|The NIHR Rare Diseases Clinical Infrastructure Team (RDCIT) supports observational research for a UK national programme in Rare Diseases across multiple studies in different disease areas. This challenge is extreme with multiple systems, multiple datasets and multiple standards. Bringing this data into a single national, federated, dataset requires new facilities & tools for interoperability and effective standardization.
The objective of this workshop is to showcase 2 open-source tools developed to collect high quality clinical data that can easily be integrated with the patient’s EHR data. The tools help automate the production of standardized data plans and CRFs, and manage the synchronization of studies between OpenClinica instances.
1. The Data Plan Composer provides an easy to use mechanism for the development of data plans. Previously defined data items and their response options harvested from other studies, can be ‘selected’ and placed in a ‘shopping basket’ from which the v0 CRF is automatically built from existing item/response/controls which also used to populate an excel spreadsheet of the data plan.
2. At OC15 we presented a data mapping and importing tool “ODIN”. A new extension (ODIN:Sync) has been developed to synchronise data between OpenClinica instances. This requirement comes from our studies where off-line data entry is required, where the testing cycles involve many iterations of CRF, where projects need to be distributed between different instances for performance & security and where large data import work requires a project based roll-back facility. Using this tool gives the user the ability to collect data on laptops (with a local OC installed) and feed it back to a Master Study as well as migrating a study, or part of a study, between different instances.
The workshop will be interactive and hands-on. The Data Plan Composer will provide a selection of previously defined data items such as patient demographics and common lab tests (i.e. blood tests) which can be used to generate a data plan and CRF. Participants’ own CRFs can then be used to demonstrate ODIN:Sync with study synchronisation to a different OpenClinica instance.
Requirements: Participants are required to bring a laptop with Wi-Fi capability. No specific technical knowledge is required but participants need to be familiar with OpenClinica. Two preconfigured training instances of OpenClinica will be provided. The source code used in this workshop will be made available on GitHub.