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Study Pipeline from Concept to Completion

This resource serves as a guide for the investigators in the Department of Radiology at USC who are interested in undertaking human clinical trials that are either investigator initiated or industry funded. The following flow chart intends to outline and explain the general steps involved in the clinical trial process and provide contact details of the personnel who can help you in successfully completing each individual component.

➢ Please contact Bhushan Desai, Director of Clinical Research, at bhushand@usc.edu or 323-865-9949 for below mentioned steps. All research related activities should be routed through him. Bhushan will then be assigning the tasks, as seemed appropriate, to other members in the research division.

➢ Additionally, as highlighted in the steps below, the newly formed Radiology Research Committee will be reviewing (before submitting to funding agencies, before study initiation) and monitoring (recruitment, data management, and research productivity) both investigator-initiated and industry-funded studies at various stages to provide feedback about the merit of the study and recommendations/guidance about scuccesful completion of the research study.

CLINICAL TRIAL PROCESS DIAGRAM– INVESTIGATOR INITIATED STUDIES

CLINICAL TRIAL PROCESS DIAGRAM– INDUSTRY FUNDED STUDIES

CLINICAL TRIAL PROCESS DIAGRAM– Investigator Initiated Non-Funded Studies

|Radiology Research Committee Members |

|Edward Grant |Peter Conti |Meng Law |Sravanthi Reddy |Kai Chen |

|Vinay Duddalwar |Eric White |Michael Katz |Bhushan Desai |Steven Cen |

|Hossein Jadvar |Suzanne Palmer |Linda Hovanessian-Larsen |Alison Wilcox |Darryl Hwang |

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IRB, CIC, and CTO preparation and sumbission

POST - AWARD TASKS

PRE – AWARD TASKS

Clinical Research Idea

Liaison between the PI & Sponsor, IRB, CTO

Develop Concept, Study Feasibility, Design Consultation

Literature Review & Scientific Proposal Writing

Manage Contract & Grant Funds

Research Co-ordinator Support

Statistical Methods, Estimating Sample Size & Power

Develop Case Report Forms & Electronic Data Capture Tools

Monitoring by Radiology Research Committee

(Recruitment, data management, productivity and other project related issues)

Identifying Funding Possibilities

IRB & CIC Protocol Submission

Contact: Bhushan Desai (bhushand@usc.edu)

Diana Shycoff (shycoff@med.usc.edu)

Preliminary Budget Preparation & Assistance

Statistical Analysis / Interpreting Results

Grant Proposal reviewed by Radiology Research Committee

Submitting Progress Report, Abstracts, and Manuscript Writing

Grants Submission to various funding sources

Liaison between the PI & Sponsor, IRB, CTO

IRB, CIC & CTO Protocol Submission

Grant Proposal reviewed by Radiology Research Committee

Monitoring by Radiology Research Committee

(Recruitment, data management, productivity and other project related issues)

Research Co-ordinator Support

(Recruitment and Data Management)

Clinical Research Idea

Develop Study Protocol, Case Report Forms & Electronic Data Capture Tools

IRB & CIC protocol preparation and submission

Statistical Analysis / Interpreting Results

Progress Report, Abstracts, and Manuscript Writing

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