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					                    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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