IRB Progress Report / Final Report

IRB Progress Report / Final Report
Middle Tennessee State University’s
Institutional Review Board (IRB)
Progress/Final Report
As per (45 CFR 46.109(e)), the IRB must conduct continuing review of research at
intervals appropriate to the degree of risk, but not less than once per year. As such, progress
reports are requested to evaluate the benefit of research projects at least every year, but
sometimes more frequently as determined by the IRB. Complete this form and email to
[email protected] If this is a final report, please complete the first 5 sections. If this is a
continuing review, please complete all of the sections.
Protocol Information
1. Protocol Number:
2. Primary Investigator:
3. Project Title:
4. What is the status of the project?
a.
Completed (this is a Final Report)
b.
Ongoing (this is a Progress Report requesting continuing review for IRB
approval)
Timing and Completion
1. Was the project started?
a.
Yes
No
b. If not, please explain why:
2. Project Start Date:
3. Project Completion Date:
Unexpected Events
1. Where there any unusual of unexpected events that occurred that caused deviations
from the standard, approved procedures?
Yes
No
2. If yes, describe what happened:
3. Was the event reported?
a.
Yes
No
b. If so, when?
Storage and Disposition of Primary Data and Identifiers
1. Describe secure data storage and final disposition arrangements (i.e., disposal for each
type of data medium collected).
Participant Statistics
1. How many potential participants were contacted?
2. How many participants started the study?
1
2. How many participants completed the study?
3. If there is a deviation from the number of participants that started the study to the
number of participants that finished the study, please explain why.
4. Was written informed consent obtained from all subjects?
Yes
No
N/A
5. Are all signed consent forms on file (unless requirements were formally
altered/waived)?
Yes
No
N/A
Additional Information (if requesting continuing review only)
1. Please list all current investigators working on the project:
2. Are you aware of any new relevant information, either through the study itself or
through outside sources (published or unpublished), that may indicate a possible
increased risk of social, psychological, or physical harm to participants in this study?
Yes
No
a. If yes, please describe the changes and the current risks to participants.
3. Do you need to make any modifications to your procedures or consent form?
Yes
No
a. If yes, please describe the modifications in detail and email a revised consent
form with this form.
b. If no, please send the current informed consent document that you are using
with this form.
2
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