PRINCIPLES OF CLINICAL RESEARCH - Editor : Dr. Monali Desai - General responsibilities of Investigators

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.

The Investigator shall:

  • 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.

  • Maintain a file of all communications with the IRB on issues related to the clinical trial.

  • 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.

  • Conduct the study in strict adherence to the protocol.

  • 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.

  • 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.

  • Maintain adequate records of the receipt and disposition of all study drug (including dates, quantities and use by the study subjects).

  • 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.

  • 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.

  • Report all SAEs to the IRB.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Provide information to all staff members involved with the study or with other elements of the subject’s management.

  • Ensure that the confidentiality of all information about the subjects and the information supplied by Kendle is respected by all persons.



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