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VIRTUAL WORKSHOP

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

Tuesday, Dec. 1 and Thursday, Dec. 3, 2020 • 10:00 a.m. - 4:30 p.m. EST
Presented by WCG-CenterWatch and Cerulean

Agenda


Day 1 — Tuesday, Dec. 1, 2020


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

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. EST

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. EST

Morning Break (offline)


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

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. EST

Lunch (offline)


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

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. EST

Afternoon Break (offline)


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

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. EST

Wrap Up and Review

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

4:30 p.m. EST

Adjournment of Day One



Day 2 — Thursday, Dec. 3, 2020


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

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. EST

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. EST

Morning Break (offline)


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

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. EST

Lunch (offline)


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

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. EST

Afternoon Break (offline)


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

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. EST

Wrap Up and Review

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

4:00 p.m. EST

Adjournment of Day Two


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