Definitions in Digital Decentralized Clinical Trials (DDCT)

Actors: People who are involved in the conception, planning, implementation, data management, evaluation and publication of the clinical trial, 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 influence on the quality of the study.

Digital Decentralized Clinical Trial (DDCT): According to the FDA, these are trials conducted by telemedicine and mobile/local healthcare providers using methods and technologies that differ from the traditional clinical trial model. Digital elements are used at different times for different tasks and to different extents.

Dynamic file formats: Dynamic files involve automatic processing and/or enable an interactive relationship with the user. A certified electronic copy may be retained in electronic file formats that differ from the original record, but the corresponding dynamic nature (including metadata) of the original record should be preserved.

Electronic data capture system (EDC): This is a computerized system for recording clinical data in electronic form, which is primarily used in clinical studies. It replaces conventional analog data acquisition with the aim of making data acquisition faster, more efficient and safer.

Event log: An automated log of events related to the use of a system, e.g. system access, warning messages 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-centered clinical trials for important innovative medical devices unites all in this network.

Lifecycle of data: All processes related to the creation, recording, processing, review, modification, analysis, reporting, transfer, storage, migration, archiving, retrieval and deletion of data.

LKP (Head of Clinical Trial): A legally defined role in a clinical trial 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 trials and corresponding further qualifications. He or she is responsible for deciding on the medical justifiability, start, continuation and termination of the study in the event of unacceptable risks to subjects and patients. He or she is responsible for conducting the trial 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 trials of medicinal products and, if applicable, medical devices according to Art 62 or 82 MDR (approval 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 receiving the positive vote of the ethics committee and after successful test runs.

Source data: The permanent data from an 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 recognizable as such in the solution characteristics, there is no need to extract and retain 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 analog elements.

Study phases: These are usually strategy development, conception, 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.

Study platform of MEDIACC: It enables the implementation of hybrid (analogue and digital) through to completely digital decentralized clinical trials (DDCT). For this purpose, an electronic data collection 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 analog elements of a DDCT by test persons 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.