STUDY ASSESSMENTS. Subjects randomized to BA058 Injection 80 µg/Placebo in Study BA058-05-003 will receive alendronate at a dose of 70 mg once per week for a total of 24 months. The assessments performed at each study visit are displayed in the Schedule of Visits and Procedures in Appendix 14.1. Appendix 14.2 provides a more detailed schedule of the study procedures by study visit with a suggested order of procedure conduct. Exact procedures for centrifuging, storage, and shipping of laboratory samples will be detailed in a separate document. The actual time of each blood collection will be recorded on the appropriate source documents and in the eCRF. Study-specific assessments are to be conducted only after the subject has provided written informed consent to participate in this study. The study assessments are described in more detail in Section 7.1 below.
Appears in 2 contracts
Samples: Clinical Trial Services Agreement (Radius Health, Inc.), Clinical Study Protocol (Radius Health, Inc.)
STUDY ASSESSMENTS. Subjects randomized to BA058 Injection 80 µgAbaloparatide-SC/Placebo in Study BA058-05-003 will receive alendronate at a dose of 70 mg once per week for a total of 24 months. The assessments performed at each study visit are displayed in the Schedule of Visits and Procedures in Appendix 14.1. Appendix 14.2 provides a more detailed schedule of the study procedures by study visit with a suggested order of procedure conduct. Exact procedures for centrifuging, storage, and shipping of laboratory samples will be detailed in a separate document. The actual time of each blood collection will be recorded on the appropriate source documents and in the eCRF. Radius Health, Inc. Confidential Study-specific assessments are to be conducted only after the subject has provided written informed consent to participate in this study. The study assessments are described in more detail in Section 7.1 below.
Appears in 1 contract
STUDY ASSESSMENTS. Subjects randomized to BA058 Injection 80 µgAbaloparatide-SC/Placebo in Study BA058-05-003 will receive alendronate at a dose of 70 mg once per week for a total of 24 months. The assessments performed at each study visit are displayed in the Schedule of Visits and Procedures in Appendix 14.1. Appendix 14.2 provides a more detailed schedule of the study procedures by study visit with a suggested order of procedure conduct. Exact procedures for centrifuging, storage, and shipping of laboratory samples will be detailed in a separate document. The actual time of each blood collection will be recorded on the appropriate source documents and in the eCRF. Study-specific assessments are to be conducted only after the subject has provided written informed consent to participate in this study. The study assessments are described in more detail in Section 7.1 below.
Appears in 1 contract