Application For Continuing Review And Study Closure

IRB #: Date of IRB Expiration: Principal Investigator: Study Title: NCT#: Abington Memorial Hospital Institutional Review Board Application for Continuing Review or Study Closure Please complete ALL sections of this form whether applying for Continuing Review or Study Closure.

1. STATUS OF THE RESEARCH Check the one choice that best describes the current state of the research: No participants have been enrolled to date. Recruitment and/or enrollment of new participants or review of records/specimens continue. Study is no longer enrolling, but participants still receive research-related interventions, (e.g., still receiving treatment, obtaining blood draws).

Study is no longer enrolling and participants have completed research-related interventions. The study remains active only for long-term follow-up. IRB fees do not apply. Study enrollment is permanently closed, participants have completed all research-related interventions, and long-term follow-up has been completed. The remaining research activities are limited only to data analysis that may require contact with records or specimens. IRB fees do not apply.

2. CLOSE THE STUDY Final study report, progress reports, and publications are to be submitted to the IRB as they become available. Close the study. Enrollment and follow-up are complete and no further contact with participants/records/specimens is anticipated. Describe the reason for closure (i.e., enrollment goals achieved, reason for early termination) and include closure date. IRB fees do not apply.

3. SUMMARY OF PROGRESS SINCE THE PREVIOUS IRB CONTINUING REVIEW APPROVAL * Record numbers reflective of activities where an AMH investigator is involved in the conduct of the research or is responsible for regulatory reporting (i.e., adverse events, progress reports):

A. Maximum number of participants previously approved by the AMH IRB to be consented by this PI for the life of the study

B. Total number of participants consented by this PI to participate to date (including any withdrawals by participant, deaths, PI or sponsor OR consented screen failures) How many of these participants completed the study to date? How many of these participants are deceased to date? How many of these participants are still in follow-up to date? How many of these participants were withdrawals/transfers to date?

C. Total number of participants consented by this PI since the previous IRB continuing review approval* (including any withdrawals by participant, deaths, PI or sponsor OR consented screen failures) How many of these participants completed the study since the previous IRB review? How many of these participants are deceased since the previous IRB review? How many of these participants are still in follow-up since the previous IRB review? How many of these participants were withdrawals/transfers since the previous IRB review?

4. Are there competing studies or studies that require the same eligibility criteria? YES NO If Yes, List all other competing studies that you currently have open to enrollment and the number enrolled in the past year:

5. Yes No Has the adverse event profile experienced by participants differed from that expected since the most recent IRB continuing review approval*? (“Adverse event” as defined here means any untoward or undesired outcome of the research, including both serious and non-serious events, expected and unexpected events, and events related and unrelated to the research.) If “Yes”, attach a narrative summary describing how the adverse event profile differs from expected.

Application for Continuing Review or Study Closure (Form #1101) 1 Form Revision Date: March 26, 2010 IRB #: Date of IRB Expiration: Principal Investigator: Study Title: NCT#: 6. Yes No Is an Independent Safety Monitor or Data Safety Monitoring Board (DSMB) assigned to periodically review data from this study for risks to participants? If “Yes”, how often does the monitor or board perform a review?

Yes No Has the Independent Safety Monitor or Data Safety Monitoring Board (DSMB) provided any reports of its reviews? If “Yes”, attach copie(s) of the report(s) and a narrative summary.

7. Yes No Since the previous IRB continuing review approval*, have all unanticipated problems involving risk to participants or others that require prompt reporting to the IRB been reported? If “No”, provide the IRB with the required reports within 5 business days.

8. Yes No Since the previous IRB continuing review approval*, have any unanticipated problems involving risks to participants or others occurred at non- AMH sites and, in the case of multi-center research, sites where a AMH investigator is not involved in the conduct of the research? If “Yes”, attach a narrative summary describing the unanticipated problems involving risks to participants or others, including the number of events.

9. Yes No Since the most recent IRB continuing review approval* have any participants withdrawn from the research? If “Yes”, attach a narrative summary describing the reasons for the withdrawals.

10. Yes No Since the most recent IRB continuing review approval* have there been any participant complaints regarding the research? If “Yes”, attach a narrative summary describing the complaints.

11. Yes No Since the most recent IRB continuing review approval* have any literature relevant to the research been published? If “Yes”, attach copies of the publications and a narrative summary.

12. Yes No Since the most recent IRB continuing review approval* have there been any interim findings? If “Yes”, attach copies of the interim findings and a narrative summary.

13. Yes No Since the most recent IRB continuing review approval* have there been any progress reports on the research? If “Yes”, attach copies of the progress reports and a narrative summary.

14. Yes No Since the most recent IRB continuing review approval* have there been any multi-center trial reports? If “Yes”, attach copies of the reports and a narrative summary.

15. Yes No Since the most recent IRB continuing review approval* have there been any other information relevant to this research discovered, especially information about the risks and benefits associated with the research? If “Yes”, attach copies of the information and a narrative summary.

16. Yes No Since the most recent IRB continuing review approval* have you had any problems recruiting subjects? If “Yes”, attach a narrative summary describing the problems recruiting subjects.

17. Yes No Since the most recent IRB continuing review approval* have subjects experienced any benefits? If “Yes”, attach a narrative summary describing the subject benefits. 18. Yes No Did the IRB require the use of a written informed consent document for this study? If “Yes”, submit a copy of the currently approved informed consent document (used for the previous IRB continuing review approval* period) AND two clean copies of the identical informed consent document for approval and date stamping for use during the next approval period. Application for Continuing Review or Study Closure (Form #1101) 2 Form Revision Date: March 26, 2010 IRB #: Date of IRB Expiration: Principal Investigator: Study Title: NCT#: 19. INVESTIGATOR’S CONFLICT OF INTEREST (COI) STATEMENT

Yes No Has a new conflict of interest developed since the previous IRB continuing review approval* for the Principal Investigator or key study personnel? Assessment should include anyone listed as Principal Investigator, or other research personnel on page 1 of the IRB application. Please note that the thresholds of ownership described below apply to the aggregate ownership of an individual investigator, his/her spouse, domestic partner and dependent children (e.g., if an investigator, his/her spouse, domestic partner and dependent children own together $10,000 or 5% worth of equities in the sponsor, it should be reported below). Do not consider the combined ownership of all investigators.

Yes No If “Yes”, has this COI been reviewed by the AMH Conflict of Interest Committee?

19. CONTACT INFORMATION

Principal Investigator Information: First Name: Middle Initial: Last Name: AMH ID:

Phone: Fax: Pager: Email:

Study Contact Information (complete if primary contact is different from PI) NA First Name: Middle Initial: Last Name: AMH ID:

Phone: Fax: Pager: Email:

20. BUDGETARY AUTHORIZATION

Yes No Is this continuing review for an Industry-Supported study? (If so, it is expected that the sponsor will pay the IRB continuing review fee of $500 at the time of submittal to the IRB.) If “yes”, I have attached a check payable to the “Abington Memorial Hospital IRB” in the amount of $500

21. RISK ASSESSMENT

A. Please check appropriate risk level for study:

Significant - Periodic review within 6 months of approval (studies involving genetics, medical devices and studies that have a large number of toxicities) Non-significant - Periodic review within 1 year of approval

B. Reason for risk level chosen above:

22. PRINCIPAL INVESTIGATOR’S ASSURANCE STATEMENT

In addition to the above responses, I confirm that a current IRB-approved consent form has been signed, dated, and is retained in my files for every participant enrolled in this study and a copy was provided to the person who signed the form (if use of a consent form was required). I also confirm that no changes to study procedures or the consent form(s) were initiated without prior IRB approval.

______Principal Investigator’s Signature Date

*IRB initial study or continuing review approval

Application for Continuing Review or Study Closure (Form #1101) 3 Form Revision Date: March 26, 2010