Barnett International's Core Curriculum courses are comprehensive role-based clinical research training programs designed to provide industry professionals with hands-on training in a dynamic virtual setting. Held four times a year during our “Clinical Research Training Weeks,” courses offer clinical research-focused, performance-based training and core competency development.
Investigator-Initiated Trials (IITs) and the Role and Responsibilities of the Investigator
Upcoming Courses
This course provides an overview of the applicable regulations for Investigator-Initiated Trials (IITs), including the role and responsibilities of the individual investigator who acts as an investigator and a sponsor in conducting the study. The seminar includes a review of the reporting requirements and essential documentation required for these trials, and illustrates the risks involved. Tips on how to avoid the common pitfalls are addressed, including examples from FDA inspections and how to prepare for a possible inspection.
- Explain the applicable federal regulations for IITs, including sponsor and investigator responsibilities
- Recognize GCPs and the principles involved in quality research
- State the steps involved in initiating an IIT, and review the regulatory reporting requirement of investigators and sponsors, including safety reporting and investigational product accountability
- Examine protocol development and compliance
- Examine informed consent development and the HIPAA authorization
- Discuss required essential documentation and the need to remain “audit-ready” throughout the study
- Discuss the need for adequate monitoring and a monitoring plan
- Cite ways to minimize risks associated with IITs
- Provide examples of regulatory deficiencies as noted in FDA Warning Letters
- Discuss the principles of ethics and the quality control process, including possible FDA inspections
- Investigators/Site Study Team Members
- Sponsor Study Team Members
- Ethics Committee Members
The course will be led by one of the following instructors:
Gary B. Freeman, M.S.
Click here for complete trainer biographies
Day 1: 8:30 a.m. – 5:00 p.m.
- Federal Regulations for Investigator-Initiated Trials (IITs)
- GCPs and the Principles Involved in Quality Research
- Steps Involved in Initiating an IIT
- Regulatory Reporting, including Safety and Investigational Product Accountability
- Protocol Development and Compliance
- Informed Consent Development and HIPAA Authorization
- Essential Documentation
- Adequate Monitoring
- Ways to Minimize Risks Associated with IITs
- Regulatory Deficiencies – FDA Warning Letters
- Principles of Ethics and Quality Control Process
- Investigator Responsibilities
- Sponsor Responsibilities
- Issues with Informed Consent Process
- Differences between industry-sponsored and investigator –initiated studies
- Value of a Monitor
- Avoiding Common Pitfalls
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.
Click here for our seminar cancellation policy
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 7 hours (0.7 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE# 0778-0000-16-013-L01-P. Released 3/16.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.
