Data Integrity for GCP Professionals:
Core Requirements, Expectations and Challenges

10:00 a.m. - 10:30 a.m. EDT

Welcome, Verification of Attendee Workshop Tools, Session Overview

• Review of connectivity and interactive tools
• Session agenda overview
• What to do in case of connectivity issues

10:30 a.m. - 11:30 a.m. EDT

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)
• Interactive Q&A on this section — Attendees have the chance to ask questions and have them answered by the instructor

11:30 a.m. - 12:00 p.m. EDT

Morning Break (offline)

12:00 p.m. - 1:00 p.m. EDT

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)
• Interactive Q&A on this section — Attendees have the chance to ask questions and have them answered by the instructor

1:00 p.m. - 2:00 p.m. EDT

Lunch (offline)

2:00 p.m. - 3:00 p.m. EDT

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
• Interactive Q&A on this section — Attendees have the chance to ask questions and have them answered by the instructor

3:00 p.m. - 3:30 p.m. EDT

Afternoon Break (offline)

3:30 p.m. - 4:00 p.m. EDT

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

4:00 p.m. - 4:30 p.m. EDT

Wrap Up and Review

• Attendees have time to ask any final questions for the day

4:30 p.m. EDT

Adjournment of Day One

10:00 a.m. - 10:30 a.m. EDT

Welcome, Verification of Attendee Workshop Tools, Session Overview

• Review of connectivity and interactive tools
• Session agenda overview
• What to do in case of connectivity issues

10:30 a.m. - 11:00 a.m. EDT

GCP Data Integrity Enforcement

• Examples and statistics from regulatory agencies
• Recent updates to FDA’s Pre-Approval Inspection methodology
• Interactive Q&A on this section — Attendees have the chance to ask questions and have them answered by the instructor

11:00 a.m. - 11:30 a.m. EDT

Morning Break (offline)

11:30 a.m. - 12:30 p.m. EDT

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
• Interactive Q&A on this section — Attendees have the chance to ask questions and have them answered by the instructor

12:30 p.m. - 1:30 p.m. EDT

Lunch (offline)

1:30 p.m. - 2:00 p.m. EDT

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
• Interactive Q&A on this section — Attendees have the chance to ask questions and have them answered by the instructor

2:00 p.m. - 2:30 p.m. EDT

Afternoon Break (offline)

2:30 p.m. - 3:30 p.m. EDT

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

3:30 p.m. - 4:00 p.m. EDT

Wrap Up and Review

• Attendees have time to ask any final questions for the day

4:00 p.m. EDT

Adjournment of Day Two