FREQUENTLY Asked Questions
What personnel are key to the success of your animal study?
View All FAQs
About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

Each test report must contain a section that lists key study personnel. FDA believes that this information is relevant to regulatory review because 21 CFR 58.29(a) requires that study personnel are appropriately trained and experienced to properly carry out their duties. This regulation underscores the importance of the training and expertise of animal study personnel. FDA recommends that the animal study team include skilled clinical veterinary staff in order to:

  • detect and resolve adverse outcomes;
  • make decisions about the necessity to intervene,intervene accordingly, or deviate from the protocol in the interest of humane care;
  • preserve valuable tissue; and
  • assist in the determination of device associations with any adverse finding.

Animal models may frequently impart the need for unique surgical approaches, anatomical limitations, and important features of wound closure that best argue for trained veterinary surgical expertise as part of the research team.

FDA recommends that the animal study involve investigators with a combination of expertise, including human clinical, veterinary clinical, and veterinary pathologic fields. In keeping with the requirements, you must maintain a current summary of the training and experience and job description of all personnel engaged in, or supervising the conduct of, animal studies. FDA recommends that any assessment of the competencies of key personnel be based on a rationale for why the individuals are suited for the type of studies being conducted.

FDA notes that appropriate training and experience of study personnel are also addressed in other relevant guides, and other agency regulations and policies.

In addition to assembling a team of competent oversight personnel (including the study director, QAU, and attending veterinary and interventional staff), FDA recommends that you select the number of qualified personnel and their resources (including equipment, lateral and subordinate personnel, records and reports, and standard operating procedures) such that monitoring, treatments, and test sampling can be obtained at appropriate time points and to ensure that there is active surveillance at these periods for risks known or predicted in previous animal or bench testing, or possibly from previous experience with similar products. Finally, FDA recommends that you employ veterinary professionals with adequate training and experience to perform animal welfare audits of facilities, personnel, and methodology for those business entities that you may wish to contract from, such as contract animal research or holding facilities.

Related Terms:
No items found.
Related FAQs:
More Questions? We're here to help!
SPEAK WITH A SPECIALIST