Principal Investigator's Responsibilities

  • The PI is responsible for ensuring that the research is conducted according to all regulatory guidelines and IRBco policies and procedures.
  • The PI must obtain approval from the IRB before initiating any research activities.
  • The PI proposing the drug/device research will be required to provide a plan – to be evaluated by the IRB - that includes storage, security, and dispensing of the drug/biologics/device.
  • The PI is responsible for the investigational drug/device accountability that includes storage, security, dispensing, administration, return, disposition, and records of accountability.
  • All investigational drugs will be stored under lock and key and dispensed by the Investigator or assigned Pharmacy Service.
  • All devices received for a study must be stored in a locked environment under secure control with limited access. The area must be within an area of PI’s control. Proper instructions on the use of the device must be provided to the subjects. A log must be kept regarding the receipt, use, and/or dispensing of the device and the disposition of remaining devices at the conclusion of the investigation.
  • The PI shall report all unanticipated problems involving risk to subjects or others to the IRB according to the procedures outlined in Section 8.
  • For research involving investigational new drugs:
    • The PI is required to inform Pharmacy Service that IRB have approved the protocol through submission of the IRB approval letters.
    • The PI must inform the IRB and Pharmacy Service when a study involving investigational drugs has been terminated by the sponsor.
    • The PI will report to the sponsor any adverse effect that may reasonably be regarded as caused by, or probably caused by, the drug (21 CFR 312 (b)) according to the procedures in the protocol.
    • The PI will maintain the following:
      • Current curriculum vitae (CV)
      • Protocol
      • Records of receipt and disposition of drugs
      • List of any key personnel & sub-investigators with their curriculum vitae
      • Certification that all physicians, dentists, and/or nurses responsible in the study have appropriate valid licenses for the duration of the investigation, and
      • Case histories with particular documentation on evidence of drug effects. Emphasis is on toxicity and possible untoward happenings. All unexpected adverseare reportable; even if the investigator considers that the event is not related to the drug. All unexpected adverse effects shall be reported immediately to Pharmacy Service and the IRB in the manner defined by the protocol.
      • IRB letters of approval.
      • Other documents as outlined in the Human Subject Protection Program Standard Operating Procedures.
  • For research involving investigational devices:
    If a device is considered NSR by the PI or sponsor, but after review the IRB determines the device to have significant risk, upon receipt of written notice the PI is responsible for notifying the sponsor of the IRB’s determination. The PI must provide the IRB with confirmation of this action. If the PI is storing the devices, he/she must maintain a log indicating the identification/serial number of the device, name of subject, date dispensed, by whom it was dispensed, and amount remaining.

    The PI will maintain the following:
    • Current curriculum vitae (CV)
    • Protocol of the study
    • Records of animal study reports
    • Records of receipt and disposition of devices
    • List of any co‑investigators with their curriculum vitae
    • Certification that all physicians, dentists, and/or nurses responsible in the study have appropriate valid licenses for the duration of the investigation,
    • Case histories with particular documentation on evidence of effects. Emphasis is on safety and possible untoward happenings. All Unanticipated adverse device effects are reportable.
    • IRB letters of approval and the EOC Committee approval letter if applicable.
    • Device training.
    • Other documents as outlined in the Human Subject Protection Program Standard Operating Procedures.

Following completion of the study the termination procedure for investigational drugs must be applied if pharmacy control, or if the devices are kept by the investigator the log must be completed regarding the receipt, use and/or dispensing of the device and the disposition of remaining devices at the conclusion of the investigation.

If, after use, the PI keeps the devices, he/she must maintain a log regarding the receipt, use and/or re-dispensing of the device and the disposition of remaining devices at the conclusion of the investigation. The PI will submit to the sponsor and to the IRB a report of any unanticipated adverse device effect occurring during an investigation as soon as possible, but in no event later than 10 working days after the investigator first learns of the effect.

When a PI files an IND or IDE, the PI is considered the sponsor and as such is accountable for all of the FDA regulatory responsibilities and reporting obligations of both the PI and the sponsor, as described in the FDA regulations. In this situation where Investigator is also sponsor, Investigator will be required to comply with the regulatory responsibilities of a sponsor and IRBco will request Investigator to submit study monitoring plan and data safety monitoring plan (if applicable).
 
 

Awards

IRBco is awarded Full Accreditation by the Association for the Accreditation of Human Research Protection Programs Inc. (AAHRPP). Accreditation validates our comprehensive program which integrates ethical reviews, state-of-the-art technology and staff development to create an environment of responsible and ethical human subject protection. We provide our services at levels beyond client expectations and that exceed federal requirements for safeguarding participants. We believe that accreditation leads to an increased level of professional accountability.

 
 
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