Definitions in Digital Decentralised Clinical Trials (DDCT)

Have you read our documents or legal texts and standards and would like to look up definitions again? We have compiled important definitions from the field of digital decentralised clinical investigations for you here:

• Actors: people who are involved in the design, planning, implementation, data management, analysis and publication of the clinical study, e.g. as physicians, study assistants, project managers, LKP, IT developers, employees in the laboratory, practices or clinics, and who therefore cannot be so-called "active participants".
• Active participants: People who take part in a clinical study, e.g. as patients, relatives or test subjects, after being informed by medical staff.
• Data integrity: Data integrity refers to the reliability and trustworthiness of data throughout its entire life cycle. Data integrity is the building block of data quality, which has a significant impact on the quality of the study.
• Digital decentralised clinical trial (DDCT): According to the FDA, these are studies conducted by telemedicine and mobile/local healthcare providers using procedures and technologies that differ from the traditional clinical study model. Digital elements are used at different times for different tasks and different scopes.
• Dynamic file formats: Dynamic files involve automatic processing and/or enable an interactive relationship with the user. A certified electronic copy may be kept in electronic file formats that are different from the original record, but the corresponding dynamic nature (including metadata) of the original record should be preserved.
• Electronic Data Capture (EDC) system: This is a computerised system for capturing clinical data in electronic form, primarily used in clinical studies. It replaces conventional analogue data collection with the objective of making data collection faster, more efficient and safer.
• Event log: An automated log of events related to the use of a system, e.g. system access, alerts or triggering of processing controls.
• Coordinated network: MEDIACC works as an independent company in a dynamic, fluid network with other participants who together form the network. Depending on the contractually agreed task, MEDIACC coordinates the entire system or subsystems. The mission to make scientific evidence easy for all stakeholders through optimal patient-centred clinical studies for significant innovative medical devices unites everyone in this network.
• Data lifecycle: All processes related to creating, recording, processing, reviewing, modifying, analysing, reporting, transferring, storing, migrating, archiving, retrieving and deleting data.
• LKP (clinical investigation manager): A legally defined role in a clinical investigation in accordance with the MDR 2017 and the Medical Device Law Implementation Act. The LCP has overall medical responsibility for the study with at least two years of experience in clinical investigations and corresponding further qualifications. He or she is responsible for deciding on the medical justifiability, start, continuation and cancellation of the study in the event of unacceptable risks to subjects and patients. He or she is responsible for conducting the study in accordance with the protocol, reporting the results and submitting a final assessment to the sponsor.
• Metadata: Data only becomes information through context. Without the context provided by metadata, the data has no meaning. The loss of metadata can lead to a lack of data integrity and render the data unusable. Essential for clinical investigations of medicinal products and, if applicable, medical devices according to Art 62 or 82 MDR (authorisation studies) or for the safety of MP RK IIb to III or according to other regulatory requirements or compliance with laws and regulations.
• Trial run: First series of inclusions of active participants recruited for the study. The trial run can therefore only take place after the ethics committee has given its favourable opinion and after successful test runs.
• Source data: The permanent data from electronic data generation/capture should be defined as the electronic source data. This process should be validated to ensure that the generated/collected source data is representative of the original observation and should contain metadata including an audit trail to ensure compliance with the ALCOA++ principles (see below). The location where the source data was first obtained should be part of the metadata. If the processing is an integral part of the solution used and is recognisable as such in the solution characteristics, there is no need to extract and store the unprocessed data. It must be possible to validate the correct functioning of the processing. As a general rule, the source data should be processed as little as possible and as much as necessary.
• Static file formats: Static files that contain information or data that is unchangeable and does not allow dynamic interaction.
• Study infrastructure: Study platform and analogue elements.
• Study phases: These are usually strategy development, conceptualisation, planning, setting up the digital elements, study implementation, data management, evaluation and publication. While these study phases tend to be arranged in a linear fashion in a conventional study, DDC results in a non-linear, complex arrangement.
• MEDIACC study platform: It enables the implementation of hybrid (analogue and digital) through to completely digital decentralised clinical studies (DDCT). For this purpose, an electronic data recording system is used as the basis and additional digital elements, such as electronic signatures, web-based appointment calendars or medical video consultation software.
• Test run: First series of tests of all digital and analogue elements of a DDCT by test subjects who are not included in the study. Successful test runs and complete elimination of all technically necessary and safety-relevant weak points or problems are a prerequisite for the release of the system by MEDIACC, LKP and the sponsor for the trial run.

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