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T.A.B.S. RRC STATUS REPORT
Research Review Page 1 of 6
Committee
To ensure a timely review of the attached forms, please read and complete the form in its
entirety. The form is considered complete only if all questions are answered, all requested
documents are attached and the report is signed. Failure to do so will result in a delay of
review by T.A.B.S. Research Review Committee.
Please submit the following documents with the completed form to T.A.B.S. Research Review
Committee:
For Continuing Review:
Summary Report of the clinical study results and outcome measures as defined in
the clinical protocol.
A copy of the consent form currently being used for subject enrollment.
Copies of the signature page of the consent form for the first and last subject
enrolled.
A copy of the Investigator’s current medical license.
A copy of the investigator’s current curriculum vitae.
Renewal Fee per clinical site and Principal Investigator is $400.00 (to be submitted
with the request for extension and Status Report)
For Final Report:
Copies of the signature page of the consent form for the first and last subject
enrolled.
Summary Report of the clinical study results and outcome measures as defined in
the clinical protocol.
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T.A.B.S. RRC STATUS REPORT
Research Review Page 2 of 6
Committee
Today’s Date: Completed by:
Study Start Date: Approval Expiration Date:
CONTINUING REVIEW (Study is FINAL REVIEW
ongoing): If subjects have been enrolled, attach a
Attach a copy of the following: copy of the signature page of the
A copy of the consent form being consent for the first and last subject
used for enrollment enrolled.
Signature page of the consent form
Study has been:
for the first and last subject enrolled
Cancelled, cancelled, no subjects
A copy of your current license
enrolled,
A copy of your current CV
Terminated, or completed
Complete pages 3 - 6 Complete page 3 - 6
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T.A.B.S. RRC STATUS REPORT
Research Review Page 3 of 6
Committee
COMPLETE FOR CONTINUING REVIEW AND FINAL REPORTS
STUDY INFORMATION:
Company (sponsor), protocol number, complete study title:
Device Classification (i.e., Significant risk, Nonsignificant risk):
Investigator’s Name: Project Manager:
Sponsor:
Address: Phone Number:
City, State, and Zip: Fax Number:
SUBJECT EXPERIENCES:
Do you have any serious or unexpected adverse events on File? Yes No.
If yes, have you sent copies of all serious or unexpected adverse events to T.A.B.S.? Yes No.
If no, please attach copies of all serious or unexpected adverse events for T.A.B.S. review.
Please complete the following: Total
Number of patients/subjects with life-threatening or serious adverse experiences.
(Describe on attachment).
Number of patients/subjects withdrawn from study due to life-threatening or serious
adverse experiences. (Describe on attachment).
Number of patients/subjects who have received test article (investigational
drug/comparators) / medical device or have been treated with a medical device).
Principal Investigator or Sub-investigator Date
T.A.B.S. RRC Chairperson Date
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Committee
COMPLETE FOR CONTINUING REVIEW ONLY
SUMMARY REPORT OF THE CLINICAL STUDY RESULTS AND OUTCOME MEASURES
AS DEFINED IN THE CLINICAL PROTOCOL
Date: Department: Telephone:
Brief Title of Project:
IRB Project Number: Principal Investigator:
Funding Source:
Name Person to Contact: Telephone:
Date of initial approval:
Date of most recent continuing (renewal) approval:
Estimated completion date of the research project:
Study Enrollment
Total Subjects Enrolled Subjects Completed Active Subjects Subjects Withdrawals* Screen Failures**
*“Withdrawals” signed the consent form, but later withdrew from the study, either before or after receiving
study drug, device or intervention.
** Screen failures” signed the consent form, but later proved not to qualify for the study during screening
procedures.
Protocol Summary
Provide a summary (350 words or less) of the research project including the purpose, subject population,
investigative methodology, procedures applied to subjects, and potential for subject risk.
Attach a separate sheet
Provide a summary (350 words or less) of all substantive revisions to the research project since the most recent
approval. Attach a separate sheet.
Problems, Complications, Subject Withdrawal
Did any subjects express complaints about their participation in the research project? Yes No
If yes, describe on a separate sheet the complaints and corrective measures, if any
Did any subjects voluntarily withdraw from the study for non-medical reasons? Yes No
If yes, describe on a separate sheet any known reasons for each subject’s withdrawal
Were any subjects prematurely terminated by the investigator from the research study for non-
Yes No
medical reasons (such as poor compliance)?
If yes, describe on a separate sheet the reasons for each subject’s withdrawal
Was there an unusually high frequency of serious but anticipated (expected) adverse events? Yes No
If yes, describe this finding on a separate sheet
Did any subject suffer an unanticipated (unexpected) adverse event, serious adverse event, or
death that was reported to the IRB since the last IRB review? Yes No
If yes, describe on a separate sheet the number, nature, and significance, and
Attach the relevant Form 4 for all such events
Were any subjects withdrawn from the study because of medical problems or complications?
Yes No
If yes, describe on a separate sheet the medical problem or complication for each subject
who was withdrawn
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Committee
Study Results and Risk-Benefit Assessment
(Questions in this section apply to all study sites and pertain to the entire period since initiation of the study)
What results (preliminary or final) have been obtained in the study? Attach a separate sheet.
If the study is a multi-center trial, this should be stated and any available results provided, including
interim summary reports of data and safety monitoring boards.
If there are no results that can be reported to the IRB at this time, this should be stated and explained.
Have any external unanticipated problems, unanticipated (unexpected) adverse events, serious
adverse events, or deaths been reported? Yes No
If yes, summarize on a separate sheet those developments associated with the research
interventions
Have any clinical or laboratory research results been published or presented which are relevant to
Yes No
the modification or continuation of this study?
If yes, explain these developments on a separate sheet
Has anything occurred since the last IRB review which may have altered the risk/benefit
assessment? Yes No
If the answer is “yes”, describe on a separate sheet the current risk/benefit assessment
and how it differs from the original assessment
Informed Consent Evaluation
Did any problems occur in obtaining and documenting informed consent? Yes No N/A
If yes, explain on a separate sheet
Is the most recent version of the consent form still acceptable?
In answering this question, it should be considered whether the document is
accurate, complete and in language understandable to subjects, and does not
exclude any new information about the study procedures or results that should be Yes No N/A
disclosed to subjects.
If the answer is yes, attach a copy of the current consent form
If the answer is no, describe necessary changes on a separate sheet and attach
copies of the current and revised consent forms
Have informed consent documents and information pertaining to the identity of the subjects been
Yes No
securely stored?
If not, explain on a separate sheet
Have any significant new findings developed in the course of the research that may relate to the
Yes No
willingness of current subjects to continue participation?
If yes, explain on a separate sheet plans to inform subjects of this information
Principal Investigator or Sub-investigator (Print Name) Date
Signature (Principal Investigator or Sub-investigator) Date
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Committee
DESCRIPTION OF SERIOUS ADVERSE EVENTS
Subject Life-Threatening or Serious Relation to Study Medications;
Identifier Adverse Experiences unknown, unlikely, possible, caused by,
or probably caused by.
Return by mail to T.A.B.S Research Review Committee
12101 Cullen Blvd, /suite A Houston, Texas 77047
Phone: 713 / 734-4433
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