Progress Report/Renewal Application

RR 406-A PROGRESS REPORT/RENEWAL APPLICATION – Dec 2009

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Progress Report Form

Category (Check One): IRB 1 IRB 2

Review Type: (Check One): Expedited Exempted Full Board

TITLE:

RP#:

IRBNet ID:

SPONSOR:

Principal Investigator:
Co-Investigators:
Other Staff:
ORIGINAL PROJECT APPROVAL DATE:
CURRENT EXPIRATION DATE:
RENEWAL PERIOD: 3 6 12 Months
Contact Person: / Phone:
Address: / E-mail:
Total Number of Subjects: / Summa / Other Sites
Expected to be enrolled at this site:
Enrolled since initial approval:
Enrolled since last review:
Enrolled and dropped:
Is the research identified above still ongoing? / Yes No
Check most applicable:
In Progress
In Progress Closed to Accrual Following # SHS Patients
Patients Still Being Treated with Research Interventions
Only Remaining Research Activity is Data Analysis
Research Remains Active Only for Long-Term Follow-Up
Completed
Please explain the status (for all items checked above):
WILL THE STUDY POPULATION INCLUDE ANY OF THE FOLLOWING? You must check if your study might include any of the following vulnerable populations. Check all that apply
Men / Fetuses
Women / Human in vitro fertilization
Pregnant Women / Children under 18 years of age
Normal Healthy Volunteers / Students
Elderly/Aged Persons >65 years old / Institutionalized (mentally infirm)
Minorities / Cognitively Impaired Persons
Employees of the PI or SHS / Terminally Ill Patients
Prisoners / Comatose Patients
Other likely vulnerable participants (Explain below) / None of the Above
1. / On a separate sheet please provide a summaryof 1)All internal Unanticipated Problems involving risks to subjects or others or adverse events/deviations that have not been reported to the IRB within this renewal period. 2) All internal Promptly Reportable Events within this renewal period. 3) Any data safety monitoring reports, if applicable. / Summary
attached
2. / Number of study subjects who died at this site since the research project was initiated: / Total #
Treatment-related mortality:
Illness-related mortality:
Uncertain etiology:
3. / Have any adverse effects necessitated a change to the consent form? / No Yes
3a. / If YES, Have these changes been approved by the IRB
If NO, attach necessary changes. / No Yes
4. / Have there been any incarcerations?
If yes, provide information regarding the incarceration. / No Yes
5. / Have there been any complaints?
If yes, provide information concerning the complaint. / No Yes
6. / Number of subjects withdrawn?
Reason(s) for withdrawal:
7. / Has the project changed in any way since the last approval?
If YES, please indicate the dates the changes were reported to and approved by the IRB and whether the change was approved via Full Board review or Expedited review. / No Yes
8. / Has there been additional or new information about this study which may affect a subject’s willingness to continue their participation, or that may need to be given to prior participants?
If YES, please explain in the progress report and provide information to be given to existing or prior participants. / No Yes
9. / Are you using a consent form for this study?
If YES, one copy (Clean copy for date stamping) of the current consent must be provided with this form. If the study is completed, the consent form does not need to be attached. / No Yes
N/A Closed to
Accrual
10. / A.Do personnel or any member of the personnel’s family involved in this research have any financial interest or relationship with a sponsor or agency that would appear to be a conflict of interest with your participation in this study? A conflict of interest is defined as any significant financial interest in the sponsoring company defined as $10,000 in the form of equity interest in a publicly held company or 5% equity interest in the company sponsoring the research (whichever is less) or significant payments of any sort that have a cumulative monetary value of $10,000;
B. Do personnel or any member of the personnel’s family involved in this research have any other type of conflict that may interfere with the safety or the rights of subjects accrued to the study or to the integrity of the data obtained from this study?
If yes to either or both of these questions, attach a letter regarding the Conflict of Interest Disclosure.
Attached / No Yes
No Yes
PROGRESS REPORT: / DESCRIBE IN DETAIL THE PROGRESS OF THIS PROJECT SINCE ITS LAST REVIEW, SPECIFICALLY:
a. / Preliminary review of results to date
b. / Abstracts/Presentations/Publications
c. / Multi-center trial report (if applicable)
d. / Summary of major protocol deviations
e. / Summary of relevant recent literature

By signing this form, the Principal Investigator certifies that he/she has disclosed to the IRB all relevant information concerning adverse events or other issues that might affect the risk-to-benefit analysis of this study.

Principal Investigator Signature / Date

Add text to answer (a) through (e) above or attach separate documents.

RR 406-A Progress Report/Renewal ApplicationPage 1 of 4