Salute e Ricerca Clinica
Supporto a 360 gradi
L’Accademia SRC fornisce servizi di consulenza altamente specializzati a professionisti ed aziende impegnati nella ricerca clinica.
Il nostro team di professionisti con anni di esperienza nel settore, offre un supporto completo relativo alla ricerca clinica su:
- leggi
- procedure
- aggiornamenti
- linee guida
- informazioni
- know-how
Il nostro obiettivo è assistere i nostri clienti in ogni fase del processo di ricerca, dalla definizione del progetto alla stesura del protocollo, dalla selezione dei partecipanti alla conduzione dello studio clinico, dall’analisi dei dati alla diffusione dei risultati.
Inoltre, l’Accademia SRC organizza corsi di formazione e aggiornamento per garantire un continuo miglioramento delle competenze del personale impegnato nella ricerca.
Affidarsi ai servizi di consulenza dell’Accademia SRC significa avere il supporto di professionisti altamente qualificati, aggiornati sulle ultime novità del settore e capaci di garantire piena conformità alle normative e la massima affidabilità dei risultati delle ricerche cliniche.
Guida al catalogo di formazione CTIS
Il programma di formazione è diviso in moduli di apprendimento mirati ai diversi gruppi di utenti coinvolti in CTIS. Questi moduli mirano a garantire una chiara comprensione dei diversi processi del sistema. Di seguito è riportato l’elenco dei moduli:
Module 1: Introduction to the Clinical Trials Regulatio
Module 2: Overview of CTIS workspaces and common system functionalities
Module 3: User Access Management
Module 4: Support with workload management by workspace
Module 5: How to manage a Clinical Trial (Notifications, Ad hoc assessment, Corrective measures, and Trial results)
Module 6: Evaluate a Clinical Trial Application (Selection of Reporting Member State (RMS) and validation of the clinical trial application)
Module 7: Management of registered users and role matrix
Module 8: Evaluate a Clinical Trial Application: Assessment and Decision-making
Module 9: How to search, view and download a Clinical Trial and a Clinical Trial Application (Sponsors)
Module 10: How to create, submit and withdraw a Clinical Trial Application
Module 11: How to respond to Requests For Information received during the evaluation of a Clinical Trial Application
Module 12: Data protection in CTIS
Module 13: Clinical Study Reports submissions
Module 14: Supervise a Clinical Trial – Corrective measures
Module 15: How to search, view and download a Clinical Trial and a Clinical Trial Application (Authority)
Module 16: Supervise a Clinical Trial – Inspection records
Module 17: Supervise a Clinical Trial – Ad hoc assessment (including safety)
Module 18: How to submit an Annual Safety Report and respond to related Requests for Information
Module 19: CTIS for SMEs and academia
Module 20: Assess an Annual Safety Report
Module 21: Manage Union Controls
Module 22: Introduction to CTIS for Public Users
Module 23: Transition of trials from EudraCT to CTIS
Module 24: Business Intelligence Reporting
Module 1: Introduction to the Clinical Trials Regulatio
Module 2: Overview of CTIS workspaces and common system functionalities
Module 3: User Access Management
Module 4: Support with workload management by workspace
Module 5: How to manage a Clinical Trial (Notifications, Ad hoc assessment, Corrective measures, and Trial results)
Module 6: Evaluate a Clinical Trial Application (Selection of Reporting Member State (RMS) and validation of the clinical trial application)
Module 7: Management of registered users and role matrix
Module 8: Evaluate a Clinical Trial Application: Assessment and Decision-making
Module 9: How to search, view and download a Clinical Trial and a Clinical Trial Application (Sponsors)
Module 10: How to create, submit and withdraw a Clinical Trial Application
Module 11: How to respond to Requests For Information received during the evaluation of a Clinical Trial Application
Module 12: Data protection in CTIS
Module 13: Clinical Study Reports submissions
Module 14: Supervise a Clinical Trial – Corrective measures
Module 15: How to search, view and download a Clinical Trial and a Clinical Trial Application (Authority)
Module 16: Supervise a Clinical Trial – Inspection records
Module 17: Supervise a Clinical Trial – Ad hoc assessment (including safety)
Module 18: How to submit an Annual Safety Report and respond to related Requests for Information
Module 19: CTIS for SMEs and academia
Module 20: Assess an Annual Safety Report
Module 21: Manage Union Controls
Module 22: Introduction to CTIS for Public Users
Module 23: Transition of trials from EudraCT to CTIS
Module 24: Business Intelligence Reporting
