Once the required number of participants have been recruited, the study is closed and this reported to funders and regulators. Follow up may be required by the study protocol.
Study closure is a clearly defined part of the study protocol, and is the stop point for delivering a study on time. Some studies include a period of participant follow up while others do not. Researchers continue to collect data during the follow up phase of a study if it has been included in the protocol. Staff and other resources may be required to support the follow up of participants and this needs consideration during study set up.
Delivering the participation phase of studies on time is a key measure of research delivery for Health and Care Research Wales. Study closure marks the stop point for this, and notification of study closure is an important step.
Beyond this phase researchers still have to ensure the study continues to run to time and to report to funders, regulatory and review bodies on progress.
Complete study closure is the point at which all data has been collected. Study documents can be archived after a period of time defined in the protocol.
Analysis of data
The data generated and collected during the study is analysed in order to report findings from the study. The method of analysis is described in the study protocol and is agreed during the development of the research idea and protocol.
Data analysis may also involve specific software and skills so this responsibility may be delegated to a clinical trials unit offering specialist support.
For support contact the Health and Care Research Wales research directory team.
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In some cases, the Clinical Trials Unit may manage the close down and reporting of the study.