ࡱ>   $bjbj IQz z HHH\\\8H\AjD"000 | 4 iiiiiii$lniH"@ ""i00i&&&"R0H0i&"i&&j]&"b0@a[*#v_2ij0Aj_o#odbb\oHb Z5!@&u!4! ii%H Aj""""o z :  SAINT LOUIS UNIVERSITYIRB #:Institutional Review Board (IRB) Caroline Bldg, Room C110 (314) 977-7744 (314) 977-7730 (fax) NOTICE OF STUDY COMPLETION (Use to Close Existing Non-Exempt Protocols OR submit a Final Report in eIRB) DATE:IRB Approval Expiration Date:Principal Investigator: Phone/Pager: Department: Address: E-Mail: Degree: Contact Person: Phone/Email: Study Title: (If applicable, use the exact title listed in the grant/contract application.)   FORMCHECKBOX  NOTICE OF STUDY COMPLETION, Check here if your study should be closed.  FORMCHECKBOX Research activities are complete. (Complete sections A, B, C, D) When all human research procedures (including data analysis) are completed at 91Ů, the research no longer requires continuing review by the 91Ů IRB. For multi-center studies, continuing review of the research by the 91Ů IRB is not required after all human research activities have been completed at 91Ů even if (i) interactions or interventions with subjects may be occurring at other study sites, or (ii) data analysis of identifiable private information is ongoing at another central site that collects and analyzes data from all study sites. For multi-center investigator-initiated studies (e.g., 91Ů Investigator is the head of this multi-center trial and is responsible for reporting to IRB, FDA, and/or other sites), the 91Ů IRB would require the study to remain open until all sites have completed the research project and data analysis.  FORMCHECKBOX Study can be terminated because research activities never started. (Complete section A and section D ONLY) A. STUDY STATUS 1. When was the study initially approved by the IRB? (should match date provided in IRB approval letter)  2. What was the last approval date for continuing review? (if this is first continuing review, state N/A) 3. Have research activities started?  FORMCHECKBOX  No  FORMCHECKBOX  Yes If no, please explain in the box below (e.g., awaiting funding, lag in subject accrual with reasons for lag included). Also if this study is on hold, please explain what needs to occur before accrual can resume.  4. Have there been any significant amendments or revisions to the protocol during the past approval period? Significant changes include changes in study design or risk level including those that resulted in a change in consent  FORMCHECKBOX  No  FORMCHECKBOX  Yes If yes, please briefly summarize the changes below.  B. SUBJECT STATUS Does this study only involve research limited to the review of data, documents, records, or specimens (i.e., there are never any interactions with human subjects)?  FORMCHECKBOX No (Proceed to question 2)  FORMCHECKBOX Yes (Answer questions in the records/specimens accrual table, below) RECORDS/SPECIMENS ACCRUAL TABLE Number of records/specimens approved by the IRB for the study as stated in the current protocol (Section E: Study Design on 91Ů IRB Application)Total number of items (records or specimens) that have been collected/reviewed to date (total) (Proceed to Question #4) Please refer to the 91Ů IRB HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/guidelines_subject_accrual.doc"Policy on Subject Accrual for assistance in answering the following: SUBJECTS ACCRUAL TABLE Number of subjects currently approved by the IRB for the study as stated in current protocol (Section E: Study Design on 91Ů IRB Application)Subject Accrual Totals  B1. Total number of subjects that have given consent (verbal or written) to date B2. Total number of subjects that failed screening* (if not applicable, state N/A) B3. Total number of subjects accrued** to dateNumber of Accrued Subjects Withdrawn or Discontinued (If any subjects have withdrawn or discontinued, see question #3, below)* Subjects are screen failures if they signed a consent form and underwent study screening procedures, but participation did not yield evaluable data. **Accrued subjects are those who have given consent and whose participation yields evaluable data. Evaluable data are data that are intended to contribute to generalizable knowledge (i.e., the study goals). FOR MULTI-CENTER STUDIES ONLY TOTAL STUDY SUBJECT ACCRUAL TABLE Number of subjects approved for accrual in the total study (91Ů site plus all other study sites) Total Study Subject Accrual (according to study sponsor)  If any of the subjects in 2C (above) were withdrawn or discontinued due to safety or increased risk, please explain. If withdrawn for any other reason than safety or risk issues, state Not applicable.  To your knowledge, were there any subject complaints about the research?  FORMCHECKBOX  No  FORMCHECKBOX  Yes. If yes, please explain below:  C. SUMMARY OF PROGRESS OR FINDINGS: Briefly describe (1 page maximum) the progress of the study to date/study findings. If possible, include any observations, results, or findings. For multi-center studies, include progress for the total study (all sites) if available.  2. Publications, Presentations, and Recent Findings: Have there been any submissions for presentation or publications resulting from this study during the last approval period? Please include only copies published/presented from 91Ů researcher(s).  FORMCHECKBOX  No  FORMCHECKBOX  Yes. If yes, please provide a copy of the abstract or manuscript submitted or published. Have there been any recent findings either from this study, or a related study, which would have an effect on subject safety or the risk/benefit sections of the protocol and/or consent document(s)?  FORMCHECKBOX  No  FORMCHECKBOX  Yes. If yes please explain how subjects were/will be informed:  D. INVESTIGATOR ASSURANCE AND SIGNATURE Investigators Assurance: I certify that the information provided is complete and accurate. As Principal Investigator, I have ultimate responsibility for the conduct of this study, the ethical performance of the project, the protection of the rights and welfare of human subjects and strict adherence to any stipulations designated by the 91Ů IRB. 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