ࡱ>  =?456789:;<#` -Hbjbj "A   DR$6 2=h~%d%<% i<k<k<k<k<k<k<$>hA<] %$|$"%%< <n0n0n0%R i<n0%i<n0n0V7@" e8v | ŽWj(7 5<4=02=7xA*Ae8A e8%%n0%%%%%<<-%%%2=%%%%6 6 6 D6 6 6 Nb,  Initial Review Coversheet  INSTRUCTIONS: Please complete this form and send to the appropriate Working Group (addresses below). In addition to this Coversheet, include the BRAIN summary report, consent form, and full protocol. These items can be sent to the PRMC at the same time as the IRB submission; you do not need IRB approval first. Send Adult Protocols to: Send Pediatric and CAGT protocols to: PRMC Review - AWG Bambi Grilley 450A Cullen, BCM 305 270 Feigin Center, BCM 320 Fax: 713-798-2716 Fax: 832-825-4203 Email:  HYPERLINK "mailto:cscherer@bcm.edu" cscherer@bcm.edu Email:  HYPERLINK "mailto:grilley@bcm.edu" grilley@bcm.edu  Protocol H #:  FORMTEXT       Expected Activation Date:  FORMTEXT       Expected Duration of Accrual:  FORMTEXT       Expected Local Accrual: Annual  FORMTEXT       Total  FORMTEXT       Institutional Status: Is the study s primary author a BCM Investigator?  FORMDROPDOWN  Sponsor and/or Funding Source: Check all that apply, and name the sponsor(s).  FORMCHECKBOX  National Cooperative Group:  FORMTEXT        FORMCHECKBOX  Other Externally Peer Reviewed (NIH, ACS, etc):  FORMTEXT        FORMCHECKBOX  Institutional (in-house, internally reviewed, including those conducted with industry sponsorship in which the institutional investigator is a primary contributor to design and implementation; or participation in a multi-site trial initiated by an investigator at another institution):  FORMTEXT        FORMCHECKBOX  Industry (design and implementation controlled by pharma co.):  FORMTEXT       Research Category: Please select the category which most accurately describes the protocol (select only one).  FORMCHECKBOX  Therapeutic: Clinical trial with therapeutic intent using drugs, radiation, surgery, and/or biological agents.  FORMCHECKBOX  Prevention: Clinical trial for the modulation of cancer risk and inhibition of cancer progression using chemoprevention drug, nutritional, dietary, behavioral, or other intervention.  FORMCHECKBOX  Supportive Care: Clinical trial intended to improve the comfort and quality of life for the patient using drugs, nutritional, dietary, behavioral, or other interventions.  FORMCHECKBOX  Screening, Early Detection or Diagnostic: Clinical trial directly testing the efficacy of device, technique or procedure; or trial which tests for earlier or more accurate detection or diagnosis of disease.  FORMCHECKBOX  Epidemiologic, Observational, or Outcome: Study among cancer patients and healthy populations that involve no intervention or alteration in the status of participants, e.g., surveillance, risk assessment, outcome, environmental, and behavioral studies.  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Must be linked to an active trial, and only include patients accrued to that trial.  FORMCHECKBOX  Correlative: Lab based study using specimens to assess cancer risk, outcomes, response to therapies, etc. Does this protocol meet one or more of the following criteria? (select all that apply):  FORMCHECKBOX  Approved by the NCI Cancer Therapy Evaluation Program (CTEP), NCI Cancer Prevention and Control Protocol Review Committee, or the BMT Clinical Trials Network (CTN).  FORMCHECKBOX  Supported by an NIH funding mechanism (e.g., R01, U01, U10, etc) which required full peer review as part of the funding process.  FORMCHECKBOX  Is a non-intervention study and is not requesting DLDCC support.       Protocol Review and Monitoring Committee (PRMC) Principal Investigators Signature Required If sent from PIs email account, that will serve as his/her signature. Otherwise, send with signature. v. 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