FORMS-E: Changes to the NIH Appendix Policy for Application Due Dates on or After January 25, 2018

You may remember that we recently published a blog post detailing changes to the NIH appendix policy (NOT-OD-16-129). This notice eliminated most appendix material for NIH, AHRQ, or NIOSH applications submitted for due dates on or after January 25, 2017. An exception to this policy allowed clinical trial protocols to be included as an appendix for those applications proposing clinical trials. Please note, however, that with the upcoming debut of FORMS-E, NIH has again modified its appendix policy (NOT-OD-17-098). As of January 25, 2018, applicants can no longer include clinical trial-related materials, including protocols, in their appendices. This information will instead be captured within the new “Human Subjects and Clinical Trials Information” form. Please note that failure to adhere to this new policy may result in a rejection of the submitted application. Our Coeus team has been hard at work building in these new changes and is proud to announce that Coeus currently has system-to-system (S2S) capabilities in line with the

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Reviewing NIH Appendix Guidance

Have you recently received a warning on a grant application that included appendices? Last year NIH issued NIH-OD-16-129, which eliminated most appendix material from NIH, AHRQ, and NIOSH applications submitted for due dates on or after January 25, 2017. As a result NIH now designates only the following material as allowable or acceptable: For all applications: Informed consent/assent forms (blank) Surveys, questionnaires, and data collection instruments (blank) Items required by the FOA If appendix material is specified as required in the FOA, any review criteria for that FOA will address those materials. Any application submitted without required appendix materials will be considered incomplete and will not qualify for review For applications proposing clinical trials (in the absence of other specific instructions in the FOA): Clinical trial protocols Investigator’s brochure from an Investigational New Drug (IND) application (as appropriate for the application guidelines) Applications with appendix materials that do not fall within the exceptions outlined above will be withdrawn by the

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