2012 RSQA Educational Program
The Office of Regulatory Support and Quality Assurance is pleased to offer the “Research Compliance Training Program” to help raise and maintain knowledge and awareness of research compliance by University employees who conduct human subjects research. The program is composed of 16 training courses (seven new, seven existing and two modified) that will be offered multiple times throughout 2012 on both the medical and Coral Gables campuses.
Principal investigators, research nurses, clinical coordinators, study team members, and anyone else involved in human subjects or clinical research are strongly encouraged to attend the “Research Compliance Training Program” courses. Nurses, social workers and psychologists will receive continuing education credits for attending and retaking courses on an annual basis. Continuing education units for these courses can be used for certification renewals with professional organizations such as ACRP and SOCRA. Participants will receive a certificate after completing each class.
The courses do not have to be completed in order. Please visit the ULearn calendar to see the schedule for the courses, which are described below.
New Training Courses
- Regulatory Support and Quality Assurance Services
This course will provide an overview of the services offered by the Office of Regulatory Support and Quality Assurance. Upon completion, attendees will understand the difference between quality assurance and quality control, the meaning of corrective and preventive action systems, and the importance of quality systems in research.
- Regulatory Binder/Trial Master File
This course provides an overview of the regulatory binder/trial master file and its required documents. Upon completion, attendees will understand the purpose of the regulatory binders/trial master files, how they evolve throughout the study, and the underlying regulations and guidelines.
- Investigational Product
This course provides the respective FDA and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use’s good clinical practices regulations, guidelines and definitions related to investigational products. Upon completion of the course, participants will understand the process and documentation involved in the maintenance of investigational products, including receiving, accountability, storage, labeling, dispensation, reconciliation, and disposition.
- Protocol Compliance
Upon completing this course, participants will understand how to achieve, improve and maintain protocol compliance and prevent, identify and report protocol deviations. The course will provide a broader knowledge of the underlying federal and local regulations and guidelines and preventive measures to avoid protocol compliance issues.
- Principal Investigators’ Oversight of Clinical Study
By attending this course, participants will understand what is expected from principal investigators with regard to providing and demonstrating appropriate oversight of clinical research activities. Other topics of discussion include regulatory requirements and the FDA’s current thinking with respect to principal investigator oversight.
- Monitoring Process/Preparation
This course will provide an overview of the FDA requirements of monitoring investigational new drug and investigational device exemption studies, the importance of selecting qualified monitors, monitoring expectations, and the process of preparing for the monitoring visit. Upon completion, attendees will have a better understanding of the reason monitoring is required, the importance of selecting experienced monitors, the role of a monitor, the extent of a monitoring visit and how to be prepared.
- Investigational New Drug Submission Process
This course will provide an overview of what documents are required and how to prepare for an investigational new drug application and investigational device exemption submission. Upon completion, attendees will understand the FDA regulations for IND/IDE submissions and maintenance.
Modified Training Courses
The Informed Consent Course is now offered in two different classes:
- History and Principles of Informed Consent
By attending this course, participants will learn about the history and regulatory requirements of informed consent and documentation of the informed consent process.
- The Informed Consent Process
Attendees will gain practical knowledge on how the consent process is to be conducted at the University, with an emphasis on regulatory and administrative requirements.
Existing Training Courses
- Documentation Practices
This course provides an overview of documentation practices, record retention requirements and supporting federal and local regulations and guidelines.
- The Audit Process
This course provides an overview of the Office of Regulatory Support and Quality Assurance and its auditing process.
- Preparing for an FDA Audit
This course provides an overview of the preparation for and the conduct during an FDA audit.
- Responding to FDA Observations/FDA Form 483
This course provides detailed information on FDA form 483 responses and includes examples of FDA warning letters and acceptable and inadequate responses. Prerequisite: Completion of “Preparation for an FDA Audit.”
- Good Clinical Practice
This course provides an overview of the good clinical practice components and their supporting federal, local and international regulations and guidelines.
- Responsibilities of IND/IDE Holders/Sponsor-Investigator Responsibilities
After completion of this course, attendees will be able to understand the dual responsibilities of sponsor-investigators and know how to implement necessary processes to maintain and achieve compliance with FDA requirements in investigator-held IND/IDE studies. Prerequisite: Completion of “Good Clinical Practice.”
- Standard Operating Procedures in Research
This course provides an overview of the need for standard operating procedures in research.