Data Management SOPs

Why Should You Attend:

Standard Operating Procedures (SOPs) for many aspects of clinical trial conduct are required, including those for data management. Whether you perform clinical data management in-house or outsource these processes, these SOPs must still be present, and must accurately reflect the processes that are employed. When multiple vendors are involved in the clinical trial process for an investigational product, it is essential that your own company’s SOPs for data management are followed as integrating clinical databases utilizing varying methodologies and formats becomes a large challenge and is a routine cause for significant filing delays. It is also essential that your SOPs meet and address formatting and conventions standards to help prevent delays with regulatory agency reviews.

This webinar will explain how to develop efficient data management SOP including SOPs specific to electronic data capture (EDC) trials and SOPs specific to paper-and-pencil trials.

Areas Covered in the Webinar:

• Mandatory data management SOPs
• Clinical data management workflows
• Specific examples of content which must be included in the SOPs
• Items to avoid incorporating into SOPs
• How to develop efficient data management SOPs for your company’s needs
• SOPs specific to EDC trials and SOPs specific to paper-and-pencil trials
• Integrating external databases (labs, ECGs, ePRO) into your database management systems

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

• Clinical Data Management
• Clinical Project Management
• Clinical Operations
• Regulatory Affairs and Document Management Specialists
• Supervisors

Instructor Profile:

Dr. 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:

Statistical Operating Procedures (SOPs) are required for all aspects of clinical trials. The data management SOPs are part of that list. Whether you perform data management in-house or outsource this work these SOPs must still be present. If outsourced, an understanding of the workload as specified in the SOPs is beneficial, as is the standardization of these SOPs between vendors and studies.

The specific SOPs vary by whether your trials are performed by electronic data capture (EDC), by paper-and-pencil, or a combination thereof. Statements such as “vendor’s SOPs will be used” are not sufficient when it comes time for NDA or 510(k) filings. Additionally, SOPs that are developed in-house may provide more efficiency than many vendors often utilize and can save large amounts of money and time without compromising any quality when the vendors are directed to use those SOPs. However, it is imperative that the SOPs are thorough so there are no gaps or misinterpretations without being too directive or detailed leading to unnecessary delays in order to follow overly complicated procedures without a corresponding benefit.

Effective Clinical Project Managers and Clinical Operations staff should be fully versed in the Data Management procedures to have a much better understanding of their requirements and timelines to help with planning of timelines and instructions to their own staff.

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