Medical Sciences Division has recently purchased the OpenSpecimen Sample Inventory Management System, supplied by Krishagni Solutions Pvt Ltd, to be implemented across the division to support research involving human tissue material collected, processed or stored under either Human Tissue Authority (HTA) licence or Research Ethics Committee (REC) approval. This has been done to address serious risk of non-compliance with HTA licencing requirements in regard of human tissue sample traceability and permissible usage arising through continued reliance on legacy software that is no longer supported and increasingly incompatible with modern IT operating environments. A major driver moving forward is to provide a strategic, well-managed and risk based approach to ensuring that IT systems supporting the collection, processing, storage and use of human tissue material for research are implemented, maintained and developed to comply fully with licensing and regulatory requirements and information governance best practice.
OpenSpecimen is a highly configurable open source biobanking / biospecimen management system used by over 70 prestigious institutions in over 20 countries. It supports a wide range of sample collection scenarios from simple one-time ad-hoc collection of a single sample through to complex longitudinal studies collecting many samples, of different types, at various time points during the study lifetime. Customisable screens and fields allow collection of additional clinical or pathology data to meet specific research requirements. This is further extended with an extensive API and also additional, paid, modules available for integration with other clinical data collection solutions such as REDCap and OpenClinica. Highly flexible storage container hierarchy management features allow configuration of sample storage locations accurately to reflect those physically available, with one-click creation of, for example, a freezer with multiple shelves, racks and boxes. Containers can be moved in bulk or with a single click, and contents can be restricted by sample type or study. Powerful reporting features allow users to create and share complex queries though an easy to use user-interface without requiring IT support. The hierarchical organisational architecture of OpenSpecimen in conjunction with role-based user privileges controlling access to allow a high degree of autonomy and flexibility in allowing groups to configure users, sites and study protocols at various levels within the organisation. This is achieved through easy-to-use User Interface functionality which does not require high levels of specialist IT skills on the part of the user.
The project is a joint venture involving the Human Tissue Governance (HTG) team and MSD IT, and is overseen by a Steering Committee chaired by the Head of Commercial Strategy and Risk for MSD. An MSDIT HGT IT Lead has been appointed and in post since May this year, and a recruitment process is in progress for an MSDIT HGT Migration & Onboarding Officer to provide additional support where needed. An OpenSpecimen platform infrastructure, consisting of a production system and a separate test / development system, has been installed and is now being configured. There has been already very encouraging engagement from a large number of groups around the division who have been approached as part of the initial implementation plan. An HTG OpenSpecimen Community team has been created in MS Teams to act as a forum for disseminating information, making available documentation and other learning resources, asking questions, raising issues and generally promoting best practice in configuring and using the system.
Anyone having a requirement to collect and manage clinical material for research purposes who has not so far been approached, and who would like to learn more about how OpenSpecimen could support this activity is invited to contact the MSDIT HGT IT Lead, Richard Renshaw, who would be happy to discuss the opportunities OpenSpecimen opens up.