MASSEY CANCER CENTER PROTOCOL REVIEW AND MONITORING COMMITTEE For Cancer Prevention and Control PROTOCOL REVIEW INSTRUCTIONS Determine whether the study is appropriate for abbreviated review. Abbreviated review will focus on feasibility of completing the study based on the enrollment procedures and study design (sections 5, 6, 7, and 11 of the review form). Studies appropriate for abbreviated review: Peer-reviewed studies approved by any of the following CCSG-approved agencies: Agency for Healthcare Research and Quality (AHRQ) All National Institutes at NIH American Cancer Society (ACS): national office only American Foundation for AIDS Research (AFAR) American Institute for Cancer Research (AICR) Cancer Research and Prevention Foundation Centers for Disease Control and Prevention (CDC) Central Office of the Veterans Administration (VA) - excluding local/regional awards and “block” grants Environmental Protection Agency (EPA) Food and Drug Administration (FDA) Howard Hughes Foundation Leukemia and Lymphoma Society Multiple Myeloma Research Foundation National Institute for Occupational Safety and Health (NIOSH) National Science Foundation (NSF) Susan G. Komen Breast Cancer Foundation University of California-Wide Breast Cancer Research Program U.S. Army (DOD) special research programs in ovarian, breast and prostate cancer Florida Biomedical Research Program Melanoma Research Alliance Studies peer-reviewed and approved by agencies other than those listed above may undergo abbreviated PRMC review at the discretion of the PRMC reviewer, upon appraisal of the outside peer evaluation. Goal for turn around for qualifying Just in Time studies is 4 days from receipt of submission. PROTOCOL REVIEW FORM Massey Cancer Center Cancer Prevention and Control Subcommittee of the Protocol Review and Monitoring Committee Study: Principal Investigator: Protocol Date: __________ Reviewed By: Review Date: __________ Determine type of review, and evaluate appropriate review categories. Comment on each review category, do not paraphrase the protocol. If the proposal is unacceptable within a review category, insert comments detailing deficiencies. Type of review: Abbreviated review (complete only sections 5, 6, 7, and 11 of the review) Peer reviewed and approved by CCSG-approved agency PRMC reviewer discretion Standard review (complete all sections of the review) Review Categories: 1. Objectives/Specific Aims: Acceptable: Unacceptable/Needs revision: 2. Rationale: Acceptable: Unacceptable: 3. Subject Population: Not Applicable: Acceptable: Unacceptable: 4. Exclusion of Special Populations: Not applicable: Acceptable: Unacceptable: 5. Study Design: Acceptable: Unacceptable: PROTOCOL REVIEW FORM Massey Cancer Center Cancer Prevention and Control Subcommittee of the Protocol Review and Monitoring Committee Study: Principal Investigator: Protocol Date: __________ Reviewed By: Review Date: __________ 6. Enrollment Procedures: Not Applicable Acceptable: Unacceptable: 7. Documentation of Study Support from Clinical Providers: Not Applicable: Acceptable: Unacceptable: 8. Data Collection Procedures: Not Applicable Acceptable: Unacceptable: 9. Sample Size: Not Applicable Acceptable: Unacceptable: 10. Data Analysis: Not Applicable Acceptable: Unacceptable: 11. Feasibility: Not Applicable Acceptable: Unacceptable: PROTOCOL REVIEW FORM Massey Cancer Center Cancer Prevention and Control Subcommittee of the Protocol Review and Monitoring Committee Study: Principal Investigator: Protocol Date: __________ Reviewed By: Review Date: __________ 12. Confidentiality and Human Subjects: Not Applicable Acceptable: Unacceptable: 13. Informed Consent Form: Not Applicable Acceptable: Unacceptable: 14. Appropriate Statistical Support: Not Applicable Acceptable: Unacceptable: Reviewer Recommendation: Approved Deferred – needs revision and resubmission Disapproved Additional Comments: PROTOCOL REVIEW INSTRUCTIONS 1. Specific objectives and specific aims should be clear and quantifiable. If there are multiple objectives, a primary objective should be identified. 2. The rationale for the study should be clearly described. 3. The subject population should be described in terms of their sociodemographic and disease characteristics and eligibility criteria. 4. Exclusions of special populations (women, children, minorities), if any, should be defended scientifically (this is an NIH mandate). 5. Study design should be scientifically sound and understandable and should relate to answering the research objectives; all elements of the study design should relate to the objectives. The data collection instruments or surveys should be reviewed for appropriateness. Standardized instruments should be used where possible and appropriate. If necessary, recommendations may be made by the reviewer. A discussion of major study variables should be included here. 6. A specific and detailed description of enrollment procedures should be provided that indicates enrollment authority and clarifies the time points at which patients eligible to become a subject and will be recruited. 7. Documentation of Study Support from Clinical Providers Approval and a supporting letter from clinical care providers is recommended to assure that the study will accrue patients and will have the cooperation of the clinical staff. If there is no letter of support from the appropriate clinical care providers, detailed descriptions of the following should be included: How will potentially eligible patients be identified How will the clinicians be contacted for approval to solicit their patients for enrollment? This should include names of providers. Who will perform enrollments? What is the timing for patient contact if the study will include patients who are recently diagnosed? 8. A plan for data collection should describe the transfer of data to a research database from which study analyses will be conducted. 9. The study sample size should be described numerically and/or operationally and justified. Qualitative studies can provide appropriate discussions of sample size in terms of ‘saturation’ . 10. The data analysis plan should specifically address relevant bio-statistical issues. 11. Feasibility of the study in terms of participant accrual, timeframe, available human and physical resources, and complexity of study procedures should be established. 12. Maintenance of confidentiality and human subjects’ protection should be addressed, including behavioral, nutritional, and populations-based intervention studies. It is appropriate to provide the information that will be supplied to the IRB. Protocol will only be reviewed for clear and obvious departures from human subjects procedures. 13. Informed Consent Form should describe in lay language the procedures and risks of protocol participation. 14. The reviewer may determine whether biostatistical review is required. If so, the PRMC CC & P subcommittee biostatistician will be asked to review the study for statistical appropriateness. For qualitative studies that will not be accruing sufficient numbers for a statistically significant sample or for exploratory studies or student studies that are not accruing enough subjects to support statistical analyses beyond simple descriptive statistics a biostatistical review may not be required.
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