Office of Clinical Research Administration

Thông tin thiết kế đặc biệtThe Office of Clinical Research Administration is supported by five offices:

• Investigational New Drug (IND) Office
• Office of Clinical Research Finance (OCRF)
  
• Office of Human Subjects Protection Office (OHSP)
• Office of Protocol Review and Reporting (OPRR)
• Office of Protocol Support and Management (OPSM)

Learn more about each office below.

The Investigational New Drug (IND) Office provides regulatory and monitoring oversight for investigator-initiated IND studies. Services include assisting the principal investigators (PIs) in the preclinical concept stage, arranging a pre-IND meeting with the FDA, formatting the initial IND submission, and facilitating all communications with the FDA and the Recombinant DNA Advisory Committee (RAC) throughout the life of the trial. Clinical Research Monitors review these IND trials for compliance every 8-12 weeks based on protocol specific, risk-based monitoring plans. The new Medical Affairs/Safety group is dedicated to pharmacovigilance, responsible for reviewing serious adverse events and toxicity and safety summaries.

The Office of Clinical Research Finance (OCRF) develops a detailed coverage determination for all clinical and lab studies with patient care charges to assist clinical researchers in negotiating adequate clinical trial funding. OCRF also ensures compliance with institutional internal controls, reviews all research-related patient care charges to maintain regulatory compliance, facilitates clinical research billing and invoicing and assists clinical departments in reconciling sponsor-paid charges in a timely manner. An important responsibility is to ensure appropriate budgeting for clinical trials in compliance with federal and state regulations, and the OCRF centralizes all functions under one reporting line.

The Office Human Subjects Protection (OHSP) supports MD Anderson'sThông tin thiết kế đặc biệt human subjects protection program, which provides regulatory oversight and monitoring of research studies. The office provides administrative support for the IRBs and DSMBs, including regulatory submissions, post-IRB approval and review of grants for compliance with the federal requirements. Editorial services are provided for informed consent documents, including consent authoring, conflict of interest review, sponsor negotiations and common adverse event language database maintenance. In addition, the office facilitates the electronic research consent process (iConsent).

The Office of Protocol Review & Reporting (OPR&R) provides support for MD Anderson’s human subjects protection through scientific review of new study submissions, study activation and continuous accrual monitoring of active research trials. The office provides administrative support for the scientific review committees for both clinical and psychosocial/behavioral research, accrual monitoring committees and operational database support for our regulatory software systems. In addition, data management services are provided for multi-institutional consortium trials including online document management, remote user management for external sites and online image repositories.

The Office of Protocol Support and Management (OPSM) has dedicated support for NCI-sponsored clinical trials, including those that are part of the NCI National Clinical Trial Network (NCTN) and the Early Therapeutics Clinical Trial Network (ETCTN). This group acts as a liaison between MD Anderson and the NCI to facilitate communication, collaboration and quality in the conduct of NCI-supported research. Services for NCTN/ETCTN trials include protocol development, study management, data support, investigator registration, research staff credentialing, quality assurance and administrative support. A recent initiative to open more NCTN trials in the Houston Area Location sites has assisted in providing Houston Area Location patients with access to NCI-supported clinical trials. The Houston Area Location sites are participating in several active NCTN trials.