Mother Frances Hospital Tyler
Institutional Review Board
irb@tmfhc.org / (903) 606-2472
Continuing Review
Principal Investigator:
IRB # and Protocol title:
Protocol version and date:
Investigator brochure version and date:
Current informed consent version and date:
Current assent version and date:
Name of person completing this form:
Date:
Handwritten, copied or scanned versions of this form are not accepted. To prevent errors and
delays due to legibility problems, submit the original to irb@tmfhc.org. All questions must be
answered. Indicate NA for questions that are not applicable.
All modifications and/or changes that have not been reviewed and approved by the IRB must be
submitted using the appropriate form.
Research staff
List all co-investigators, research coordinators and others who have substantive interaction with
subjects (recruiting, obtaining consent, evaluating response). The Principal Investigator and each
person listed must complete and sign a Conflict of Interest statement.
Description and current status
1. Brief protocol summary:
2. Progress report: Summarize progress to date. If enrollment has not begun, explain why and
the likelihood that subjects will be enrolled during the next approval period.
3. Estimated study completion date:
4. Current status: (If all research related activities at this site are completed, or the study has
been terminated, or the study never was conducted use the “Closure report”).
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Open to enrollment and no subjects have been enrolled to date
Open to enrollment and subjects have been enrolled to date
Closed to enrollment and subjects are still on the protocol regimen
Closed to enrollment and follow-up of subjects continues
Closed to enrollment and analysis of identifiable/coded data continues
Design and procedures
1. Summary of findings to date, including preliminary results and interim findings where
available.
2. List, any publications relevant to this research since the last review, and include copies.
None
List:
3. Provide a summary of any problems with, or changes in, the research since the last review.
Include details.
Subject recruiting:
Advertising:
Subject compensation:
Inclusion or exclusion criteria:
Costs to subjects:
Investigator inducements:
Informed consent:
Documentation of informed consent:
Privacy or confidentiality protections:
Safety monitoring:
Vulnerable subject protections:
None of the above
4. If any changes listed above were not prospectively reviewed and approved by the IRB prior
to implementation, explain why.
Not applicable
List and explanation:
Subject selection, recruitment and vulnerable populations (local site only). If there is more than
one cohort, provide answers for each.
1. Indicate total number of subjects approved for enrollment. (IRB approval must be obtained
prior to enrolling more subjects than approved).
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2. Indicate total number of subjects enrolled since the start of the study. (Do not include those
subjects that consented to participate but failed screening procedures).
3. Indicate total number of subjects enrolled since the last continuing review. (If this is the first
continuing review, list the number since study approval. Do not include subjects that
consented to participate but failed screening procedures).
4. If screening procedures are used to determine eligibility, how many subjects were consented
and failed screening?
Not applicable. No screening procedures used.
Number:
5. If gender and minority status is collected, provide the cumulative accrual (for all consented).
Not applicable. Gender and minority status not collected.
African
American
American
Indian
Asian
White
Hispanic
Other
Total
Men
Women
Total
6. If the IRB has approved the enrollment of vulnerable subjects, provide the cumulative
accrual.
Not applicable. No enrollment of vulnerable subjects.
Category
Adults who cannot consent for themselves
Children
Children who are wards of the state
Cognitively impaired
Economically disadvantaged
Educationally disadvantaged
Employees / staff directly supervised by the Principal Investigator or
sub-investigator
Employees / staff of the research site or research sponsor
Institutionalized
Limited or non-readers
Mentally disabled
Non-English speaking
Nursing home residents recruited in the nursing home
Pregnant women, fetuses or neonates
Prisoners
Students of any member of the research team
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Total Enrolled
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Students to be recruited in their educational setting
Others vulnerable to coercion (specify)
7. Indicate number of subjects still active (includes follow-up procedures).
8. Indicate number of subjects that have completed the study.
9. Indicate number of additional subjects to be enrolled.
10. If any subjects have withdrawn, provide a summary of withdrawals and the reasons for
withdrawal.
Not applicable. No subjects have withdrawn.
Number Reason
Discontinued early due to unanticipated problem
Withdrew consent
Lost to follow up
Transferred sites
Terminated by the Principal Investigator / sponsor
Expired
Other:
11. If any prospective subjects have been excluded on the basis of race, ethnicity, understanding
of English, socioeconomic status, education, gender, or pregnancy, please explain.
Not applicable. No prospective subjects excluded.
Explanation:
Risks and benefits
Since the last review …
Yes
No
1. Has there been any new relevant information regarding this research,
especially information about risks / benefits? If yes, describe and indicate
date provided to the IRB:
2. Have there been any study wide or multi center reports / sponsor reports /
annual reports? If yes, include copy and/or indicate date provided to the
IRB:
3. Have there been any Data and Safety Monitoring Board reports? If yes,
include copy and/or date provided to the IRB:
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4. Has the expectation of adverse events (frequency, severity, specificity)
changed? If yes, provide a summary of the changes and indicate date
reported to the IRB:
5. Have there been any unanticipated problems involving risks to subjects or
others? If yes, provide a summary of the problems and indicate date
reported to the IRB:
6. Have there been any complaints about the research from subjects or
others? If yes, summarize the number and nature of the complaint(s) and
indicate date reported to the IRB:
7. Have subjects experienced any unexpected benefits? If yes, summarize
and indicate date reported to the IRB:
8. In the opinion of the Principal Investigator, have the risks or potential
benefits changed? If yes, describe:
9. Overall risk classification (select one):
Minimal. “The probability and magnitude of harm or discomfort anticipated in the
research are not greater in and of themselves than those ordinarily encountered in
daily life or during the performance of routine physical or psychological
examinations or tests.”
Greater than minimal.
10. If continuation of the research is NOT justified in light of the above information, please
explain.
Additional information
Summary of amendments since the initial review (add lines as necessary):
Date Description
Attachments
Indicate items attached: (*=required)
*Conflict of Interest statements for all members of research team
If open to enrollment, copy of the latest IRB approved stamped:
informed consent form(s)
assent document(s)
oral script(s) / letter(s) information sheet(s)
translated and authenticated versions of the above consent(s), assent(s), oral
script(s), letter(s), information sheet(s), for likely non-English speakers
*Copies of the signed consent / assent for the last two subjects enrolled since the last
review
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Publication(s) related to the research since the last review
Copies of any interim findings reported by the sponsor or investigator since the last
review
Study wide or multi-center reports / sponsor reports / annual reports since the last review
Data Safety and Monitoring Board Report(s) since the last review
IND safety reports from the sponsor since the last review
*Summary of Local Adverse Events since the last review (includes all adverse events)
Audit reports (Includes local IRB, U. S. Food and Drug Administration, Office for
Human Research Protections, sponsor, Contract Research Organization and any other
regulatory agencies) since the last review
Copies of monitoring reports since the last review
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