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.

Services

Protocol development

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.

Services include:

• Preparing and submitting concepts and protocols to internal review committees and external agencies
• Coordinating multicenter studies, including developing protocols and coordinating trials within the Alliance for Clinical Trials in Oncology, a national clinical trials network sponsored by the National Cancer Institute

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:

• Submitting regulatory documents and reporting adverse events to Mayo Clinic committees and appropriate external agencies
• Submitting and maintaining Food and Drug Administration investigational new drug and device applications
• Coordinating monitoring visits and audits

Compliance services include:

• Creating and implementing audit policies
• Planning and implementing compliance activities
• Interpreting and applying regulatory and policy requirements
• Assisting with the development and planning of education programs for Mayo Clinic and external staff

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.

Services include:

• Reviewing patient data for accuracy
• Ensuring adherence to protocol criteria
• Conducting site-specific education

Study coordination

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.

Services include:

• Verifying eligibility criteria
• Collecting and maintaining study data
• Managing study participants

Operational support

General operational activities within the Clinical Research Office include developing policies, standard operating procedures and best practices related to clinical trial activities.

Services include:

• Budget preparation
• Assistance with negotiating and executing study agreements

Contacts

Steven R. Alberts, M.D.
Medical Director
alberts.steven@mayo.edu

Kelly D. Paulson
Administrative Director
paulson.kelly@mayo.edu