Insights into CTR and CRO - Experiences, Advantages, and Challenges
Explore the first experiences in CTR and CRO perspective with insights on advantages like easy submission via CTIS, clear guidance, and challenges such as short timelines, compliance issues, and more. Dive into the world of clinical trials regulation and optimization.
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Presentation Transcript
FIRST EXPERIENCES IN CTR CRO PERSPECTIVE 10 March 2023
Sara Weytjens BeCRO Board member Tom Van Paepegem BeCRO Board member INTRODUCTION
Advantages Easy and fast submission via CTIS Clear guidance and templates Consolidated feedback by all CAs in part 1 Commitment FAMHP for phase I clinical trials Clear timelines for each step in the process Single EC application in part 2
Advantages Clear guidance and templates Easy and fast submission via CTIS Structure of the submission dossier Templates to use Reduction of effort & time
Advantages Consolidated feedback by all CAs Single EC application in part 2 No contradictory feedback Avoidance of country- specific protocol versions One submission file covering all involved sites Reduction of effort & time
Advantages Clear timelines for each step in the process Commitment FAMHP for phase I clinical trials BE remains attractive for early phase clinical trials Theoretically easy to plan
Challenges More documents requested Short timelines to respond Redacted documents Additional procedures outside CTR Compliance CTR versus GCP Sponsor outside EU
Challenges More documents requested Redacted documents ICF procedure Suitability sites document Declaration of interest Compliance with applicable rules for Biological samples Translation costs Labour intensive GDPR and Commercial Confidential Information
Challenges Compliance CTR versus GCP Short timelines to respond Participant facing materials Response within 12 calendar days required
Challenges Additional procedures outside CTR Sponsors outside EU Registration procedure (OMS) Key user management concepts User roles concept Local procedures pre or post CTR at site level (e.g., local application forms, how to obtain site suitability form)
Wishlist for CTIS implementation Harmonization local procedures (if any) Timeline compliance Regular feedback most frequent shortcomings + timelines Consistency between evaluators
