Visits and Examinations. 5.1.1 Visit 1 (Day 1) – Baseline/Dispense Lens 1 1 Explain the purpose and nature of the study, and have the subject read, sign, and date the IRB-approved informed consent document. Additionally, have the individual obtaining consent from the subject and a witness, if applicable, sign and date the informed consent document. Provide a photocopy of the signed document to the subject and place the original signed document in the subject’s chart. After signing the ICF, a subject will be assigned a subject number by the EDC system. A signed informed consent document defines the point of enrollment.
Appears in 1 contract
Samples: clinicaltrials.gov
Visits and Examinations. 5.1.1 5.1.2 Visit 1 (Day 10) – Screening/Baseline/Dispense Lens 1 1 Explain the purpose and nature of the study, and have the subject read, sign, and date the IRB-approved informed consent document. Additionally, have the individual obtaining consent from the subject and a witness, if applicable, sign and date the informed consent document. Provide a photocopy of the signed document to the subject and place the original signed document in the subject’s chart. After signing the ICF, a subject will be assigned a subject number by the EDC system. A signed informed consent document defines the point of enrollment.
Appears in 1 contract
Samples: Investigator Agreement
Visits and Examinations. 5.1.1 Visit 1 (Day 1) – Baseline/Screen / Baseline / Lens 1: Dispense Lens 1 1 Explain the purpose and nature of the study, and have the subject read, sign, and date the IRB-approved informed consent document. Additionally, have the individual obtaining consent from the subject and a witness, if applicable, sign and date the informed consent document. Provide a photocopy of the signed document to the subject and place the original signed document in the subject’s chart. After signing the ICF, a subject will be assigned a subject number by the EDC system. A signed informed consent document defines the point of enrollment.
Appears in 1 contract
Samples: Investigator Agreement
Visits and Examinations. 5.1.1 Visit 1 (Day 1) – Baseline/Fitting/Dispense Lens 1 1 Explain the purpose and nature of the study, and have the subject read, sign, and date the IRB-approved informed consent document. Additionally, have the individual obtaining consent from the subject and a witness, if applicable, sign and date the informed consent document. Provide a photocopy of the signed document to the subject and place the original signed document in the subject’s chart. After signing the ICF, a subject will be assigned a subject number by the EDC system. A signed informed consent document defines the point of enrollment.
Appears in 1 contract
Samples: classic.clinicaltrials.gov