Coeus In-Person: eCat and Human Subjects Proposals

Since NIH’s release of the new human subjects and clinical trial data form in January 2018, VUMC has submitted more than 750 human subjects proposals using the new form. We have all learned a lot from this experience. This month the Coeus team invites interested administrators to discuss best practices for submitting human subjects and clinical trial proposals to NIH. Potential topics include: Granting investigators permission/access to eCat Determining data/specimens vs. human subjects Dividing a clinical trial proposal into multiple studies Exemption 4 vs. data/specimens The ‘Date of First Enrollment’ field There is limited room available, so if you are interested, please complete the form below. Interested parties will receive further communication regarding time, place, and content.   Please feel free to contact us with any questions. The Coeus team is also open to additional relevant topics and hopes this session is more of a discussion than purely an informational session.

eCat: Verifying NCT Numbers in the New FORMS-E Human Subjects Information Section

OSP would like to remind all applicants to verify that any NCT numbers listed on a grant application (Section 1 in the FORMS-E human subjects section, i.e., eCat) link to an existing clinical trial within ClinicalTrials.gov. Any incorrectly listed identifiers will error out upon submission to NIH. To check an NCT number: Visit ClinicalTrials.gov Select “Advanced Search” from either the home page or under the “Find Studies” ribbon at the top of the page Enter the NCT number in the “Study IDs” field under “Targeted Search” To locate an NCT number, use the same general search process as above but with different search terms/fields. Upon finding the intended result, the NCT number will be located under “Contacts and Locations.” If you need assistance or information on registering a new clinical trial at ClinicalTrials.gov, please visit VUMC’s ClinicalTrial.gov resource page.

Proposal Narratives in Coeus and eCat

OSP consistently receives questions about the ability of applicants to exchange and/or edit narratives after the department has routed a proposal for review and approval. This is indeed allowed; in fact, VUMC is unique in providing researchers the ability to exchange and edit narrative documents throughout the routing and approval process. These permissions are not limited to the proposal aggregator, either. Additional persons (including the PI) can be given the specific ability to upload and replace narratives through the use of the “Narrative Writer” role. To apply this role, open the proposal in edit mode, navigate to the “Proposal Roles” (Edit ⇒Proposal Roles), and click the “Users” button to search for the individual. Finally, drag the intended individual to the Narrative Writer role. The processes for replacing narratives within the relevant VUMC systems are as follows: In Coeus  Once the proposal routes and has “Approval in Progress” status, the proposal is locked for editing, with the exception of those narratives that have

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FORMS-E: R01 and R21 Parent Announcements

You may remember our recent post about NIH’s publication of clinical trial-specific parent announcements for the upcoming FORMS-E rollout. NIH has now published its R01 and R21 parent announcements. Please visit the following links for more information: R01: Non-Clinical Trial Clinical Trial Required R21: Non-Clinical Trial Clinical Trial Required For questions and concerns, please contact your OSP specialist.  

Tips of the Trade: Mechanism-Specific Instructions for SF-424 Budgets (FORMS-E)

Did you know that NIH provides a library of filtered application form instructions, organized by grant mechanism? The following instructional guides are available: Research Career Development Training Fellowship Multi-Project SBIR/STTR As always, OSP recommends consulting the individual program announcement to determine applicable instructions. Please also note that FORMS-E are required for due dates on or after January 25, 2018. For questions please contact your OSP specialist.

FORMS-E: Avoiding Redundancies

The January 25, 2018, roll-out of NIH’s FORMS-E application package is fast-approaching. The following post is part of OSP’s ongoing FORMS-E series: The new FORMS-E package requires researchers to separate their human subjects information into numerous text fields, drop-down menus, and several new narrative attachments. While much of this information already existed in FORMS-D submissions, the new format may be jarring for some proposal writers and administrators. NIH describes the new format as meeting three main administrative objectives: Using form fields to capture a greater level of detail required for peer review Creating a consistent format to present key information to reviewers and agency staff Aligning data with ClinicalTrials.gov (where possible) and positioning NIH for future data exchange with ClinicalTrials.gov In other words – the new form set is intended to make peer review faster and more consistent. The new form set also allows NIH to use proposal information to create large comparable data sets that easily lend themselves to analysis. However,

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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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FORMS-E: How to Determine if a Funding Opportunity Announcement (FOA) Accepts Clinical Trials

In line with the new requirement that all grant applications and contract proposals involving one or more clinical trials must be submitted through a Funding Opportunity Announcement (FOA) or Request for Proposal (RFP) specifically designated for clinical trials, NIH has provided guidance on how best to determine whether a specific FOA accepts clinical trials. There are two main locations to consult on the FOA: The FOA title will say whether clinical trials are required—example: “Early Phase Clinical Trials in Imaging and Image-Guided Interventions (R01 Clinical Trial Required).” Please note that only the titles of new FOAs will have this indicator. There are four possibilities: Clinical Trial Required Clinical Trial Not Allowed Clinical Trial Optional No Independent Clinical Trials [only for Career Development (K) and Fellowships (F)] Section II (Award Information) will have a section labeled “Clinical Trial?” that will not only list whether clinical trials are required, but also provide helpful information to consult when determining whether an application is

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FORMS-E: Clinical Trial-Specific Parent Announcements

NIH will begin publishing clinical trial-specific parent FOAs for select activity codes at least 60 days before the first due date after January 25, 2018. While some NIH institutes and centers will join the parent FOAs, others may publish IC-specific notices. NIH released NOT-OD-18-010 in late October. This notice details clinical trial-specific parent R01s and parent R21s and notes that, unless otherwise specified, these FOAs will accept trials of safety, efficacy, mechanistic, and other types, according to the new clinical trials guidance. However, some ICs may limit applications to mechanistic trials. For example, on November 3, 2017, NIAMS and NIMH announced that, effective immediately, they will only accept clinical trial applications proposing mechanistic studies for clinical trial parent R01 and R21 announcements. NHLBI published a similar announcement that it would only accept mechanistic studies in response to NIH parent R01 clinical trial required announcements. NIH released NOT-OD-18-001 in early November. Please consult this notice for information regarding whether independent clinical trials will be allowed on individual career development (K) awards,

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