Cancer Center Protocol Number:



Reviewer Name: FORMTEXT ?????Review Date: FORMTEXT ?????Protocol Title: FORMTEXT ?????Protocol Version Number: FORMTEXT ?????Protocol Version Date: FORMTEXT ?????Review Type: FORMCHECKBOX Initial Protocol Review FORMCHECKBOX Resubmission to Full Committee FORMCHECKBOX Protocol Amendment ReviewUCSF Principal Investigator: FORMTEXT ?????Sponsor: FORMTEXT ?????Source(s) of Funding: FORMTEXT ?????Is Funding Adequate? FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX UnknownData Management ResourcesAdequate/Available? FORMCHECKBOX Yes FORMCHECKBOX No-----------------------------------------------------------Phase of Study:UCSF Involvement (Please select only one): FORMCHECKBOX Compassionate/Emergency Use FORMCHECKBOX Investigator-Initiated: Single Center FORMCHECKBOX Pilot/Feasibility FORMCHECKBOX Investigator-Initiated: Multicenter – UCSF or Affiliate is lead site FORMCHECKBOX Phase I FORMCHECKBOX Investigator-initiated: Multicenter – other center is lead site FORMCHECKBOX Phase I/II Disease-Specific FORMCHECKBOX National (Cooperative) Group FORMCHECKBOX Phase I/II Non-Disease-Specific FORMCHECKBOX Industry: Single Center FORMCHECKBOX Phase II FORMCHECKBOX Industry: Multicenter – Significant UCSF or Affiliate Input on FORMCHECKBOX Phase II/III Design/Reporting FORMCHECKBOX Phase III FORMCHECKBOX Industry: Multicenter – No UCSF or Affiliate Input on FORMCHECKBOX Phase IV Design/ Reporting FORMCHECKBOX N/A FORMCHECKBOX Other: FORMTEXT ?????-----------------------------------------------------------STUDY SUMMARY:Please summarize the key components of the study (relevant background information, study objectives and design, key eligibility criteria, treatment regimen, treatment-related procedures, and any safety issues), limiting your response to the space below. FORMTEXT ?????ACCRUAL CONSIDERATIONSList Competing Trials (what is relative priority of this trial?): FORMTEXT ????? FORMCHECKBOX Section includes information provided by CRNOExpected UCSF Accrual Total: FORMTEXT ????? FORMCHECKBOX N/AExpected UCSF Annual Accrual: FORMTEXT ????? FORMCHECKBOX N/AExpected Affiliate Accrual Total: FORMTEXT ????? FORMCHECKBOX N/AExpected Affiliate Annual Accrual: FORMTEXT ????? FORMCHECKBOX N/AProvide a rationale for how the above Target Accrual figures were determined: FORMCHECKBOX Based on Current Patient Population/Tumor Registry Data FORMCHECKBOX Previous Accrual for Similar Protocol(s)Did previous protocol(s) successfully complete enrollment? FORMCHECKBOX Yes FORMCHECKBOX No FORMCHECKBOX Not Applicable (e.g., study is still enrolling) FORMCHECKBOX Other: FORMTEXT ?????----------------------------------------------------Score (no decimals, please):Scoring Scale:For each category below, enter numeric score from 1 - 9, one (1) being the best and nine (9) being the worst. See last page for additional guidance.1)Clinical Importance FORMTEXT ?????2)Trial Design FORMTEXT ?????3)Innovation/Science FORMTEXT ?????4)UCSF Involvement in Development FORMTEXT ?????(include career development/grant component)5)Potential for UCSF Publication FORMTEXT ?????6)Accrual/Feasibility FORMTEXT ?????Now, assign a whole number that merges all preceding category scores in terms of relative importance in executing a successful trial; do not average the preceding scores. Your overall score will be used to guide the Site Committee in selecting the Final Overall Score, which in turn will guide Site Committee prioritization.Overall Score (not the average) FORMTEXT ?????----------------------------------------------------List of Concerns that Must be Addressed Before Approval FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????Suggestions (response not required) FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????----------------------------------------------------Recommendation: FORMCHECKBOX Approval FORMCHECKBOX Deferred for Revision FORMCHECKBOX Disapproval ____________________________________________________Expedited Reviewer’s SignatureDateScientific Scoring ScaleScoreDescriptorAdditional Guidance on Strengths/Weaknesses1ExceptionalExceptionally strong with essentially no weaknesses2OutstandingExtremely strong with negligible weaknesses3ExcellentVery strong with only some minor weaknesses4Very GoodStrong but with numerous minor weaknesses5GoodStrong but with at least one moderate weakness6SatisfactorySome strengths but also some moderate weaknesses7FairSome strengths but with at least one major weakness8MarginalA few strengths and a few major weaknesses9PoorVery few strengths and numerous major weaknessesMinor Weakness: An easily addressable weakness that does not substantially lessen the impactModerate Weakness: A weakness that lessens the impactMajor Weakness: A weakness that severely limits the impact ................
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