Office of Clinical Research

The Office of Clinical Research is supported by several offices:

• FDA Submissions Team
• Clinical Research Finance (CRF)
  
• Office of Human Subjects Protection Office (OHSP)
• Multicenter & Strategic Collaborations Office
• Clinical Research Services  

Learn more about each office below.

The FDA Submissions team 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. The Medical Affairs/Safety group is dedicated to pharmacovigilance, responsible for reviewing serious adverse events and toxicity and safety summaries.

Clinical Research Finance (CRF) 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. CRF 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 CRF centralizes all functions under one reporting line.

The Office of Human Subjects Protection (OHSP) facilitates MD Anderson’s compliance with ethical and legal requirements for the conduct and oversight of Human Research by providing:

• Operational and regulatory support to the Institutional Review Board (IRB)
• Regulatory oversight and monitoring of all studies and subsequent regulatory submissions
• Continuous quality improvement (CQI) for the institution's Human Subjects protection activities

The Multicenter & Strategic Collaborations Office is designed to deliver high quality multi-site clinical research studies at MD Anderson. The office oversees the management and execution of multicenter studies, provides operational and regulatory support and serves as the central source for coordinating all activities between internal functional teams, study sites and sponsors.

The Multicenter & Strategic Collaborations Office aims to:

• Provide an infrastructure that supports the planning, activation, and management of multicenter clinical studies
• Integrate electronic solutions into processes to facilitate efficiency and transparency
• Drive process simplification and standardization  to fast-track innovative therapies to market

The Clinical Research Services 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.