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. This course will provide an overview of the Clinical Trial Process. It will discuss in detail the responsibilities of the Sponsor (company or institution managing the trial) and Investigators conducting a clinical trial.

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.

Areas Covered in the seminar:

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

Who Will Benefit:

• Personnel in the Pharmaceutical
• Biotechnology
• Device Industries