4.2.a Narrative Study Description - UCLA CTSI



4.2.a Narrative Study Description400050109220GuidelinesRequired for clinical trialsFormat: This data will be entered into a Text Field on the PHS Human Subjects and Clinical Trials Information Form. Text Field rules apply:Limited to 32,000 charactersAllowable/Unallowable CharactersUnicode, with UTF-8 encoding (i.e. Plain text only)Do NOT use smart/curly quotes or Em/Long DashDo NOT use proprietary fonts or special charactersDo NOT use formatting (font, bolding, bullets, subscript, superscript)Do NOT include tables, graphics, figuresTo format paragraph spaces, include a blank line between paragraphsTo format bulleted lists, use “list item” characters such as hyphen (-) or asterisk (*), followed by a space and then the item listContent:Enter a narrative description of the protocol, including more technical informationDo NOT include the entire protocolDo NOT duplicate information elsewhere (i.e. Eligibility Criteria, Outcomes)Describe your plans for assignment of participantsDescribe your plans for delivery of interventionsShow that your methods for sample size and data analysis are appropriate given those plansFor trials that randomize groups or deliver interventions to groups, special methods are requiredSee for additional guidanceWhen form is complete:Remove this boxVerify character limit has not been exceeded (32,000 incl. spaces)Save file as “4.2.a Narrative Study Description”00GuidelinesRequired for clinical trialsFormat: This data will be entered into a Text Field on the PHS Human Subjects and Clinical Trials Information Form. Text Field rules apply:Limited to 32,000 charactersAllowable/Unallowable CharactersUnicode, with UTF-8 encoding (i.e. Plain text only)Do NOT use smart/curly quotes or Em/Long DashDo NOT use proprietary fonts or special charactersDo NOT use formatting (font, bolding, bullets, subscript, superscript)Do NOT include tables, graphics, figuresTo format paragraph spaces, include a blank line between paragraphsTo format bulleted lists, use “list item” characters such as hyphen (-) or asterisk (*), followed by a space and then the item listContent:Enter a narrative description of the protocol, including more technical informationDo NOT include the entire protocolDo NOT duplicate information elsewhere (i.e. Eligibility Criteria, Outcomes)Describe your plans for assignment of participantsDescribe your plans for delivery of interventionsShow that your methods for sample size and data analysis are appropriate given those plansFor trials that randomize groups or deliver interventions to groups, special methods are requiredSee for additional guidanceWhen form is complete:Remove this boxVerify character limit has not been exceeded (32,000 incl. spaces)Save file as “4.2.a Narrative Study Description” ................
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