Research at Fox Chase »Research Facilities »Clinical Research

Staff

Function

Approximately one-third of patients enrolled on studies managed by the Protocol Office participate in investigator-initiated research. These studies often use investigational drugs and may incorporate combined modality therapy, pharmacokinetics, and other laboratory correlates, with a greater impact on protocol resources. The scope of responsibilities for the clinical research coordinator (CRC) and clinical research associate (CRA, data manager) are generally more detailed for these studies in comparison to cooperative group or industry-sponsored studies. The protocol office staff are involved in the initial review and evaluation of the protocol as well as responsible for the content and design of the data collection forms that are to be used in conjunction with the protocol. In addition, the CRC and CRA are involved with the recruitment of patients, as well as the coordination and processing of pharmacokinetic samples. The Protocol Office compiles and tabulates internal data summary reports, such as toxicity tables, for each of these studies.

The Protocol Office staff perform all of the functions inherent to that of a study sponsor for these institutional studies, which may extend to coordination over multiple participating institutions. This continuum of obligation includes study initiation, monitoring, protocol changes, disseminating information, safety reports and annual reports. The CRC and CRA function as a team in conjunction with the principal investigator to evaluate protocols and the data collected for completeness, accuracy and compliance to protocol in accordance to federal regulations and guidelines.

Description

The CRC and the CRA work as a team to provide overall study management, patient coordination, collection of data, and analysis of results.