In recent years there has been a growing acceptance that to accurately assess the results of trials and other clinical research, and in particular to combine the results from different trials in meta-analyses, it is necessary to have access to the original source data, the “individual participant data” (IPD), as well as the result summaries found in published papers.
In addition, to make sure that the IPD can be fully understood and properly analysed, a variety of other study documents (protocols, analysis plans, etc.) are required. As a result, under pressure from funders and journal editors, more and more researchers are making such material (generically, “clinical trial data objects”) available for sharing with others. The datasets are rarely freely available - instead a variety of access mechanisms (e.g. individual request and review, membership of pre-authorised groups, or web based self-attestation), are used in combination with different access types (e.g. download versus in-situ perusal). Furthermore the various data objects are stored in a wide variety of different locations: a rapidly growing number of general and specialised data repositories, trial registries, publications, the original researchers’ institutions, etc.
The researcher or reviewer wishing to locate relevant data objects for a study is therefore faced with a bewildering mosaic of possible source locations and access mechanisms, and this problem of ‘discoverability’ will almost certainly become much worse in the future as more and more materials are made available for sharing.
Aims of the Project
The principal aim of the project is to combat this discoverability problem, by making the data objects generated from clinical research easier to locate, and by describing how each of those data objects can be accessed, providing direct links to them where that is possible. The central idea is to develop systems that can collect the metadata about the data objects, including object provenance, location and access details, and aggregate it into a single MetaData Repository (or MDR). The MDR is therefore designed to assemble, standardise and display the metadata about clinical studies and the data objects generated by them, and provide access to that metadata through a single system, accessed via a web portal.
Acceptable Use Policy
This Acceptable Use Policy and Conditions of Use (“AUP”) defines the rules and conditions that govern your access to and use (including transmission, processing, and storage of data) of the resources and services (“Services”) as granted by the EGI Federation, and the Virtual Organisation to which you belong, for the purpose of meeting the goals of EGI, namely to deliver advanced computing services to support researchers, multinational projects and research infrastructures, and the goals of your Virtual Organisation or Research Community.
1. You shall only use the Services in a manner consistent with the purposes and limitations described above; you shall show consideration towards other users including by not causing harm to the Services; you have an obligation to collaborate in the resolution of issues arising from your use of the Services
2. You shall only use the Services for lawful purposes and not breach, attempt to breach, nor circumvent administrative or security controls.
3. You shall respect intellectual property and confidentiality agreements.
4. You shall protect your access credentials (e.g. passwords, private keys or multi-factor
tokens); no intentional sharing is permitted.
5. You shall keep your registered information correct and up to date.
6. You shall promptly report known or suspected security breaches, credential compromise, or
misuse to the security contact stated below; and report any compromised credentials to the
relevant issuing authorities.
7. Reliance on the Services shall only be to the extent specified by any applicable service level
agreements listed below. Use without such agreements is at your own risk.
8. Your personal data will be processed in accordance with the privacy statements referenced
9. Your use of the Services may be restricted or suspended, for administrative, operational, or
security reasons, without prior notice and without compensation.
10. If you violate these rules, you may be liable for the consequences, which may include your
account being suspended and a report being made to your home organisation or to law enforcement.
The privacy statements (e.g. Privacy Notices) are located either at: https://egi.eu/privacy-policy/ or are presented to the user accessing a Service having its own Privacy Notice.