Common use of Discontinued Subjects Clause in Contracts

Discontinued Subjects. Discontinued subjects are those who withdraw or are withdrawn from the study after signing the informed consent, including screen failures. Subjects may discontinue from the study at any time for any reason. Subjects may also be discontinued from the study at any time if, in the opinion of the Investigator, their continued participation poses a risk to their health. Discontinued subjects will not be replaced (ie, their subject numbers will not be re-assigned/re-used). Should a subject exhibit any clinically relevant signs, symptoms, or other clinical observations that possibly could be associated with suspected sensitivity or intolerance to one of the study treatments, the Investigator must document those observations on an AE Form. Any subject who exits early from the study (excluding screen failures) must undergo all procedures outlined at Visit 3, as applicable. The Investigator must document the reason for study or treatment discontinuation in the subject’s case history source documents. To ensure the safety of all subjects who discontinue early, Investigators must assess each subject and, if necessary, advise them of any therapies and/or medical procedures that may be needed to maintain their health.

Appears in 3 contracts

Samples: Investigator Agreement, classic.clinicaltrials.gov, clinicaltrials.gov

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Discontinued Subjects. Discontinued subjects are those who withdraw or are withdrawn from the study after signing the informed consent, including screen failures. Subjects may discontinue from the study at any time for any reason. Subjects may also be discontinued from the study at any time if, in the opinion of the Investigator, their continued participation poses a risk to their health. Discontinued subjects will not be replaced (iei.e., their subject numbers will not be re-assigned/re-used). Should a subject exhibit any clinically relevant signs, symptoms, or other clinical observations that possibly could be associated with suspected sensitivity or intolerance to one of the study treatments, the Investigator must document those observations on an AE Form. Any subject who exits early from the study (excluding screen failures) must undergo all procedures outlined at Visit 34, as applicable. The Investigator must document the reason for study or treatment discontinuation in the subject’s case history source documents. To ensure the safety of all subjects who discontinue early, Investigators must assess each subject and, if necessary, advise them of any therapies and/or medical procedures that may be needed to maintain their health.

Appears in 1 contract

Samples: Investigator Agreement

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Discontinued Subjects. Discontinued subjects are those who withdraw or are withdrawn from the study after signing the informed consent, including screen failures. Subjects may discontinue from the study at any time for any reason. Subjects may also be discontinued from the study at any time if, in the opinion of the Investigator, their continued participation poses a risk to their health. Discontinued subjects will not be replaced (ie, their subject numbers will not be re-assigned/re-used). Should a subject exhibit any clinically relevant signs, symptoms, or other clinical observations that possibly could be associated with suspected sensitivity or intolerance to one of the study treatments, the Investigator must document those observations on an AE Form. Any subject who exits early from the study (excluding screen failures) must undergo all procedures outlined at Visit 35, as applicable. The Investigator must document the reason for study or treatment discontinuation in the subject’s case history source documents. To ensure the safety of all subjects who discontinue early, Investigators must assess each subject and, if necessary, advise them of any therapies and/or medical procedures that may be needed to maintain their health.

Appears in 1 contract

Samples: Investigator Agreement

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