Clinical Trials Support Core

Purpose

The Clinical Trials Support Core (CTSC) provides administrative services and data management to all members of The Holden Comprehensive Cancer Center who conduct clinical studies.

The CTSC is a shared resource, and is designed to facilitate the conduct of high quality clinical and translational cancer research.

The CTSC is composed of dedicated staff with expertise in protocol management and study coordination. The CTSC provides investigators with services including:

1. Routing of protocols through the University of Iowa IRB or Western IRB and the appropriate internal regulatory committees.
2. Providing expertise in coordination of clinical trial activities (recruitment of patients, determining eligibility, obtaining consent, scheduling procedures, coordinating patient care needs, managing data collection).
3. Serving as liaison to pharmaceutical companies, governmental regulatory agencies and other outside vendors.
4. Budget writing and billing.
5. Assisting investigators with annual reviews, protocol modifications and reporting of adverse events.
6. Providing assistance with collection and processing blood and tissue samples for translational research.
7. Listing of all current clinical trials in the clinical trials booklet.

Contacts:

In addition to providing support for numerous University of Iowa clinical trials and industry initiated studies, the HCCC is an active participant of seven National Cooperative Groups and investigators within the Center enroll over 550 patients on clinical research studies each year. The National Cooperative Group Trials that are involved within the Holden Comprehensive Cancer Center include:

• Cancer and Acute Leukemia Group B (CALGB)
• National Surgical Adjuvant Breast Project (NSABP)
• Eastern Cooperative Oncology Group (ECOG)
• Collaborative Ocular Melanoma Study (COMS)
• Children's Oncology Group (COG)
• Gynecological Oncology Group (GOG)
• Radiation Therapy Oncology Group (RTOG)