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U.S. National Institutes of Health
Last Updated: 09/14/15

About the Branch Chief

Michael Montello, PharmD, MBA

Michael Montello, PharmD, MBA, was appointed Branch Chief of OIB July 2015. Dr. Montello has been with CTEP for over 20 years. He has been a member of four different Branches and one Office within the Program. He is a retired Public Health Service (PHS) Officer. More…

Operations and Informatics Branch (OIB)

CTEP's Operations and Informatics Branch serves to improve the protocol development and conduct process through the use of efficient business practices and informatics tools. The creation of OIB in 2008 brought together the operations hub and informatics strength of the Protocol and Information Office (PIO) and the CTEP Enterprise System (ESYS) in one formal organization.

The PIO continues to support CTEP by collecting, processing, tracking and monitoring all protocol related information between CTEP and its extramural collaborators as well as with other CTEP and NCI programs.

The purpose of the Protocol and Information Office is to:

  • Facilitate the development and conduct of quality clinical trials in the most efficient and expeditious manner possible.
  • Minimize the administrative burden related to clinical trial development and conduct and management on CTEP staff and the extramural community.
  • Abstract protocol related keywords and milestones into CTEP ESYS to assist with Program decision making.
  • Promote, inform, and educate all concerned parties regarding NCI programs, policies, and objectives related to clinical trial development, conduct and management.

The CTEP ESYS is a 22 application system that allows CTEP, other NCI staff and the extramural community to enter pertinent agent and protocol related data as part of the clinical trial development process. This includes reporting information to the FDA, managing agent inventory, processing agent orders, registering investigators and associates, supporting audit activities, reporting accrual and demographic data, entering adverse event information and managing disease and agent portfolios.

The primary objectives of the CTEP Enterprise System are to:

  • Capture data and translate it into a usable format to address the scientific, safety, regulatory and administrative needs of CTEP and the NCI
  • Eliminate data redundancy throughout the oncology community through the integration with other systems
  • Streamline clinical research operations
  • Reduce the administrative burden on NCI staff, contractors, and extramural researchers
  • Improve communication between CTEP and its collaborators
  • Assure the security and confidentiality of proprietary and patient information
  • Increase access to clinical trials to all interested investigators
  • Support broad patient access to clinical trials
  • Expedite the protocol development and review process within both clinical trial organizations and reviewing bodies