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Study Start-Up Workshop 

Too little preparation for complex studies is a recipe for non-compliance. This 3.5-hour workshop will provide attendees with information and tools to be prepared prior to enrolling the first subject. Putting efforts towards the start-up phase of studies can save time and frustration, leaving you with the wonderful feeling of “being prepared.” This workshop uses a “real” protocol and attendees will work in groups to exchange ideas and create processes for a smooth study start-up.

Corrective Action/Preventive Action Plan – Workshop

The goal of this workshop is to achieve a better understanding of how to create corrective and preventive actions, in response to identified non-compliance issues. Attendees will learn about methods and approaches to make sure that problems are adequately corrected, and then prevented. Problem definition, root causes analysis and the creation of meaningful actions to correct and prevent non-compliance will be discussed by using real-life examples.

Achieving Compliance in Human Subject Research

This course highlights the importance of research compliance and quality and identifies the elements of compliance and quality systems. Attendees will be able to recognize how subjects, Principal Investigators, their research teams and the University are protected by applying quality driven processes.

Compliance with the Informed Consent Process

This course highlights the importance of a well-conducted Informed Consent process and identifies the elements of compliance within this process. By discussing real-life examples, attendees will be able to learn how to conduct an informed consent process and avoid common errors.

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 Compliance for Adverse Events

This course highlights the importance of recording and documenting adverse events to adhere to federal, state and local regulations and policies. Attendees will learn how to identify potential causes for non-compliance and discuss 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.

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.

 


 


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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 from the RCQA team.

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 facilitate compliance with 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 from the RCQA team.