Template Communication Plan For SMART IRB
Purpose of the form: This form can be used by Reviewing IRBs and others to identify and document key communication roles for astudy. It is recommended that the form be used to document the various responsibilities. However, the form also could be used lessformally to guide conversations among the Reviewing IRB, Relying Institutions, and Lead Study Team.Template Communication Plan for SMART IRBDefinitions REVIEWING IRB – Point of Contact (POC): Main person responsible for addressing questions related to the Reviewing IRB’s policies and procedures and review status for aceded study LEAD STUDY TEAM – POC: Main person responsible for communication with the Reviewing IRB and facilitating communication between relying site study teams and the ReviewingIRB regarding the ceded study RELYING SITE – POC: Main person responsible for communication with the Reviewing IRB and local study team regarding the ceded study (e.g., personnel in the local IRB office orlocal human research protection program personnel) RELYING SITE STUDY TEAM POC: Main person responsible for communication with the Lead Study Team regarding the ceded studyROLENAME(S)CONTACT INFORMATIONREVIEWING IRB – POCLEAD STUDY TEAM – POCwww.smartirb.orgFunded by the NIH National Center for Advancing Translational Sciences through its Clinical and Translational Science Awards Program, through grant number 3UL1TR002541-01S1.SMART IRB encourages use and distribution of this content. If you extract any language, please cite SMART IRB as follows, “This information was obtained from [doc name] as part of SMART IRB, which is funded bythe NIH National Center for Advancing Translational Sciences through its Clinical and Translational Science Awards Program, grant number 3UL1TR002541-01S1.”
Communication PlanCOMMUNICATION RESPONSIBILITYCOI: Providing applicable conflict of interestmanagement plans for relying site study teams tothe Reviewing IRBRESPONSIBLE PARTYNOTESReviewing IRBLead Study TeamRelying Site Study Team(s)Relying Site(s) POC(s)Other, specify:STUDY TEAM TRAINING & QUALIFICATIONS: Providingconfirmation to the Reviewing IRB that relying sitestudy teams have completed relevant training and arequalified to conduct the proposed researchReviewing IRBLead Study TeamRelying Site Study Team(s)Relying Site(s) POC(s)Other, specify:LOCAL CONTEXT INFORMATION: Providing localcontext information to the Reviewing IRB regardingstate laws and institutional requirements that pertainto the review of the ceded studyReviewing IRBLead Study TeamRelying Site Study Team(s)Relying Site(s) POC(s)Other, specify:IRB APPLICATION – STUDYWIDE: Preparing andsubmitting the studywide application for initialIRB review and studywide amendments to theReviewing IRBReviewing IRBLead Study TeamRelying Site Study Team(s)Relying Site(s) POC(s)Other, specify:www.smartirb.orgFunded by the NIH National Center for Advancing Translational Sciences through its Clinical and Translational Science Awards Program, through grant number 3UL1TR002541-01S1.SMART IRB encourages use and distribution of this content. If you extract any language, please cite SMART IRB as follows, “This information was obtained from [doc name] as part of SMART IRB, which is funded bythe NIH National Center for Advancing Translational Sciences through its Clinical and Translational Science Awards Program, grant number 3UL1TR002541-01S1.”
COMMUNICATION RESPONSIBILITYRESPONSIBLE PARTYIRB APPLICATION – SITE-SPECIFIC: Preparing andsubmitting the site-specific applications and sitespecific amendments to the Reviewing IRB thataddress site variations in study conduct, informedconsent language, HIPAA Privacy Rule requirements,subject identification and recruitment processes(including recruitment materials), and any otherapplicable components of the researchReviewing IRBIRB DETERMINATIONS: Providing documentation ofIRB determinations to relying site study teamsReviewing IRBNOTESLead Study TeamRelying Site Study Team(s)Relying Site(s) POC(s)Other, specify:Lead Study TeamRelying Site Study Team(s)Relying Site(s) POC(s)Other, specify:IRB-APPROVED DOCUMENTS: Providing copies ofIRB-approved materials to the lead study teamReviewing IRBLead Study TeamRelying Site Study Team(s)Relying Site(s) POC(s)Other, specify:IRB-APPROVED DOCUMENTS – RELYING SITES:Providing copies of the most current versions ofIRB-approved materials to relying site study teamsin a timely mannerReviewing IRBLead Study TeamRelying Site Study Team(s)Relying Site(s) POC(s)Other, specify:www.smartirb.orgFunded by the NIH National Center for Advancing Translational Sciences through its Clinical and Translational Science Awards Program, through grant number 3UL1TR002541-01S1.SMART IRB encourages use and distribution of this content. If you extract any language, please cite SMART IRB as follows, “This information was obtained from [doc name] as part of SMART IRB, which is funded bythe NIH National Center for Advancing Translational Sciences through its Clinical and Translational Science Awards Program, grant number 3UL1TR002541-01S1.”
COMMUNICATION RESPONSIBILITYCONSENT FORM TEMPLATE: Providing the consentform template to relying site study teamsRESPONSIBLE PARTYNOTESReviewing IRBLead Study TeamRelying Site Study Team(s)Relying Site(s) POC(s)Other, specify:CONSENT FORM LANGUAGE: Incorporating sitespecific language into consent form(s) and providingthese consent form(s) to the Reviewing IRBReviewing IRBLead Study TeamRelying Site Study Team(s)Relying Site(s) POC(s)Other, specify:REVIEWING IRB POLICIES: Providing relevantReviewing IRB policies to the lead study teamReviewing IRBLead Study TeamRelying Site Study Team(s)Relying Site(s) POC(s)Other, specify:CONTINUING REVIEW INFORMATION: Obtaining andcollating studywide information for continuing reviewto the Reviewing IRBReviewing IRBLead Study TeamRelying Site Study Team(s)Relying Site(s) POC(s)Other, specify:www.smartirb.orgFunded by the NIH National Center for Advancing Translational Sciences through its Clinical and Translational Science Awards Program, through grant number 3UL1TR002541-01S1.SMART IRB encourages use and distribution of this content. If you extract any language, please cite SMART IRB as follows, “This information was obtained from [doc name] as part of SMART IRB, which is funded bythe NIH National Center for Advancing Translational Sciences through its Clinical and Translational Science Awards Program, grant number 3UL1TR002541-01S1.”
COMMUNICATION RESPONSIBILITYCONTINUING REVIEW SUBMISSION: Submittingcontinuing review progress report to the Reviewing IRBRESPONSIBLE PARTYNOTESReviewing IRBLead Study TeamRelying Site Study Team(s)Relying Site(s) POC(s)Other, specify:REPORTABLE EVENTS: Reporting reportable eventsto the Reviewing IRB (e.g., unanticipated problems,noncompliance, subject complaints)Reviewing IRBLead Study TeamRelying Site Study Team(s)Relying Site(s) POC(s)Other, specify:CLOSURE REPORTS: Providing the Reviewing IRB withrequired information when a study is closed.Reviewing IRBLead Study TeamRelying Site Study Team(s)Relying Site(s) POC(s)Other, specify:www.smartirb.orgFunded by the NIH National Center for Advancing Translational Sciences through its Clinical and Translational Science Awards Program, through grant number 3UL1TR002541-01S1.SMART IRB encourages use and distribution of this content. If you extract any language, please cite SMART IRB as follows, “This information was obtained from [doc name] as part of SMART IRB, which is funded bythe NIH National Center for Advancing Translational Sciences through its Clinical and Translational Science Awards Program, grant number 3UL1TR002541-01S1.”
Title: Template Communication Plan for SMART IRB Subject: Institutions can use this template to document key communication roles, such as submitting initial and continuing reviews, amendments, and reportable events to the Reviewing IRB; providing conflict of interest management plans to the Reviewing IRB; and pr oviding IRB-approved docume
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