Science & Research
Volume III - 6.4 Roles and Responsibilities
Section 6 ORA Method Development and Validation Program
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- 6.4.1 Associate Commissioner for Regulatory Affairs (ACRA) and the Office of Operations (OO)
- 6.4.2 Regional Food and Drug Directors (RFDDs)
- 6.4.3 Office of Regulatory Science (ORS)
- 6.4.4 ORA Laboratory and Science Branch Directors
- 6.4.5 ORA Analysts
- 6.4.6 Science Advisors
- 6.4.7 FDA Center Scientists
The Office of Regulatory Affairs Associate Commissioner and the Director of OO share responsibility for promoting and supporting a strong ORA method development and validation program as well as determining ORA goals.
The Regional Food and Drug Directors assign a specific number of FTEs to each laboratory based on past method development/validation accomplishments, laboratory expertise, and agency need in specialty and program areas.
The Office of Regulatory Science (ORS) develops and implements the method development and validation guidelines and manages the overall program. ORS issues the call for proposals, assigns reviewers and approves proposals, and maintains the approved and completed project list. ORS also maintains and administers the Component Automated Research Tracking System (CARTS) designed to capture, monitor and archive all ORA research efforts.
ORS works with the Laboratory Directors, the Centers, and analysts to guide and assist with the method development and validation process. The Director of ORS is the recommending and approving official for field laboratory method development and validation programs. ORS monitors the various steps in the process, issues requests for proposals, coordinates proposal review, approves projects, and receives progress reports.
Direction and management of the ORA method development and validation resources reside at the local laboratory management level. Laboratory management is responsible for developing and executing their laboratory’s method development and validation program. This includes: developing and selecting the most significant projects, providing funding, and assuring that work plan resources are fully planned and executed. Timely planning, direction, and accomplishment of these projects are crucial. Laboratory Directors rely on supervisors, senior laboratory staff, and Science Advisors.
Laboratory management must establish an environment where there is vigorous growth, development, and accomplishment of projects within the laboratories. Recognition that is commensurate with the level of contribution to the regulatory mission of ORA and FDA by scientists who successfully complete method development and validation projects is an important aspect of a successful program.
Laboratory management is responsible for ensuring that all research undertaken in the field labs or Centers addresses the needs of the FDA as defined by the Expected Research Outcomes (ERO) requirements for the year. To ensure that supported research focusses on critical capacity building as defined by the ERO’s all research projects should be submitted and approved through CARTS before initiation.
ORA analysts are responsible for the following:
- submitting proposals through the Component Automated Research Tracking System (CARTS) for all method development and validation studies in response to ORS’ Call for Proposals;
- developing and submitting proposals through CARTS before initiating the research project. Projects should be approved and appear on the active Intramural or Extramural Project List prior to initiation of the research study
- timely accomplishment of approved projects;
- adhering to the highest standards of intellectual honesty and ethical standards in formulating, conducting, and presenting method development and validation work; and
- following research and publication requirements and guidelines written in sections 6.5 and 6.6.
Science Advisors aid laboratory management and analysts by providing technical analytical guidance and method development and validation process guidance at the local level. More specifically, the advisors provide direction towards the development of concept and method development and validation project papers, and assist in the conduct, evaluation, and presentation of method development and validation end-products. They promote interaction and collaborations with their respective universities and other science advisors where appropriate.
Additionally the science advisors recommend improvements towards the method development and validation program, provide periodic follow-up reports regarding method development and validation’s regulatory impact including associated publications, presentations, collaborative studies, adoption as official methods by additional field and headquarters laboratories, and inclusion in compliance programs.
FDA Center scientists respond to ORS’ requests for method development and method validation projects involving ORA participation. These projects will be reviewed by ORS for inclusion in the program. Center scientists may serve as project leads. Center scientists provide technical guidance, method documents and validation protocols as requested by ORA scientists and ORS for projects included in the method development and validation program.