Committee For the Protection of Human Subjects

CPHS Record Keeping

POLICY

CPHS records shall be maintained in a manner that contains a complete history of all CPHS actions related to the review of a research proposal. All records regarding a submitted study (regardless of whether it is approved) shall be retained in an appropriate manner.

Records will be accessible for inspection and copying by authorized representatives of the Sponsor, funding department or agency, regulatory agencies and institutional auditors at reasonable times and in a reasonable manner. Records shall be retained in compliance with federal, state and local law, and sponsor requirements.

 

PROCEDURE

Protocol Specific Information - Records shall be maintained in iRIS or, for records prior to the implementation of iRIS, they shall be in Documentum. Both systems are password protected to ensure confidentiality.

The protocol research files in iRIS are organized to allow a reconstruction of a complete history of all CPHS actions related to the review and approval of the protocol. The documents that will be maintained include, but are not limited to:

§  Copies of all versions of the research proposal reviewed.

§  Scientific evaluations, if any, that accompany the proposals.

§  Department of Health and Human Services (DHHS) approved sample consent documents.

§  Progress reports submitted by investigators.

§  Reports of serious adverse events and unanticipated problems involving subjects and others.

§  Copies of correspondence between the IRB, the Office of Research Support Committees staff, and investigators pertinent to each protocol.

§  Reports of Data Safety Monitoring Boards (DSMBs).

§  Amendments or changes to research and documents.

§  Record of Continuing Review activities.

§  Statements of significant new findings provided to participants.

§  Documentation of protocol specific findings required by local policy and applicable regulations.

 

CPHS Administrative Documents: The following items shall be retained by the Office of Research Support Committees, either in electronic or paper format:

§  Agenda and Minutes of IRB meetings.

§  A list of IRB members and alternates with the following information on each:

o   name;

o   curriculum vitae;

o   representative capacity;

o   indications of experience such as board certifications, licenses, etc., sufficient to describe each member’s chief anticipated contributions to IRB deliberations; and

o   any employment or other relationship between each member and the institution; for example: full-time or part-time employee or member of governing panel or board.

o   Documentation of required human subjects protection training.

§  Policies and procedures for CPHS addressing the following:

o   Initial and continuing review of research, including procedures for reporting its findings and actions to the principal investigator (PI) and the institution.

o   Determining which projects require review more often than annually and which projects need verifications from sources other than the PI that material changes have not occurred since previous IRB review.

o   Assuring prompt reporting to the CPHS of proposed changes in a research activity, and for assuring that such changes in approved research, during the period for which IRB approval has already been given, are not initiated without prior CPHS review and approval except when necessary to eliminate apparent immediate hazards to the participants;

o   Assuring prompt reporting to the CPHS, appropriate institutional officials, and the department or agency head of the funding source of any serious and expected adverse events and/or unanticipated problems involving risks to participants or others, or any serious or continuing noncompliance with the Federal regulations and CPHS policies and procedures, or the requirements or determinations of the IRB and any suspensions or terminations of CPHS approval.

 

Record Retention – CPHS records relating to research are retained for at least three years after completion of the research, and all other records are retained for at least three years. For studies in which children were enrolled, files must be retained for at least three years after the last subject reached adulthood.

 

APPLICABLE REGULATIONS

1.       45 CFR 46.115(b)

2.       21 CFR 56.115

REFERENCE TO OTHER POLICIES

1.       None.

ATTACHMENTS

1.       None.

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

 

Document Number:

101-F02

Document Name:

Record Keeping

Approved by:

ORSC Director

Effective:

1 Aug 2008

Revision History:

1 Aug 2011

 


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
6410 Fannin, Suite 1100
Houston, Texas 77030

Phone 713.500.7943
Fax     713.500.7951
Email cphs@uth.tmc.edu 

IRIS Support 713.500.7960

CLINICAL TRIALS RESOURCE CENTER 

OFFICE OF RESEARCH 

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