PB2593: ESTABLISHING THE VACCELERATE SITE NETWORK: CAPACITY MAPPING OF CLINICAL TRIAL SITES

Abstract

Topic: 30. Infections in hematology (incl. supportive care/therapy) Background: The clinical research network VACCELERATE established the VACCELERATE Site Network, a platform for clinical trial sites mapping. The Site Network is organized and coordinated within the communication platform ClinicalSite (https://clinicalsite.org/). Aims: Acting as an information broker between sites and sponsors, the ultimate aim of the Site Network is to boost the conduct of clinical trials across country borders. Methods: The Site Network is open for registration for all clinical trial sites in Europe, with a worldwide expansion planned. Sites can participate by applying to the VACCELERATE Coordination Office ([email protected]), receiving access to ClinicalSite. ClinicalSite is a platform for information and data exchange between stakeholders in clinical trials, adapted to support the needs of the Site Network. Site information such as location and type of organization, information about previous experience conducting (vaccine) clinical trials, available infrastructure and preferences, as well as certificates for site and staff can be stored and updated by designated persons in respective partnership spaces. A certification system was set up to prioritize qualified, experienced and motivated trial sites and encourage inexperienced trial sites to improve their qualification. Uploading current GCP certificates and investigator CVs, experience in vaccine trials and cooperating certified laboratories is awarded with different levels of certification badges. To also conduct capacity building, VACCELERATE offers online courses to the sites. Once, the uploaded certificates are reviewed, the corresponding certification badge is available for download. ClinicalSite offers the option to share documents such as SOPs and to request a read receipt. Results: A network of capable clinical trial sites in Europe has been built and is constantly expanding, with 487 sites in 39 countries as of January 2023. It has been employed for 21 requests from vaccine developers as well as for scientific surveys, allowing a better understanding of pandemic situations from a trial site’s perspective. Summary/Conclusion: The capacity mapping performed by the ClinicalSite tool within the VACCELERATE Site Network enables functional matching of clinical trial sites with sponsors. The platform provides necessary functions to collect relevant information and organize the trial sites according to their capabilities, alongside other quality assessment tools developed within VACCELERATE. Keywords: Vaccination, Treatment, Clinical trial

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