NONCOMPLIANCE

 

 

POLICY

 

The Principal Investigator is responsible for the proper conduct of research. It is the Investigator’s responsibility to comply with CPHS 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 Agreements

 

§  The PI must be qualified by education, training and experience to assume responsibility for the proper conduct of a research study and should meet all qualifications specified by the applicable regulatory requirements

 

§  The PI should be thoroughly familiar with the study protocol. When conducting clinical trials, the PI should be thoroughly familiar with the investigational product as described in the Investigator’s Brochure, in the product information and other sources.

 

§  The PI should maintain 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 should ensure 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 Principal Investigator should ensure 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 CPHS 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 CPHS. The PI must use the consent document approved by the CPHS.

 

§  PI must maintain all relevant documents and recognize that the CPHS staff 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 INDs

 

§  An investigator administering an investigational drug, agent, or biologic is responsible for the research to be conducted in accordance with the plan of investigation as described in the FDA-approved IND, the signed investigator statement, and the CPHS-approved investigational plan.

 

§  Responsibility for Control of Drugs – The investigator may not give the investigational drug to any person not authorized under the protocol to receive it. The drug, agent, 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 drug, 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 CPHS

 

§  The Principal Investigator must obtain CPHS approval before initiating a research project involving human subjects when the research is conducted by or under the direction of any employee of UTHSC-H or the research is conducted using the facilities of any UTHSC-H institution.

 

§  Serious Adverse Event Reporting - The Investigator must report all unanticipated problems that occur during the conduct of a research project to the CPHS in accordance with the timelines set by CPHS.

 

§  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 CPHS 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 CPHS annually or more frequently, if requested by the CPHS.

 

Reporting Requirements to Sponsor for Industry Sponsored Projects

 

§  The investigator must provide all protocol-specified reports to the sponsor of study.  The sponsor is required to submit annual reports to the FDA on the progress of the clinical investigations.

 

§  Serious or unexpected adverse events must be reported to the sponsor immediately.   Non-serious adverse events must be reported promptly.

 

§  The investigator must provide the sponsor with accurate financial information to allow an applicant to submit complete and accurate certification of disclosure statements as required. 

 

§  After completion of the study, the investigator must provide the sponsor with a report.

 

Reporting Responsibility to Federal Agencies - In the event that an employee of the FDA requests access to records or reports made by the investigator (at a reasonable time), the investigator may permit such access for copying or verifying.  However, the investigator is not required to divulge subject names unless the records of particular individuals require a more detailed study of the cases, or unless there is reason to believe the records do not represent actual case studies.

 

Reporting Responsibility to Other Authorities - The PI must report to relevant authorities if any research subject is suspected of having a notifiable disease according to relevant regulations and institutional requirements. If abuse or neglect of a child or an elderly person is detected, the PI must ensure this is reported to relevant authorities according to institutional requirements.

 

Other Responsibilities

 

Conflict of Interest - The PI must disclose any real or apparent conflict of interest in the application form to the CPHS according to policy and procedure Conflict of Interest – Investigators.

 

Sponsored Clinical Trials - The PI must not conduct sponsored studies without a signed Clinical Trial Agreement. The PI should ensure that the clinical trial is conducted according to the signed Agreement.

 

Responsibility for Maintaining Records  - In order to maintain adequate records, it is expected that the investigator will keep case histories that record all observations and other data needed in the investigation for each individual receiving the investigational drug.  Each case history should include the signed and dated consent forms and medical records including progress notes of the physician, the individual’s hospital chart, and the nurses’ notes.  It is important to document in the case history that informed consent was obtained prior to participation in the study.

 

The 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. 

 

Change of Principal Investigator

 

If the Principal Investigator is resigning from UTHSC-H or is going away for an extended duration of time, the research project should be formally transferred to another Investigator. This Investigator assumes all the responsibilities as the Principal Investigator for the conduct of the research project until the original Principal Investigator returns. This change must be reviewed and approved by the CPHS.

 

 

APPLICABLE REGULATIONS AND GUIDELINES

 

1.          21 CFR 312.60

2.          21 CFR 812.100

3.          21 CFR 812.110

 

REFERENCE TO OTHER POLICIES

 

1.          HOOP 23.01 to 23.13

2.          CPHS Policy and Procedure – Conflict of Interest – Investigators

 

ATTACHMENTS

 

1.          None

 

 

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

 

Document Number:

101-G01

Document Name:

Investigator Responsibility

Approved by:

ORSC Director

Effective:

1 Aug 2008

Revision History:

1 Aug 2011