Day 1 – Tuesday, March 29, 2022

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

• 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

• 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

• 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

• 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

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

Day 2 – Thursday, March 31, 2022

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

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

• 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

• 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
• How this also plays into data migration (such as into the eTMF)
• Interactive Q&A on this section — Attendees have the chance to ask questions and have them answered by the instructor

• 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

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