STUDY ASSESSMENTS Clause Samples
STUDY ASSESSMENTS. Subjects randomized to Abaloparatide-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.
STUDY ASSESSMENTS. Physical examinations, ▇▇▇▇▇ ▇▇▇▇▇, ECGs, clinical labs (hematology, chemistry, urinalysis), serum total and ionized calcium, phosphorus, thyroid hormones, adverse events, and local tolerability. · Pharmacokinetics: serial PK samples taken on a subgroup of patients. · Pharmacodynamics (i.e., biochemical markers of bone metabolism and resorption): procollagen 1 carboxy terminal propeptide (PICP) bone specific alkaline phosphatase (BSAP), osteocalcin, cathepsin K, urine N telopeptide (NTX) urinary free deoxypyridinoline, nephrogenic cAMP level, urinary calcium excretion, creatinine clearance, vitamin D, intact PTH (1-84). · Efficacy: measure a reduction in the proportion of patients with new vertebral fractures following treatment. Other assessments changes in BMD (lumbar spine, hip, forearm). · Anti-BA058 antibody.
STUDY ASSESSMENTS. Physical examinations, ▇▇▇▇▇ ▇▇▇▇▇, ECGs, clinical labs (hematology, chemistry, urinalysis), serum total and ionized calcium, phosphorus, thyroid hormones, adverse events, and local tolerability. · Pharmacokinetics: serial PK samples taken on a subgroup of patients. · Pharmacodynamics (i.e., biochemical markers of bone metabolism and resorption): [*]. · Efficacy: measure a reduction in the proportion of patients with new vertebral fractures following treatment. Other assessments changes in BMD (lumbar spine, hip, forearm). · Anti-BA058 antibody.
STUDY ASSESSMENTS. 11.4.1 Data control measures In order to assure adequate control and provide study data that are consistent and of the highest quality, the following measures are employed:
1. Each clinical procedure (i.e. physical examination) for a particular patient is conducted by the same person if possible throughout the patient's study participation.
2. Each clinical laboratory procedure is conducted by the same laboratory throughout the study.
3. Data generated automatically is reviewed by the appropriate specialist, i.e. computer generated EKG interpretation is reviewed and signed off by a cardiologist.
STUDY ASSESSMENTS. For study assessments not included in sections below (e.g., vital signs, performance status, ECHO, bone monitoring), refer to Table 11 for details.
STUDY ASSESSMENTS. At each visit, the following examinations will be performed in both eyes in the following order: - OSDI questionnaire - ▇▇▇▇▇ - ▇▇▇▇▇▇▇▇ test - TBUT - Corneal staining evaluation (Oxford scale) All above mentioned examinations and all evaluations required by the study are part of the normal clinical practice.
STUDY ASSESSMENTS. The research component of the Community Pediatric Acceptability Study (CPAS) study included the following data collection instruments for parents (Appendix II):
STUDY ASSESSMENTS. All clinical laboratory assessments will be conducted locally at the clinical site facilities.
STUDY ASSESSMENTS. All images taken from the study will be saved and shared to the Sponsor via a data-protected platform.
10.1 Wrinkle Assessment Scale Clinical grading of NLF will be performed at baseline for screening purpose. The grading will be based on a 6-point Wrinkle Assessment Scale6 according to the numerical definitions (describe in Figure 1 below).
STUDY ASSESSMENTS. All images taken from the study will be saved and shared to the Sponsor via a data-protected platform.
9.1 Clinical Photography (VISIA) Digital images of the subject’s face will be taken at baseline (pre-injection), week 4 (pre-touch up), and week 24. Clinic staff needs to ensure subjects to have a clean face with no makeup and to remove any jewelry from the area to be photographed. Subjects will be provided with a headband to keep hair away from the face. Subjects will be instructed to adopt neutral expression (3/4 left, front, 3/4 right), closed-mouth smile (3/4 left, front, 3/4 right), and open-mouth maximum smiling expression (3/4 left, front, 3/4 right) for each photograph. A total of 9 full-face digital images will be taken of each subject’s face using the VISIA CR photo-station (▇▇▇▇▇▇▇▇ Imaging Systems, Fairfield, New Jersey) with a Canon digital SLR camera (manufacture name, location) under the standard lighting condition.
9.2 Clinical Photography (Vectra 3D) Three (3) dimensional images of the subject’s face will be taken at baseline (pre-injection), week 4 (pre-touch up), and week 24. Clinic staff needs to ensure subjects to have a clean face with no makeup and to remove any jewelry from the area to be photographed. Subjects will be provided with a headband to keep hair away from the face. Subjects will be instructed to adopt neutral, nonsmiling expression with their eyes gently closed, and in a relaxed positioned for each scan. Photography will be performed using the Vectra H2 Imaging system (▇▇▇▇▇▇▇▇ Scientific, Inc., Canfield, NJ). The Vectra H2 utilizes raised flash to provide raked lighting to better capture and view skin topography and contours. Its software allows 3D viewing of the images and quantitative assessment of 3D parameters of the face. Change in volume on each cheek will be analyzed by the Vectra H2 software (left and right cheek separately). The 3D images will be uploaded to a secure database that can be accessed by the Sponsor remotely.