Study Enrollment Sample Clauses
Study Enrollment. To participate in the Study, the School must complete a study enrollment form online, which will be accessible from the Study websites described in Section 3. The completed enrollment form serves as an application by the School to participate in the Study. SoundRocket and the PI must approve the school seeking to enroll in the Study before the School may participate in the Study. SoundRocket and the PI reserve the right to deny enrollment to any applicant or to close enrollment early.
Study Enrollment. Section 5.1: Inclusion Criteria Individuals must meet the following criteria:
Study Enrollment. Procedures This protocol and the informed consent will be reviewed and approved by the Massachusetts General Hospital/Partners Protection of Human Subjects Committee (MGH IRB) prior to implementation of the study. When an individual has been identified as a potential candidate for the study, study staff will explain the details of the study and obtain written informed consent.
5. Study Treatment No treatment will be given to any subject enrolled in this study. If a subject becomes eligible for antiretroviral therapy, treatment can be initiated at the discretion of the subject and his/her health care provider. Subjects who initiate antiretroviral therapy may continue on the study.
6. Clinical Evaluations 6.
1. Schedule of events Three study visits are scheduled at 3 month intervals over the course of 6 months. There will be a window period of +/- 7 days around the specific study date in which the subject will be allowed to participate in thc scheduled encounter. The date of all study visits will be determined at study entry. ------------------------------------------------------------------------------ Evaluation Entry 3 month 6 month ------------------------------------------------------------------------------ Medical History X ------------------------------------------------------------------------------ Physical Exam/medications X ------------------------------------------------------------------------------ HIV ELISA and Western Blot X ------------------------------------------------------------------------------ CMV, EBV, VZV serology X ------------------------------------------------------------------------------ HLA typing X ------------------------------------------------------------------------------ HIV RNA viral load X X X ------------------------------------------------------------------------------ CD4+/CD8+ subsets X X X ------------------------------------------------------------------------------ Clinical Trial Agreement ------------------------------------------------------------------------------ Immunology studies X X X ------------------------------------------------------------------------------ Virology studies X X X ------------------------------------------------------------------------------