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Achieving Compliance in Human Subject Research

This course highlights the importance of research compliance at an academic institution and identifies the elements of compliance and quality systems. Additionally, attendees will be able to recognize how research compliance protects subjects, Principal Investigators, their research teams and the University.

Compliance with the Informed Consent Process

This course 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.

Coercion and Undue Influence

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 provide examples of both.

Protocol Compliance from Start to Finish

This class 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.

Documentation and Recording Compliancy for 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.

The Audit Process

This course provides an overview of the Office of Research Compliance and Quality Assurance (RCQA) and their auditing process.

Preparation for an FDA Audit

This course provides an overview of the preparation for and the conduct of an FDA audit. The course describes 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.

Responding to FDA Observations / Form FDA 483 (please complete Preparation for an FDA Audit prior to attending)

This course provides detailed information in regards to Form FDA 483 responses. It includes examples of FDA Warning Letters, outlining acceptable and inadequate PI responses.

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.

Quarterly Review of FDA Warning Letters

This presentation includes a review and discussions of Warning Letters for Principal Investigators (Clinical Investigators), Sponsor-Investigators and Institutional Review Boards, issued by the FDA during the past six to twelve months.

FDA Enforcement Actions Beyond the Warning Letter

This course will describe operations of FDA’s Office of Criminal Investigations and discuss examples of recent court cases and criminal enforcement actions by FDA, Strategies will be identified and discussed to mitigate compliance risk.


Corrective and Preventive Actions in Clinical Research

This training will help you to develop effective corrective and preventive actions to resolve non-compliance identified in clinical research.


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Introduction and Overview of ClinicalTrial Disclosure

This presentation is intended as an introduction to clinical trial registration and results disclosure requirements.

Registering Your Record on ClinicalTrials.gov

Participants will have the opportunity for hands-on data entry within the ClinicalTrials.gov Protocol Registration System (PRS) with guidance.

Managing Your Record  on ClinicalTrials.gov

Participants will have the opportunity for learning various methods and helpful hints that can be used to manage records on ClinicalTrials.gov. to ensure compliance with the regulations and UM Policies.

Result Reporting on ClinicalTrials.gov

Participants will have the opportunity for hands-on data entry within the ClinicalTrials.gov Protocol Registration System (PRS) with guidance.