Core B - Clinical Protocol/Data Management

$649,365P30FY2009CANIH

Dana-Farber Cancer Inst, Boston MA

Investigators

Linked publications & trials

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Abstract

The CPDM serves the function of ensuring the high quality performance of protocols within DF/HCC. Protocol eligibility checking, consent form checking, and registration/randomization occur in the QACT for all patients entered on DF/HCC cancer-related protocols. This registration system is linked with pharmacy systems to ensure safety, to ascertain that investigational drugs and treatments are appropriately used for protocol patients with proper eligibility only, and to monitor consent and registration. In addition, Principal Investigators for DF/HCC-initiated protocols utilize the expertise of QACT to design case report forms, to manage quality control and to computerize data. QACT also administratively manages CLINPOC, as well as the DSMB and DSMC. The CTEO runs training classes for research staff in regulations and policy and procedures for clinical research at DF/HCC, and helps study teams prepare protocols for submission to the review committees.

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