Study Visits Sample Clauses
The 'Study Visits' clause defines the requirements and schedule for participants to attend specific appointments or sessions as part of a research study or clinical trial. It typically outlines the frequency, timing, and purpose of these visits, such as medical assessments, data collection, or treatment administration. By clearly specifying when and why study visits occur, this clause ensures that both participants and researchers understand their obligations, thereby supporting protocol compliance and the integrity of study data.
Study Visits. Upon signing of the informed consent, patients will enter a 1-4 week period of screening and prestudy training. Patients will be trained on self-administration of study drug and on recording of medication usage and local tolerance. After eligibility is assessed during the Screening period, a one week Pretreatment period is used to collect baseline data. Once enrolled, patients will return to their study center for safety and efficacy assessments at baseline (Day 1) and 1, 3, 6, 9, 12, and 18 months, and at any other time as warranted by safety, efficacy or compliance concerns. A final study visit is planned one month after the last dose of study drug. The study periods and number of clinic visits are summarized below:
Study Visits. The sending Party will pay the international return air fares of its visitors to the airport nearest to the first host institution in the programme, while the host Party will provide for the local costs of the visit (board, lodging and transport connected with the objects of the visit) in accordance with the Financial Annex to this agreement.
Study Visits. Usually for short periods of from one to three weeks, with the aim of visiting a number of laboratories in the host country for discussions and liaison, or for study visits.
Study Visits. At the End-of-Treatment Visit (Visit 9) for Study BA058-05-003, the possibility of participating in the Extension Study will be discussed with subjects randomized to Abaloparatide-SC/Placebo. This Extension Study will be comprised of 24 months of treatment with alendronate. In the month between Visit 9 and Visit 10 (between months 18 and 19 of Study BA058-05-003), the Investigator will consider the results of the assessments performed at Visit 9, including a local review of BMD, and determine if alendronate is appropriate for the subject, as part of this Extension Study. At the Follow-up (Visit 10 for Protocol BA058-05-003, Day 1 for Protocol BA058-05-005) subjects; who were randomized to Abaloparatide-SC/Placebo, who fulfill the inclusion/exclusion criteria (Section 4.1 and Section 4.2), and who have agreed to participate in the Extension Study; will sign the Informed Consent Form and be enrolled in the study. Subjects who have been determined by the Investigator to be candidates for alendronate therapy will receive open-label oral alendronate treatment at a total dose of 70 mg once per week for 24 months. Subjects will be instructed to take their first dose of alendronate for Study BA058-05-005 in the morning, within a week of their Day 1 visit. Following the initial six months of treatment in this study, subjects will enter the long-term observational phase of this study, during which subjects will continue to receive alendronate treatment for an additional 18 months. All subjects will have clinic visits for study related procedures at Day 1, Month 3, Month 6, Month 12, Month 18 and Month 24. For the purpose of this study one month is equal to 30 days.
Study Visits. At the End-of-Treatment Visit (Visit 9) for Study BA058-05-003, the possibility of participating in the Extension Study will be discussed with subjects randomized to BA058 80 µg/Placebo. This Extension Study will be comprised of standard-of-care osteoporosis management, including 24 months of treatment with alendronate. In the month between Visit 9 and Visit 10 (between months 18 and 19 of Study BA058-05-003), the Investigator will consider the results of the assessments performed at Visit 9, including a local review of BMD, and determine if alendronate is appropriate for the subject, as part of this Extension Study. At the Follow-up (Visit 10 for Protocol BA058-05-003, Day 1 for Protocol BA058-05-005) subjects; who were randomized to BA058 Injection 80 µg/Placebo, who fulfill the inclusion/exclusion criteria (Section 4.1 and Section 4.2), and who have agreed to participate in the Extension Study; will sign the Informed Consent Form and be enrolled in the study. Alendronate is the recommended osteoporosis treatment for this Extension Study. Subjects who have been determined by the Investigator to be candidates for alendronate therapy will receive open-label oral alendronate treatment at a total dose of 70 mg once per week for 24 months. Subjects will be instructed to take their first dose of alendronate for Study BA058-05-005 in the morning, on the day following their Day 1 visit. Following the initial six months of treatment in this study, subjects will enter the long-term observational phase of this study, during which subjects will continue to receive alendronate treatment for an additional 18 months. All subjects will have clinic visits for study related procedures at Day 1, Month 3, Month 6, Month 12, Month 18 and Month 24. For the purpose of this study one month is equal to 30 days. Exploratory statistical analyses will assess longer term safety, fracture incidence (including vertebral and non-vertebral fracture), and BMD change following treatment with alendronate for six months after the completion of a subject’s participation of 18 months in study BA058-05-003. The analyses performed at six months will be used as a follow-up to the 18 month fracture endpoint for Study BA058-05-003. At this time-point, subjects will be analyzed based on the randomization assignment in the BA058-05-003 study. Other analyses performed on the data in this study will be descriptive in nature.
Study Visits. The study comprises three visits: Visit 1 (baseline), Visit 2 (3rd month), and Visit 3 (6th month).
Study Visits. Visit # Visit Type Visit Day Visit Window
Study Visits. 1. With a view to planning and organizing common cultural project the Parties shall organize study visits for experts in the field of culture employed in national cultural institutions.
2. All details pertaining to organization of study visits shall be agreed upon by relevant institutions from each Party, through working contacts.
Study Visits. Screening/Baseline Visit (Study Day 1)
1. Obtain a signed and dated patient informed consent form/Authorization to disclose Health Information/assent and authorization to use and disclose medical information prior to performing any study-specific procedures;
2. Collect demographic information including date of birth, sex, race, and ethnicity;
3. Collect a medical history;
4. Collect prior and concomitant medication use;
5. Perform a urine pregnancy test;
6. Perform a physical exam, including ▇▇▇▇▇ ▇▇▇▇▇, weight and height;
7. Perform a pelvic examination including assessment of vaginal discharge, and collection of vaginal samples as follows:
a. Perform clinical assessment of trichomoniasis genital symptoms (e.g., itching, discharge, odor).
b. Collect vaginal sample for T. vaginalis testing via:
i. OSOM® Trichomonas Rapid test (If needed, see below).
ii. BioMed InPouch™ TV test.
c. Vaginal saline wet mount for assessment of clue cells and trichomonads;
Study Visits. Joint seminars on issues of mutual interest.