Immunogenicity Measure/Variable and Endpoint Sample Clauses

Immunogenicity Measure/Variable and Endpoint. The immunogenicity variable/endpoint for this study is as follows: • any presence of anti–IPP-201101 Ab at visits at weeks 2, 4, 12, 20, 28, 36, 44, and 52 (or final assessment) Any patient with a positive test result for anti–IPP-201101 Ab at the final study visit will be followed with additional immunogenicity testing at 8-week intervals until the level returns to baseline value or the levels are judged by the investigator to be chronic, or the patient is lost to follow-up.
AutoNDA by SimpleDocs

Related to Immunogenicity Measure/Variable and Endpoint

  • Safety Measures Awarded vendor shall take all reasonable precautions for the safety of employees on the worksite, and shall erect and properly maintain all necessary safeguards for protection of workers and the public. Awarded vendor shall post warning signs against all hazards created by the operation and work in progress. Proper precautions shall be taken pursuant to state law and standard practices to protect workers, general public and existing structures from injury or damage.

  • Study Population ‌ Infants who underwent creation of an enterostomy receiving postoperative care and awaiting enterostomy closure: to be assessed for eligibility: n = 201 to be assigned to the study: n = 106 to be analysed: n = 106 Duration of intervention per patient of the intervention group: 6 weeks between enterostomy creation and enterostomy closure Follow-up per patient: 3 months, 6 months and 12 months post enterostomy closure, following enterostomy closure (12-month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 month of overall study duration).

  • Target Population TREATMENT FOR ADULT (TRA) Target Population

  • Population The Population shall be defined as all Paid Claims during the 12-month period covered by the Claims Review.

  • Protective Measures We have implemented and will maintain appropriate technical and organisational measures in relation to the Services taking into account the state of the art, the costs of implementation, and the nature, scope, context and purposes of Processing, as well as the likelihood and severity of risk to the rights and freedoms of data subjects. This includes measures relating to the physical security of Our facilities used to deliver them, measures to control access rights to Our assets and relevant networks, and processes for testing these measures. In accordance with Our obligations under applicable law, We may undertake digital forensic investigations in relation to the use of the Services and Subscriptions. You are responsible for using, and ensuring that your Users use, the controls and advice provided by the Services correctly and consistently.

  • Security Measures Lessee hereby acknowledges that the rental payable to Lessor hereunder does not include the cost of guard service or other security measures, and that Lessor shall have no obligation whatsoever to provide same. Lessee assumes all responsibility for the protection of the Premises, Lessee, its agents and invitees and their property from the acts of third parties.

  • Interim Measures Notwithstanding any requirements for alternative dispute resolution procedures as set forth in Articles 18(B), any party to the Dispute may apply to a court for interim measures (i) prior to the constitution of the arbitral tribunal (and thereafter as necessary to enforce the arbitral tribunal’s rulings); or (ii) in the absence of the jurisdiction of the arbitral tribunal to rule on interim measures in a given jurisdiction. The Parties agree that seeking and obtaining such interim measures shall not waive the right to arbitration. The arbitrators (or in an emergency the presiding arbitrator acting alone in the event one or more of the other arbitrators is unable to be involved in a timely fashion) may grant interim measures including injunctions, attachments and conservation orders in appropriate circumstances, which measures may be immediately enforced by court order. Hearings on requests for interim measures may be held in person, by telephone, by video conference or by other means that permit the parties to the Dispute to present evidence and arguments.

  • Multiple Measures of Student Learning Measures must include a combination of classroom, school and district assessments, student growth percentiles on state assessments, if state assessments are available, and student MEPA gain scores. This definition may be revised as required by regulations or agreement of the parties upon issuance of ESE guidance expected by July 2012.

  • Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation. 1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required. 1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting. 1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery. 1.5 Participates in xxxx rounds/case conferences as appropriate. 1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate. 1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care. 1.8 Completes clinical documentation and undertakes other administrative/management tasks as required. 1.9 Participates in departmental and other meetings as required to meet organisational and service objectives. 1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice. 1.11 Monitors and maintains availability of consumable stock. 1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016. 1.13 Promotes and participates in team building and decision making. 1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!