Services of the Clinical Research Administration Division for Clinical Trials

MARKETING

• Marketing to pharmaceutical companies
• Marketing to contract research organizations
• Establish relationships with sponsors in order to recruit new trials as a result of previous studies
• Recruit studies from sponsors on behalf of individual investigators
• Maintain a file of physician interests
• Receive notification of new studies and recruit investigators

PRE-INITIATION

• Attend site evaluation visits to answer institutional questions study processing and activation time
• Serve as centralized sponsor contact point for the Medical Center
• Provide protocol development services for investigators
• Prepare consent form for investigator's review
• Secure Human Subjects Committee approval of protocol and consent form
• File regulatory documents required by FDA and sponsor
• Submit research administration checklist to Office of Sponsored Programs
• Prepare and negotiate trial budgets
• Request discounts for hospital and clinical services
• Apply for study billing number
• Coordinate confidentiality agreement and contract approval with Contracts Division of the Research Institute
• Notify investigator and sponsor of final HSC approval
• Prepare and submit initial IND documents, amendment and annual progress reports for IND

POST-INITIATION

• Secure HSC approval of protocol revisions and revised consent forms
• Obtain HSC approval for print or media advertising
• Process internal adverse events and IND safety reports for HSC submission and approval
• Provide status reports of each investigator's trials as requested
• Submit reports to HSC for annual re-certification of trials
• Coordinate ongoing communication between sponsor and investigator

STUDY CLOSURE

• Process study closure for trial termination

QUALITY IMPROVEMENT FOR CLINICAL RESEARCH

• In conjunction with the Office of Compliance, conduct quality improvement visits [QIV]

EDUCATION OPPORTUNITIES

• Host and organize Clinical Trial Education Lecture (CTEL) series on a monthly basis
• Provide training workshops (CTEC) for investigators and study coordinators
• Meet with physicians and study coordinators to review Research Institute services
• Provide new study coordinator/research nurse orientation
• Facilitate coordinator certification, networking and educational opportunities