For participants who were previously enrolled and are no longer part of long-term follow-up, how should new safety information about a drug be communicated to them?
A – With each safety update or amendment, the local Principal Investigator is responsible for assessing the potential impact on all current and previously enrolled participants. This assessment should be submitted to the IRB to be reviewed on a case-by-case basis. In some cases, re-consent may be necessary.
Related Questions
- For participants who were previously enrolled and are no longer part of long-term follow-up, how should new safety information about a drug be communicated to them?
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