Training for Study Teams

OVPRS offers training opportunities to the University research community. Below are a few educational offerings offered by OVPRS for individuals involved in research. 

Before starting any research activities, investigators and research staff may need to complete specific training. Researchers often have to renew training. Visit the Training for Researchers page

RQA Educational Offerings

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  • RQA - Adobe Self-Sign Digital ID Electronic Signature Process

    The purpose of this training is to learn how to implement a 21 CFR Part 11 compliant electronic signature in FDA-regulated human subject research studies, when study records need to be signed outside of Complion or other Part 11 compliant systems at the University of Miami. In this course you will learn how to create your Adobe Self Sign Digital ID and how to use it to apply your electronic signature. This is an online module. Register in ULearn.

  • RQA - The Audit Process

    This course offered by Research Quality Assurance provides an overview of the Office of Research Quality Assurance (RQA) and the auditing process. Register for upcoming sessions in ULearn.

  • RQA - Electronic Research Records

    This training offered by Research Quality Assurance will highlight common challenges in the creation and maintenance of electronic research documentation, and provide suggestions to help achieve and maintain compliant records. Register for upcoming sessions in ULearn.

  • RQA - Preparation for an FDA Audit

    This course offered by Research Quality Assurance provides an overview of the preparation for and the conduct of an FDA audit.Upon completion of this course, the attendees should be able to describe what is involved in an FDA inspection, know how to prepare for an FDA audit, the Do's and Don'ts during and what takes place after the inspection. The attendees should be able to implement learned knowledge by inspecting their records and being "FDA ready". Register for upcoming sessions in ULearn.

  • RQA - Review of Warning Letters

    This presentation includes a review and discussion of Warning Letters for Principal Investigators (Clinical Investigators), Sponsor-Investigators and Institutional Review Boards, issued by the FDA.  Recent examples of Warning Letters will be analyzed and causes, significance, and consequences of Warning Letters will be discussed. Register for upcoming sessions in ULearn.

  • RQA - Coercion and Undue Influence in Research

    This course will define coercion and undue influence and the professionals’ perceptions of both. This course will also discuss the ways in which coercion and undue influence manifest in research and examples of both. This course will assist attendees to identify strategies to protect against coercion and undue influence in research. Register for upcoming sessions in ULearn.

  • RQA - Compliance with the Informed Consent Process

    This course offered by Research Quality Assurance highlights the importance of a well conducted informed Consent process at an academic institution and identifies the elements of compliance within this process. Attendees will be able to recognize how a well conducted informed consent process protects subjects, Principal Investigators, their research teams and the University. Register for upcoming sessions in ULearn.

  • RQA - Protocol Compliance From Start to Finish

    This class offered by Reesearch Quality Assurance will present examples of protocol non-compliance, focus on identifying preventable errors in new studies, and offer strategies for correcting protocol deviations in ongoing research. Register for upcoming sessions in ULearn.

  • RQA - Documentation and Recording Compliance with Adverse Events

    This course highlights the importance of recording and documenting adverse events in regards to being compliant with federal, state and local regulations and policies. In addition, attendees will learn how to identify potential causes for non-compliance and steps to correct and prevent such issues amongst their research teams. Register for upcoming sessions in ULearn.

  • RQA - Corrective and Preventive Actions in Clinical Research

    This training offered by Research Quality Assurance will help you to develop effective corrective and preventive actions to resolve non-compliance identified in clinical research. Register for upcoming sessions in ULearn.

  • RQA - Lessons Learned from FDA 483 Observations at UM

    This course provides a review of FDA observations issued at the University of Miami. Examples of FDA 483 observations will be evaluated and potential preventive actions to avoid future citations will be discussed. Register for upcoming sessions in ULearn.

  • RQA - Understanding FDA's Part 11 Regulation on Electronic Records & Signatures

    This class will define FDA’s 21 CFR 11 regulation, review the requirements for electronic systems and signatures and examine how Part 11 applies to electronic records in clinical research at the University. Register for upcoming sessions in ULearn.

Additional UM Training

Talent and Organizational Development (TOD)

Talent and Organizational Development (TOD) offers a wide variety of classes that encourage you to explore, develop, and grow professionally and personally, while learning practical skills that support your career development.
Learn more about TOD offerings

Workday

To register for Workday’s instructor-led training, computer-based learning, webinars, and curriculum, log into ULearn. Once logged into ULearn, search the training catalog by keyword. For technical assistance, contact the IT Service Desk.

Click here to view the Training Catalog

Additional Non-UM Training

NIH - OCRECO

The Office of Clinical Research Education and Collaboration Outreach (OCRECO) provides a range of high‑quality training programs designed to strengthen the skills of clinical research study teams. Their courses cover core areas such as the principles and practice of clinical research, clinical pharmacology, ethical and regulatory requirements, and specialized programs like the NIH‑Duke Clinical Research Training Program and the NIH Summer Course in Clinical and Translational Research. These offerings support investigators and research staff across all levels in conducting safe, ethical, and effective clinical research.
Learn more about OCRECO training

NCURA

NCURA provides training, conferences, and workshops for individuals involved in research. They offer professional development opportunities and networking resources.

Learn more about NCURA training
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