Drug Evaluation Committee Requirements for an ideal clinical trial network and self-assessment (May 2013)
Clinical Evaluation Subcommittee
May 2013
The requirements that are considered important for clinical trial networks to improve case collection and efficiency of clinical trial operations are summarized in the categories of "clinical trial implementation system," "site selection," "management," and "information disclosure. The report also describes how to utilize the Clinical Trial Network Self-Assessment Sheet.
Requirements for an ideal clinical trial network and self-assessment (853KB)
Clinical Trial Network Self-Assessment Sheet
The sheet was created as a tool for self-checking the status of achievement of requirements considered important for improving case collection and efficiency of clinical trial operations in a clinical trial network, and for disclosing the results as numerical values. By disclosing the results of self-checks using this sheet, we hope to identify and improve shortcomings in our own clinical trial networks and to appeal to sponsors.
Clinical Trial Network Self-Assessment Sheet (113KB)
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