An Investigator is responsible for
ensuring that an investigation is conducted according to the
signed investigator statement, the investigational plan, and
applicable regulations; for protecting the rights, safety,
and welfare of subjects under the investigator’s care; and
for the control of drugs under investigation. An
investigator shall, in accordance with the Code of Federal
Regulations and ICH/GCP Guidelines, obtain the informed
consent of each human subject to whom the drug is
administered, except as provided in CFR50.23.
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Maintain IRB approval to conduct the clinical trial and
report to the IRB as required. The IRB must assume
continued responsibility for the study and review the
research on at least an annual basis.
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Maintain a file of all communications with the IRB on issues
related to the clinical trial.
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Complete, sign, and return to Kendle a Form FDA 1572
including a current CV for the Principal Investigator, Sub-Investigator(s),
and any study personnel involved, if listed.
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Conduct the study in strict adherence to the protocol.
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Supervise the use of the study drug as outlined in the
protocol. The study drug may be provided by medical doctors
or study staff working under the supervision of an
Investigator who is a medical doctor.
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Store the study drug in a secure and locked area with
limited access. The storage and custody of the study drug
are responsibilities of the Investigator.
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Maintain adequate records of the receipt and disposition of
all study drug (including dates, quantities and use by the
study subjects).
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Inform each subject of the risks and benefits of
participating in the study and obtain a properly signed,
dated and witnessed (if applicable) informed consent form
for each subject before he or she begins any study–related
procedures.
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Document all adverse events on the CRF; document all Serious
Adverse Events (SAEs) on the SAE Form and immediately notify
Kendle via phone and fax.
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Report all SAEs to the IRB.
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Maintain a master log of all subjects screened for the study
and establish a system to alert clinic staff of scheduled
follow-up visits; provide clinic staff with a system for
contacting study subjects who do not return for scheduled
follow-up.
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Document and maintain accurate CRFs for all subjects. As
required, sign forms ascertaining the accuracy of data
recorded. Storage and custody of all study related records
are the responsibility of the Investigator.
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Retain the copies of the CRFs, the original informed consent
forms and all study-related documentation of the study site
for at least 2 years after the last approval of a marketing
application in an ICH region and until there are no pending
or contemplated marketing applications in an ICH region or
at least 2 years have elapsed since the formal
discontinuation of clinical development of the
investigational product. It is the responsibility of the
sponsor to inform the investigator/institution as to when
these documents no longer need to be retained.
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Make available all study subjects’ records to staff and
representatives from monitoring or regulatory office.
Be thoroughly familiar with the properties of the
investigational agent as described in the Clinical
Investigator Brochure.
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Ensure that sufficient time is allotted to conduct and
complete the study; ensure adequate staff and facilities are
available for the duration of the study; and ensure that
other studies do not divert essential subjects or facilities
from the study at hand.
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Provide information to all staff members involved with the
study or with other elements of the subject’s management.
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Ensure that the confidentiality of all information about the
subjects and the information supplied by Kendle is respected
by all persons.
