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 condition or concomitant medication • Assess and record VAs • Perform biomicroscopy (assessments with or without lenses, as possible) In addition, all procedures for Visit 5 (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

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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 condition or concomitant medication Assess and record VAs Perform biomicroscopy (assessments with or without lenses, as possible) possible)‌‌ In addition, all procedures for Visit 5 3 (Follow-upup 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: clinicaltrials.gov

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 condition or concomitant medication • Assess and record VAs • Perform biomicroscopy (assessments with or without lenses, as possible) possible)‌‌ In addition, all procedures for Visit 5 3 (Follow-upup 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: classic.clinicaltrials.gov

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 condition health or concomitant medication • Assess and record VAs • Perform biomicroscopy (assessments with or without lenses, as possible) In addition, all procedures refer to Table 1-1 Unscheduled Visit for Visit 5 (Follow-up/Exit) should be completed (as possible)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 condition or concomitant medication • Assess and record VAs • Perform biomicroscopy (assessments with or without lenses, as possible) possible)‌‌ In addition, all procedures for Visit 5 3 (4-Week 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: classic.clinicaltrials.gov

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