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
Ensuring appropriate institutional and regulatory
approval (see below)
Study conduct, including responsibility for ensuring
appropriate medical safeguards, medical monitoring,
medical supervision and reporting of adverse
Monitoring of the study.
Analysis and interpretation of the results
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.
General communication of results (e.g. publication).
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
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
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
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:
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).
Inpatient hospitalization or prolongation
of existing hospitalization (i.e., hospitalization
was required to treat or diagnose the
AE; excludes hospitalization for unrelated
A persistent or significant disability or
incapacity (disability here means that
there is a substantial disruption of
a person's ability to conduct normal
A congenital anomaly/birth defect.
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).
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.
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):
It does not follow a reasonable temporal
sequence from the administration
of the test drug.
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.
It does not follow a known pattern of
response to the test drug.
It does not reappear or worsen when the
drug is re-administered.
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):
It follows a reasonable temporal sequence
from administration of the drug.
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.
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
It follows a known pattern of response
to the test drug.
Adverse Drug Experience and Other Reporting
Investigator-sponsor shall notify the relevant bodies
(IEC/IRB/health authority/ies, etc.) as applicable
according to local/regional legislation
Investigator/sponsor shall notify Teva within 24 hours,
by email or facsimile, upon learning
of the occurrence during the study of:
All Serious AE, regardless of causality,
as defined in section 1 under reporting
of serious adverse events or adverse
All Expedited AEs of interest as described
in the Investigator Sponsored Study Agreement.
Any exposure of a pregnant study participant
to the study drug within thirty (30)
days of exposure.
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).
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
The Sponsor-Investigator shall submit to Teva a Final
Study Report as contractually obligated, that
shall, at a minimum, include the following information:
A listing of Patient Accounting.
A listing of any incidences of Overdose.
A listing of Inadvertent Exposures.
Unexpected Therapeutic Effect.
A “safety summary” means a comprehensive summary
of all safety information that was collected
during the course of the study, including:
All AEs that are specified below
All Serious AE/ADR as defined
in Section 1 under reporting
of serious adverse events
or adverse drug reactions,
regardless of causality;
All Expedited AE/ADR of Interest
as described in the investigator-sponsored
Any exposure of a pregnant study
participant to the study
drug within thirty (30) days
A female partner of a male study
participant becoming pregnant
within thirty (30) days of
Any medical event which may reasonably
be believed to impair the
integrity, validity or ongoing
viability of the study
All non-serious adverse events.
All other relevant safety information
that was collected.
In order to expedite your proposal review, we request that all submissions are in English.