PHS Plan for N N Incl: Excl: Both Required attachment. The Plan for Instruction E New Rule for Forms V2.0 D, March 2016 398 Instruction in NIH, in Methods for Release Methods for AHRQ Enhancing Enhancing Reproducibility is Training Reproducibility required. Plan PHS Progress 014.6.1 N N Incl: Excl: Both Both Required for renewals. The Progress Report E New Rule for Forms NIH, V2.0 D, March 2016 398 Report Publication List AHRQ Release (for RENEWAL attachment is required applications for renewal Training only) applications. Plan PHS Progress 014.6.2 N N Incl: Excl: Both Both Must not be included The Progress Report E New Rule for Forms NIH, V2.0 D, March 2016 398 Report for a new or revision Publication List should AHRQ Release (for RENEWAL application not be attached for a applications new or revision type of Training only) application. Plan PHS Human 014.7.1 N N Incl: Incl: Both Required if Human A Human Subjects E Update to existing T01, T02, T03, rule 398 Subjects NIH, Subjects is on the attachment must be ‘yes’ T14, T42, T90, (removed KM1) CDC, Other Project Info form included if the T90/R90, FDA, within the same response to the TU2,T15, T32, Training AHRQ component Human Subjects T34, T35, T36, question on the Other T37, K12, D43, Plan Project Information D71, U2R form is ‘Yes’. PHS Data Safety N N Incl: Excl: Both Required if is The Data Safety E New Rule for Forms “Yes” V2.0 D, March 2016 398 Monitoring Plan NIH, selected as the answer Monitoring Plan Release AHRQ to the attachment is required “Clinical Trial?” question on the PHS if the response to the
PHS 398 Training Plan Plan for Instruction in Methods for Enhancing Reproducibility N N Incl: NIH, AHRQ Excl: V2.0 Both Required attachment. The Plan for Instruction in Methods for Enhancing Reproducibility is required. E New Rule for Forms D, March 2016 Release PHS 398 Training Plan Progress Report (for RENEWAL applications only) 014.6.1 N N Incl: NIH, AHRQ Excl: V2.0 Both Both Required for renewals. The Progress Report Publication List attachment is required for renewal applications. E New Rule for Forms D, March 2016 Release PHS 398 Training Plan Progress Report (for RENEWAL applications only) 014.6.2 N N Incl: NIH, AHRQ Excl: V2.0 Both Both Must not be included for a new or revision application The Progress Report Publication List should not be attached for a new or revision type of application. E New Rule for Forms D, March 2016 Release PHS 398 Training Plan Human Subjects 014.7.1 N N Incl: NIH, CDC, FDA, AHRQ Incl: T01, T02, T03, T14, T42, T90, T90/R90, TU2,T15, T32, T34, T35, T36, T37, K12, D43, D71, U2R Both Required if Human Subjects is ‘yes’ on the Other Project Info form within the same component A Human Subjects attachment must be included if the response to the Human Subjects question on the Other Project Information form is ‘Yes’. E Update to existing rule (removed KM1) PHS 398 Data Safety Monitoring Plan N N Incl: NIH, AHRQ Excl: V2.0 Both Required if “Yes” is selected as the answer to the “Clinical Trial?” question on the PHS The Data Safety Monitoring Plan attachment is required if the response to the E New Rule for Forms D, March 2016 Release