GOG 152 IRB APPLICATION by G101WZP

VIEWS: 2 PAGES: 5

									                                                                     Protocol No.
                                                                     Receipt Date



                                          Institutional Review Board (IRB)
                                 INFORMATION FOR CONTINUING REVIEW

      Principal Investigator:                                               Date:
      Protocol Title:
      Protocol Number:

     1) Is this Continuing Review for an Industry Sponsored Protocol
            Yes
            No
     2) STATUS OF THE RESEARCH

         A)
               Open                                       Open, Not Initiated, pending funding
               Open, Closed to Subject Accrual            Open, Not initiated (state reason)
               Open, Data Analysis Only                   Closed, Study Completed

         B) Date study was closed to subject accrual:

         C) If the study is closed to subject accrual, please answer the following:
         i. How many subjects are still active on the protocol (Please note, subjects of a chart review are not considered
         active): _________
         ii. How many of the currently active subjects are still receiving study intervention (i.e., study drug, research related
         tests and procedures, etc.): _________
         iii.How may of these subjects are in long term follow-up (i.e., all study interventions are complete and the subjects are
         only being following for disease progression or clinical outcome (Please go to
         http://www.hhs.gov/ohrp/policy/continuingreview2010.html for further information regarding subjects in long term
         followup):_________
3. Please give a brief summary of the protocol:




4.   Have there been amendments to the protocol since the last approval (either initial or the last Continuing Review
     Approval)?

               Yes – Please submit a copy of the IRB approval letter and the cover letter or Amendment Request Form (if this
            form was used) for each amendment. Do NOT submit documentation for amendments that have not yet been
            approved.
               No
5. Is an amendment being submitted with this Continuing Review?

                Yes – Please submit the Amendment Request Form.
                No


6. How many subjects were accrued in this protocol since the last Continuing Review (Please note, subjects are considered
   accrued to the study if they have signed a consent form; if this is a chart review or tissue procurement, please indicate the
   number of charts reviewed or the number of tissues that have been procured) ? ______



Revised 1-2012
 7. How many subjects have been accrued in this protocol since the initial approval (subjects are considered accrued to a study
    if they have signed a consent form; if this is a chart review or tissue procurement, please indicate the number of charts
    reviewed or the number of tissues that have been procured)? ______

                     a.   If no subjects have been recruited to this protocol since its initial approval, please provide an
                          explanation as to why and what steps will be taken over the course of the next year to improve
                          recruitment.




  8.        If this is a multisite study, how many subjects have been recruited study-wide (if available): ______

  9.        A) Did any subjects voluntarily withdraw consent since the last Continuing Review or approval?________
            If so, please indicate how many and state the reason(s) for withdrawal: ___________

            B)        Were any subjects lost to follow-up._________
                 If so, please indicate if any of these subjects had received study intervention: _________

            C. Were any subjects removed from the study by the investigator (including not passing screening if applicable)?
            _______
            If so, please state the reason(s) the subjects were removed from the study: ______________

 10. Did any subjects complain about the study since the last Continuing Review? ______
         If so, please describe the complaint(s): ______________

 11. Within the population of research subjects at WCMC and other sites, have any adverse events, expected or unexpected,
 occurred since the last Continuing Review for which ANY of the following apply? (If this is the first Continuing Review for
 this protocol, please answer within the context of since initial approval.)

        1) Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of
           hospitalization indicated; disabling; limiting self care activities of daily living. (Grade 3)(Under certain conditions, the
           reporting of Grade 3 adverse events can be waved; Please refer to the AE reporting table for further information)
        2) Life-threatening consequences; urgent intervention indicated (Grade 4)
        3) Death related AE (Grade 5)

          No
          Yes - Please submit a copy of the Adverse Event & IND Safety Reporting Table listing these events. The table template
       can be found at the following website: http://weill.cornell.edu/research/forms_and_policies/irb_forms/index.html

                     Are changes to the consent being proposed due to an AE

                                  No
                                  Yes (In addition to submitting 2 copies of the modified consent document – one clean and one
                               with highlighted changes, please submit an adverse event reporting form)


12. Please list with a brief description all incidents (e.g., protocol deviations, temporary study suspensions) or information (e.g.,
          revised drug inserts, new safety related information) which resulted in an amendment to your protocol, consent/assent,
          or data safety monitoring plan since your last Continuing Review.




13.      Has there has been a change to the risks or benefits of your study since your last Continuing Review and why.
                    No

 Revised 1-2012
              Yes-Please explain; include any information in the literature related to the risks or benefits to the subjects, the
           significance of the research, or the development of new treatment modalities




14.    Have there been any audits of this study conducted within the last year? In answering this question, consider any
       audits conducted by the sponsor, a federal agency, IRB or the WCMC Office of Research Integrity & Assurance.
       Please answer yes if there is one currently in progress, as well.
          No
          Yes - please attach a copy of the audit findings. If no such document is available, explain why no document is
       available, indicate the status of the audit below, and indicate any findings you are aware of to date.




15.    Does this research study have a Data Safety Monitoring Board (DSMB) or Data Monitoring Committee?

          No
          Yes – Please summarize any DSMB/DMC findings/reports below since the last Continuing Review approval (or
       since initial approval if this protocol is undergoing its first Continuing Review) and submit the report. Please attach
       copy of the report and/or findings to submission. If there is no report to submit, please explain below.




16.    Is this study being conducted under an IND or IDE held by an investigator at WCMC

          Yes-Please attach a copy of the last annual report submitted to the FDA, or a memo explaining why the report has
          not been submitted.
          No


 17.   Is this a human gene transfer study?

           Yes – Please attach a copy of your most recent NIH-OBA annual report (as per Appendix M-I-C-3 of the NIH
       Guidelines) to the Institutional Biosafety Committee to submit2ibc@med.cornell.edu. The deadline for this IBC
       submission is the same as your IRB Continuing Review deadline.
       If your gene transfer study is a vaccine trial, then submit a letter to the IBC with (1) a brief description of the
       protocol, (2) a summary of key study laboratory and clinical results for the last year, and (3) a statement explaining
       whether the laboratory and clinical results have had an impact on biological safety.
           No

 18.   Give a brief description of your preliminary findings.




19.    Please list all co-investigators that are currently on the protocol (Please ensure that all investigators hold a valid CITI
       course or an equivalent certificate. If you have any questions, please call 646-962-8200).

Revised 1-2012
20.    Do any investigators and/or co-investigators, or members of their families, have a Financial Interest in a business or
                    outside entity, or an Intellectual Property interest, that relates to this project?

           Yes –A signed electronic version of the WCMC Study Specific Report must be attached for each investigator
       and/or co-investigator involved in this study. WCMC investigators must complete the forms online at
       conflicts.med.cornell.edu. External investigators must complete the external form available at
       http://weill.cornell.edu/research/rea_com/SSR_External.html.
        However, if the protocol is “Closed, Study Completed,” Study Specific Reports do not need to be submitted.

           No

21.    If you answered “Yes” to question #20, have you included a disclosure of the conflict of interest in the informed
                    consent document?

          Yes
          No – Please explain why you believe that disclosure to potential subjects is not necessary or not appropriate.




       Conflicts of interest exist when investigators, their families, or the institution have financial interests that may
       compromise or present the appearance of compromising an individual’s, group’s, or institution’s judgment in
       conducting, reviewing, or reporting research. These relationships vary from those with negligible potential to those
       with great potential to influence judgment, and not all relationships represent true conflicts of interest. A fully
       informed consent is one in which all related financial interests are disclosed.

22.    Does this protocol use Human Tissue that will be obtained from the WCMC/NYPH Pathology department ?

           Yes –Please submit a copy of the Pathology Research Tissue Form located at the IRB Website:
       http://weill.cornell.edu/research/forms_and_policies/irb_forms/index.html, signed by the IRB Human Tissue
       Compliance Leader. A new Human Tissue Request Form, the most recent IRB protocol, consent form (if applicable),
       and this renewal form must be submitted each year to submit2pathology@med.cornell.edu. Upon approval of the
       continuing review, a copy of the IRB approval letter and the Human Tissue Section C must be sent to
       submit2pathology@med.cornell.edu.

          No


23.    Please indicate the HIPAA documentation associated with this protocol

                    HIPAA Authorization
                    HIPAA Full Waiver
                    HIPAA Partial Waiver
                    Exempt from HIPAA review

       Please submit the HIPAA documentation with the continuing review submission.

24.    Signatures




Revised 1-2012
                        Signature of Principal Investigator                                       Date



                Signature of IRB Human Tissue Compliance Leader                                   Date
                          (See #22on this form for details)




    Instructions for submitting the protocol application:
Electronic Submission Directions: Please submit the following to submit2IRB@med.cornell.edu:

   1.   The following documents should be submitted as a single PDF:
           a. The Continuing review form
           b. The last approved protocol; please make sure the protocol is up to date, including updating the end of study
                date, the list of co-investigators and the number of subjects to be recruited if that number exceeds what was
                originally proposed in the protocol. If any of these need to updated, then amendment will need to be
                submitted.
           c. If submitting an amendment with the continuing review, please include the amendment form and a clean and
                highlighted copy of the protocol application and any other documents as indicated in the amendment form.
           d. The last approved, stamped consents/assents, HIPAA documents, recruitment notices or advertisement
                materials any other approved, stamped materials related to the protocol and any amendment forms/approvals
                of amendments submitted since the last approval.
           e. If this is FDA regulated research, the current Investigator’s Brochure, if available, including any
                modifications.
           f. The Human Research Billing Analysis form.

   2.   If this protocol has been reviewed under the cooperative agreement, where the WCMC IRB is not the IRB of record,
        in addition to the WCMC Continuing Review form, please submit the last approved protocol and the continuing
        review documents, including the approval documents, from the cooperative institution’s IRB.

   3.   If this protocol has been reviewed as part of the CIRB, in addition to the WCMC continuing review form, please
        submit all relevant CIRB documents (CIRB facilitated review form, CIRB continuing review approval document)
        and other WCMC site specific forms (e.g. continuing review form, consent forms, advertisements, etc.).

   4.   If you are still recruiting subjects, please make the following changes to the informed consent(s):

                As per the new FDA regulations that take effect as of March 7, 2011, if this is clinical trial that is registered
                 on ClinicalTrials.gov, please include the following statement in the confidentiality section of the informed
                 consent. Previously enrolled subjects do not have to be re-consented: “A description of this clinical trial
                 will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include
                 information that can identify you. At most, the Web site will include a summary of the results. You can
                 search this Web site at any time”.
                If this study involves obtaining tissue that will be stored at WCMC (i.e., a WCMC sponsored tissue bank),
                 please add the following line to the consent under the section entitled “Why is the study being done?”: By
                 signing this consent form, you agree to give these samples to WCMC for research purposes. (This does not
                 apply if the samples will not be part of a WCMC repository or tissue bank).
                If this study involves obtaining tissue that will be stored at WCMC (i.e., a WCMC sponsored tissue bank),
                 please be sure that all references to the samples are referred to as “the samples” and not the subject’s
                 samples.
                If the study involves future genetic testing, in the paragraph that begins “You have the right to withdraw your
                 consent at any time…”, please add the following statement: Although you are free to withdraw your consent,
                 it is possible the samples may already have been used for research purposes and data derived from such
                 research will not be destroyed.


If you have any questions, call the IRB office: 646-962-8200.
Revised 1-2012

								
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