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BEFORE ACCESSING THIS SITE, PLEASE READ THE FOLLOWING TERMS AND CONDITIONS CAREFULLY AS THEY GOVERN YOUR USE OF THIS SITE. IF YOU DO NOT AGREE WITH THESE TERMS AND CONDITIONS, YOU ARE NOT GRANTED PERMISSION BY TEVA, INC. TO ACCESS OR OTHERWISE USE THIS SITE.

iss.tevapharm.com User Agreement

Welcome to the iss.tevapharm.com web site (also referred to as the "Site") made available by Teva Pharmaceutical Industries Ltd. ("Teva"). This Agreement contains the terms, covenants, conditions, and provisions (the "Terms and Conditions") upon which you ("You") may access and use this Site.

Terms and Conditions

As both the sponsor and investigator of this trial you are responsible for all sponsor responsibilities as detailed in the Clinical Trial Directive 2001/20/EC (for EU), Code of Federal Regulation Title 21 (US), and ICH Guidelines (E6, E2A, E8) including, but not limited to:

  1. Trial design
  2. Ensuring appropriate institutional and regulatory approval (see below)
  3. Study conduct, including responsibility for ensuring appropriate medical safeguards, medical monitoring, medical supervision and reporting of adverse events.
  4. Monitoring of the study.
  5. Analysis and interpretation of the results
  6. Registering the trial on clinicaltrials.gov, EU CT Register, or other National registries or public websites, as appropriate and posting study results on same within one year of study completion.
  7. General communication of results (e.g. publication).
  8. For studies conducted in the EU, follow the European Clinical Trials Directive requirements, including obtaining a EudraCT number, filing a Clinical Trial Application (CTA) and communicating with Competent Authority(ies) and Ethics Committee(s), as required by EU and local laws.
Institutional and Regulatory Approval
  1. The study should comply with all requirements for obtaining institutional review board (IRB)/Ethics Committee (EC) approval(s) and informed consent of study subjects, as set forth in applicable International Conference for Harmonization (ICH) Guidelines and as required by local laws (e.g. Code of Federal Regulations (CFR), Title 21, EU Clinical Trials Directive, local and national laws).
  2. The study must meet the conditions and requirements set forth in applicable regional and national laws and regulations. For studies conducted in the US, the investigator-sponsor is required to obtain an IND, or otherwise obtain an exemption of the study from FDA under title 21, CFR 312.2(b) or equivalent regulatory authorization. For studies conducted in the EU, the investigator-sponsor is required to follow applicable ICH guidelines and EU Clinical Trials Directive.
Reporting of Serious Adverse Events or Adverse Drug Reactions
  1. In keeping with Good Clinical Practice ("GCP") principles, Teva requests that the sponsor-investigator report all "Serious Adverse Events or Adverse Drug Reactions", which means any AE occurring at any dose that results in any of the following outcomes:
    1. Death.
    2. A life-threatening AE (i.e., the patient/subject was, in the view of the initial reporter/investigator, at immediate risk of death from the AE as it occurred. It does not refer to an AE that hypothetically might have caused death if more severe).
    3. Inpatient hospitalization or prolongation of existing hospitalization (i.e., hospitalization was required to treat or diagnose the AE; excludes hospitalization for unrelated reasons).
    4. A persistent or significant disability or incapacity (disability here means that there is a substantial disruption of a person's ability to conduct normal life functions).
    5. A congenital anomaly/birth defect.
    6. An important medical event (i.e., AEs that might not be immediately life-threatening, or result in death or hospitalization might be considered serious when, based upon appropriate medical and scientific judgment, they might jeopardize the patient/subject or might require medical or surgical intervention to prevent one of the other serious outcomes listed above).
    7. Any Suspected transmission via a medicinal product of an infectious agent.

Sponsor-Investigator shall use his/her judgment to determine the relationship between the Serious Adverse Drug Experience and the Study Drug.

TERM DEFINITION CLARIFICATION
No Reasonable Possibility This category applies to those adverse events which, after careful consideration, are clearly due to extraneous causes (disease, environment, etc.) or to those adverse events, which after careful medical consideration at the time they are evaluated, are judged to be unrelated to the test drug. An adverse experience may be considered No Reasonable Possibility if it is clearly due to extraneous causes or when (must have two):
  1. It does not follow a reasonable temporal sequence from the administration of the test drug.
  2. It could readily have been produced by the subject’s clinical state, environmental or toxic factors, or other modes of therapy administered to the subject.
  3. It does not follow a known pattern of response to the test drug.
  4. It does not reappear or worsen when the drug is re-administered.
Reasonable Possibility This category applies to those adverse events for which, after careful medical consideration at the time they are evaluated, a connection with the test drug administration cannot be ruled out with certainty or felt with a high degree of certainty to be related to the test drug. An adverse experience may be considered Reasonable Possibility related if or when (at least two of the following):
  1. It follows a reasonable temporal sequence from administration of the drug.
  2. It could not be reasonably explained by the known characteristics of the subject’s clinical state, environmental or toxic factors or other modes of therapy administered to the subject.
  3. It disappears or decreases on cessation or reduction in dose. There are important exceptions when an adverse event does not disappear upon discontinuation of the drug, yet drug-relatedness clearly exists.
  4. It follows a known pattern of response to the test drug.


Adverse Drug Experience and Other Reporting
  1. Investigator-sponsor shall notify the relevant bodies (IEC/IRB/health authority/ies, etc.) as applicable according to local/regional legislation
  2. Investigator/sponsor shall notify Teva within 24 hours, by email or facsimile, upon learning of the occurrence during the study of:
    1. All Serious AE, regardless of causality, as defined in section 1 under reporting of serious adverse events or adverse drug reactions.
    2. All Expedited AEs of interest as described in the Investigator Sponsored Study Agreement.
    3. Any exposure of a pregnant study participant to the study drug within thirty (30) days of exposure.
    4. Any exposure of a female partner of a male study participant becoming pregnant within thirty (30) days of exposure (only if applicable by the study protocol).
    5. Any medical event which may reasonably be believed to impair the integrity, validity or ongoing viability of the Study.

    All such occurrences listed above shall be reported to Teva using the SAE Transmittal Form provided by Teva. The SAE form will be completed by the site and sent preferably typed in Microsoft Word or Adobe PDF format to the contact person in Teva.

  3. The Sponsor-Investigator shall submit to Teva a Final Study Report as contractually obligated, that shall, at a minimum, include the following information:
    1. A listing of Patient Accounting.
    2. A listing of any incidences of Overdose.
    3. A listing of Inadvertent Exposures.
    4. Unexpected Therapeutic Effect.
    5. Drug Disposition.
    6. Efficacy Summary.
    7. Safety Summary.

    A “safety summary” means a comprehensive summary of all safety information that was collected during the course of the study, including:

    1. All AEs that are specified below
      1. All Serious AE/ADR as defined in Section 1 under reporting of serious adverse events or adverse drug reactions, regardless of causality;
      2. All Expedited AE/ADR of Interest as described in the investigator-sponsored study agreement;
      3. Any exposure of a pregnant study participant to the study drug within thirty (30) days of exposure;
      4. A female partner of a male study participant becoming pregnant within thirty (30) days of exposure;
      5. Any medical event which may reasonably be believed to impair the integrity, validity or ongoing viability of the study
    2. All non-serious adverse events.
    3. All other relevant safety information that was collected.


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