FORM: Modification



Use to request a modification to previously approved activityStudy Number: FORMTEXT ?????Protocol Name: FORMTEXT ?????Investigator: FORMTEXT ?????Primary Contact: FORMTEXT ?????Current Protocol StatusCheck all that are true or not applicable FORMCHECKBOX The protocol is permanently closed to enrollment at this organization. FORMCHECKBOX All subjects enrolled at this organization have completed all protocol related interventions and interactions, including interventions and interactions related to collection of long-term follow-up data. FORMCHECKBOX No additional identifiable private information about the subjects is being obtained by this organization’s investigator. FORMCHECKBOX Analysis of private identifiable information at this organization is completed. (This can be checked even if a statistical center at another organization will analyze private identifiable from subjects enrolled at this organization.)If all above are checked, submit a continuing review to close this protocol. FORMCHECKBOX Subjects are currently enrolled FORMCHECKBOX Current subjects will be notified of these changesIf either is checked, ensure that the submitted documents describe how current or former subjects will be notified FORMCHECKBOX Former subjects will be notified of these changesProvide the following documents when they have changed (provide 1 track change copy for review that indicates only the changes being made as a part of this amendment request):*To upload new versions of previously submitted documents, go to the Designer Page and locate the appropriate form under “Documents from Previous Packages that you can Revise”. Once you have located the document, click the pencil icon . You will then be prompted to upload a new version of the document.NOTE: If you fail to use the pencil icon for new versions of previously submitted documents, you will be asked to edit your submission which will delay IRB action on your amendment.Investigator Protocol (See TEMPLATE PROTOCOL (HRP-503) for instructions)Point-by-point response (For a response to modifications to secure approval, deferral, or disapproval)Evaluation of any Related Financial Interest.Appendix A of this form: External Site ApprovalsAppendix B of this form: Drugs and Device (include associated attachments, such as package insert, investigator brochure, or labeling, verification of IND/ IDE number) Written materials to be provided to or meant to be seen or heard by subjectsEvaluation instruments and surveys1Advertisements (printed, audio, and video)Recruitment materials and scriptsConsent documents (The IRB does not require an informed consent document for HUD use.)If consent will not be documented in writing, a script of information to be provided orally to subjectsForeign language versions of the aboveComplete sponsor protocol 1Grant applicationDHHS protocol and DHHS-approved sample consent document 1For Department of Energy (DOE) research, a completed “Checklist for IRBs to Use in Verifying that HS Research Protocols are In Compliance with Department of Energy (DOE) Requirements”Provide a brief description of the changes and a reason for each requested change: FORMTEXT ?????Investigator AcknowledgementI will conduct this protocol in accordance with requirements in the INVESTIGATOR MANUAL (HRP-103).Investigator signatureDate FORMTEXT ????? Must be provided by signing the IRBNet Package FORMTEXT ????? ................
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