Common use of Unscheduled Visits Clause in Contracts

Unscheduled Visits. Any visit that occurs between regularly scheduled visits is an Unscheduled Visit. If a subject requires an Unscheduled Visit, he/she must be advised to return to the office wearing the study lenses, if at all possible (unless he/she is experiencing a sign or symptom [as indicated in Section 3.3 Risks and Benefits]). During all unscheduled visits, the Investigator must conduct the following procedures: • Collect AE and Device Deficiency information • Assess and record changes in medical health or concomitant medication • Assess and record VAs • Perform biomicroscopy (assessments with or without lenses, as possible) In addition, refer to Table 1-1 Unscheduled Visit for required procedures. The Investigator may perform additional procedures for proper diagnosis and treatment of the subject. The Investigator must document this information in the subject’s case history source documents. If during an Unscheduled Visit the subject is discontinuing the study lenses or discontinuing from the study, the Investigator must conduct Exit procedures according to Table 1-1: Schedule of Study Procedures and Assessments, as possible.

Appears in 1 contract

Samples: Investigator Agreement

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Unscheduled Visits. Any visit that occurs between regularly scheduled visits is an Unscheduled Visit. If a subject requires an Unscheduled Visit, he/she must be advised to return to the office wearing the study lenses, if at all possible (unless he/she is experiencing a sign or symptom [as indicated in Section 3.3 Risks and Benefits]). During all unscheduled visits, the Investigator must conduct the following procedures: • Collect AE and Device Deficiency device deficiency information • Assess and record changes in medical health condition or concomitant medication • Assess and record VAs • Perform biomicroscopy (assessments with or without lenses, as possible) possible)‌‌ In addition, refer to Table 1all procedures for Visit 3 (4-1 Unscheduled Visit for required proceduresWeek Follow-up/Exit) should be completed (as possible). The Investigator may perform additional procedures for proper diagnosis and treatment of the subject. The Investigator must document this information in the subject’s case history source documents. If during an Unscheduled Visit the subject is discontinuing the study lenses or discontinuing from the study, the Investigator must conduct Exit procedures according to Table 1-1: Schedule of Study Procedures and Assessments, as possible.

Appears in 1 contract

Samples: Investigator Agreement

Unscheduled Visits. Any visit that occurs between regularly scheduled visits is an Unscheduled Visit. If a subject requires an Unscheduled Visit, he/she must be advised to return to the office wearing the study lenses, if at all possible (unless he/she is experiencing a sign or symptom [as indicated in Section 3.3 Risks and Benefits]). During all unscheduled visits, the Investigator must conduct the following procedures: • Collect AE and Device Deficiency device deficiency information • Assess and record changes in medical health condition or concomitant medication • Assess and record VAs • Perform biomicroscopy (assessments with or without lenses, as possible) possible)‌‌ In addition, refer to Table 1all procedures for Visit 3 (Follow-1 Unscheduled Visit for required proceduresup Lens 2/Exit) should be completed (as possible). The Investigator may perform additional procedures for proper diagnosis and treatment of the subject. The Investigator must document this information in the subject’s case history source documents. If during an Unscheduled Visit the subject is discontinuing the study lenses or discontinuing from the study, the Investigator must conduct Exit procedures according to Table 1-1: Schedule of Study Procedures and Assessments, as possible.

Appears in 1 contract

Samples: Investigator Agreement

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Unscheduled Visits. Any visit that occurs between regularly scheduled visits is an Unscheduled Visit. If a subject requires an Unscheduled Visit, he/she must be advised to return to the office wearing the study lenses, if at all possible (unless he/she is experiencing a sign or symptom [as indicated in Section 3.3 Risks and Benefits]). During all unscheduled visits, the Investigator must conduct the following procedures: • Collect AE and Device Deficiency information • Assess and record changes in medical health condition or concomitant medication • Assess and record VAs • Perform biomicroscopy (assessments with or without lenses, as possible) In addition, refer to Table 1all procedures for Visit 5 (Follow-1 Unscheduled Visit for required proceduresup/Exit) should be completed (as possible). The Investigator may perform additional procedures for proper diagnosis and treatment of the subject. The Investigator must document this information in the subject’s case history source documents. If during an Unscheduled Visit the subject is discontinuing the study lenses or discontinuing from the study, the Investigator must conduct Exit procedures according to Table 1-1: Schedule of Study Procedures and Assessments, as possible.

Appears in 1 contract

Samples: Investigator Agreement

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