Credentialing

Overview

The clinical trials credentialing process is intended to improve protocol compliance in NCI-sponsored studies. IROC uses state-of-the-art analysis and tools to ensure that a clinical site can use imaging and/or radiotherapy technology to provide high-quality care in a clinical trial setting.

Credentialing ensures that clinical physicians and physicists have the steps in place to carry out protocol specifications for any enrolled subject. Our goal is to encourage participation in clinical trials; therefore, an emphasis is placed on reducing the burden of the credentialing on clinical sites. We accept pre-existing site qualification for certain trials when possible. We also work with clinical site personnel to suggest remedial actions necessary to meet protocol criteria.

Radiotherapy Credentialing

IROC’s radiotherapy credentialing provides a tiered approach to improve quality of radiotherapy treatment deliveries in the clinical trial setting and to improve protocol compliance. Credentialing requirements are built to fit the needs of evolving treatment techniques and modalities and to fit the needs of individual protocols.

Completion of one or more of the following credentialing steps is required prior to enrolling patients:

  • Completion of facility questionnaire.
  • Completion of a Credentialing Status Inquiry, as needed.
  • Web-based protocol knowledge assessment.
  • Benchmark cases demonstrating treatment planning capabilities and implementation of appropriate dosimetry parameters.
  • End-to-end phantom irradiation study to assess the entire treatment process for a specific modality.
  • Image-guided RT study to ensure clinical site processes allow for the accurate alignment of anatomy following protocol-specific instructions.

For more information view the IROC RT Credentialing brochure and visit the IROC Houston QA Center.