Clinical Trial Operations for Network Study Sites
Helpful Information for NCI-Supported Network Trial Operations
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Registration and AccessLearn how to create a CTEP-IAM account and register to access CTEP-supported trial systems and applications.
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CTCAE and Adverse Event ReportingThe latest version of CTCAE and CTEP adverse event reporting requirements
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Agent ManagementAccountability training, forms, and inventory management for CTEP-IND agents.
Resources for CTEP-Supported Trial Operations
Quick Links to Applications and Websites for Network Trials
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AURORA
Inventory management system (ordering, accountability, document access) for trials using CTEP-supplied agents.
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CTSU
The Cancer Trials Support Unit (CTSU) facilitates access to NCI-funded clinical trials for qualified clinical sites; it supports the management and conduct of these clinical trials.
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CTEP-AERS
The CTEP Adverse Event Reporting System is a web-based system for submission and distribution of expedited reports for adverse events. STUDIES USING THE RAVE-CTEP-AERS INTEGRATION: start all AE reports in Rave, which will link to CTEP-AERS as needed.
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NCI CIRB
All U.S.-based sites must use the NCI Central Institutional Review Board (NCI CIRB) as the IRB of record for participation in CTEP- and DCP- supported network trials.
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OPEN
CTSU's Oncology Patient Enrollment Network (OPEN) allows a site that has an approved registration for a protocol and credentialed site staff to enroll eligible patients.
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CLASS
CTSU's Compliance, Learning, and SOP Solutions platform for credentialed staff and investigators.
Additional Network Site Resources
- CTEP Investigators Handbook (PDF): A Handbook for Clinical Investigators Conducting CTEP-Supported Therapeutic Clinical Trials.
- Cyberattack Response Procedures for CTEP-supported clinical trial site personnel.
- Commercial Drug Shortages: Information about managing shortages of commercially-sourced cancer agents while participating in cancer clinical trials.
- RECIST Guideline v1.1 (PDF): The 2008 EJC article describing the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
- OHRP's Human Research Protection Training satisfies the NIH educational requirement for training on human research protections for investigators and key personnel.
- How to Open a Study and other step-by-step Quick-Guides to trial operations are available on the CIRB website.