The statistical/data analysis plans are acceptable: Yes No The stopping rules are appropriate: Yes No N/A (none) The collection, use and retention of biological samples is acceptable: Yes No N/A (none) The plan for the return of genetic testing results is acceptable: Yes No N/A (none) The use of the proposed surveys, questionnaires, interviews or focus groups is appropriate acceptable: Yes No N/A (none) PIA Section 3.0 – Clinical Trial Information (refer also to the protocol and relevant appended documents)
PIA-Reviewer-Form-2017-Jun-27.docx