Oct. 1, 2014:

What are the responsibilities of BTCRC project managers?

BTCRC project managers coordinate and supervise the clinical trial from concept to close out. They serve as the main point of contact with pharmaceutical companies, physicians, and site staff. Project managers train all study staff on each protocol through a Site Initiation Visit (SIV). They also create and maintain a Study Procedures Manual (SPM) for each study.

Whom should I contact with questions regarding eligibility or other trial-related issues?

All trial-related questions should come to the project manager at BTCRC Administrative Headquarters. The project manager will document all relevant site communications and will reach out to the sponsor investigator as needed.

What information should I report to the project manager?

The project manager should be notified of any deviations that occur on trial, any change in staff, protocol questions, and any pertinent trial information. Although monitors will regularly visit your site for audit, it is preferred that you contact the project manager with all communications.

Does the project manager work at the same institution as the sponsor investigator?

No, the project manager is based at the BTCRC Administrative Headquarters at Hoosier Cancer Research Network in Indianapolis.

What if I have an urgent after-hours question regarding patient safety?

BTCRC project managers monitor email in the evening and may also be reached by phone after hours. If your project manager is out of the office, an alternate project manager will be noted in the out-of-office message.

About the Big Ten Cancer Research Consortium: The Big Ten Cancer Research Consortium creates a unique team-research culture to drive science rapidly from ideas to treatment-changing paradigms. Within this innovative environment, today’s research leaders collaborate with and mentor the research leaders of tomorrow with the unified goal of improving the lives of all patients with cancer.

About the Big Ten Conference: The Big Ten Conference is an association of world-class universities whose member institutions share a common mission of research, graduate, professional, and undergraduate teaching and public service. Founded in 1896, the Big Ten has sustained a comprehensive set of shared practices and policies that enforce the priority of academics in student-athletes’ lives and emphasize the values of integrity, fairness, and competitiveness. The broad-based athletic programs of the 14 Big Ten institutions provide nearly $200 million in direct financial aid to almost 9,500 student-athletes for more than 11,000 participation opportunities on 350 teams in 42 different sports. The Big Ten sponsors 28 official conference sports, 14 for men and 14 for women, including the addition of men’s and women’s lacrosse as official sports for the 2014-15 academic year. For more information, visit www.bigten.org.