Discontinuations. Discontinued subjects are individuals who voluntarily withdraw or are withdrawn from the study by the investigator after signing informed consent. Subject numbers of discontinued subjects must not be re-used (i.e., subject replacement is not allowed). Subjects may discontinue from study or study treatment at any time for any reason. Subjects may also be discontinued from study treatment at any time if, in the opinion of the investigator, continued treatment poses a risk to their health. For subjects discontinuing from the study, the investigator must complete all Exit procedures according to Table 3-1 Schedule of Study Procedures and Assessments, if the subject is willing and able, and if in the opinion of the investigator it is safe for the subject to do so. 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
Discontinuations. Discontinued subjects are individuals who voluntarily withdraw or are withdrawn from the study by the investigator Investigator after signing the informed consent, including screen failures. Subject numbers of discontinued subjects must not be re-used (i.e., subject replacement is not allowed)used. Subjects may discontinue from study or study treatment at any time for any reason. Subjects may also be discontinued from study treatment at any time if, in the opinion of the investigatorInvestigator, continued treatment poses a risk to their health. For subjects discontinuing from the study, the investigator Investigator must complete all Exit procedures according to Table 3-1 Schedule of Study Procedures and Assessments, if the subject is willing and able, and if in the opinion of the investigator Investigator it is safe for the subject to do so. The investigator 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 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
Discontinuations. Discontinued subjects are individuals who voluntarily withdraw or are withdrawn from the study by the investigator after signing the informed consent. Subject numbers of discontinued subjects must not be re-used (i.e., subject replacement is not allowed). Subjects may discontinue from study or study treatment at any time for any reason. Subjects may also be discontinued from study treatment at any time if, in the opinion of the investigator, continued treatment poses a risk to their health. For subjects discontinuing from the study, the investigator must complete all Exit procedures according to Table 3-1 3–1 Schedule of Study Procedures and AssessmentsAssessments , if the subject is willing and able, and if in the opinion of the investigator it is safe for the subject to do so. 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
Discontinuations. Discontinued subjects are individuals who voluntarily withdraw or are withdrawn from the study by the investigator after signing informed consent. Subject numbers of discontinued subjects must not be re-used (i.e., subject replacement is not allowed). Subjects may discontinue from study or study treatment at any time for any reason. Subjects may also be discontinued from study treatment at any time if, in the opinion of the investigator, continued treatment poses a risk to their health. For subjects discontinuing from the study, the investigator must complete all Exit procedures according to Table 3-1 Schedule of Study Procedures and Assessments, Assessments if the subject is willing and able, and if in the opinion of the investigator it is safe for the subject to do so. 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
Discontinuations. Discontinued subjects are individuals who voluntarily withdraw or are withdrawn from the study by the investigator Investigator after signing the informed consent, including screen failures. Subject numbers of discontinued subjects must not be re-used (i.e., subject replacement is not allowed)used. Subjects may discontinue from study or study treatment at any time for any reason. Subjects may also be discontinued from study treatment at any time if, in the opinion of the investigatorInvestigator, continued treatment poses a risk to their health. For subjects discontinuing from the study, the investigator Investigator must complete all Early Exit procedures according to Table 3-1 1, Schedule of Study Procedures and Assessments, if the subject is willing and able, and if if, in the opinion of the investigator Investigator it is safe for the subject to do so. The investigator 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 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
Discontinuations. Discontinued subjects are individuals who voluntarily withdraw or are withdrawn from the study by the investigator after signing the informed consent. Subject numbers of discontinued subjects must not be re-used (i.e., subject replacement is not allowed)used. Subjects may discontinue from study or study treatment at any time for any reason. Subjects may also be discontinued from study treatment at any time if, in the opinion of the investigator, continued treatment poses a risk to their health. For subjects discontinuing from the study, the investigator must complete all Exit procedures according to Table 3-1 Schedule of Study Procedures and AssessmentsAssessments and Section 10.4.3, if the subject is willing and able, and if in the opinion of the investigator it is safe for the subject to do so. 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
Discontinuations. Discontinued subjects are individuals who voluntarily withdraw or are withdrawn from the study by the investigator Investigator after signing the informed consent. Subject numbers of discontinued subjects must not be re-used (i.e., subject replacement is not allowed)used. Subjects may discontinue from study or study treatment at any time for any reason. Subjects may also be discontinued from study treatment at any time if, in the opinion of the investigatorInvestigator, continued treatment poses a risk to their health. Subjects missing consecutive follow-up visits will be evaluated to determine if discontinuation may be necessary. For subjects discontinuing from the study, the investigator Investigator must complete all Exit procedures according to Table 3-1 Schedule of Study Procedures and Assessments1, if the subject is willing and able, and if in the opinion of the investigator Investigator it is safe for the subject to do so. The investigator 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 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