ࡱ>  5bjbj E-1888x_0oST,^^^^^^^$$ac^M"o^883_(###88^#^##2mXp[@ XM Z.^<_<x_/Zd_!<d\[d[sr#\AT^^"x_d : Saint ֱοƵ University Institutional Review Board INSTRUCTIONS FOR COMPLETING THE CHANGE-IN-PROTOCOL/FOR INFORMATION/UP FORM (the form follows these instructions) For submission of changes affecting an existing protocol: Complete this form and with it, submit any affected IRB materials needing revision (IRB application/protocol, consent documents, etc). Highlight (in yellow) changes to the materials being revised and give documents a revised version date. Please provide the entire revised documents (not just revised pages). If the changes increase risk to subjects or make substantial alterations to the protocol, submit an original set of revised materials and three (3) complete copies. Otherwise, submit one original set of revised materials. Revisions to a consent document and/or a HIPAA authorization document: If computer highlighting/shading is used to indicate changes to a consent document, also provide a clean copy (i.e., without shading) for the IRB to stamp upon approval. The stamped document is the one you will use as your new original from which to make copies. You do not need to submit the most current HIPAA authorization form if no changes are made to the document. For studies with currently accrued subjects: You may submit a new addendum consent document that discusses specific changes instead of having subjects sign a revised consent document (see HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/consent_addendum_template.doc"Model Addendum Consent on the IRB website). This may make discussion of the changes easier. The main consent may still need to be revised for subsequent subjects unless the study is closed to accrual. You may provide subjects with a letter if subjects do not need to be re-consented (e.g., for low risk studies or minor changes). Please indicate your intent in your response to questions #4 and #5 below. For sponsored studies: Please note that changes to the sponsors protocol also will need to be highlighted (in yellow) if applicable. Briefly summarize the sponsors changes in the CIP form so that the IRB will know what the changes involve. You may reference the amendment and amendment date in question #1 and attach the summary, but this alone will not suffice. Forms with incomplete descriptions of changes may be returned to the investigator. If your SLU protocol refers to sections or page numbers from the sponsors protocol, make sure your references are still correct because the sponsors protocol may have changed. To change the Principal Investigator (PI), please provide a revised IRB application/protocol (and consent documents, including HIPAA authorization, if appropriate) with new information. The PI listed at the top of the change-in-protocol form should be the outgoing PI. Section 1 should describe the change to the new PI and sections 2-5 should be completed as appropriate. The change in protocol form and revised IRB application should be signed by the new PI. NOTE: Per the Food and Drug Administration (FDA), protocol amendments must receive IRB review and approval before they are implemented, unless an immediate change is necessary to eliminate an apparent hazard to the subjects (21 CFR 56.108(a)(4)). Those subjects who are presently accrued and actively participating in the study should be informed of the change if it might relate to the subjects' willingness to continue their participation in the study (21 CFR 50.25(b)(5)). FDA does not require re-consenting of subjects that have completed their active participation in the study, or of subjects who are still actively participating when the change will not affect their participation, for example when the change will be implemented only for subsequently accrued subjects. For submission of For Information Only materials: Complete this form and with it, submit one set of the informational material (e.g., general sponsors correspondence). If an investigators drug brochure has been updated but the study is not affected because the information has been supplied to the IRB before, the updated version can be submitted for information only. However, new risk information not previously reported, would be considered a change-in-protocol submission. For submission of Unanticipated Problems (UP) : If reporting an Unanticipated Problem (UP), please review reporting HYPERLINK "http://www.slu.edu/Documents/research/IRB/Safety_Reporting_Requirements.doc"guidelines. Then complete this form and with it, submit one set of any related/supplemental materials. Please do not submit these instructions with the form SAINT LOUIS UNIVERSITY *IRB #: Institutional Review Board (IRB) Caroline Bldg, Room C110 (314) 977-7744 Fax (314) 977-7730 REQUEST FOR IRB APPROVAL OF A CHANGE-IN-PROTOCOL OR FOR INFORMATION ONLY OR UNANTICIPATED PROBLEM NOTIFICATION If an approved study requires a change, this form should be submitted to the IRB along with any pertinent materials for review by the IRB prior to implementation (however, changes may be implemented immediately when it is necessary to eliminate apparent hazards to subjects). This form may also be used to notify the IRB of study related information or unanticipated problems. *Please fill in the IRB# (top right corner) for the affected study. (cells below will expand as needed) DATE: Contact Person (if not PI): Principal Investigator: E-mail: Department or Address: Phone/Pager: Study Title: FOR INDUSTRY SPONSORED STUDIES ONLY (IRB FEES): FORMCHECKBOX  Bill Sponsor - OR -  FORMCHECKBOX  Bill SLU DepartmentSponsor/CRO Name: Protocol Number: Sponsor/CRO Contact: Address: E-Mail: Phone: SLU Contact Name: SLU Billing Address: E-Mail: Phone:  Number of accrued subjects:Status of study: (check one) FORMCHECKBOX  Continuing to accrue study subjects  FORMCHECKBOX  Closed to accrual Date closed: __________________Special populations (mark as applicable) FORMCHECKBOX  Children (< 18 yrs of age)  FORMCHECKBOX  Prisoner population targeted or study participant became a prisoner Check one:  FORMCHECKBOX  This submission involves a Change to an existing protocol Complete all sections of this form  FORMCHECKBOX  This submission is For Information Only Complete section 1 only   FORMCHECKBOX  This submission is reporting an Unanticipated Problem (UP) How many UPs have been submitted similar to the event being reported? UP with NO changes, complete question 1 only. UP with changes, complete all sections on this form 1) Provide a description of the submission referenced above. If the submission involves a CHANGE, please provide a description of the change(s) in the box below, including the type of change AND what the change involves. For example Personnel changes include replacing Mary Smith with Ann Jones or Amendment #2 dated xx/xx/xx involves the addition of another X-ray. NOTE: If you are submitting a change that originated from an external sponsor, your response below should include the date of the sponsors correspondence and a brief description of the changes. Include the summary with this submission. If the submission is FOR INFORMATION ONLY, describe what is being submitted and include any relevant dates (general correspondence dated xx/xx/xx, version dated xx/xx/xx, etc.) If the submission is reporting an UNANTICIPATED PROBLEM, describe the event, the date the event occurred, the location where the event occurred, and any actions taken as a result of this event.  2) If the submission involves a change, provide the justification (reason) for the changes described above in #1. You may refer to a sponsors summary if the justification is provided in the summary.  3) Does the SLU IRB Protocol (application/protocol) need to be modified?  FORMCHECKBOX  Yes  FORMCHECKBOX  No 4) A: Does the consent document need to be modified?  FORMCHECKBOX  Yes In the box below, list affected consent documents (e.g., main consent or assent document, new sub-study, or new addendum consent document) and indicate which section(s) were modified. Please submit a revised consent document, a newly-prepared addendum consent, etc. addressing specific changes. Please update the version date (i.e., the footer) for all affected documents.   FORMCHECKBOX  No In the box below, explain why the consent document does not need updating (subjects are not affected by the change, the study is closed to accrual, a waiver of consent was granted for this study, etc.):  B: Does the HIPAA Authorization document need to be modified?  FORMCHECKBOX  Yes , A revised HIPAA authorization document is included.  FORMCHECKBOX  No  FORMCHECKBOX  Not Applicable NOTE: If the study has not accrued (enrolled) any subjects, please skip question 5. 5) Do currently accrued subjects require notification of the changes? (For example, changes to the role/participation of the subjects, and/or the addition of risks would warrant notification.)  FORMCHECKBOX  Yes In the box below, please explain how AND when notification or re-consenting will occur:   FORMCHECKBOX  No In the box below, please indicate why notification will not occur:  FORMCHECKBOX  Changes are only minor or administrative (e.g., personnel, grammar, formatting changes) FORMCHECKBOX  Subjects are no longer receiving active study treatment  FORMCHECKBOX  This study was granted a waiver of consent  FORMCHECKBOX  Other; please explain: Proposed changes may not be initiated without IRB approval, except when necessary to eliminate apparent immediate hazards to study participants. If the changes increase risk to subjects or make substantial alterations to the protocol, submit an original set of revised materials and three (3) complete copies. Otherwise, submit one original set of revised materials. Please provide the entire revised document (protocol, consent form, etc.) not just revised pages and be sure to highlight the changes on all sets of materials. Update the version date on affected SLU documents. 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