Study Discontinuation. This study may be terminated by Sydney Retina Clinic or Novartis Australia Ltd at any time. Reasons for terminating the study may include the following: The incidence or severity of adverse events in this or other studies indicates a potential health hazard to subjects Subject enrolment is unsatisfactory Data recording is inaccurate or incomplete
Study Discontinuation. The study may be discontinued at any time by the pharmaceutical supporters, local ministry of health, the IRB or EC, the OHRP, the NIAID, or other government agencies as part of their duties to ensure that research participants are protected. PUBLICATION OF RESEARCH FINDINGS Publication of the results of this trial will be governed by ACTG policies. Any presentation, abstract, or manuscript will be made available for review by the pharmaceutical supporters prior to submission. BIOHAZARD CONTAINMENT As the transmission of HIV and other blood-borne pathogens can occur through contact with contaminated needles, blood, and blood products, appropriate blood and secretion precautions will be employed by all personnel in the drawing of blood and shipping and handling of all specimens for this study, as currently recommended by the Centers for Disease Control and Prevention and the National Institutes of Health. All dangerous goods materials, including diagnostic specimens and infectious substances, must be transported according to the instructions detailed in the International Air Transport Association (IATA) Dangerous Goods Regulations.
Study Discontinuation. If the Sponsor, the Investigator, the medical monitor, the study monitor, institutional review board/independent ethics committee(s) (IRB/IEC), or appropriate regulatory officials discover conditions arising during the study that indicate the study should be halted or that the study center should be terminated, appropriate action may be taken after consultation among (at a minimum) the Sponsor, the Investigator, IRB/IEC and the medical monitor. Conditions that may warrant termination of the study or an individual site include, but are not limited to, the following: • The discovery of an unexpected, serious, or unacceptable risk to patients enrolled in the study • A decision by the Sponsor to suspend or discontinue testing, evaluation, or development of the product • Failure of the Investigator to enroll patients into the study at an acceptable rate • Failure of the Investigator to comply with pertinent regulations of IRB/IEC or appropriate regulatory authorities • Failure of the Investigator to comply with the protocol • Submission of knowingly false information from the research facility to the Sponsor, the study monitor, IRB/IEC or regulatory authority • Insufficient adherence to protocol requirements consistent with 21 CFR 312 or the European Clinical Trial Directive 2001/20/EC Study termination and follow-up will be performed in compliance with the conditions set forth in International Conference on Harmonisation (ICH) E6 on Good Clinical Practice (GCP) as well as 21 CFR 312.56b and the European Clinical Trial Directive 2001/20/EC which require a Sponsor to ensure an Investigator’s compliance with these requirements and to promptly secure a plan for compliance or discontinue shipments of the IP to the Investigator and end the Investigator’s participation in the study.
