Expedited Review Of

Expedited Review of

Continuing Review Form / IRB Project
Number:

IDENTIFICATION OF THE MATERIALS SUBMITTED FOR REVIEW (IC LISTS SEPARATE)

Your Continuing Review Form dated (received on ) and attachments were reviewed by Dr. on . The Continuing Review qualifies for expedited review according to 63 FR 60364-60367 (November 9, 1998) as category . The Continuing Review was .

Protocol [sponsor’s or investigator’s protocol number and identification of the change as amendment, revision or version number] dated [date of sponsors protocol change], was .

Protocol Detail revised dated .

was .

The investigator is reminded of the requirement to submit any annual grant progress reports, non-competing continuations or competing renewals to the IRB review and approval.

Based on expedited review you must address the following contingencies before final approval is granted: [If the contingencies were not fully satisfied attach the Contingencies Form]

CHANGE TO EXPEDITED REVIEW (Category E)

This study is in follow-up and was changed to Review Category E. The study qualifies for expedited review according to 45 CFR 46.110 as Research Category 8. No future subject enrollment is allowed.

FOR DELIQUENT STUDIES

NOTE TO PI: The investigator is reminded of the importance of compliance with 45CFR46. 45CFR.109(e) requires the IRB to review a study at intervals appropriate to the degree of risk, but not less than once per year. Approval for your study expired on . You signed the CRF on . This does not provide the IRB adequate time to consider the continuing review of research before the expiration of prior approval. In the future, please submit the Continuing Review form in a timely fashion (one month prior to expiration of the study). You may not enter subjects on the study before IRB approval or if IRB approval expires. In the latter case, you must immediately contact the IRB to obtain permission to continue subjects on the trial.

FOR CRFS WITH CONTINGENCIES

APPROVAL FOR YOUR STUDY WILL BE VALID FROM UNTIL ONLY AFTER THE CONTINGENCIES HAVE BEEN ADDRESSED AND APPROVED BY THE IRB

[New Projects]This research project cannot be initiated until the investigator addresses these contingencies and the response has been approved by the IRB. You must receive a letter of final approval from the IRB Office before you initiate the research project. If you do not receive such a letter, you should contact the IRB Office to obtain a copy before you initiate this research project.

[Continuing Projects] You may continue the research related activities [including study drug] in subjects previously entered in your research project however you may not enter (accrue or enroll) additional subjects until these contingencies are addressed by the investigator and the response has been approved by the IRB. You must receive a letter of final approval from the IRB Office before you continue enrollment in this research project. If you do not receive such a letter, you should contact the IRB Office to obtain a copy before you continue enrollment in this research project.

When responding to these contingencies include a cover letter that addresses each contingency point by point using the same number sequence identifier.

The revised protocol must have a revision date and the revised text must be identified.

The revised informed consent form document must have a revision date on every page. Two copies of the proposed revised informed consent must be submitted. One copy must have all deleted text identified with a strikethrough and all added text must be underlined. The second copy of the informed consent must be without revision marks and will be the IRB approved informed consent. An approved copy with the IRB stamp noting the expiration date will be returned for use in the study.

FOR CRFs GIVEN FINAL APPROVAL WITH NO CONTINGENCIES

APPROVAL FOR YOUR STUDY IS VALID FROM UNTIL .

[As the Principal Investigator you are required to ensure that this research and the actions of all project personnel involved in conducting the study will conform with the research project and it’s modifications approved by the IRB; HHS regulations (45CFR46); FDA regulations (21CFR50,56); International Conference on Harmonization Good Clinical Practice Consolidated Guideline; IRB Policies and Procedures and applicable state laws. Failure to comply may result in suspension or termination of my research project, notification of appropriate governmental agencies by the IRB, and/or suspension of your freedom to present or publish results. Any proposed changes in the research project must be submitted, reviewed and approved by the IRB before the change can be implemented. The only exception is a change necessary to eliminate apparent immediate hazards to the research subjects. In such a case, the IRB should be promptly informed of the change following its implementation for IRB review. You must inform the IRB immediately if you become aware of any violations of HHS regulations (45CFR46), FDA regulations (21CFR50,56), applicable state laws or IRB Policies and Procedures for the protection of human subjects. You are required to notify the IRB office in the event of any action by the sponsor, funding agency or FDA, including warnings, suspension or termination of your participation in this trial. You must maintain all required research records and recognize the IRB is authorized to inspect these records.

Approval of your study will expire at the end of the day (i.e. midnight) on . IRB approval is valid for a maximum period of one year with continuing review by the IRB required at least annually in order to maintain approval status. You may not enter subjects on the study before IRB approval or if IRB approval expires. In the latter case you must immediately contact the IRB to obtain permission to continue subjects on the trial. You must submit a progress report (Continuing Review Form) sufficiently (one to two months) prior to your study expiration date to permit IRB review before the expiration date.

You must inform the IRB of any unanticipated adverse event or injury no later than two (2) business days following the time it becomes known that a subject suffered an adverse event/injury. To report adverse events you must use the Internal Adverse Event Report form for internal events and the External Adverse Event Report form for external events. These forms and their instructions may be downloaded from the IRB WEB site at www.usc.edu/medicine/irb. Furthermore you must inform the IRB immediately of any significant negative change in the risk/benefit relationship of the research as originally presented in the protocol and approved by the IRB.

FOR PROJECTS WITH WRITTEN INFORMED CONSENT DOCUMENTS

Revised [Label of Informed Consent for studies with multiple informed consents] Informed Consent Document dated .

Revised [Label of Informed Consent for studies with multiple informed consents] Informed Consent Document / Script / Information Sheet dated .

Informed consent must be obtained by the investigator or person authorized to obtain informed consent from all research subjects or their legally authorized representatives. You must ensure that all project personnel involved in the process of consent/assent are trained properly and are fully aware of their responsibilities relative to the obtainment of informed consent/assent according to the IRB guidelines and applicable federal regulations.

The IRB office has stamped the approved informed consent form(s) for use in this research project. It should be photocopied, as appropriate, onto the correct letterhead for the hospital or institute. You may not use this informed consent form document to consent new subjects after its expiration date. A photocopy of this IRB approved informed consent form document(s) bearing this stamp must be used for consenting and/or reconsenting the study subjects. The study subject must sign and date the informed consent document. The person obtaining informed consent must also sign the study consent form at the time consent is obtained. One copy of the informed consent should be given to the study subject, one copy placed in the hospital medical record, and the investigator should retain one copy.

The California Health and Safety Code that provides the (minimum) statutory protection for residents of California with regard to human experimentation. The LAC/USC Medical Center subject's demographic information was obtained and according to that information the California Bill of Rights has been translated to the main languages used by the target population. The English, Spanish, Korean, Cantonese and Vietnamese versions of the California Bill of Rights are available now at the IRB website.

As a result of this new information, you are required to re-consent all study subjects (including subjects who had previously signed an informed consent) with this updated informed consent document containing the new information.

The assent of a minor subject and the permission/consent of one / both parent(s) must be obtained.

NOTE TO IRB OFFICE: Do not stamp informed consents for more than a 1 year period.

Stamp Informed Consent Document(s) From To AND

Stamp Informed Consent Document(s) From To

Diana Shycoff
Director / Darcy Spicer, MD
Chairman, IRB / Deirdre Anglin, MD
Vice-Chair, IRB / Robert Larsen, MD
Vice-Chair, IRB
Matthew Carabasi, MD
Vice-Chair, IRB
Expedited Review of Continuing Review Form / April 12, 2004 / Page 2 of 2