Application for Continuing Review

Institutional Review Board

Application for Continuing Review

ENROLLMENT CLOSED – DATA ANALYSIS ONLY

This Continuing Review application should be used when enrollment is closed, no subjects remain on treatment or long-term follow-up and the research activities are limited to data analysis or report writing. Please submit this application to the IRB office by the due date noted on your renewal notification. Type the information onto this form. Do not leave blank spaces – if something is “not applicable,” please check “N/A.”

NOTE: If you can de-identify all data, with no code that could link the data to the subject, you may close the study. Please submit a Study Closure form.

Please provideone copy of signed application and any other documents, if applicable (e.g., progress reports not previously submitted to the IRB, interim analysis, publications). In addition, E-mailall documents to .

Study Information

IRB Number:
Protocol Title:
Sponsor:
Principal Investigator:
E-mail:
Study Coordinator:
E-mail:

Summary of Enrollment, Withdrawals and Subject Recruitment

1.Subjects enrolled at BCHO since initial approval (include screenings).
(If multiple study arms, phases or parts, provide a detailed summary on a
separate sheet in table format)
2.Subjects who have completed the study at BCHO.
3.Subjects not completing the study? Please check and specify the number in each category below. None
Voluntarily at subject's request
Failed Screening
Withdrawn by Investigator / Lost to follow up
Moved from area
Died
4.Explain the circumstances of any withdrawals that were noted in question 3.
5.Have there been any significant new findings (either good or bad) that should be disclosed to participants of the study?
Yes No If yes, please describe below, or attach a description.
Adverse Events
6.Have all Serious Adverse Events that required reporting to the IRB been submitted?
Yes
No. There have been no unanticipated problems, and adverse events (if any) have occurred at the expected frequency and level of severity as documented in the protocol, consent form and IB (if applicable).
Study Protocol
7.Version date of current protocol:

Comments/Remarks

Certification of the Principal Investigator: This study is submitted for expedited continuing review pursuant to 45 CFR §46.110 (8)(c). The remaining research activities are limited to data analysis only.

Principal Investigator’s SignatureDate

Continuing Review-Data Analysis Only – 03-16Page 1 of 2