The glossary explains some important terms used in clinical research and clinical trials. In addition to our own knowledge and expertise, the following sources were used to define the terms:
| Begriff | Definition |
|---|---|
| standard operating procedure - SOP |
Established procedure to be followed in carrying out a given operation or in a given situation.
|
| subject |
A subject describes an individual who participates in a clinical investigation.
Synonyme -
patient |
| technical documentation - TD |
Technical documentation represents the entirety of the documents describing a device. The manufacturer supplies information materials, device's design, development, the instruction for use and the regulatory status within target markets. Technical documentation is require for the assessment of conformity to th essential requirements and for the approval of a medical device.
Synonyme -
technical file |
| trial master file - TMF |
A trial master file (TMF) is the collection of essential documents that is used by sponsors, CROs and investigators/institutions for the management of the trial and by monitors, auditors and inspectors to review and verify whether the sponsor and the investigators/institutions have conducted the trial in line with the applicable regulatory requirements and the principles and standards of GCP.
Unlike the ISF, the TMF remains by the sponsor. |
| unanticipated serious adverse device effect - USADE |
A unanticipated serious adverse device efect (USADE) is a serious adverse device effect which by its nature, incidence, severity or outcome has not been identified in the current version of the risk analysis report.
|
| user |
A user describes the person, who can either be a healthcare professional or lay person using the device.
|
| vulnerable subject |
A vulnerable subject is an individual whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate.
Individuals with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, and those incapable of giving informed consent. Other vulnerable subjects include, for example, members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in detention. |
| withdrawal |
A withdrawal describes any measure aimed at preventing a device in the supply chain from being further made available on the market.
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