<p> CONTINUING REVIEW APPLICATION Johns Hopkins Medicine-IRB</p><p>Submit to: Office of Human Subjects Research 1620 McElderry Street, Reed Hall, Suite B-130 Phone: (410) 955-3008 Fax: (410) 955-4367 or (443) 287-5353 Website http://irb.jhmi.edu E-mail: [email protected]</p><p>Do not submit proposed changes on this application. If you are submitting changes, submit the “Changes in Research Application” with this application. Date Protocol expires: Application Number: Approval Granted by JHM-IRB #: Principal Investigator: Department/Division: PI Title: Email Address: Phone Number: Co-Investigators: Title of Research: A. RESEARCH STATUS: Check the applicable category below: 1. Enrollment/Recruitment has not started 2. Active Enrollment 3. Enrollment closed and participants are receiving study intervention Date Closed: Participants receiving drugs/devices (including eye drops, Lidocaine, etc) Participants receiving other research-related procedures (including protocol-specified testing, radiation, etc.) Participants were consented since last continuing review before enrollment closed 4. Enrollment Closed. Research open for collection of follow-up (including Date Closed: survival, if applicable) data and data analysis only Participants were consented since last continuing review before enrollment closed</p><p>PARTICIPANT ACCRUAL: 1. Number of participants approved for this research in original application: 2. 2. Number of participants added through IRB approved changes: 3. 3. Total number of participants approved by IRB: 4. Study population approved by IRB: a. Age Range: b. Number of participants signed a Hopkins consent form, gave oral Since Last Since Original consent, or were studied under a waiver of consent Approval Approval Male Adults Female Adults Male Children Female Children Total Enrolled</p><p>D:\Docs\2017-12-28\0eac5791ad61a8984a4804cff3446922.doc Revised 08/2007</p><p>Page 1 of 6 CONTINUING REVIEW APPLICATION Johns Hopkins Medicine-IRB</p><p> c. Number of Hopkins enrollees who failed screening (insert “0” if the Since Last Since Original study has no screening procedures) Approval Approval Male Adults Female Adults Male Children Female Children Total Screen Failures Total Hopkins Participants (Total Enrolled minus Total Screen Failures) d. For Multi-Center Studies Only Since Last Since Original Approval Approval Number of participants for total study from all sites (including “Total Hopkins Participants above) Adults Children Total for all Sites 5. Are you recruiting directly from any of the following categories? JHH/JHBMC Emergency department patients Employees/staff of the Johns Hopkins Hospital (including fellows, residents and interns) JHU School of Medicine students JHH Obstetric patients Hopkins Inpatients Hopkins Outpatients</p><p>6. Are you allowing any of the following populations to be enrolled? Adults lacking capacity to consent Non-English speakers Pregnant women, fetuses or neonates Prisoners Children who are in foster care or wards of the state.</p><p>C. FUNDING STATUS: 1. Yes No Is there monetary support for this research? If yes, complete the following: a. Sponsor or Grantor name(s): b. Grant/sponsor protocol number: c. Status: Awarded Pending Did not apply for funding d. Yes No If this research has commercial funding, is the funding in excess of $10,000? NA If yes, you may be billed for continuing review. (See Notices/Updates: April 2006 http://irb.jhmi.edu/Notices/DeskoftheViceDean/ChangesinWIRBReview.html ) 2. Yes No Is there material or equipment support for this research? (such as drug products, botanical or biological substances, or devices) If yes, complete the following:</p><p> a. Source of funding or sponsor name(s): b. Type of material or equipment:</p><p>D:\Docs\2017-12-28\0eac5791ad61a8984a4804cff3446922.doc Revised 08/2007 Page 2 of 6 CONTINUING REVIEW APPLICATION Johns Hopkins Medicine-IRB</p><p>D. RENEWAL SUMMARY: 1. Research Summary: Provide a brief summary of the research, including the purpose of the research, the research design, inclusion criteria, exclusion criteria, study population, outline of methods and significant interventions, risk and benefits, and outline of safety monitoring plan: (You do not need to complete this section if you are submitting Form A; type “See Form A”).</p><p>2. Progress Report: Briefly describe the progress of the research during the last approval period:</p><p>3. Interim Findings: Briefly describe any significant preliminary observations/interim findings during the last approval period:</p><p>4. Literature: Summarize recent (within the last year) relevant literature from peer reviewed publications (if any exist) and their relevance to your research. Note: Do not merely provide a list of publications without analysis as to significance to the research: </p><p>5. Data Safety Monitoring:</p><p>Check the type of Data Safety Monitoring Plan (DSMP): a. The principal investigator has sole responsibility for monitoring, or b. A group of designated JH faculty/staff has responsibility for monitoring, or c. An independent individual or group of non-JH individuals will have responsibility for monitoring ( e.g., coordinating center) and oversight of problem/events for this research, or d. A designated medical monitor, or group of monitors, for commercially funded or for not-for- profit sponsored studies has responsibility for monitoring, or e. A formal Data and Safety Monitoring Board (DSMB) will have responsibility for monitoring, or f. The SKCCC Clinical Research Office performs data and safety monitoring for the research. For a-e, describe data safety monitoring plan. If the research involves more than minimal risk, include procedures for analysis and interpretation of data, actions to be taken concerning specific events or end points, time points for review and reporting procedures. For e, include a description of the criteria for membership on the DSMB.</p><p>Yes No Are there any reports or interim findings generated by the DSMP? If yes, submit any reports or interim findings generated by the DSMP. If no, explain why. 6. Multi-Center Studies: Yes No Is this a multi-center study? If yes, does the coordinating center distribute multi-center trial reports? Yes No If yes, submit a copy of the most recent report. 7. Projected date of study completion: 8. Approved Protocol Changes:</p><p>D:\Docs\2017-12-28\0eac5791ad61a8984a4804cff3446922.doc Revised 08/2007 Page 3 of 6 CONTINUING REVIEW APPLICATION Johns Hopkins Medicine-IRB</p><p>Yes No Have there been any changes approved by the JHM IRB during the last approval period?</p><p>If yes, briefly describe the changes below:</p><p>Date of Description of Change: Approval 1. 2.</p><p>9. Consent/Assent: Check the type(s) of consent: Written Oral Waiver/Alteration None Number of consent forms: Yes No Will you be using the same consent form(s) without any changes? If yes, do not resubmit the consent form(s). If no, submit a Changes in Research application with the revised consent form(s) on the currently posted consent template (http://irb.jhmi.edu/Forms), with tracked changes. 10. Drugs/Substance Yes No Are marketed drugs or diagnostic reagents administered to human subjects? If yes, list the drug/substance names:</p><p>Yes No Are investigational drugs to be administered? If yes, list the drug/substance names:</p><p>Yes No Is there an Investigational New Drug (IND) number? If yes, list the IND number(s): Who holds the IND? Sponsor *Investigator *Attach the IND application annual report submitted to the FDA? If not submitted to the FDA enter projected date to be submitted Name IND holder: Yes No Did you submit the annual IND application report to FDA as the sponsor? If yes, attach a copy of the report or indicate the projected date to be submitted. ______(Submit a copy to the IRB when available) Yes No Are non-FDA approved substances (botanicals, dietary substance, etc.) administered? If yes, list the substance (botanicals, dietary substance, etc.) names:</p><p>Yes No Is there IND #? If yes, list the IND number(s): Yes No Is there an FDA letter of exemption? If yes, provide a copy of the FDA letter of exemption.</p><p>D:\Docs\2017-12-28\0eac5791ad61a8984a4804cff3446922.doc Revised 08/2007 Page 4 of 6 CONTINUING REVIEW APPLICATION Johns Hopkins Medicine-IRB</p><p>11. Devices Yes No Are medical devices used in this study? If yes, list the device(s) names: Yes No If yes, is the device FDA-approved for this indication? If an approved Humanitarian Use Device (HUD), provide HDE#: Yes No Is there an Investigational Device Exemption (IDE) number? If yes, provide IDE# and provide FDA documentation as attachment. If no, is an IDE # required? Yes If yes, list IDE#: No Yes No Has the device had 510(k) clearance? Yes No Do you believe this is a Non-Significant Risk Medical Device Research? If yes, provide to the IRB with an explanation to support your determination.</p><p>12. Radiation: Yes No Has the amount of radiation or radioactive materials changed? If yes, submit a Changes in Research Application. 13. Human Biologicals: Yes No Are fetal tissue samples collected in this research? Yes No Are any infectious or biohazardous agents or specimens obtained in this research?(Any specimens involving blood or body fluids) Yes No Has biosafety registration been renewed, or is it under review for renewal? Submit to IRB when available 14. Unanticipated Problems: Yes No During the last approval period, have there been any unanticipated problems (events involving risks to participants or others)? If yes, attach a summary of the problems. Yes No During the last approval period, has the profile of adverse events (in terms of frequency, severity, or specificity) changed from previous experience or from protocol expectation? If yes, attach a summary of the changes. Yes No During the last approval period, have any participants or others complained about the research? If yes, attach a summary describing the number and nature of the complaints, and explain whether the complaint was resolved. Yes No During the last approval period, have any participants withdrawn from the research? If yes, attach a summary describing the numbers of withdrawals and their reasons.</p><p>Yes No During the last approval period, have there been any protocol deviations? If yes, attach a summary describing the protocol deviations. 15. Information: Yes No During the last approval period, has any new information affected the reasonableness of the risks associated with the research in relation to the anticipated benefits, and/or affected the willingness of participants to enroll, or to continue in the research?</p><p>D:\Docs\2017-12-28\0eac5791ad61a8984a4804cff3446922.doc Revised 08/2007 Page 5 of 6 CONTINUING REVIEW APPLICATION Johns Hopkins Medicine-IRB</p><p>If yes, attach a summary of the new information. 16. Benefits/Risks: Yes No During the last approval period, have participants experienced any direct medical benefits as described in the consent form (if any)? If yes, attach a summary of participant benefits. Yes No During the last approval period, has there been any new risk information that would affect this research? If yes, attach a summary of this information. Yes No In the opinion of the principal investigator, have the risks or potential benefits of this research changed? If yes, attach a summary description of those changes and the rationale behind the PI’s opinion. 17. Conflict of Interest: Yes No Do any of the participating faculty (or their immediate family, staff, or students) have a financial interest (royalty, equity, or consulting) in the sponsor and/or products used in this research? If yes, submit a written statement of disclosure and request for review of conflict of interest to the designated official. If yes, list a non-conflicted designee for inclusion in the consent forms. Name of non-conflicted designee: 18. Clinical Trials: Yes No Is this research a Clinical Trial? (If no skip the next set of questions) Yes No If yes, does the JHUSOM Clinical Trials Registry policy (See Guidance at: http://irb.jhmi.edu/Policies/103_25.html?) require registration of this trial? If no, describe why the trial does not need to be registered:</p><p>Yes No Has this trial been registered? If yes, List the site where the trial was registered and the registration number. (Note: www.clinicaltrials.gov is the preferred site.) Registration Site: Registration Number: If registered on a site other that www.clinicaltrials.gov, provide justification for using this site:</p><p>If this trial requires registration but has not been registered, describe why it was not registered?</p><p>______Signature of Principal Investigator Date </p><p>D:\Docs\2017-12-28\0eac5791ad61a8984a4804cff3446922.doc Revised 08/2007 Page 6 of 6</p>