Clinical Trials Process: Study Sponsor's and Investigator's Responsibilities

FDA Regulations and Good Clinical Practice Guidelines will be discussed with an emphasis on data integrity and the protection of study subject's welfare/rights. At the end of this course participants will have an understanding of how both the Sponsor and Investigator are able to assure that data integrity and the protection of study subject's welfare/rights are met.

• Detailed Review of Sponsor Responsibilities including:
• Protocols and protocol amendments
• Investigator’s brochure/information
• Investigator selection and qualification
• Study management and monitoring
• Investigational product accountability
• Data management
• Adverse event reporting
• Recordkeeping and reports
• Quality control and assurance
• Transfer of obligations to a Contract Research Organization (CRO)
• Detailed Review of Investigator Responsibilities including:
• IRB/IEC communication
• Informed consent
• Protocol compliance
• Investigational Product Accountability
• Source Documents vs. Case Report Forms (CRFs)
• Adverse events reporting
• Recordkeeping and reports
• Quality control and assurance
• Investigator disqualification/blacklist
• Responsibilities of research subjects

• Personnel in the Pharmaceutical
• Biotechnology
• Device Industries

Instructor Profile:
Elizabeth Bergan, has over 10 years of clinical research experience in the pharmaceutical and medical device industry. She recently held the position of Managing Partner for Eye Trials, a contract research organization overseeing a number of multi-center clinical trials. Prior to that, she had held various management positions at STAAR Surgical including Manager of Clinical Affairs. Her clinical studies experience includes protocol design, trial site initiation, study close-out, final data collection and submission of Pre-Market Application (PMA).

At STAAR Surgical, Elizabeth managed several large multi-center clinical trials and was instrumental in preparing clinical trial data for an FDA Advisory Panel meeting. Consequently, her team was successful in obtaining FDA approval for STAAR Surgical Visian ICL™. She has extensive experience preparing for and participating in FDA Bioresearch Monitoring audits.

Through her various positions, Elizabeth has been involved with the development of policies and procedures for clinical protocol and case report form design, clinical monitoring, adverse event reporting, and clinical data management. She has trained a number of employees on applicable FDA Guidelines and Good Clinical Practices (GCPs) as well as ICH Guidelines.

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