College of Medicine / Research / Cores and Shared Services


       

Charles E. Schmidt College of Medicine
Florida Atlantic University
777 Glades Road
Boca Raton, FL 33431

561-297-4828
COMinfo@health.fau.edu

New Clinical Translational Research Unit (CTRU) Feasibility Committee


CTRU Feasibility Committee Charge:

  1. Assess proposals for scientific merit and feasibility.
  2. Promote quality, collaboration, and excellence in research.

The CTRU Feasibility Committee must review and approve all new

a. industry and non-industry funded clinical trials with FDA oversight
b. clinical research studies (including pre-proposals) using CTRU resources (i.e. space, equipment, staff)

Committee approval must be attained prior to any sponsor negotiation or proposal submission.

Proposals must be routed via the proposal submission button below. All site qualification forms must be completed in collaboration with the CTRU administration. The Confidential Disclosure Agreement (CDA) must be reviewed both by the CTRU administration and the Office of Sponsored Programs, the signatory official.


Submission and Review Process:

A. Complete the online submission form and upload the following items:

    1. Study Protocol (IRBNet FAU Basic Protocol template is located under Other Tools-Forms and Templates)
    2. Informed Consent/Assent Document(s) - up to 6 files (IRBNet FAU Consent templates are located under Other Tools-Forms and Templates)
    3. Study Calendar/Schedule of Events
    4. Investigator Brochure (if applicable)
    5. Draft Clinical Trials Agreement (if applicable)
    6. Draft Budget
    7. Draft 1572 (if applicable)
    8. Letters of Support/Collaboration detailing services/resources (and respective fees) to be rendered from all third-party facilities

B. Once your submission is reviewed for completeness by CTRU administrative staff, the proposal will be routed to the committee for review.

C. The investigator will be informed if the proposal needs revisions or proceeds to the Office of Sponsored Programs and Office of Research Integrity.

    1. If the proposal needs revision, it will be returned with suggested revisions that need to be addressed before resubmission
    2. If the proposal does not need revisions, the PI will receive notification to submit to the Office of Sponsored Programs and Office of Research Integrity

The CTRU Feasibility Committee will consider the following issues in reviewing the research proposals:

1. Investigator Initiated Protocols:

a. Scientific merit and impact of project are evident
b. Lead investigator demonstrates necessary expertise
c. Project is well conceived, logical, and organized
d. Aims are clear and appropriate
e. Methodology is clearly stated and appropriate
f. Knowledge/understanding of research methods is demonstrated
g. Research subjects and sites are clearly identified and justified
h. Data collection and analysis plan is clearly stated
i. Data management plan is clearly stated
j. Potential limitations are clearly identified and addressed
k. Recruitment strategy/plan is clearly delineated and reasonable
l. Dissemination plan is clearly stated
m. All required resources (staffing, FAU research sites, third party facilities) are clearly identified and appropriate (including
     explicit letters of support/collaboration detailing services/resources to be rendered from all third party facilities including
     any fees)
n. Inclusion/exclusion criteria are appropriate
o. Risks are identified, evaluated, and minimized
p. Benefits to subjects/science/society are clearly stated
q. Privacy of subjects is addressed
r. Confidentiality of data is addressed, including use of protected health information (PHI)
s. Informed consent/assent (including LAR, if needed) process is comprehensive and appropriate
t. Budget is adequate (complete time & cost analysis and cost coverage analysis when required)

2. Industry initiated sponsored protocols & Peer Reviewed Grants (i.e. federal):

a. Recruitment strategy/plan is clearly delineated and reasonable
b. All required resources (staffing, FAU research sites, third party facilities) are clearly identified and appropriate (with
    explicit letters of support/collaboration detailing services/resources to be rendered from all third party facilities)
c. Budget is adequate (time & cost analysis and cost coverage analysis, when required)

*In order for the FAU Office of Research Integrity to review any CTRU affiliated application or Office of Sponsored Programs to execute agreements or submit proposals, the CTRU Feasibility Research Committee approval must be submitted in Grants eRA and IRBNet. Please be sure to consider your proposal submission deadlines when preparing to submit your proposal to the CTRU Feasibility Research Committee.


CTRU Feasibility Committee

The committee is comprised of representatives from the College of Medicine and from FAU Offices which may interface with human subject research. Ad hoc members may be requested as content experts as needed.

 Contact Joanne B. Krasnoff, Ph.D. Administrative Director, Clinical Translational Research Unit | Office: (561) 297-1027



Last Modified 8/21/18