Clinical Research Office
The Mayo Clinic Cancer Center Clinical Research Office supports researchers and patients by providing centralized management and oversight functions related to the conduct of clinical trials. Through a variety of services that facilitate and strengthen research, the Clinical Research Office provides a comprehensive infrastructure that ensures high-quality, efficient clinical trials.
Protocol development specialists in the Clinical Research Office develop and coordinate studies written by Mayo Clinic researchers, studies within cooperative groups and studies sponsored by industry.
Regulatory and compliance guidance
Specialists in this unit of the Clinical Research Office provide regulatory guidance about policies and procedures to investigators, study teams and internal review committees. Specialists also review protocols to ensure accurate and complete regulatory information.
Regulatory services include:
Compliance services include:
Specialists are also responsible for planning and executing audits for several research bases, including the Alliance for Clinical Trials in Oncology. This includes reviewing audited studies, auditing records and source documentation, conducting exit interviews, and writing audit reports.
Data quality assurance
The Clinical Research Office ensures high-quality standards for data collection and management of clinical trials. This unit provides support to Mayo Clinic and its affiliates and members of the Alliance for Clinical Trials in Oncology.
Study coordination provides support for activities related to identifying and recruiting patients for studies and entering them into studies. Study coordinators ensure that each patient is managed according to the protocol and take responsibility for timely, accurate collection and reporting of adverse event data.
General operational activities within the Clinical Research Office include developing policies, standard operating procedures and best practices related to clinical trial activities.
Steven R. Alberts, M.D.
Kelly D. Paulson
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