Masters Classes in - Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

Michael C Redmond

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Is the FDA’s increasing scrutiny on your clinical trials’ data integrity giving you a data migraine?

FDA data integrity requirements are among the most stringent within regulated industries, so compliance is quite the challenge. Unless you establish internal competency and assessment programs, you can expect 483s and warning letters to come rolling in.

It’s no surprise: the FDA continuously trains its investigators on how to conduct data integrity inspections. The result is inspectors who cite a significant number of data integrity observations during inspections, taking action against companies that commit data fraud or provide false information.

Making matters worse, investors and business partners are getting into the act: they’re filing multimillion-dollar class-action lawsuits against firms that misrepresented their compliance with FDA requirements.

Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges is an interactive virtual workshop that will give you the tools you need to ensure your clinical trials’ electronic records are trustworthy and reliable across their entire data lifecycle, from initial data creation through long-term archives.

This webinar will explain complex FDA data integrity regulations in simple “what to do, how to do it” language using real-world examples and offering practical advice you can follow.

Virtual Workshop Takeaways:

  • How to apply the elements of data integrity characteristics — attributable, legible, contemporaneous, original and accurate (ALCOA+) — to real-world clinical development, trial conduct and post-trial analysis
  • An exploration of overlooked guidance documents that can help define expectations (including what the FDA and the European Medicines Agency inspect for and why)
  • How to deal with suppliers, including data integrity chain-of-custody in the clinical space, typical clinical supplier red flags that FDA and other regulatory health agencies look for and dealing with critical suppliers that collect, handle and store clinical digital data… but are not regulated
  • What, where, how and why to document your data integrity controls and institute a risk-based approach, including monitoring data integrity controls with contract research organizations (CROs) and investigator sites
  • Considerations regarding emerging issues: long-term archival storage, cloud-based technologies, wearables data and patient-submitted digital data; plus, the impact of inspectional changes in the clinical arena
  • What you must know about GCP data integrity enforcement, using real-world examples and statistics from regulatory agencies and providing recent updates to FDA’s pre-approval inspection (PAI) methods
  • Takeaways regarding both on-site and remote clinical digital data inspections, with questions and tactics you must be prepared to handle
  • The risks of true and certified copies with digital records, from the basics of true/certified copy and legal admissibility, to true-copy requirements from submission guidances and putting together a true-copy scanning process for clinical trial usage
  • How to prepare for and handle GCP data integrity: address challenges with remote inspection handling, perform sponsor-specific and CRO-specific activities, points to remember when responding to allegations of untrustworthy data and more

No more data migraines. You can avoid the data integrity 483s and warning letters while compliantly managing your clinical trials’ essential data — without it overwhelming you. Join us by registering today.

Chapter – 1

Clinical Data Integrity — Requirements and Realities

  • Core regulatory requirements — regulatory health agencies
  • Practical elements of data integrity characteristics (ALCOA+) — how this looks in the “real-world” of clinical development, trial conduct and post-trial analysis
  • Overlooked guidance documents that can help define expectations (including what FDA and EMA inspect for and why)

Chapter 2

Suppliers and Data Integrity

  • Accountability v. responsibility (the legal view)
  • Data integrity chain-of-custody in the clinical space
  • Digital data record keeping challenges for clinical data
  • Typical clinical supplier red flags — cloud providers, IT data hosting, etc. — that FDA and other regulatory health agencies look for
  • Dealing with critical suppliers who collect, handle and store clinical digital data (i.e., Medidata, et al) who are NOT regulated
  • Qualifying record/archival storage vendors (e.g., Iron Mountain, et al)

Chapter 3

Risk-Based Data Integrity and Operationalizing DI Controls

  • Basics of computerized system assurance as a risk-based approach
  • Monitoring data integrity controls with CROs and investigator sites
  • Putting it all together from trial planning to pre-approval inspection (PAI) readiness to long-term data retention
  • Documenting your data integrity controls — what, where, how, and why

Chapter 4

Open, Emerging Issues with Digital Data Integrity and Control

  • Long-term archival especially for digital photos, videos and imagery
  • Cloud-based technology and data reliability
  • Wearables data and patient submitted digital data
  • Impact on inspectional changes in the clinical arena

Chapter 6

GCP Data Integrity Enforcement

  • Examples and statistics from regulatory agencies
  • Recent updates to FDA’s Pre-Approval Inspection methodology

Chapter 7

Clinical Digital Data Inspectional Tactics — Onsite v Remote

  • Example regulatory agency inspection questions to prepare for — sponsor v. CRO v. clinical investigator
  • Example regulatory agency tactics during clinical inspections — how the new inspection protocol program (NIPP) plays into finding data integrity issues at the sponsor, at clinical sites, and with the CRO

Chapter 8

True and Certified Copies with Digital Records — Risks and Realities

  • Basics of the true/certified copy and legal admissibility
  • True copy requirements from submission guidances
  • Putting together a true-copy scanning process for clinical trial usage

Chapter 9

Preparing for and Handling GCP Data Integrity Inspections

  • Challenges to address with remote inspection handling
  • Sponsor-specific activities — pre-submission vs. PAI handling
  • CRO-specific — during trial conduct vs. PAI handling
  • Clinical investigator site — sponsor and CRO preparation activities for a PAI whether remote, onsite or combination
  • Points to remember for responding to allegations of untrustworthy data

Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Michael C Redmond, CEO and Lead Consultant, Redmond Worldwide

Dr. Michael C. Redmond, PhD, is a certified project manager, PMP, has two master certifications in business continuity/disaster recovery MBCP and FBCI and is certified in emergency management. She is active in cyber security and holds multiple ISO certifications (ISO/IEC 27001 Information Security Management, ISO/IEC 27032 Lead Cyber Security Manger, ISO/IEC 27035 Security Incident Response, ISO/IEC 22301 Business Continuity Management Systems, ISO/IEC 21500 Project Management, and ISO/IEC 41001 Environmental Management). She is an international consultant, speaker and published author.

Michael's MBA in Risk Management included courses in Information Security and Risk Management for Medical Devices and Healthcare. Michael is certified as a Senior Lead Manager in Information Security for Healthcare ISO 27999.As a practitioner, she has been implementing ISO 27999 and ISO 14971 for over 10 years for clients. 

Her past experience includes 13 years as a senior manager with Deloitte, KPMG and Chubb in the areas of: compliance, crisis management, business continuity, disaster recovery, emergency management, internal audit/ gap analysis. She was a business continuity/disaster recovery manager with the Bank of New York. She consults for clients in diverse industries such as banking, manufacturing, pharmaceutical, hospitals, government agencies, colleges and universities, law firms, and media.

Dr. Redmond spent 4 years on active duty with the army and 18 1/2 years as National Guard and Reserve before retiring as a major. She is a graduate of Command & General Staff College (Fort Leavenworth), attended civil affairs courses at the US Army JFK School of Special Warfare and is Hazmat trained and DOD certified. The White House honored Dr. Redmond at a luncheon as one of the Top Women in Her Field of Business Continuity.

Get in touch

(315) 632-0735,
(315) 750-4379