Investigator Responsibilities (Compliance)


POLICY

The Principal Investigator is responsible for the proper conduct of research. It is the Investigator’s responsibility to comply with IRB policies and applicable regulatory requirements. 

Key Terms:

Principal Investigator (PI): A person responsible for conduct of research. If the research is conducted by a team of individuals, the leader of the team is called Principal Investigator.

Qualifications and Agreement: All study investigators must be qualified by education, training and experience to assume responsibility for the proper conduct of a research study. Investigators should be thoroughly familiar with the study protocol. When conducting clinical trials, investigators should be thoroughly familiar with the investigational product as described in the Investigator’s Brochure, in the product information and other sources. The PI is responsible for maintaining a list of appropriately qualified persons to whom the PI has delegated significant research related responsibilities.

Adequate Resources: The PI should have sufficient time and adequate qualified staff to properly conduct and complete the research. The PI is responsible for ensuring that all persons assisting with the research are adequately informed about the protocol, investigational product(s) and their research related duties.

Care of Subjects: A qualified physician (or dentist, when appropriate) who is an investigator or a co-investigator for the research study should be responsible for all research related medical (or dental) decisions. The PI is responsible for ensuring that adequate medical care is provided to a subject for any adverse events, including clinically significant laboratory values, related to the research.

Conduct of Research: The PI should conduct research in compliance with all applicable regulations and the approved protocol. The PI bears direct responsibility for conduct of the research study. The PI should employ sound study design in accordance with standards of the discipline. The study design should minimize harm and maximize benefits. In studies involving greater than minimal risk to participants, the PI must submit a data safety monitoring plan for review and approval by the IRB and comply with the plan. The PI or research staff must recruit participants in a fair and equitable manner, weighing potential benefits of the research to the participants against their vulnerability and risks to them.   

The PI must ensure that informed consent is obtained from subjects prior to their enrollment into the research, unless waived by the IRB. The PI must use the consent document approved by the IRB. PI must maintain all relevant documents and recognize that the IRB and applicable regulatory authorities may inspect these records. The PI must ensure accuracy and completeness of data in case report forms and all reports.

Additional Investigator Responsibilities Under IND/IDE: An investigator administering an investigational test article (drug, device, or biologic) is responsible for the research to be conducted in accordance with the plan of investigation as described in the FDA-approved IND/IDE, the signed investigator statement, and the IRB-approved investigational plan.

The investigator may not dispense an investigational drug to any person not authorized under the protocol to receive it. The drug, device, or biologic may only be used in subjects under the investigator’s personal supervision or under the supervision of physicians who are directly responsible to the investigator. Additionally, the investigator is required to maintain adequate records of the disposition of the test article, including dates, quantity, and use by subjects.

If the investigational drug is subject to the Controlled Substances Act, the investigator must take adequate precautions, including storage of the investigational drug in a securely locked, substantially constructed cabinet, or other securely locked enclosure, access to which is limited, to prevent theft or diversion of the substance into illegal channels of distribution.

Communication with IRB: The Principal Investigator must obtain IRB approval before initiating a research project involving human subjects when the research is conducted by or under the direction of any employee of UTHealth or the research is conducted using the facilities of any UTHealth institution.

  •  Problem Reporting - The Investigator must report all problems that occur during the conduct of a research project to the IRB in accordance with the timelines set by IRB as described in the policy on Problem Reporting.
  • Compliance with Protocol - The Investigator must not implement any deviation from or changes of the protocol without agreement by the sponsor and prior review and documented approval from the IRB of an amendment, except where necessary to eliminate an immediate hazard (s) to subjects.
  • Continuing Review Reports - The Investigator should submit written summaries of the trial status to the IRB annually or more frequently, if requested by the IRB.

Responsibility for Maintaining Records  - The PI is responsible for maintaining essential research records including regulatory binder documents, case report forms, source documents and signed consent documents.

 

For research under FDA oversight, records should be retained for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated.  If no application is to be filed or the application is not approved for such indication, records are kept until 2 years after the investigation is discontinued and FDA is notified.  The sponsor may have record retention requirements specified in the clinical trial agreement that must be followed instead of the 2 year minimum. 

For all other research studies, records should be retained for at least 6 years after end of study and publication of the results (whichever is later).

Change of Principal Investigator: If the Principal Investigator is retiring or resigning from UTHealth or is going away for an extended duration of time, the research project should be formally transferred to another investigator or closed. This investigator then assumes all the responsibilities as the PI for the conduct of the research project until the original PI returns. This change must be reviewed and approved by the IRB. (PI Separation Checklist)

APPLICABLE REGULATIONS AND GUIDELINES

  1. 21 CRF 312 Investigational New Drugs
  2. 21 CFR 812 Investigational Device Exemption
  3. Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects

REFERENCE TO OTHER POLICIES

  1. CPHS Policy and Procedure – Problem Reporting

ATTACHMENTS

  1. PI Separation Checklist

If you find errors in this document, contact cphs@uth.tmc.edu 

Document Number:

101-G01

Document Name:

Investigator Responsibility

Reviewed by:

Executive Director, Research Compliance

Effective:

1 Aug 2008

Revision History:

1 Aug 2011, I Jun 2016, 21 Jan 2019, 31 May 2021

 

 

 

 


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