RQA conducts internal Quality Reviews of human subject research conducted at the University of Miami. Medical research studies, as well as social-behavioral studies, may be reviewed by RQA. These reviews are intended to assess the research teams' level of adherence to Federal and State regulations and guidelines, University policies and procedures, as well as to provide guidance and recommendations to improve research practices.
RQA provides support to the University of Miami research community in the creation, development, implementation, and follow-up of CAPA Plans. These CAPA Plans are created to identify, remediate and prevent recurrence and occurrence of existing or potential causes of non-compliance or other quality issues.
Human subject research at the University involves the complex interaction of many federal and state regulations as well as internal institutional policies that govern human subject research and related areas such as electronic records and signatures; electronic system validation and security; electronic medical records; privacy and confidentiality, among others.
The GxP Compliance Director collaborates with various offices at the University of Miami that contribute to the conduct of human subject research, to ensure that appropriate controls, processes and systems are in place to protect data integrity and the quality of our research data.
In today’s world, much of our data is maintained in electronic format. This means that we must protect and ensure the integrity and security of our electronic data, if we expect it to be reliable, reproducible and accurate. In 1997, the FDA issued its regulation on Electronic Records and Electronic Signatures (21 CFR 11) which defines FDA’s criteria for considering electronic records and electronic signatures to be:
- trustworthy
- reliable
- equivalent to paper records and handwritten signatures executed on paper
The FDA has since issued several guidance documents (see Resources and Tools) to assist Industry in complying with this regulation, which remains in effect today.
The Educational Program offered by the Office of Research Quality Assurance (RQA) is a research compliance training program for Principal Investigators (PIs), Research Nurses, Clinical Coordinators, Study Team members, and anyone involved in human subject research. It is recommended that employees involved in Human Subject Research complete this training program on a yearly basis.
The program currently consists of sixteen live courses. Each course will disseminate comprehensive instruction and information pertinent to clinical research at the University of Miami. All participants will be able to print a certificate from ULearn after the completion of each class.
