Can I Get An OnCore, Do You Want More (Money In Your Budget)

To bring you up to speed, the use of OnCore is School of Medicine policy on all studies with human subjects.  It’s canon.  We need to see that you’ve accounted for this in your submissions.  The use of OnCore is mandated to help track human subjects populations here at Wayne State and, until recently, OnCore fees were to be budgeted into all studies with human subjects.  While a good portion of budgets still need to reflect this, the mandate has been altered slightly.

 

Going forward, investigators applying for funding from non-corporate (i.e., federal and foundation) sources no longer need to include OnCore fees in their budget.  They DO, however, need to ensure that their protocol and human subjects populations are registered in the OnCore database at time of award. Please note that proposals and contracts with corporate entities (i.e. pharmaceuticals, biomarkers, and devices) that exceed $50,000 in total direct costs WILL still need to include OnCore fees in their budgets. For all funded studies (corporate and non-corporate) that wish to use OnCore as their Clinical Research Management tool, respective OnCore fees will apply.

 

This should bring some relief to federal and foundational proposal budgets that are often subject to caps.  To reiterate, however: your human subjects populations must still be registered with OnCore (this includes non-clinical trial populations).  Please be sure to contact the Clinical Research Services Center (CRSC) for assistance in registering your population,  or for questions regarding study management capabilities.

May your June submissions be fruitful!

What Do You Want From Me? A Field Guide to SoM-Level Review

School of Medicine-level review in the proposal queue has been around for a while now, but long cycles of funding can prevent even the most well-funded among us from subjection to our scrutiny.  And, as in all protocols sponsor-related, new compliance elements are being added all the time.  Here’s a quick-reference guide on what we’re looking for, and why:

 

  1. The full proposal. We have to see what is going to the agency, even if internal budgets are provided.  This way, we can say “yes, we knew that this is what Dr. X communicated to the sponsor, and we can support that with necessary School of Medicine resources.”  If you are using the system-to-system submission feature through Evisions, your full proposal is already included!  If your proposal needs to be submitted by other means (such a sponsor website), use the “Print to PDF” or similar feature to save a copy of the proposal, and upload the PDF to the “Attachments” section of the Evisions record.
  • For subcontracts: if WSU is the subcontractor, we don’t need the prime proposal, but we do need the letter of intent to subcontract, and the supporting documents that are being submitted to the prime recipient institution.

 

  1. Your internal budget. If you are doing a detailed budget on a system-to-system submission, you’re probably covered.  If, however, you are submitting a budget overview or a modular proposal, we need to verify that the funds requested are commensurate with planned funding.  This also helps us check for cost share.

 

  1. Cost share commitment forms. Speaking of cost share, any cost share commitment forms must be uploaded to the “Attachments” section of the Evisions record.  If there is a cash match commitment in the proposal, there must be evidence of the agreement of the match source uploaded.  In addition to the uploaded forms, choose “YES” on the Evisions “Proposal Budget” page as the answer to “Cost Sharing.”  This will reveal the ability to enter cost share information, such as department and index, so that the cost sharing department can verify their commitment to the cost share.
  • For over-the-cap:  In pre-award, we do not require a fully-executed cost share commitment form for the amounts over-the-cap (no Dean signature, no Fiscal Affairs signature) but we do require a department signature for awareness documentation.  Please also provide the index that will fund the cost share.  Note: over-the-cap cost share is considered “Voluntary.”

 

  1. OnCore accountability, or waiver: If you have human subjects, you have to either include OnCore fees in your budget, show how you will be cost sharing the fees, or upload a waiver to “Proposal Attachments.” Waivers are obtained from the Clinical Research Service Center, whether your project is clinical or not.  Unfamiliar with the policy?  Check out the handbook!

 

  1. Correct coding. Evisions coding is super important!  The data that is input at this phase is the basis for a whole host of reporting that affects such things as department rankings and investigator credit.  To be sure that you are getting full and accurate credit for the submission, be sure the “General Information” is input correctly; take a look at our coding table for guidance, or ask us if you’re not sure.
  • Investigator credit: This is done on the “Personnel Roster” page of the Evisions record.  If your investigator has a retreat to more than one department, s/he will have to be listed twice (or as many times as s/he has appointments) and the credit split proportionally between departments.  Confused?  Give us a shout.

 

Most of what we need to see is what your GCO also needs, with a few additions and for different reasons.  We’re not here to duplicate SPA review; we’re here to ensure the School of Medicine can support your project in a compliant way.  Remember: it’s extremely important to route your proposal before submission!  This way, every source of manpower and resources on your project is aware and on board.  The result?  Fewer headaches at award time, and more credit where credit is due.

Where we’re going, we don’t need downloads.

We’re all clear that Forms-D are being retired in favor of the new, improved Forms-E, right?  Right.  Forms-E must be used for due dates on or after January 25, 2018.  We’re all on the same page here.  This is old news.

 

BUT WAIT, THERE’S MORE!  As of December 31, 2017, downloadable Forms packages will no longer be available.  You read that correctly: downloadable application packages are no longer a thing (don’t say we didn’t warn you).  Your only options for submission after December 31, 2017 are:  system-to-system submissions (our Evisions, for example), ASSIST (your life will be easier if you just do Evisions, but OK), or Workspace (just… don’t).

 

Do yourself a favor: if you haven’t transitioned Evisions yet, do it now and get used to it for your upcoming (likely October) deadlines.  If you need help, we at RAS are happy to walk you through your application (and Tim Foley in SPA offers training on Evisions as well, if you don’t have a specific application yet).

Show Me Where It Says That

“We’ve always done it that way.”

“That’s just the way we do it.”

“I don’t know what they want to see.”

“I don’t know who to ask.”

 

In an effort to have a jumping-off point for policy compliance, we at RAS have compiled a digital, (hopefully) handy School of Medicine Policy Handbook.  Some policies originate in the SoM, some are University-wide, all affect award submission and management.  The Policy Handbook is not exhaustive (we’ll keep adding and updating), but it’s a great place to start when crafting your award strategies (and figuring why, in fact, “that’s just the way we do it”).  Let us know if you have questions!

Appendices 2017: Do Not Pass Go. Do Not Collect $200.

With the major November NIH deadlines about to pass us by, many will turn their attention to their 2017 submissions.  As you pursue your application strategies, chances are you’re considering the use of an appendix to bolster your argument for funding.  Proceed with caution: the appendix rules for 2017 are not what they once were.

 

The only allowable appendix materials in 2017 are:

  • Blank informed consent/assent forms
  • Blank surveys, questionnaires, data collection instruments
  • Funding opportunity announcement-specified items

Clinical trial applications may also include clinical trial protocols and/or investigator’s brochures from Investigational New Drug (IND), as appropriate.

 

Note that the revision of allowable appendix material has significantly reduced inclusion potential.  If you weren’t sure before whether you could submit that manuscript, good news: under the new rules, you definitely cannot!  No manuscripts allowed!

 

This announcement was made via NOT in August (check out the full text of NOT-OD-129). The penalties for submitting out-of-bounds material is withdrawal and non-review.  Ouch.   If you have questions about what this change means, or how it may affect your application, give us a shout and we’ll help you talk through it.