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Background: Given the increasing number and heterogeneity of data repositories, an improvement and harmonisation of practice within repositories for clinical trial data is urgently needed. The objective of the study was to develop and evaluate a demonstrator repository, using a widely used repository system (DSpace), and then explore its suitability for providing access to individual participant data (IPD) from clinical research. Methods: After a study of the available options, DSpace (version 6.3) was selected as the software for developing a demonstrator implementation of a repository for clinical trial data. In total, 19 quality criteria were defined, using previous work assessing clinical data repositories as a guide, and the demonstrator implementation was then assessed with respect to those criteria. Results: Generally, the performance of the DSpace demonstrator repository in supporting sensitive personal data such as that from clinical trials was strong, with 14 requirements demonstrated (74%), including the necessary support for metadata and identifiers. Two requirements could not be demonstrated (inability to incorporate de-identification tools in the submission workflow, lack of a self-attestation system) and three requirements were only partially demonstrated (ability to provide links to de-identification tools and requirements, incorporation of a data transfer agreement in system workflow, and capability to offer managed access through application on a case by case basis). Conclusions: Technically, the system was able to support most of the pre-defined requirements, though there are areas where support could be improved. Of course, in a productive repository, appropriate policies and procedures would be needed to direct the use of the available technical features. A technical evaluation should therefore be seen as indicating a system's potential, rather than being a definite assessment of its suitability. DSpace clearly has considerable potential in this context and appears a suitable base for further exploration of the issues around storing sensitive data., Competing Interests: No competing interests were disclosed., (Copyright: © 2020 Tilki B et al.)

Background: Given the increasing number and heterogeneity of data repositories, an improvement and harmonisation of practice within repositories for clinical trial data is urgently needed. The objective of the study was to develop and evaluate a demonstrator repository, using a widely used repository system (DSpace), and then explore its suitability for providing access to individual participant data (IPD) from clinical research. Methods: After a study of the available options, DSpace (version 6.3) was selected as the software for developing a demonstrator implementation of a repository for clinical trial data. In total, 19 quality criteria were defined, using previous work assessing clinical data repositories as a guide, and the demonstrator implementation was then assessed with respect to those criteria. Results: Generally, the performance of the DSpace demonstrator repository in supporting sensitive personal data such as that from clinical trials was strong, with 14 requirements demonstrated (74%), including the necessary support for metadata and identifiers. Two requirements could not be demonstrated (the ability to include de-identification tools and the availabiltiy of a self-attestation system) and three requirements were only partially demonstrated (ability to provide links to de-identification tools and requirements, incorporation of a data transfer agreement in system workflow, and capability to offer managed access through application on a case by case basis). Conclusions: Technically, the system was able to support most of the pre-defined requirements, though there are areas where support could be improved. Of course, in a productive repository, appropriate policies and procedures would be needed to direct the use of the available technical features. A technical evaluation should therefore be seen as indicating a system's potential, rather than being a definite assessment of its suitability. DSpace clearly has considerable potential in this context and appears a suitable base for further exploration of the issues around storing sensitive data., Competing Interests: No competing interests were disclosed., (Copyright: © 2020 Tilki B et al.)

Objectives: We examined major issues associated with sharing of individual clinical trial data and developed a consensus document on providing access to individual participant data from clinical trials, using a broad interdisciplinary approach., Design and Methods: This was a consensus-building process among the members of a multistakeholder task force, involving a wide range of experts (researchers, patient representatives, methodologists, information technology experts, and representatives from funders, infrastructures and standards development organisations). An independent facilitator supported the process using the nominal group technique. The consensus was reached in a series of three workshops held over 1 year, supported by exchange of documents and teleconferences within focused subgroups when needed. This work was set within the Horizon 2020-funded project CORBEL (Coordinated Research Infrastructures Building Enduring Life-science Services) and coordinated by the European Clinical Research Infrastructure Network. Thus, the focus was on non-commercial trials and the perspective mainly European., Outcome: We developed principles and practical recommendations on how to share data from clinical trials., Results: The task force reached consensus on 10 principles and 50 recommendations, representing the fundamental requirements of any framework used for the sharing of clinical trials data. The document covers the following main areas: making data sharing a reality (eg, cultural change, academic incentives, funding), consent for data sharing, protection of trial participants (eg, de-identification), data standards, rights, types and management of access (eg, data request and access models), data management and repositories, discoverability, and metadata., Conclusions: The adoption of the recommendations in this document would help to promote and support data sharing and reuse among researchers, adequately inform trial participants and protect their rights, and provide effective and efficient systems for preparing, storing and accessing data. The recommendations now need to be implemented and tested in practice. Further work needs to be done to integrate these proposals with those from other geographical areas and other academic domains., Competing Interests: Competing interests: TG is the editor-in-chief of BMJ Open, the journal that publishes this article. During the paper evaluation she recused herself from the peer review and decision-making process. BB reports various unrestricted gifts (see) supporting travel and effort; grants from Laura and John Arnold Foundation and the Greenwall Foundation during the conduct of the study; and non-financial support from Vivli, outside the submitted work. RK reports she was Founder of CDISC and President during the development of the submitted work. DaS was employed by BioMed Central at the time of the consensus process., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: Over the last decade, the United Kingdom has invested significant resources in its clinical trial infrastructure. Clinical research networks have been formed, and some general oversight functions for clinical research have been centralised. One of the initiatives is a registration programme for Clinical Trials Units involved in the coordination of clinical trials. An international review panel of experts in clinical trials has been convened for three reviews over time, reviewing applications from Clinical Trials Units in the United Kingdom. The process benefited from earlier work by the National Cancer Research Institute that developed accreditation procedures for trials units involved in cancer trials. This article describes the experience with the three reviews of UK Clinical Trials Units which submitted applications., Purpose: This article describes the evolution and impact of this registration process from the perspective of the current international review panel members, some of whom have served on all reviews, including two done by the National Cancer Research Institute., Process: Applications for registration were invited from all active, non-commercial Clinical Trials Units in the United Kingdom. The invitations were issued in 2007, 2009 and 2012, and applicants were asked to describe their expertise and staffing levels in specific areas. To ensure that the reviews were as objective as possible, a description of expected core competencies was developed and applicants were asked to document their compliance with meeting these. The review panel assessed each Clinical Trials Unit against the competencies. The Clinical Trials Unit registration process has evolved over time with each successive review benefiting from what was learned in earlier ones., Results: The review panel has seen positive changes over time, including an increase in the number of units applying, a greater awareness on the part of host institutions about the trials activity within their organisations, more widespread development of Standard Operating Procedures in key areas and improvements in information technology systems used to host clinical trials databases. Key funders are awarding funds only to registered units, and host institutions are implementing procedures and structures to ensure improved communication between all parties involved in trials within their organisation., Conclusion: The registration process developed in the United Kingdom has helped to ensure that trials units in the United Kingdom are compliant with regulatory standards and can meet acceptable standards of quality in their conduct of clinical trials. There is an increased awareness among funders, host institutions and Clinical Trials Units themselves of the required competencies, and communication between all those involved in trials has increased. The registration process is an effective and financially viable way of ensuring that objective standards are met at a national level., (© The Author(s) 2014.)

The pilot phase of the ECRIN (European Clinical Research Infrastructure Network) certification programme for European data centres, in late 2011, led to a substantial revision of the original ECRIN standards, completed by June 2012. The pilot phase, the conclusions drawn from it and the revised set of standards are described. Issues concerning the further development of standards and related material are discussed, as are the methods available to best support that development. A strategy is outlined based on short-lived specific task groups, established as necessary by a steering group drawn from ECRIN-ERIC. A final section discusses possible future developments.

Background: A recent survey has shown that data management in clinical trials performed by academic trial units still faces many difficulties (e.g. heterogeneity of software products, deficits in quality management, limited human and financial resources and the complexity of running a local computer centre). Unfortunately, no specific, practical and open standard for both GCP-compliant data management and the underlying IT-infrastructure is available to improve the situation. For that reason the "Working Group on Data Centres" of the European Clinical Research Infrastructures Network (ECRIN) has developed a standard specifying the requirements for high quality GCP-compliant data management in multinational clinical trials., Methods: International, European and national regulations and guidelines relevant to GCP, data security and IT infrastructures, as well as ECRIN documents produced previously, were evaluated to provide a starting point for the development of standard requirements. The requirements were produced by expert consensus of the ECRIN Working group on Data Centres, using a structured and standardised process. The requirements were divided into two main parts: an IT part covering standards for the underlying IT infrastructure and computer systems in general, and a Data Management (DM) part covering requirements for data management applications in clinical trials., Results: The standard developed includes 115 IT requirements, split into 15 separate sections, 107 DM requirements (in 12 sections) and 13 other requirements (2 sections). Sections IT01 to IT05 deal with the basic IT infrastructure while IT06 and IT07 cover validation and local software development. IT08 to IT015 concern the aspects of IT systems that directly support clinical trial management. Sections DM01 to DM03 cover the implementation of a specific clinical data management application, i.e. for a specific trial, whilst DM04 to DM12 address the data management of trials across the unit. Section IN01 is dedicated to international aspects and ST01 to the competence of a trials unit's staff., Conclusions: The standard is intended to provide an open and widely used set of requirements for GCP-compliant data management, particularly in academic trial units. It is the intention that ECRIN will use these requirements as the basis for the certification of ECRIN data centres.