[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-163049-105":53,"doc-detail-163049-en":127},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":120,"head_meta":122,"extra_data":124,"updated_unix":126},105,"en","nimh-dsmb-amendment-memo-template-july-2019-submission-guide","NIMH DSMB Amendment Memo Template - July 2019 - Submission guide","","Template memo for submitting a protocol or consent amendment to the NIMH Data and Safety Monitoring Board (DSMB). Designed for the Principal Investigator and study team, it explains how to replace instructional italic text, remove footnotes, and edit bracketed example content. 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Footnotes to instructional text should also be deleted. This text provides information on the content that should be included. Example text is included to further aid in document development and should either be modified or deleted. Example text is indicated in [brackets in regular font]. Within example text, a need for insertion of specific information is notated by \u003Cangle brackets>.  Example text can be incorporated as written or tailored to a particular document. If it is not appropriate to the document, however, it too should be deleted.\n\u000f\nPlease ensure letter is on Institutional Letter Head and signed by the study PI\nDate:\nTo: NIMH Data and Safety Monitoring Board\nFrom:\t\u003Cinvestigator name, degree>\nSubject:\tAmendment to Protocol \u003Cprotocol title, date and version #>\n1. Requested Changes and Rationale: State purpose and provide rationale for each requested change.\n2. Table of changes: add as many rows as needed to cover all amendments made\nA track changed and clean version of the complete protocol and/or consent form(s) incorporating the requested changes is included in the submission.\n3. Institutional Review Board (IRB) Approval: Please indicate if the IRB has approved this amendment. If so, please include IRB approval letter as attachment\n4.  Need to re-consent subjects: Please indicate if there is a need to re-consent subjects\n5. Impact on risk/benefit ratio: Brief assessment if the ratio is affected due to the proposed changes\nAttachments (if applicable) (i.e., IRB approval letter)","cbCaibo2DQ8rqmGb","https://ap.wps.com/l/cbCaibo2DQ8rqmGb","docx",28437,"English","# Purpose and Audience\n# How to Use This Template\n# Letter Format and Required Sections\n## Requested Changes and Rationale\n## Table of Changes\n## IRB Approval\n## Need to Re-consent Subjects\n## Impact on Risk/Benefit Ratio\n## Attachments","[{\"question\":\"Who is the intended audience for this DSMB amendment memo template?\",\"answer\":\"The template is intended for the Principal Investigator and study team members submitting a protocol and/or consent amendment to the NIMH DSMB.\"},{\"question\":\"What text should be removed or modified when using the template?\",\"answer\":\"Italic instruction/explanatory text and their footnotes should be deleted, and bracketed example text should be modified or deleted as appropriate.\"},{\"question\":\"What key sections must be included in the amendment memo submission?\",\"answer\":\"The memo should cover requested changes with rationale, a table of changes, IRB approval status (and attachment if applicable), whether re-consent is needed, and a brief assessment of impact on the risk/benefit ratio, plus applicable attachments.\"}]","NIMH DSMB Amendment Memo Template - July 2019 - Submission guide | DOCX"]