Xổ số miền bắc thứ 4 hàng tuần*FY 2017 statistics
Office of Clinical Research Administration
Jennifer Litton, M.D.
Vice President, Clinical Research Administration
The Office of Clinical Research Administration provides high-quality, efficient infrastructure support for all aspects of clinical protocol research at The University of Texas MD Anderson Cancer Center. Through our five offices, we are devoted to the needs and protection of all those participating in or conducting clinical research while maintaining high ethical standards and compliance with all regulatory policies.
Our services include:
- regulatory oversight of all research studies
- submission, activation and management of clinical trials
- education of research staff on clinical research
- auditing and monitoring of active clinical trials
- assurance of regulatory compliance of IND studies
- financial management of protocols
- data safety and monitoring
Clinical Research Productivity
5500+
protocols managed
26K+
new patient registrations
500+
protocols reviewed
Office of Clinical Research Administration Structure
Xổ số miền bắc thứ 4 hàng tuầnThe 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)
Xổ số miền bắc thứ 4 hàng tuầnLearn more about each office below.
IND Office
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.
Roles at a Glance
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Regulatory Affairs
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Monitoring Services (IND Trials)
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Xổ số miền bắc thứ 4 hàng tuầnMedical Affairs/Safety
Office of Clinical Research Finance
Xổ số miền bắc thứ 4 hàng tuầnThe 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.
Roles at a Glance
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Coverage Determination
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Budget Review
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Quality Assurance
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Research Billing Review
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Close Out
Office of Human Subjects Protection
The Office Human Subjects Protection (OHSP) supports MD Anderson'sXổ số miền bắc thứ 4 hàng tuần 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).
Roles at a Glance
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Institutional Review Boards (IRBs)
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Data Safety Monitoring Boards (DSMBs)
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Xổ số miền bắc thứ 4 hàng tuầnAccreditation of the Human Subjects Protection Program
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Scientific Editing
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iConsent
Office of Protocol Review and Reporting
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.
Roles at a Glance
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Scientific Review Committees (SRCs)
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Xổ số miền bắc thứ 4 hàng tuầnPsychosocial Health Services Research Committee (PBHSRC)
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Xổ số miền bắc thứ 4 hàng tuầnElectronic Protocol Accrual Auditing Committee (ePAAC)
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Research Informatics Systems
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Regulatory Software Applications
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Xổ số miền bắc thứ 4 hàng tuầnInstitutional Reporting
Office of Protocol Support and Management
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 AndersonXổ số miền bắc thứ 4 hàng tuần 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.
Roles at a Glance
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Clinical Research Electronic Health Record Support
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Houston Area Locations and LBJ Research Support
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Xổ số miền bắc thứ 4 hàng tuầnNCI Study Support
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Xổ số miền bắc thứ 4 hàng tuầnMulticenter Study Support and Monitoring
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Research Education
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Xổ số miền bắc thứ 4 hàng tuầnClinical Research Auditing
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Xổ số miền bắc thứ 4 hàng tuầnBiospecimen Auditing Support and Oversight