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Early Termination

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A research study might terminate prematurely. This may be due to recommendations from the Independent Data Monitoring Committee (IDMC) over safety concerns; or after a temporary halt, where the decision has been made not to restart. It might also be due to poor recruitment or financial/management difficulties.

The circumstances that have led to a research study terminating early will need to be documented in the study's Trial Master File. This should include documenting any decisions that have been made, for the purpose of the audit trail. Any potential implications for participants such as the study is terminating due to their personal risk or other safety grounds must be detailed at the end of the study declaration form. Equally, the consequences for terminating the trial and results must also be detailed in this form (possibly document; or the name of the file again).