Investigational Product Discontinuation and Early Termination from the Study Sample Clauses

Investigational Product Discontinuation and Early Termination from the Study. A participant may withdraw from the study at any time at his/her own request for any reason. The investigator may discontinue a participant from the study and/or from IP for safety, behavioral, compliance, or administrative reasons. The investigator must discontinue a participant from IP for any of the following reasons: • The participant is unwilling or unable to adhere to the protocol • Other medical or safety reason, including suicidality, based on clinical judgment • The participant becomes pregnant during the treatment period The investigator must also discontinue a participant from the study and from IP (if applicable) if the participant withdraws consent or loses the capacity to grant consent. The reason for IP discontinuation and/or the reason for early termination from the study must be documented in the participant’s study record and recorded in the participant’s electronic case report form (eCRF). The investigator must notify the sponsor and/or the medical monitor when a participant discontinues IP and/or stops participation in the study for any reason.
Sample 1
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Related to Investigational Product Discontinuation and Early Termination from the Study

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