Module 5 Presentations

05/07/2024

Clinical trial information system (CTIS) related

• No large scale test « sandbox » system available(upon request, limited to 1 account) • CTIS functionalitiescontinue to evolve • Limited opportunities for operational optimizationof activities related to CTIS until post go live (release of Sponsor Application Programming Interface Specifications) • Specific attention to be placed on upcoming CTIS development pertaining to application oversight and download / archiving functionalities in order to align TMF procedures as those functionalitiesare still sub optimal at the moment => Focus on Regulation compliance (CTIS fully aligned with CTR) to develop high level processes and communication lines => Be ready to adjust readiness strategies post go live due to further CTIS improvements to be released

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

49

In conclusion

• WhileCTR introduceschanges, fundamentals of site activation and GCP compliance still remain : essential documents collection, ethics and regulatory submissions and maintenance, site contract negotiation and TMF-related activities, with adjustments and impacts to define for each • Readiness considerationsare specificto each and every company due to the multifactorial aspects entering into play • Readiness will require strategic decisions and eventual investments to support the implementationof those decisions(resources, systems) • Whileall practicaldetailsare not fullyknown on CTIS, CTR is there to conduct readiness assessment on the requirements, if not on the Portal itself • Flexibility in readiness measures will be essential in a post go live environment • Access to a test environment will stillbe criticalto stress test the outcomes of the readiness activities and will directly influence uptake in CTR use

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

50