Investigator Responsibilities (Compliance)

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

 Adequate Resources

 Care of Subjects

 Conduct of Research

Additional Investigator Responsibilities Under IND/IDE

Communication with CPHS

Reporting Requirements to Sponsor for Industry Sponsored Projects

Other Responsibilities

 

Change of Principal Investigator

If the Principal Investigator is resigning from UTHealth 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:

Executive Director, Research Compliance

Effective:

1 Aug 2008

Revision History:

1 Aug 2011, 1 Jun 2016


CPHS HELPLINE   713-500-7943
iRIS HELPLINE    713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)

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Committee for the Protection of Human Subjects
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Houston, Texas 77030

Phone 713-500-7943
Fax     713-500-7951
Email cphs@uth.tmc.edu 

IRIS Support 713-500-7960

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