Session Title:Building a custom ePRO solutions powered by Enketo and new OC OpenRosa APIs
Time:8:00 – 11:00AM

Tomas Skripcak IT Department of Radiotherapy, IT Scientist DKTK Dresden German Cancer Consortium (DKTK), German Cancer Research Center (DKFZ

Summary:This technically oriented workshop will explain in details how to use newly supported standards in a community version of OpenClinica (XForms and OpenRosa APIs), in order to implement a custom solution for electronic patient-reported outcome (ePRO) data acquisition. The workshop will describe the components/modules that make the OpenClinica an ePRO enabled system. It will provide a brief introduction into the OpenRosa concept and it’s ecosystem that is necessary to understand for proper ePRO deployment based on these technologies. We will also review modifications to the OpenClinica source code that are necessary to fully leverage the new APIs for this purpose. Afterwards the focus will be laid on the recommended system work-flow, depicting the usage of APIs within a scope of ePRO data acquisition time-line. Some CRF design specifics that apply to mobile friendly forms will be discussed as well. At the end of the workshop a custom ePRO use case will be presented that collects patient quality of life data within clinical environment (rpb-participate), which will be available for community members. More technically inclined workshop participants will receive tools and information necessary to build their own custom ePRO solution as well.
Session Title:CRFs in OpenClinica v4

Krikor Krumlian, CTO Iryna Galchuk, Product Owner Kerri Bichekas, Software Implementation Specialist OpenClinica

Summary:Your CRF world is changing. The new OpenClinica forms engine leverages the full extent of modern technology and leading standards to deliver the best possible data capture and data management experience. This hands-on workshop will show you what the new forms engine can do for you:

  • Mobile/responsive
  • Real-time edit checks and skip logic – no more submit->reload->wait!
  • Auto-save & streamlined queries
  • Improved repeating groups capabilities
  • Flexible data structures and layouts
  • Cool new widgets: photos/video, GIS, images as selectors, VAS

You’ll learn how to create forms in this new environment and have a look at the intuitive drag-and-drop design tool which will make it easy to get powerful forms created quickly.

Session Title:Collaboration, Consolidation, and Consistency: Real World Data Handling for OpenClinica

Csaba Halmagyi, IT Integration Specialist Julie von Ziegenweidt, Clinical Research Data Lead NIHR Rare Diseases Clinical Infrastructure Team (RDCIT), University of Cambridge

Summary: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.

Session Title:What is that OpenClinica RSP Thing, and How do I Use it?

Laura Keita Director of Training & Compliance OpenClinica

Summary:The OpenClinica Regulatory Support Package (RSP) is a commercial offering from OpenClinica, LLC that provides documentation and support needed to demonstrate validation and compliance with GCP, 21 CFR Part 11, and regulatory standards. This workshop will step participants through the RSP in order to articulate the role and significance of its components, and discuss how they may be effectively utilized. This is a great opportunity for: (a) any existing customers who have never quite understood the RSP and what to do with it, and (b) anyone who would like to know more about the RSP and OpenClinica’s regulatory validation and documentation processes.