Goal: SOCRA is pleased to offer this conference that is jointly sponsored with the U.S. Food and Drug Administration. This conference on Sponsor-Investigator clinical research is designed to aid the Clinical Research Professional’s understanding the responsibilities of the research site when conducting Sponsor-Investigator research.
Objective: This three-day virtual conference is intended to share information among FDA representatives and the regulated community, and to facilitate the understanding of regulations, guidelines and practices related to Investigator initiated research. It is designed to aid the Sponsor-Investigator’s understanding of their responsibilities and to facilitate interaction with FDA representatives
Learning Objectives: Upon completion of the conference, the attendee should be able to:
Relate the history of the role of the sponsor-investigator
Contrast past regulatory requirements to present expectations
Describe the responsibilities of a sponsor-investigator who initiates an FDA regulated clinical trial
Discuss various methods that can be used to ensure compliance with federal regulations and study protocol requirements
Understand the role of quality management systems, risk assessment and management, and clinical quality by design in investigational product development programs and clinical trials.
Understand the similarities and differences in regulations and makeup of medical products in clinical trials.
Understand when an IND application is needed
Gain a general understanding of medical device classification and pre-market submission types.
Gain a greater understanding of IDEs and FDA review considerations related to IDEs.
Gain a general understanding of the 21CFR 812 regulations, the role of a sponsor investigator, and considerations for Bioresearch Monitoring (BIMO) inspections.
Understand the regulatory requirements regarding source records and data collection for Clinical Investigators who are also Sponsors
Describe the general requirements for clinical trials registration and results information submission
Understand the registration and results sections of the study record and the NLM quality control review process.
Understand FDA’s role and responsibilities related to ClinicalTrials.gov
Describe the requirements for submitting certifications of compliance to FDA and including specific language in the informed consent documents for applicable clinical trials
Understand the potential consequences of noncompliance with the requirements to submit clinical trial information to the ClinicalTrials.gov data bank and/or certifications to FDA
Describe FDA's approach to conducting its compliance and enforcement activities involving FDAAA 801 and 42 CFR Part 11
Describe the sources of drug safety information available to sponsor-investigators.
Understand the importance of monitoring and assessing safety data, and requirements for safety reporting to the FDA.
Discuss the paramount importance identifying errors that involve critical trial data and processes to prevent errors that matter most through Risk-Based Monitoring (RBM).