ࡱ> 15./0[ |bjbj a<iiii -----AAA8yA*1 C#:}$1%\$tX-%!#!#"%%-- N)*)*)*%F-- )*%)*)*Sk@;q8%m6od0mra&l;q;q-Oq I%%)*%%%%%E(%%%%%%%%%%%%%%%% Y :  Institutional Review Board Office Phone: 410-955-3193 Toll Free: 1-888-262-3242 Email: HYPERLINK "mailto:bsph.irboffice@jhu.edu"bsph.irboffice@jhu.edu Website: HYPERLINK "/offices-and-services/institutional-review-board-irb"www.bsph.edu/irb FINAL STUDY REPORT (Use this Report Form to close an active JHSPH IRB study) IRB Number:  FORMTEXT      IRB Approval Expiration Date (leave blank for Active NCR studies):  FORMTEXT      Study Title:  FORMTEXT      PI:  FORMTEXT      Study Contact:  FORMTEXT       SECTION A: STUDY STATUS SINCE LAST IRB REVIEW AND APPROVAL (Check one category only) FORMCHECKBOX Data collection has concluded, and study is in analysis or dissemination stage only, AND data have been de-identified. That is, data cannot be linked to individuals and identifiers have been destroyed. FORMCHECKBOX The studys IRB approval has lapsed FORMCHECKBOX PI is moving study to another institution which will take over ethical oversight of the study Institution Name:  FORMTEXT       FORMCHECKBOX Study is being combined with another JHU research application. IRB No.:  FORMTEXT       FORMCHECKBOX Study was never initiated  FORMCHECKBOX Other: Explain:  FORMTEXT       SECTION B: FINAL STUDY INFORMATION ON SUBJECTS, RECORDS AND/OR SAMPLES STUDIEDComplete 1 if your study had a screening consent process to determine study eligibility Complete 2 if you enrolled participants using the IRB approved consent process (oral or written) Complete 3 if the IRB waived consent for use of identifiable data or biospecimens 1. Number of Participants Consented and Screened:Adults/Minors Consenting for ThemselvesChildren Households Total  a. Since last approval FORMTEXT        FORMTEXT       FORMTEXT       FORMTEXT       b. Since original approval FORMTEXT        FORMTEXT       FORMTEXT       FORMTEXT       c. Total number of subjects consented and screened who are eligible for the study: FORMTEXT       2. Consented and Enrolled: Adults/Minors Consenting for ThemselvesChildren Households Total  a. Since last approval FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       b. Since original approval FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       c. Total number of subjects consented and screened who are eligible for the study:  FORMTEXT      NOTE: Explain enrollment numbers for specific study phases or study population subgroups in the Comments Section below. c. For multi-site studies: Total number of subjects enrolled for all sites FORMTEXT       d. Provide the IRB Approved version number(s) or approval dates of oral or written consent/permission/ assent scripts or form(s) used to enroll subjects  FORMTEXT       Comments:  FORMTEXT       3. Secondary data analysis studies of existing identifiable data or biospecimens under an IRB waiver of informed consent Number of AdultsNumber of ChildrenTotal a. Since last approval FORMTEXT       FORMTEXT       FORMTEXT       b. Since original approval FORMTEXT       FORMTEXT       FORMTEXT      SECTION C: REPORT OF PARTICIPANT WITHDRAWALS AND COMPLAINTS, STUDY PROBLEMS AND DEVIATIONS During the period since the last IRB approval, have there been any participant withdrawals from the study or complaints about the study? If yes, describe.  FORMTEXT       2. 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If yes, describe.  FORMTEXT       SECTION D. PROGRESS OVER THIS PAST APPROVAL PERIOD AND DATA PROTECTION PLANS This report should provide the IRB with a description of the progress of the study over the past approval period. It should provide information on the following (using as much space as is needed): Progress towards achieving research objectives Your plan for sharing study findings with the community Your plan for de-identifying your study data Your data security plan for transferring and storing study data (if applicable) Your data sharing plan (if applicable)  FORMTEXT        SECTION E. SUMMARY OF STUDY RESULTS Describe briefly the principal findings of the research. Provide list of articles generated by this research.  FORMTEXT        SECTION F: SIGNATURE  FORMTEXT      ________________________________________________________________  FORMTEXT      ______________ Signature of Principal Investigator Date (signature of co-investigator or study staff is not acceptable) Please submit via email to HYPERLINK "mailto:bsph.irboffice@jhu.edu"bsph.irboffice@jhu.edu. We will accept receipt from the PI s email address as equivalent to the PI s actual signature.  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