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IX.02 |
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Documentation and Record Keeping |
Objective
It is the policy of the
University of Texas Health Science Center at
Policy/Procedure
I. 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.
II. The protocol research files must be organized to allow a reconstruction of a complete history of all IRB actions related to the review and approval of the protocol including:
A. Copies of all versions of the research protocol reviewed.
B. Scientific evaluations, if any, that accompany the proposals.
C. Department of Health and Human Services (DHHS) approved sample consent documents.
D. Progress reports submitted by investigators.
E. Reports of serious adverse events and unanticipated problems experienced by participants and others. and others.
F. Copies of correspondence between the IRB, the Office of Research Support Committees staff, and investigators pertinent to each protocol.
G. Reports of Data Safety Monitoring Boards (DSMBs).
H. Amendments or changes to research and documents.
I. Record of Continuing Review activities.
J. Statements of significant new findings provided to participants.
K. IRB records documenting protocol specific findings required by local policy and applicable regulations.
L. IRB records for each study’s initial and continuing review should note the frequency (at least once yearly) of continuing review in either months or other conditions, such as after a particular number of participants are enrolled.
III. The following items must be retained by the Office of Research Support Committees, either in electronic or paper format:
A. A list of IRB members and alternates with the following information on each:
1. name;
2. Curriculum vitae;
3. representative capacity;
4. indications of experience such as board certifications, licenses, etc., sufficient to describe each member’s chief anticipated contributions to IRB deliberations; and any employment or other relationship between each member and the institution; for example: full-time employee, part-time employee, member of governing panel or board, paid or unpaid consultant.
5. Documentation of required human subjects protection training, and continuing education
B. Written procedures for the IRB addressing the following
1. Initial and continuing review of research, including procedures for reporting its findings and actions to the principal investigator (PI) and the institution.
2. 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.
3. Assuring prompt reporting to the IRB 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 IRB review and approval except when necessary to eliminate apparent immediate hazards to the participants;
4. Assuring prompt reporting to the IRB, 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 IRB policies and procedures, or the requirements or determinations of the IRB and any suspensions or terminations of IRB approval
C. Minutes of IRB meetings.
D. These records shall be accessible for inspection and copying at reasonable times and in a reasonable manner by appropriate individuals or agencies.
E. Records for initial reviews by an expedited procedure shall include:
1. The specific permissible category;
2. A description of the review;
3. A description of action taken by the reviewer;
4. Any findings required under the DHHS regulations;
5. For those requiring determinations
a) Specify the determination
b) Provide the protocol specific findings that justify the determination
6. Document protocol specific findings required by local policy and applicable regulations for waiver or alteration of informed consent;
7. Document protocol specific findings required by local policy and applicable regulations for research that includes children as subjects.
F. Records for continuing reviews by an expedited process include
1. The specific permissible category
2. A description of the review
3. A description of action taken by the reviewer
4. Any findings required under the DHHS regulations
G. All exemption determinations shall include a citation of the specific category justifying the exemption.
IV. Document retention
A. IRB 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 3 years.
B. If a study is terminated without participant enrollment, records should be maintained for at least three years after termination.
C. For studies in which children were enrolled, files must be retained for at least three years after the last subject reached adulthood.
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Applicable Regulations and Guidelines 21CFR
50 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr50_04.html
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Updated 6/5/2007, Report
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