Education, Resources & FAQs Institutional Office of Regulated Nonclinical Studies (ORNcS)

Education and Resources

ORNcS Regulatory Operations Team offers free training classes to UTMB employees. All classes are designed to educate a wide range of students with varied education and levels of experience. Courses are designed for individuals with little to no experience in the development of Quality Systems and/or conduct of regulated studies. A certificate of attendance is awarded for successful course completion.

Courses are:

  • Conducted in a classroom setting with no homework!
  • Offered annually and/or by request at orncs@utmb.edu.
  • Announced via UTMB Daily Announcements
  • Can be customized for a particular need (funding requirement)

Standard Courses:

Title: Laboratory Safety & Good Laboratory Practices
Course Length: 8 hours
Course No.: CTPS 6108
Credit Hours: 1

Course generally offered Spring and Fall semester

Course Overview: This course is designed to prepare postdoctoral scholars and advanced graduate students with basic tools and information about biomedical laboratory safety and the FDA’s Good Laboratory Practices (GLP) regulations, codified under Title 21 Part 58 of the Code of Federal Regulations. It is combined with an on-line Laboratory Safety education module. Successful completion results in 1 credit to students enrolled in UTMB's Graduate School of Biomedical Sciences Postdoctoral Scientists Certificate Program.

Title: Good Documentation Practices
Course Length: 1 hour
Course Overview: If you didn’t document it, you didn't do it! Good Documentation Practices are essential tools in working in a regulated and non-regulated research environment. The expectations and your defined quality system will be largely the same regardless of the regulatory environment you face. This course is structured to be interactive and will include plenty of opportunities for questions and discussions. Topics to be covered include the importance of good documentation practices, how to correct errors and omissions in data entry, how to sign, date and label data and records, how to complete documentation such as data collection forms and how to attach raw data to forms and lab notebooks.

Title: The Importance of Writing Effective Standard
Operating Procedures
Course Length: 1 hour
Course Overview: Standard Operating Procedures (SOPs) are essential tools for the clinical and research industries. SOPs outline responsibilities, guidelines, implementation procedures, approaches, and ensure consistency within an organization. This course provides an interactive and comprehensive introduction to designing, writing, implementing, revising, and updating of SOPs.

Who should attend?

Our courses are intended to improve the quality and integrity of research data and participants from all areas are welcome! Common participants include:

  • Principal Investigators
  • Postdoctoral Scientists
  • Research Scientists
  • Clinicians
  • Laboratory Directors
  • Research Associates
  • Veterinarians
  • Animal Care Technicians
  • Legal Counsel

Education - Gulf Coast Consortia

The Gulf Coast Consortia is a collaboration of basic and translational scientists, researchers, clinicians, and students in the quantitative biomedical sciences who help advance the region’s scientific progress through participation in joint training and research programs. Training includes Rigor and Reproducibility training and other scientific workshops to promote scientific rigor and reproducibility of published findings.

 More Gulf Course Consortia information

Education—FDA CDER

The FDA Center for Drug Evaluation and Research offers online continuing education courses through their CDERLearn Program. According to their website, “CDERLearn in the Center for Drug Evaluation and Research (CDER) offers a variety of learning opportunities for healthcare professionals, industry, consumers, and academia. The goal is to create a body of educational and information modules about human drug regulation and activities. CDERLearn is a way to share FDA expertise in specific subject areas to further instruct the public about the many ways CDER protects and promotes public health.”

  More information on FDA Center for Drug Evaluation and Research

Education—HHS ORI Educational Resources

The U.S. Department of Health and Human Services Office of Research Integrity offers educational resources, to include videos and case studies, addressing responsible conduct in research.

Resources

More references and resources available upon request at orncs@utmb.edu.

Frequently Asked Questions

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  • What is regulatory science and how does it contribute to medical practice?

    Regulatory science refers to the broad name of activities needed to develop and apply new methods, tools and standards to facilitate development of safe, effective and high quality medical products for at risk populations. For example, research aimed to incorporate methodologies that enable informed benefit-risk, science based decision making. Areas of special interest for medical countermeasure regulatory science include: (1) animal model development, (2) identification of biomarkers for safety and efficacy, (3) immune response including correlates of protection (4) assessment of product quality and (5) risk communication to improve health outcomes.

  • What role does the U.S. Food and Drug Administration play in response to the NIAID Public Health Emergency Medical Countermeasures Enterprise?

    The Medical Countermeasures Initiative MCMi lays out a vision for a flexible, nimble system to produce medical countermeasures rapidly in the face of any attack or threat, known or unknown. The FDA has organized its MCMi around a three pillar action plan based on: (I) Enhanced MCMi review process and capacity, (II) Advance regulatory science for MCMi development and evaluation, (III) Modernize the legal, Regulatory and policy framework for effective Public Health Responses.

  • How is ORNcS involved in development and testing of MCMs to treat and/or prevent human infectious diseases recognized as medical threats to public health and safety?

    Within ORNcS is an office of Regulatory Operations and Regulatory Science which houses professional staff including Study Directors who are PhD scientists that conduct regulated vaccine or therapeutic studies in animal models to determine their efficacy to prevent or treat diseases for which MCMs are required. Often these diseases do not frequently occur in humans making it impossible to do human efficacy studies; therefore the disease in animals is used as a model to establish the efficacy and safety of the MCM. Data from these studies are audited by the Quality Assurance team to assure compliance and accuracy of study conduct. The combined data from multiple studies in animal models with a vaccine or therapeutic is then submitted in an Investigational New Drug (IND) application to the FDA for review to support licensure of the product for human use.