Screening and Randomization Period Sample Clauses

Screening and Randomization Period. Screening visits will be conducted within 30 days prior to study Day 1. During the Screening Phase, each potential subject will provide informed consent prior to starting any study-specific procedures. Due to the logistics and time needed for the retest of the , for those subjects that an investigator requests a retest of these samples, as described in Section 8.2, the screening period may be extended an additional 30 days for a screening period of up to 60 days total in order to allow subjects who are waiting the retest results the opportunity to meet all study entry criteria. Once a subject is considered eligible, prior to Day 1, a concomitant medication form will be completed by the site and sent to the sponsor for approval. See Section 7.4.1 for prohibited medications. Subjects who are eligible will be randomized as described in Section 7.3.3 and as shown in Table 2. A F2/F3 12 CRV431 75 mg Observation/Follow up B 6 Placeboa C 12 CRV431 225 mg D 6 Placebob *Randomized assignment; 2:1 – CRV431:Placebo a Matching Placebo for Cohort A - 75 mg dose. b Matching Placebo for Cohort C - 225 mg dose. Potential study subjects who meet all inclusion and exclusion criteria for this study, but who, for personal or administrative reasons, are not included in the study may be re-screened if more than 30 days has passed since their previous screening. For these subjects, use of results previously obtained for this study will be extended for an additional 30 days up to a total of 60 days. There are no restrictions on the number of re-screens permitted. Potential study subjects who previously screened and failed only but met all other inclusion criteria and met none of the exclusion criteria for this study may be re-screened.
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Related to Screening and Randomization Period

  • Screening The Health Plan must work with contracted providers to conduct interperiodic EPSDT screens on RIte Care and all ACA Adult Expansion Population members under age 21 (i.e. 19 and 20-year old under this Agreement) to identify health and developmental problems in conformance with ATTACHMENT ED to this Agreement. Additional screens should be provided as Medically Necessary. At a minimum, these screens must include: • A comprehensive health and developmental history, including health education, nutrition assessment, immunization history, and developmental assessment • Immunizations according to the Rhode Island EPSDT Periodicity Schedule • An unclothed physical examination • Laboratory tests including lead, TB, and newborn screenings as medically indicated • Vision testing • Hearing testing • Dental screening oral examination by PCP as part of a comprehensive examination required before age one (1) • All other medically indicated screening services • And provide EOHHS with a list of established CPT/HCPC codes used to identify all billable services included in the EPSDT schedule.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Evaluation, Testing, and Monitoring 1. The System Agency may review, test, evaluate and monitor Grantee’s Products and services, as well as associated documentation and technical support for compliance with the Accessibility Standards. Review, testing, evaluation and monitoring may be conducted before and after the award of a contract. Testing and monitoring may include user acceptance testing. Neither the review, testing (including acceptance testing), evaluation or monitoring of any Product or service, nor the absence of review, testing, evaluation or monitoring, will result in a waiver of the State’s right to contest the Grantee’s assertion of compliance with the Accessibility Standards. 2. Grantee agrees to cooperate fully and provide the System Agency and its representatives timely access to Products, records, and other items and information needed to conduct such review, evaluation, testing, and monitoring.

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • TREE TRIMMING 16.1 Customer Agreements to provide Customer is responsible for tree trimming: Subject to any written agreement between a Customer and the Distributor, and any statutory provision, the Trader must ensure that each of its Customer Agreements provides that the Customer must comply with its obligations under the Electricity (Hazards from Trees) Regulations 2003 in respect of any trees that the Customer has an interest in that are near any line that forms part of the Network.