NOTE: All changes from previous versions of this form are highlighted in grey for your convenience. NEW PROTOCOL SUBMISSION FORM Instructions: Please complete and submit this form to the Fred & Pamela Buffett Cancer Center Protocol Review and Monitoring System (PRMS) Office (Campus Zip 6805) by the fourth Friday of each month. Submissions received after this deadline will be reviewed at the subsequent SRC meeting. NOTE: Due to the holidays, the submission deadline for November and December is the 3rd Friday of the month. SECTION I: BASIC PROTOCOL DATA Current IRB#: Title: Principal Investigator Email: PI Dept.: PI Zip: Study Coordinator/Contact: Email: Data Coordinator/Contact: Email: Statistician (if applicable): Email: Is this a re-submission of a previously tabled protocol? Yes No NOTE: Tabled protocols must be resubmitted in trial entirety. SECTION II: Check here if you believe this protocol qualifies for SRC ACCELERATED REVIEW NOTE: Many specimen studies, retrospective medical record reviews, and projects involving existing documents or records may qualify for Accelerated Review”. Some examples of SRC Accelerated Review research include: “SRC Anonymous surveys and retrospective chart reviews; Analysis of discarded pathological specimens without personal identifiers; Proposals involving previously banked materials and/or tissues; Protocols to obtain tissue or biological samples for prospective or undetermined future research. SECTION III: NCI STUDY SOURCE CLASSIFICATION (i.e. sponsor) Please select A1, A2, A3, B1, B2 OR B3 below as – the sponsor classification that best matches this protocol. A. INSTITUTIONAL TRIALS: Includes studies authored or co-authored by a local PI and studies authored by PIs at other institutions with a local PI participating. Please select A1 OR A2 below to indicate if the study is an Institutional OR a Multi-Institutional trial. A1. INVESTIGATOR-INITIATED INSTITUTIONAL TRIAL: Protocol that has been designed and developed by a local investigator with UNMC as the sponsor. Protocol may be implemented only at UNMC and its 1associated locations or at multiple 2participating clinical sites. Protocol may or may not have received external funding and may include collaborative studies conducted with industry in which the local PI is the primary contributor to the design, implementation and monitoring of the trial.
NOTE: All changes from previous versions of this form are highlighted in grey for your convenience. NEW PROTOCOL SUBMISSION FORM Instructions: Please complete and submit this form to the Fred & Pamela Buffett Cancer Center Protocol Review and Monitoring System (PRMS) Office (Campus Zip 6805) by the fourth Friday of each month. Submissions received after this deadline will be reviewed at the subsequent SRC meeting. NOTE: Due to the holidays, the submission deadline for November and December is the 3rd Friday of the month. SECTION I: BASIC PROTOCOL DATA Current IRB#: Title: Principal Investigator Email: PI Dept.: PI Zip: Study Coordinator/Contact: Email: Data Coordinator/Contact: Email: Statistician (if applicable): Email: Is this a re-submission of a previously tabled protocol? Yes No NOTE: Tabled protocols must be resubmitted in entirety. SECTION II: Check here if you believe this protocol qualifies for SRC ACCELERATED REVIEW NOTE: Many specimen studies, retrospective medical record reviews, and projects involving existing documents or records may qualify for “SRC Accelerated Review”. Some examples of SRC Accelerated Review research include: Anonymous surveys and retrospective chart reviews; Analysis of discarded pathological specimens without personal identifiers; Proposals involving previously banked materials and/or tissues; Protocols to obtain tissue or biological samples for prospective or undetermined future research. SECTION III: NCI STUDY SOURCE CLASSIFICATION (i.e. sponsor) – Please select A1, A2, A3, B1, B2 OR B3 below as the sponsor classification that best matches this protocol. A. INSTITUTIONAL TRIALS: Includes studies authored or co-authored by a local PI and studies authored by PIs at other institutions with a local PI participating. Please select A1 OR A2 below to indicate if the study is an Institutional trial OR a Multi-Institutional trial. A1. INVESTIGATOR-INITIATED INSTITUTIONAL TRIAL: Protocol that has been designed and developed by a local investigator with UNMC as the sponsor. Protocol may be implemented only at UNMC and its 1associated locations or at multiple 2participating clinical sites. Protocol may or may not have received external funding and may include collaborative studies conducted with industry in which the local PI is the primary contributor to the design, implementation and monitoring of the trial.
NewProjectForm-06-01-2014.docx