Before the start of the study, ItaCRIN can provide advice on the following items:
CONSULTING AND INFORMATION
Funding: ItaCRIN can suggest possible sources of funding appropriate to your study as well as helpful information on your funding application.
Site mapping and participant recruitment: European Correspondents can provide details of clinical sites and networks in other countries suitable to recruit participants for your study.
Selection of clinical trial units: European Correspondents contribute to select facilities in European countries that can provide all the services required for the conduction of your trial
Cost evaluation: ItaCRIN will provide you with a detailed budget covering all the costs related to the clinical trial activities committed to ECRIN
Regulatory, ethical and insurance requirements: ItaCRIN can provide information about regulatory requirements in different countries. On request, ItaCRIN can be in charge of all the regulatory dossier, including submission to competent Authorities, amendments, pharmacovigilance reporting. Information on insurance in each country can be provided as well.
Study management and coordination: Leading CTU provides global coordination of resources (study feasibility, preparation and maintenance of sponsor’s trial master file, organization of pathways for central laboratory/biobank with instructions for individual sites, elaboration of the monitoring manual, training). Local CTUs are in charge of local project management (organization of pathway for central distribution of medication from sponsor to sites, communication with local project managers and sponsor, query resolution and database locking, writing of the final report in International Council for Harmonization (ICH) format)
Monitoring: All tasks related to monitoring such as training, on-site visits, reporting and remote monitoring can be handled by ECRIN across country sites
Regulatory and ethical submission: In order to respect timelines and avoid delays, ItaCRIN can manage submissions to competent authorities and ethics committees
Pharmacovigilance/Adverse event reporting: Lead CTU can handle both the global pharmacovigilance and the management of Adverse events (AEs), including the notification of serious adverse events (SAEs) and serious unexpected serious adverse reactions (SUSARs), according to national requirements. The local CTUs take care mostly of the AEs management and of their notification to the lead CTU, and competent authorities, as recommended by European and local laws
Data management: ItaCRIN CTUs can contribute to the following items: Electronic case report form (eCRF) definition, elaboration of data management plan (DMP) and data validation plan (specified checks), performance of quality controls, data codification (AEs, medication, diseases), importation of laboratory data, support to pharmacovigilance activities (SAE reconciliation), data transfer to statistical data.