Core--Clinical Research Office

Johns Hopkins University, Baltimore MD

Investigators

Linked publications & trials

Abstract

The Clinical Research Office (CRO) is responsible for the performance of all clinical research in the JHCCC. It is part of the Clinical Trials and Biometry Unit and has Cancer Center oversight through the Executive Clinical Research Committee. Center programs are supported in disease based models lead by clinical research coordinators and staffed with data managers and research nurses. The CRO defines the standards of research through the Center by translation of regulation and good practice into effective standards of research. Adherence to standards is achieved by personnel supervision and regular quality assurance monitoring. The CRO assures performance of data managers and research nurses through establishing job descriptions, hiring skilled personnel, training and regular performance evaluations. All promotions and hiring are performed by the CRO in concurrence with programmatic goals. Essential services supplied include: a) facilitation of new trial development and IRB submissions, b) support of the scientific clinical review and monitoring process, c) recruitment and accrual of subjects for trials, d) coordination of data collection, e) monitoring clinical trial performance and assuring performance to protocol definitions, f) adverse event reporting, g) facilitation of site visits, h) coordination of research affiliates and i) maintenance of infrastructure including the Protocol Library (protocols, consents, orders and eligibility checklists)< Clinical Research Manual, Regulatory files and Newsletter. All research subjects are registered with the CRO. Regulatory oversight of clinical research is organized through protocol and document processing, evaluation, and action with timely and accurate document distribution. Funding support for the CRO includes Center support, industrial charge-backs and CCSG funding. Overall, 567 active trials (open and closed to accrual) were managed in 199 with 1,998 new subjects per years and 3,175 on trial. All trials were CRO support are approved and monitored by clinical research review and monitoring process. Developmental plans direction involves improved QA, electronic document management and automated clinical trial support of CCSG approved trials.