| Clinical Research Branch |
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| The Office of the Clinical Director and Branch Chief has the overall responsibility for the administration of the Clinical Research Branch and oversight of the clinical research program through the Protocol office as well as providing, through the Clinical Core Laboratory and Pharmacy Units, central support for laboratory and pharmacy services to all clinical trials requiring these services. Through the recently awarded MedStar Research Institute (MRI) support contract, support services including medical records, nursing and other patient care support are also provided. Patient travel in support of the BLSA and other protocols is also provided through use of central branch resources. |
| Patricia Duffey, Director of Clinical Services Clinical Support Services Section |
| The Clinical Support Services Section provides medical support services for all protocols within the NIA IRP. This includes protocol specific Clinical Research Coordination staff, many of whom are licensed RNs, research nursing staff, medical assistants, testing personnel (cardiovascular, EMG, DEXA), medical records and reception-scheduling staff. This staff is being constituted to provide flexible, adaptable support for the wide range of longitudinal and interventional trials ongoing or currently under development. |
| Patricia Duffey, Head Protocol Unit |
| The Protocol Unit provides central protocol support including implementation through study initiation meetings, regulatory monitoring and physician credentialing services for all protocols supported within the NIA Intramural Research Program (IRP). The office provides a central site through which proposed clinical studies undergo initial concept review through the monthly Clinical Investigator's Meeting. The office provides support to the individual investigator for preparation of the protocol, necessary consents and HIPAA consents for IRB submission and review. All clinical investigator and regulatory training requirements are tracked by this office and certificates maintained on file for submission as needed to meet IRB documentation requirements. In addition, the office maintains the regulatory files on all protocols including all Institutional Review Board correspondence, stamped consents, original and modified protocol submissions and on study registration via on study cards. The unit interacts with the Clinical Information and Data Management Section to complete IRP wide implementation of the Study Manager ™ program to permit monitoring of all trials within the IRP for protocol accrual, compliance and cost projection/ monitoring. |
| Dan Orenzuk, Head Research Pharmacy Unit |
| The Research Pharmacy Unit supports research pharmacy needs for protocols within the IRP. The unit, operated under the MRI-support contract, will operate a licensed on-site pharmacy at Harbor Hospital Center through which all investigational and support drugs are acquired and maintained consistent with FDA and other regulations and dispensed in response to specific protocol needs. The research pharmacist on staff participates in protocol development and safety evaluation as needed and provides pharmacy specific protocol support during and following protocol initiation. |
| Melissa Lewis, M.S., M.T. (ASCP), Head Clinical Core Unit |
| The Clinical Core Laboratory Unit operates the CLIA certified clinical laboratory that provides basic as well as sophisticated monitoring for patients requiring clinical testing support including hematology, chemistries, virology screening as well as coagulation analysis. This provides cost effective support for all protocols requiring clinical and research monitoring. The unit, interacting with the Clinical Information and Data Management Section, is instituting a Laboratory Information System (LIS) that will provide IRP-wide support for clinical laboratory order entry, specimen processing and capture of clinical results from the instrumentation operated by the unit. This LIS will also directly interface with FDA and HIPAA compliant databases including Oracle Clinical TM undergoing implementation at the present time. |
| Denis Muller, M.S., Acting Chief Clinical Information and Data Management Section |
| The Clinical Information and Data Management Section provides support for networking and management and analysis of clinical data. Major initiatives include implementation of Study Manager TM in conjunction with the Protocol Office and LIS with the Clinical Core Laboratory Unit. In addition, with Oracle database programming support personnel through the MRI contract, an initiative has begun to implement Oracle Clinical TM as the primary Clinical Research Form/Data Entry and Capture database within the NIA IRP clinical program. This provides a scalable secure environment for data storage and for generation of datasets for analysis by IRP staff. In addition, with internal audit functions, access control and security, it will provide an information capture framework that is compliant with increasingly restrictive and complex FDA, Privacy Act, HIPAA and other requirements for generation of research data consistent with Good Clinical Practice guidelines and protection of identifiable health information. |
| Dan L. Longo, M.D., Acting Chief Translational Research and Medical Support Section |
| The Translational Research and Medical Services Section supports Clinical Investigators on-site at Harbor Hospital. They lead a variety of studies and participate jointly in multidisciplinary studies that cut across subspecialties. Investigators within this section work closely with other laboratories within the IRP to develop and support translational research programs utilizing basic laboratory developments within the IRP. |
| Investigators |
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