Everything you ever wanted to know about Developing and Implementing Clinical Trial Registries

Often investigators believe that creating a “registry” is not associated with conducting clinical trials. While this may be true to some extent, more often the creation and use of patient registries is intended to answer a research question that involves human subject research. It is important to understand the variations in registry proposals and the extent to which human subject protection and privacy regulations apply. Ms. Schroeder will address some frequently asked questions about registries and provide case examples of real world experiences in developing a registry, obtaining appropriate regulatory approvals, implementation and management of a registry and proper use of the registry data for research.

• Define registry and discuss variations
• Understand how regulations apply to registries
• Identify enforcement activity as lessons to be learned
• Apply knowledge to a case example

Burning Questions about Registries that will be covered in this webinar.

• Is there specific language that should go into a consent to allow registry use?
• Are there guidelines for a registry protocol? 
• Are there known do’s and don'ts when building a registry?
• Are there guidelines on who can access a specific registry?
• Benefits to a registry
• When you are building a registry and adding data what is the best method to track contributing studies
• Examples of Registries with variations in regulatory application – disease surveillance, government mandated, longitudinal outcomes data capture, human biological samples, post market studies, etc. 
• Differentiating research registries subject to the Common Rule from Quality Improvement efforts
• The concept of being “engaged in research”
• Assessing a Registry for application of FDA regulations (IRB review, Financial Disclosure, IDE regulations)
• Assessing a Registry for the appropriate HIPAA transfer method
• Applying regulations to creating the Registry AND using the Registry for Research
• Electronic databases for Registries and 21 CFR part 11
• False Claims and antikickback statute implications for Registries

• Clinical Research Coordinators
• Clinical Research Nurses
• Regulatory Affairs professionals
• Sponsors interested in Registry study design
• Investigators
• IRB members
• IRB Coordinators
• IRB Chairpersons
• Clinical Trials legal professionals
• Clinical Trials Managers
• Clinical Trials budget and billing professionals
• IT professionals managing clinical trials databases
• Research Directors
• Research Consultants
• Clinical Trials Audit and Compliance Personnel
• Clinical Trials Risk Managers.