DCRU Protocol Review Please attach completed form to the eIRB/DCRU site Timeframe for review completion: 2 days for industry studies and up to 10 days for PI’s studies Note to reviewers:  You may enter N/A if a given question does not apply to your area.  Scale for evaluation: Use scale of 1 to 5 with 1 being poor and 5 being excellent.  Please make sure to place your question(s) under “Questions to the PI” (at the end of this form) in appropriate sub-section (Response Required or Suggestions):

IRB number: Title of study: Investigator(s): Reviewer (Please enter your full name): Please answer the following questions and complete the scale where applicable: Scientific Advisory Committee Review Section: 1. Does the proposed study have sufficient scientific originality? Notes: Criteria 1 2 3 4 5 Scientific Originality 2. Does the proposed study have sufficient scientific merit to warrant use of DCRU resources? Notes: Criteria 1 2 3 4 5 Scientific Merit 3. DCRU Resource utilization is appropriate by this protocol? Notes: Criteria 1 2 3 4 5 Resource Utilization 4. Risk level of this study to subjects: (low, moderate, high) Notes: Low Moderate High Risk Level Statistical Review Section: 1. Is the study design valid? Notes: 2. Are study objectives/hypotheses clearly stated? Notes: 3. Are statistical methods appropriate? Notes: 4. Will the study produce clinically meaningful (or scientifically sound) results? Notes: Laboratory Review Section: 1. Are the planned laboratory studies appropriate for the study and do the required

Form Version: 7/21/2008 Page 1 of 2 amounts of blood or other specimens meet guidelines established by the IRB? Notes: 2. Will samples be processed and/or analyzed in DCRU affiliated labs or will samples be sent to Duke clinical labs or both? Do these laboratory studies require any special analytical techniques not currently available in DCRU labs or in the Duke clinical labs? Notes: DCRU Staff Review Section: 1. Any Operational or Budgetary Concerns? Notes: Questions to the PI: a. Response Required: (Please place all those questions for which the PI’s response is required before the final approval is given. For example, budget issues, lab or drug manual required, changes in the DSMP, clarification about the inpatient vs. outpatient status, number of visits, special dietary needs, etc.:) Notes: b. Suggestions/Comments: (Please place all suggestions/comments for which the PI’s response is NOT required but may help improve the study.) Notes: Notes: 1. Clinical and/or Scientific Merit a. Does the program being proposed offer a contribution to patient care and/or will it provide an addition to the overall science within the defined therapeutic area? 2. Statistical Review a. Does the statistical analytical plan fit with the protocol design and will it produce a meaningful result for the therapeutic area being studied? 3. Operational Resources a. Does the DCRU have the needed resources to accomplish the clinical program in a timely manner? 4. Patient Safety a. Is the patient’s safety considered primary during the conduct of the clinical program as outlined in the protocol?

Form Version: 7/21/2008 Page 2 of 2