Regulatory Documentation for Clinical Trials

Why Should You Attend:

Missing or incomplete clinical trial documentation is one of the leading causes of 483 audit findings and delays in regulatory approval. Not knowing about required documentation and the format of each document is not considered an excuse by reviewers.

Regulatory agencies want consistency of documents not only within a company but between companies to help speed up review time. Regulatory documents for clinical trials not only consist of sponsor-level clinical operations and site-level documents, but also documents in the areas of data management, drug supply, biostatistics and others for which clinical operations and regulatory affairs often maintain primary responsibility. Having knowledge of required documentation not only in the operational and regulatory affairs portions but also in external areas is essential for efficient trial management and execution. It is also important to know how to close out a Trial Master File in a timely manner and prevent adverse regulatory agency findings.

This webinar will present a detailed list of the required clinical trial documentation and it will be broken down by industry: pharmaceutical, biotechnology, medical devices and diagnostics. Documents requiring legal review such as site contracts, vendor contracts, and Informed Consent forms will also be discussed for required content from a legal and regulatory perspective. The instructor will also review many of the documents in terms of required content and structure.

This webinar will also present additional documents for specific countries outside of the US. If you or your company have had issues finalizing the TMF in the past or have had any issues with submissions or inspections of your clinical trials, don’t miss this crucial presentation.

Areas Covered in the Webinar:

• Specific list of required regulatory documentation for clinical trials
• Content and format review of selected documents
• Legal requirements of specific clinical regulatory documents
• Typical development and review processes of these documents
• Review of required non-clinical documents for clinical professionals
• Maintenance and quality assurance practices
• Trial Master File closure activities

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

• Clinical Project Management
• Clinical Operations
• Regulatory Affairs
• Clinical Trial Assistants
• Clinical Data Management
• Legal Affairs
• Study Supply Management
• Biostatistics

Instructor Profile:

Adam Ruskin, PhD, DVM, MPH is the founder of LabCRO, Inc., one of California's largest Clinical Research Organizations. Dr. Ruskin was a researcher at the Centers for Disease Control (CDC), an FDA Advisor, and two-time TEDMED award nominee for innovation. He is the creator of LabTracker, the industry's first system for tracking clinical trial samples from the time of patient sampling until result posting. He has lead all clinical, data management and biostatistics activities at 4 successful start-up pharmaceutical, biotech, and medical device and diagnostics companies, and now leads successful clinical and data management teams for his clients through LabCRO. As a leading industry speaker for over 20 years, he knows the details of what it takes to get investigational products approved, especially under required budgets and timelines of most companies.

Topic Background:

All clinical trials are required to maintain a minimum set of regulatory documents. These documents may be reviewed during audits by regulatory agencies and can lead to adverse findings if they are not present, complete and accurate. Additional documents may be required based on industry type and trial location.

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