IUSCC Prioritization Score Card Protocol #: Protocol Title: Principal Investigator: Sponsor: PI should complete score card. For each statement below, put a check next to the appropriate points under the study sponsor column for your protocol. PI and Program Leader must sign and date on page 2. IIT Intellectual input/collaboration NCTN (or cooperative group) ☐5 points (IU IIT) ☐5 points (IU Lead) ☐4 points (non-IU IIT, e.g., HCRN, BTCRN, other academic sites) ☐2 points (IU non-Lead) Industry ☐0 points Trial translated from science developed at IU ☐5 points ☐3 points ☐2 points Includes correlative studies at IU ☐2 points ☐2 points ☐2 points Strategic study for the program, PI or IUSCC ☐5 points ☐3 points Peer review funding for clinic trial ☐4 points ☐4 points Total accrual to open studies ratio* for program in past year Competing studies with same population within your program* (include competing studies and explain prioritization below) (+2 points if first or last author) Comments ☐2 points (+2 points if first or last author) ☐4 points ☐3 points (5:1) ☐3 points (5:1) ☐3 points (5:1) ☐2 points (3:1) ☐2 points (3:1) ☐2 points (3:1) ☐0 points (< 3:1) ☐0 points (< 3:1) ☐0 points (< 3:1) ☐0 points (Yes) ☐0 points (Yes) ☐0 points (1 competing study) ☐NA (No) ☐NA (No) ☐-1 point (> 1 competing study) TOTAL SCORE Score < 5 points: Disapproval likely Score > 7 points: Approval possible *For total accrual ratio and/or competing enrollment: Email FARC (FARC@iu.edu) to obtain a list of your open trials for portfolio prioritization, ratio determination, and competing enrollment, OR (PI or representative is strongly Use calendar year or within past 12 months; may prorate open studies that opened within the past calendar year encouraged to attend SRC meeting if Include only open treatment trials (NCTN and rare/targeted excluded from ratio determination unless beneficial) score < 7 points) o Rare- ESMO set incidence rate for rare cancers at ≤ 6 newly diagnosed persons out of a population of 100,000 per year. o Targeted- http://www.cancer.gov/cancertopics/factsheet/Therapy/targeted Provide a brief rationale for including this trial in your program. Version 11/13/2015 1 IUSCC Prioritization Score Card Complete the information below. If you require specialized equipment (e.g., EKG, camera, etc.) to complete the study, do you have access to this equipment? If not, explain your plan to obtain it below. ☐Yes ☐No ☐NA Is there a National Clinical Trial Network (NCTN) cooperative group trial available for this patient population? If yes, please explain the rationale for opening this trial rather than supporting the cooperative group effort. ☐Yes ☐ No Planned enrollment period: Annual accrual goal Total accrual goal at IUSCC: at IUSCC: Are there competing studies within your program? If yes, list all studies below and provide a brief explanation for how you plan to prioritize enrollment. ☐Yes ☐ No Competing Study #s: Plan for enrollment prioritization: If this is a multisite study, answer all applicable questions below. Is IU the lead site? ☐Yes ☐ No If study has multiple phases or cohorts, which phase/cohort will be opened here? If applicable, how many cohorts are left and what is the progress of the current cohort (i.e., how many slots are open)? For industry sponsored trials, what is present total accrual? If IU is lead site, list the additional sites: Total accrual goal across all sites: If Clinical Trials Office (CTO) will manage this study, list the names of staff you have identified to run the study (minimum CRS and RN must be listed). Clinical Research Coordinator (CRS): Research Nurse (RN): Other: PI Signature: Program Leader Signature: (or alternate program leader if PI is also program leader) Program Leader Name: Date: Date: HOW TO SUBMIT: Studies exempt from feasibility assessment (i.e., IU IITs and NCTN trials) - submit score card with all other SRC required forms at time of SRC submission. All other trials NOT exempt from feasibility assessment (i.e. industry trials and non-IU IITs) - submit score card and draft budget to FARC@iu.edu ≥ 1 week prior to SRC deadline. Score card required for all trials going to Scientific Review Committee (SRC). SRC will use score card to evaluate trials for approval or disapproval in addition to scientific merit. The Feasibility Assessment Review Committee/Process (FARC) is responsible for identifying and ensuring adequate resources are available to safely and efficiently conduct the trial and ensure there is prioritization and rationale by the program that aligns with the IUSCC mission. Version 11/13/2015 2