Retrospective Chart Review
Please provide contact information for a representative who can answer any questions that the IRB might have concerning this submission:
Name:
Position:
E-mail:
Phone #:
Pager #:
2nd Contact: / name + e-mail or phone number
Group:
Form Instructions:
· Make sure your Microsoft Word program is set to display “Hidden Text”. This document contains helpful information, examples, and instructions that are only visible (and will never print) when the “Hidden Text” feature is enabled. “Hidden Text” will be displayed highlighted yellow, italics, and underlined. Go to the “Tools” menu, “Options”, on the “View” tab make sure “Hidden Text” has a check mark, and click “OK”. (Word 2007 users can download how to display Hidden Text at: http://irb.ufl.edu/docs/hidden07.doc).
· Submit One signed original plus one electronic copy (Entire Closure Packet) to the IRB-03 office. This must include copies of all paperwork including grants, surveys, data collection tools, articles, etc. You should also retain one copy of the submission for your files. You may need to submit copies to other committees/offices.
· Regardless of study status, every Section below must be completed.
· The Report must be signed by the Principal Investigator on the signature line at end of report. Co-PI, sub-I, or other signatures are NOT sufficient unless accompanied by a completed Temporary Transfer of PI Responsibility
· Subjects’ names or other identifying information (medical record numbers, etc.) must not appear in this Report or in any correspondence with the IRB. Use a black marker to block/cover up any identifying information on all copies submitted to the IRB.
· This report must be typed.
· Submissions that do not meet our Submission Acceptability Standards will be returned to the PI. Visit http://irb.ufl.edu/irb01/formsubmit.htm for more information.
Closure for Retrospective Review Page 2 of 3
IRB version date: 11/24/2009
PI version date:
Date:Principal Investigator:
PI UF ID#:
IRB Project #:
Project Title:
1. We wish to close this study:
Statistical analysis of already collected data that is now de-identified or no links to identifiers remains. NOTE: You may close the study. If so, you must attach a letter signed by the PI certifying that the data has been de-identified.
All interventions, data collection, and data analysis are completed.
Once you close your study you may only analyze data which was previously collected while your project was approved. You may not collect or analyze any new data without IRB approval AND all data must be de-identified by HIPAA standards prior to the project’s closing.
2. During this review period, have there been any changes, no matter how minor, to any part of this research project, including the IRB approved forms (Introductory Questionnaire, Protocol, or any other materials reviewed by the IRB)? Examples include, but are not limited to: changes to the study procedures, addition of a subtitle, departure or addition of an investigator, change in funding, and change in number of subjects to be enrolled?
No.
Yes. If yes, select one:
All changes implemented to this project have been previously reported to and approved by the IRB.
Changes have been implemented but were not submitted to the IRB.
Explain:
3. Study sponsor: Is your study sponsored?
No.
Yes. Provide the name(s) of all of your study’s sponsor(s): .
Have there been any changes to the study’s sponsor(s) during the past review period?
No.
Yes. Explain:
4. Study results: Have you or any of the local sub-investigators reported any data from your study?
No.
Yes. Provide a copy of the publication or meeting proceedings.
5. How did you identify potential subjects?
Under a previously approved HIPAA Waiver of Authorization for Recruitment (review of medical records, databases, part of clinical care). Describe rationale for HIPAA Waiver for Recruitment:
Other. Describe:
6. Have any subjects been enrolled (Subjects charts or information reviewed/collected) in this project:
No. Explain why you did not start this project:. Skip to question 10.
Yes. Collecting data from patient medical records was initiated using a waiver of informed consent
7. How many subjects did you enroll (charts reviewed) in this project under your waiver?
8. As listed in your last approved Introductory Questionnaire (IQ), how many subjects has the IRB approved for enrollment into this project? Federal regulatory agencies consider any subject who signs an informed consent form to be enrolled in the study.
9. Have you enrolled more subjects than currently listed in this project’s last approved Introductory Questionnaire (IQ)?
No.
Yes. Explain why: .
If you enroll more subjects than you are approved for it is considered Regulatory Noncompliance – similar to enrolling subjects on a research study that never received IRB approval. If you have enrolled more subjects than you were approved for you should attach a separate cover letter explaining how/why this occurred, any potential risks to subjects, and what corrective action steps you are going to take to prevent this from reoccurring in the future.
10. Is this a multi-center study?
No.
Yes. How many subjects have met eligibility requirements and enrolled in the study since the study started (total number of subjects enrolled at all sites)?
11. Risk/benefit ratio evaluation: Considering the above information and the potential benefits, in your opinion, did the risk/benefit ratio of this study change for any reason during this review period?
No.
Yes. Explain:
12. Which items are being submitted with this Closure report?
A clean, current copy of your protocol Required only if reported since the last approval or continuing review
Publication(s) or meeting proceedings. Required only if reported since the last approval or continuing review
Print a copy of this form and: / (1) Type and sign your name below.(2) Make a copy of the signed report for your regulatory file.
Person completing CR Form (typed): Date:
(Sign below)
Signature: ______
Signature of Principal Investigator:______
NOTE: this report must be signed by the PI unless you have attached a properly completed copy of a Temporary Transfer of PI Responsibility
Closure for Retrospective Review Page 2 of 3
IRB version date: 11/24/2009
PI version date: