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

Last modified: Sep 11, 2012
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