FORM HRP-212: Continuing/Final Review Progress Report

Protocol Name: Principal Investigator: Primary Contact Contact Name: Info: Date: Study Numbers (IF,GCO,HSM): Use for both continuing review and as a final report to close a study. If modifications are also being requested at this time, attach a completed “Form HRP-213 Modification of Approved Research” and applicable documents. A. Enrollment Status Total subjects Since last ANNUAL approval enrolled since study Number Number Screen Number Screen activation Enrolled Failures Successes Total

locally: Total all sites: B. Current Protocol Status Check off all boxes applicable to the research. If none are applicable, leave the checkboxes blank and continue to section C. 1. The research is completed. Indicate whether the following four items are all true at all sites covered by the MSSM IRB review. If all four items are checked, the research will be considered closed. Otherwise, the research must undergo continuing review; continue with section 2 below. The research is permanently closed to enrollment. All subjects have completed all research-related interventions (all medical and psychological procedures done for research purposes, including filling out questionnaires). Collection of private identifiable information is completed. Analysis of private identifiable information is completed. 2. The research is not yet completed, but may be eligible for expedited review. Indicate whether any of the following items are true at all sites covered by the MSSM IRB review. If items are checked, the research may be eligible for continuing review using the expedited procedure. The following three statements are true: 1. The research is permanently closed to the enrollment of new subjects; 2. All subjects have completed all research-related interventions (all medical and psychological procedures done for research purposes, including filling out questionnaires). 3. The research remains active only for long-term follow-up of subjects (only determining mortality of subjects or collection of data from the clinical medical record). The following two statements are true: 1. No subjects have been enrolled at your site. 2. No additional risks have been identified at any site. The remaining research activities are limited to data analysis. The continuing research activities are limited to those eligible for expedited review (See “CHECKLIST HRP-413 Eligibility for Review Using the Expedited Procedure”) Please attach a memorandum indicating the activities.

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Protocol Name: Principal Investigator: Primary Contact Contact Name: Info: Date: Study Numbers (IF,GCO,HSM): C. Additional Annual Institutional Approvals Required for Research Has a continuation or final report application been submitted to the No If NO, please explain: Grants and Contracts Office for this Yes research? If NO, a lack of current FCOIR disclosure forms For research that is requesting to No relating to this study for all personnel will continue, have all listed personnel Yes prevent the submission from being approved. submitted their yearly FCOIR N/A: Explain, if necessary: **Refer to Financial disclosure form relating to this study Conflict of Interest in Research (FCOIR) website or Sinai research study? closing Central module for details on this requirement and process. Yes* No D. The following questions refer to all sites involved in the research: Since the last IRB review, have subjects experienced any harms (expected or unexpected, but related)? Since the last IRB review, have subjects experienced any benefits? Since the last IRB review, have there been any unanticipated problems involving risks to subjects or others? Since the last IRB review, have any subjects withdrawn from the research? Since the last IRB review, have any subjects or others complained about the research? Since the last IRB review, have there been any publications in the literature relevant to the risks or potential benefits research? Since the last IRB review, have there been any interim findings? Since the last IRB review, have there been any multi-center trial reports? Since the last IRB review, have there been any data safety monitoring board reports? Since the last IRB review, has there been any other relevant information regarding this research, especially information about risks associated with the research? In the opinion of the principal investigator, have the risks or potential benefits of this research changed? Since the last IRB review, have there been any modifications to the research? Are there any problems that required prompt reporting that has NOT been submitted as required? *Attach a summary explanation or description for each question whose answer is “Yes.”

E. Other Documents If requesting to continue the research, provide 1 copy of the following documents, as applicable. If

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Protocol Name: Principal Investigator: Primary Contact Contact Name: Info: Date: Study Numbers (IF,GCO,HSM): any change is being requested at the time of continuing review, submit a Modification of Human Research application and the modified documents along with this submission. You may omit the current/previous version of documents, if the modified versions are being submitted with a modification request. If you are closing the research, you may provide only information not previously submitted (e.g. DSMB report, sponsor report).

 FORM HRP-211: Application for Human Research, including as applicable: o Appendix A: External Site Approvals o Appendix B: Drugs/Biologics o Appendix C: Devices  Template Protocol  Data collection instruments (questionnaires, etc.; do not submit case report forms)  All written material to be provided to or meant to be seen or heard by subjects*, including: o Evaluation instruments and surveys* o Advertisements (printed, audio, and video)* o Recruitment materials and scripts* o Consent documents*  If consent will not be documented in writing, a script of information to be provided orally to subjects*

*May be omitted if the research is permanently closed to enrollment

F. Principal Investigator Acknowledgement I agree to conduct this Human Research in accordance with applicable regulations and the organization’s policies and procedures. If I am closing this research, I agree that I have conducted this Human Research as above. Principal Investigator signature Date

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