IUSCC Prioritization Scoring Card

advertisement
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 ([email protected]) 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 [email protected] ≥ 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
Download
Random flashcards
Radiobiology

39 Cards

Pastoralists

20 Cards

Radioactivity

30 Cards

African nomads

18 Cards

Create flashcards