The HCV registry and data management
The HCV registry is a web-based tool hosted on an electronic platform developed by the Dublin Centre for Clinical Research (DCCR) in conjunction with ICORN. The design of the electronic Case Record Form (eCRF) and underlying database is based on the study protocol and data collection requirements. Access to the eCRF for data entry or query is by means of a secure (HTTPS) connection to the web-based installation of the Distiller® software package. The platform is a protected and secure cloud-based system that conforms to all appropriate security considerations for clinical research. This is hosted at the Irish Higher Education Authority network (HEAnet) secure hosting centre, with offsite backup and replicating facilities available. User access is by means of unique, personal username and password.
The minimal ICORN dataset of patient variables was developed to translate the research questions into measurable outcomes. A formal process of consultation with clinicians and subsequent piloting was undertaken to determine the final dataset, the visit procedures and to build and adjust the web-based registry platform in order to maximise performance. Frequent discussions with the DCCR and ICORN operations were required to finalise the registry inputs and flow of data.
Designated ICORN data collectors manually extract data at each site through chart review to facilitate collation of patient level data. Manual data collected at site visits is entered into the registry in preparation for data retrieval and analysis.
The ICORN Treatment Registry has supported the following phases of treatment:
• The 2012 DAA Treatment Programme.
• The 2014 DAA Early Access Programme for patients with decompensated liver disease.
• The 2015 DAA Treatment Programme for patients with compensated liver disease.