posilies schreef op 7 januari 2021 22:54:
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Hier heb je het over Janssen*2
2.9 Early termination of the study
The Sponsor-Investigator may terminate the study prematurely according to certain circumstances, for
example:
? ethical concerns,
? insufficient participant recruitment,
? when the safety of the participants is doubtful or at risk, respectively,
? alterations in accepted clinical practice that make the continuation of a clinical trial unwise,
? early evidence of benefit or harm of the experimental intervention
A DSMB will continuously monitor patients’ safety. The DSMB will independently judge and recommend
on the need to halt enrolment for further evaluations or to terminate the trial based on information
regarding safety.