Must See Videos and Podcasts for Human Subjects Researchers

The Grants and Contracts Office (GCO) strongly recommends that human subjects researchers take advantage of educational resources issued by the National Institutes of Health (NIH) to inform grants applications submitted for due dates on or after January 25, 2018.

A primary component of NIH’s initiative to enhance the stewardship of clinical trials is the creation of a new application form that consolidates all Human Subjects and Clinical Trial related information into one place, and also expands the information required for studies that meet the NIH definition of a clinical trial. This new form will be included in the new FORMS-E Application Packages and will be required for all applications with due dates on or after January 25, 2018.

To support this endeavor for Mount Sinai Health System (MSHS) researchers, the GCO would like to highlight the following NIH resources:

To learn more about the new Human Subjects and Clinical Trial Information form which will be included in grant application packages and contract for all human subjects and/or clinical trial research applications beginning for January 25, 2018 due dates, visit the NIH New Human Subjects and Clinical Trial Information Form web site.

For more information about conducting human subjects research at MSHS, please contact the Program for the Protection of Human Subjects.

For more information about NIH grant submissions at MSHS, please click here for a listing of Departmental Grants Specialists at the GCO who can assist you.


Helpful Hints – Summer Time and NIH Other Support

...Oh summer time,

… a beautiful time of year to relax in the sun by the beach listening to the restorative sounds of the ocean waves or at least dream about it while stuck in your clammy cubicle at work. 
… Oh summer time,

… a slower time to get to know each other better or at least to daydream about that opportunity. 
… Oh summer time,

… no time like the present to talk about how the NIH wants to get to know you better, dear senior/key personnel, through a document they call the “Other Support” page.

One type of Other Support page that the NIH wants is requested before the NIH might make that exciting award for new, resubmission or renewal applications as part of the Just In Time (JIT) process. The other type of Other Support page wants is part of the annual RPPR (i.e., non-competing) application process.  You can find instructions and helpful samples of both Other Support types here.

The Other Support (OS) page is not a portion of your Biosketch repackaged.  Pay attention to the details below and may you be rewarded with a more timely award and fewer delays in the process.

Ever hear of the “Overlap” statement that goes at the bottom of each Other Support page?  Be sure to read all about it in section “1.8 Other Support” in this NIH Supplementary Instructions document.

Other Support Page: New, Resubmission and Renewal Applications
Do Include:

  • Both active and pending sponsored projects.
  • A page for each Senior/Key Personnel.
    Is there a subaward on your project? Don’t forget to get their pages too. Same rules above and below apply for the subs.
  • An OS page for each senior/key person that says “None” if he/she has no active or pending projects.
  • Calendar months effort (e.g., 6 CM) for each sponsored project, not percent effort (e.g., 50%).  Note at Mount Sinai we use “calendar month” effort.  If you’re working with subs, they may use calendar, academic, and/or summer months effort as per their institutional policy.
  • The annual direct cost amount and not the total cost amount for each project.
  • An overlap statement at the bottom even if the overlap is “None.”
  • A commitment overlap statement at the bottom if awarding this new grant will put you over 95% effort on active sponsored projects.  Add a note to the overlap section at the bottom explaining what change you plan to make.
    Read more about Faculty Effort on Sponsored Projects in Sponsored Projects Accounting’s policy.
  • Industry awards (e.g., pharma funded clinical trials) and sponsored projects in no cost extensions.

Don’t Include:

  • The new grant –  the one you have your fingers crossed for funding.  Leave that one off.
  • Expired projects.
  • Training grants where you are listed as a Mentor.  However, are you a training grant director or participating with measurable effort (i.e., check budget – are you listed with effort)? If yes, then yes, do include on the OS page.
  • Prizes or Gifts or Major/Minor User Status on Equipment Grants.
  • Other significant contributors unless their involvement has changed so that they now meet the definition of senior/key personnel.

Other Support Page: Research Performance Progress Reports (RPPRs)
Do Include:

  • A page for each Senior/Key Personnel only when
    –  there is a new active project or projects to report on
    –  a sponsored project that was previously reported on expired or the person is no longer participating.
    Is there a subaward on your project? Don’t forget to check on their pages too. Same rules above and below apply for the subs.
  • Calendar months effort (e.g., 6 CM) for each sponsored project, not percent effort (e.g., 50%).  Note at Mount Sinai we use “calendar month” effort.  If you’re working with subs, they may use calendar, academic, and/or summer months effort as per their institutional policy.
  • The grant for which you are submitting the RPPR.  When doing so, include the effort that will be devoted in the next reporting period.
  • Active sponsored projects.
    –   Annotate what the change is; which previously active awards ended and/or which previously pending awards are now active.
  • Industry awards (e.g., pharma funded clinical trials) and sponsored projects in no cost extensions.
  • The annual direct cost amount and not the total cost amount for each project.
  • An overlap statement. See the JIT OS section above for more info.

Don’t Include:

  • Any pending sponsored projects.
  • Training grants where you are listed as a Mentor.  However, are you a training grant director or participating with measurable effort (i.e., check budget – are you listed with effort)? If yes, then yes, do include on the OS page.
  • Prizes or Gifts or Major/Minor User Status on Equipment Grants.
  • When there are only changes in levels of effort of active support.  Let’s say your co-investigator reported last year that her effort on a grant was 15% and now it’s 10%. If that’s the only change, don’t submit the Other Support page.
  • Other significant contributors unless their involvement has changed so that they now meet the definition of senior/key personnel.

Now that we’ve got the Other Support page squared away for now, here’s one final wistful note about summer…

… Oh summer time, stay with us longer.  How we enjoy you so.

Retirement of Rebecca Balentine, GCO Associate Director and Promotion of Amanda Amescua, GCO Assistant Director Announced

Rebecca Balentine and Her Team

Rebecca Balentine and Her Team
(from left to right Mary Mbabazi, Amanda Amescua, Rebecca Balentine, Olga Carr, Michelle Yoon, Edwin Berrios)

We are both saddened and delighted (for her!) to announce the retirement of Rebecca Balentine from the position of Associate Director, Grants and Contracts Office (GCO) effective Friday, April 28, 2017. She has  been an outstanding member of the GCO family, and her three year term at Mount Sinai has been a wonderful capstone to an exciting 35-year career in research administration! Her hard work, dedication, and sense of humor have been central to the success of her team, and she will be greatly missed. Please join the GCO in thanking Rebecca for her valuable years of service and wishing her well in her future travels!

While we are sad to see Rebecca go, we are also pleased to announce Amanda Amescua will be taking over her role as Assistant Director, effective May 1, 2017.  Amanda Amescua has received a well-deserved promotion from GCO Senior Grants Specialist to Assistant Director.  Amanda has approximately 10 years of experience in sponsored project administration including positions at Columbia University Medical Center, Duke University Medical Center, and the University of Texas at Austin.  We are confident that Amanda will make a fine edition to the leadership team.  Please join us in congratulating Amanda in her new role.

Reminders for Upcoming May 25 Competitive NIH Grant Application Deadline and Beyond

The Grants and Contracts Office (GCO) offers the following reminders about guidelines, updates, and policies pertaining to National Institutes of Health (NIH) grants and their administration.

Option to Report Preprints and Other Interim Research Products Effective 5/25/17 (NOT-OD-17-050)
(excerpted from NIH Notice)
Interim Research Products are complete, public research products that are not final.  A common form is the preprint, which is a complete and public draft of a scientific document. Preprints are typically unreviewed manuscripts written in the style of a peer-reviewed journal article. Scientists issue preprints to speed dissemination, establish priority, obtain feedback, and offset publication bias. Another common type of interim product is a preregistered protocol, where a scientist publicly declares key elements of their research protocol in advance. Preregistration can help scientists enhance the rigor of their work.

For applications submitted for the May 25, 2017 due date and thereafter, awardees can claim these products on their progress report publication list.  They can also report them on their RPPR as of May 25, 2017, and link them to their award in their My Bibliography account.

For complete information, please read NOT-OD-17-050.

Appendix Policy Change for NIH/AHRQ/NIOSH Applications Submitted for Due Dates On or After 1/25/17 (NOT-OD-17-035)

Updated Font Guidelines for Applications to Due Dates On or After 1/25/17 (NOT-OD-17-030)

Coming Down the Pike – Form Changes Affecting 1/25/18 Competitive Grant Applications and Beyond (NOT-OD-17-062)
The  NIH is announcing application form changes planned for competitive applications due 1/25/18 and beyond. The form changes center on consolidating human subject and clinical trial information.   Please read NOT-OD-17-062 for more information about the move form the current FORMS-D to a FORMS-E version.

Please contact Allison Gottlieb, Director, Sponsored Programs Education, GCO, if you have any questions or need additional information.

Holiday Greetings from the Grants and Contracts Office

Deadline Rhyme Just for You Before Holiday Time:

To Faculty and Staff,

From the GCO you hear sometimes once a week.
“GCO/NIH Updates” we hope is your Friday treat.
“GCO Helpful Hints” we release as need be.
Here’s one on deadlines to put under your Christmas tree
Or by a Chanukah menorah
Or a Kwanzaa candelabra
Or however you may celebrate the holiday bonanza.
Better yet, place in a high profile spot
Like a bulletin board or a trash receptacle not.
Remember these dates and submissions will go smoother
Better than plucking a four leaf cloover.
“Clover,” you say? I say, “You are right.
Now let’s get on with the rhyme, if I may be so forthright.”
ISMMS Funded Projects – One Business Day
Now that’s a call for a “Hip, Hip Hurray!”
Federal Non-Competitive Applications
Means NIH and other federal yearly continuations.
GCO policy is a two business day turnaround.
Nice to see a smile rather than a frown.
Federal Competitive Grant and Contract Applications
Those are the new /resubmission /comp. renewal submissions.
Five business days by 11 am the GCO does require.
It can save you for sure from a potential quagmire.
All other funded projects* – just one business day.
Another call for a “Hip, hip hurray!”
You made the GCO deadline. Way to go! You’re not done yet.
Wait for the GCO receipt before acknowledging faith in kismet.
InfoEd submissions do arrive like well packaged presents.
But upon review, they are missing a few segments.
Remember the GCO policy of “COMPLETE and FINAL”
Including signed Sinai Central forms and all else for no GCO denial.
Be blessed with good tidings from the GCO
For another successful year, Ho, Ho Ho.

— Allison Gottlieb, Director, Sponsored Programs Education, (and Poet Laureate) Grants and Contracts Office

For complete deadline information, click here (last page).

* Please contact your assigned Grants Specialist in advance regarding any additional time the GCO may need in the review and approval process if you are applying for a sponsored project with complex budgetary and/or administrative requirements (e.g., non- federal application with many subawards, international extramural funding agency application with nonstandard budget forms).

GCO Helpful Hints – Be a NIH Super Hero! Top 9 Ways to Avoid Potentially Fatal Foibles


GCO Sponsored Programs Education Director Allison Gottlieb’s little super hero ready for action!

Have you ever thought about quitting your day job for something more exciting and meaningful like the life of a super hero where you can take down evil villains while traveling the world at supersonic speed through fire, flood, earthquake, and wind storm?

Yes, that thought has crossed my mind once or twice but I always got cold feet at the prospect of getting bogged down by a technical snafu, like the door in the telephone booth jamming as Superman completed his costume change or Spider-Man’s under the wrist web gizmo malfunctioning.  It’s always those technicalities that can bring down an operation.  Lucky for us at Mount Sinai, our PIs don’t need to quit their day job but can remain super heroes on their own turf while avoiding those seemingly petty but potentially fatal foibles.

Here is a list of GCO’s top technical and administrative errors that will stop your NIH competitive application dead in its tracks like the Bat Mobile running out of gas or stalled on the road.

By the way, that is a photo of my son ready to battle the bad guys or perhaps NIH cyber application moles? (For those into important details, you might notice the remnants of the energy boosting power snack, chocolate, on the super hero’s face.)

#1 Driving without GPS or a Road Map? Use GCO’s Application Submission Checklist and Instructions

Use GCO’s Application Submission Checklist and Instructions each and every time you submit to the GCO (i.e., think words of encouragement and not a requirement).  There are 20 steps listed that may be applicable to your application.  Miss a step like forgetting your InfoEd eForm or all the subaward documentation or  your co-investigator has an expired FCOIR education certification? Your Bat Mobile has stalled on the road and is sinking in quicksand fast.

#2 Selecting Your Destination?  Remember to Use the NIH Assignment Request Form and NOT a Cover Letter

For those super hero vehicles that must be parked in the garage of a specific study section, remember to use the new NIH Assignment Request Form and not a cover letter.  You would select this optional form in the InfoEd SetUp questions.  Please see complete Instructions for the Assignment Request Form on the NIH site.

#3 Attention PIs and Mentors – Forgot your ID?  It’s called “Sponsor Credentials”

PIs and mentors must enter their eRA Commons ID into InfoEd.  You would enter the information in “My Profile” in “Sponsor Credentials” section. Another option is for staff working on the application to  add it in “Sponsor Credentials” box right in the Personnel tab for the investigator.  Without it, it’s like being pulled over on the side of the road for driving without your ID.  In this case, you can’t even return home. You’re just stuck out there on the open road in the hot blazing sun. Need an eRA Commons ID? E-mail, indicate your role on the project and the GCO will assign one to you.

#4 On the Wrong Road from the Get Go?  Check to Make Sure the NIH Institute / Center Will Accept your R03 or R21 Application or other non-R01 parent application

Did you know that not all NIH Institutes and Centers (IC) accept the R03 and R21 and other non-R01 applications in response to a Parent Announcement? When reading the Parent Announcement, you’ll see right at the top the “Components of Participating Organizations” section, which means the institutes/centers that will accept the application.  ICs that do not participate in the announcement will not consider applications for funding.

#5 Are these Human Subjects in My Super Hero Vehicle? What are Specimens?

Are human samples expedited, exempt, or not human subjects research?  The confusion is especially prevalent around coded or deidentified specimens. Please follow the first FAQ to help make the determination:

#6 Toll Bridge Ahead – New Enrollment Tables and Differences in Planned vs. Cumulative Enrollment

Planned means prospective enrollment; cumulative means you are using previously collected samples/specimens/data (for example, if using a biorepository). There are different instructions for completing the tables, depending on which type of enrollment is selected. For example, if you select “Planned”, but input numbers into the “Unknown” category, it generates an error, as this column is only for cumulative enrollment.  (GCO has a fill list of table validations available upon request.)  Can one select both “Planned” and “Cumulative” on the same table? No, this is not possible. It has to be either or; if using both, then two tables, one for each type of enrollment, is required.

#7 Want to Race Through the NIH Cyber Highway at Warp Speed During Rush Hour? Even Super Heroes Must Follow Traffic Rules

The warp speed button on everyone’s super hero vehicle has been disabled by Management.  It is purely ornamental and doesn’t work.  The GCO must be in receipt of the COMPLETE AND FINAL proposal, including completed and signed Conflict of Interest and Suspension and Debarment forms 5 business days prior to the NIH deadline by 11 am to guarantee an on-time delivery to NIH. In addition, please see NIH Competitive Application Due Date Information.  There always seem to be unforeseen circumstances so do plan ahead and submit on time.

  #8  Change the Radio Dial on Your Bat Mobile from the Biosketch Blues to Something More Upbeat?

GCO reminds PIs and staff in the review process that many items must be removed from the Biosketch page like pending awards, or grants completed more than 3 years ago, or completed projects that are listed as still active.  You might want to get a jump start on the process by reviewing the Biosketches prior to submission to the GCO. Please see the NIH Biosketch Instructions and Sample pages.

 #9  File Attachments: Beware of the “&” and Really Looooooooooooooooooong Attachment Titles 

Your InfoEd file PDF file attachments that get exported into the NIH forms are like little passengers in your Bat Mobile. They need to be loaded in just right.  Please follow these Dos and Don’ts adapted from:


  • Save all document attachments with descriptive filenames of 50 characters or less (including spaces).
  • Use unique filenames for all attachments in an application (or within a component of a multi-project application).
  • Use any of the following characters: A-Z, a-z, 0-9, underscore, hyphen, space, period, parenthesis, curly braces, square brackets, tilde, exclamation point, comma, semi colon, apostrophe, at sign, number sign, dollar sign, percent sign, plus sign, and equal sign.
  • Use one space (not two or more) between words or characters and do not begin the filename with a space or include a space immediately before the .pdf extension


  • Use the ampersand (“&”) since it requires special formatting.

Questions about Sponsored Projects?  Please click here for a listing of Departmental Grants Specialists at the GCO who can assist you.


What the GCO Actually Does Need From You in Your InfoEd Application

Last month GCO issued a Helpful Hints e-column on “What the GCO Doesn’t Need From You in Your InfoEd Application,” which generated some enthusiastic feedback.  So the GCO decided to let the pendulum swing the other way by offering you the Helpful Hints companion column, “What the GCO Actually Does Need From You in Your InfoEd Application.”

Here’s a list of the Top 9 Items the GCO needs to keep your project on track, in shape, and administratively healthy.

  1. Your Research or Sponsored Project Application

This one might be obvious since the GCO is the centralized office for research and sponsored project applications, but it must be not so obvious since it’s making its way to the #1 slot on this list. The list below highlights some of the more obtuse GCO submissions.  Needless to say, it is not exhaustive.

  • New Sponsored Project Application – The actual entire application.
  • Industry Sponsored Clinical Trial  – The company written protocol; GCO doesn’t need the Investigator Brochure.
  • New Project Where You (i.e., Mount Sinai) are the Sub-Award on Someone Else’s Project – Statement of Work (SOW) and relevant parts of the application if the SOW does not provide adequate information.  Refer to GCO’s Policy/Procedure Memo When Mount Sinai is the Subawardee for more information.
  • New internally funded / unfunded study – The protocol that you or a colleague wrote.  You may also use the HRP-503 Protocol Template if the project is going to the IRB.  But please, don’t give the GCO all the IRB forms.

Rule:  Whatever documentation the funding agency is asking from you, please submit that to the GCO.

  1. Your Progress Report

What is the use of a Progress Report application without a progress report?  This one is actually equally tied for the #1 slot but let’s make it # 2 to make this communication more art than science. More obtuse examples are outlined below.

  • Projects where the external funding agency requires a progress report every year- the actual entire external progress report.
  • NIH 1st No Cost Extension – Make it easy and complete this NIH 1st Time No Cost Extension and Progress Report Form.
  • Non-Competitive Continuation Where You (i.e., Mount Sinai) are the Sub-Award on Someone Else’s Project – SOW or confirmation of No Change in the SOW; and a Progress Report.  Refer to GCO’s Policy/Procedure Memo When Mount Sinai is the Subawardee for more information.
  • Internally funded study continuation or externally funded without a requirement for a progress report from the funding agency –  A progress report that you write yourself.

You may also use the HRP-212 Continuing/Final Review Progress Report if the project is going to the IRB. But please, don’t include all the other IRB forms.

Rule: When reading this column, apply the rule in #1 to # 2 too.

  1. E-Form

Forgot to click on the link at the bottom of the Internal Documents tab, choose the appropriate 1 of 2 e-forms, and complete it?  Not a problem.. The GCO will just submit your multi-million dollar InfoEd application back to after you moved major mountains to get 5 departments to sign off in 10 minutes flat and burned all your political capital to go through this routing process once again.  There’s no other workaround.  The GCO has in earnest tried.  Please remember the form and the right one at that too.  GCO takes no pride in the power of the reject button.

  1. Investigator Form (IF)  #

Think bold.  When you insert that # in your E-form, it’s like you’ve built a bridge between two cyberspace universes – InfoEd and Sinai Central, enabling your designated GCO Grants Coordinator to  transverse these parallel systems as he/she goes along methodically checking that the appropriate personnel signed off on the Sinai Central forms for your project.

Added the IF # to the box in the E-form?   Take a deep breath, internalize your achievement, and move on to the next item on the list.

Did you, by chance, insert last year’s IF #, an IF # from another project, or some other alien UFN (unidentifiable form number)?  It’s like you’ve created a volcano of confusion which can cause a meltdown of both staff as well as the actual cyberspace universes you truly seek to bridge.  New Info Ed submission = New IF #.  We’re moving on.

  1. Signed Conflict of Interest (COI) Forms and Suspension and Debarment (S&D) Form, if applicable

Now that you’ve got the IF # squared away, don’t forget the GCO can’t review your InfoEd application until all the appropriate personnel have electronically signed off on the Sinai Central COI and S&D forms (when S&D is applicable).  You don’t need to add any extra documentation in the InfoEd application.

Allison Gottlieb of the GCO reports, “If I had a nickel for every time a GCO Grants Coordinator issued an ‘Incomplete COI’ email to a PI, I’d be able to pay for private school college tuition for all my kids and that’s a lot of kids. Donations, anyone?”

Seriously, you are empowered in your spare work time to check Sinai Central to see if the investigators have signed the forms and follow up with them if you see “Status: Not started” or some other equivalent, worrisome term.   What do the statuses mean? How do you go about checking?  Go to the IF Instructions for more information and helpful tips.

  1. Up to Date Certification of COI Education Module for all Investigators

The GCO is the institutional gatekeeper for research and sponsored projects and reviews compliance with both external and internal regulations for each project under review, and that includes whether investigators are COI certified.   You don’t need to include anything extra in the InfoEd application for this requirement.

But what you can do is be proactive and check that the investigators’ education certification on your project has not expired.  It is good for four years.  How to check and what to do if it is expired?  Refer to the Sinai Central COI Education Module section of the Application Submission Checklist Instructions.  GCO must notify the COI Office of investigators who are not certified and must also remove them from NIH projects.

  1. Project with Subawards? Don’t Forget all the Subaward Documentation

This would make for a good class but until then, please do refer to GCO’s subaward policy/procedure memo.  There’s a list of what’s required. Take heed of all of the “show stopper” information in there.  Failure to include required items can result in removal of the subaward from your project.

  1. Less is Not Always More.  Include the Triple Signed Cost Sharing Memo if You Need

“Don’t worry,” your co-investigator reassures you.  “I’ve got this one covered. I’m working for free on your project.”  That might sound simple and save you the money that you need to use for something else on the project BUT you now need to jump through three administrative hurdles worth of signatures and include the signed cost sharing form in your InfoEd Application.  If you’ve put an investigator on with effort and no salary and cannot procure a triple signed cost sharing form documenting that some internal fund (i.e., not another grant fund) somewhere in the school/hospital is actually covering the cost, the GCO has no choice but to remove the investigator from your project.  Please review the cost sharing policy for more examples of cost sharing and general policy/process information.

  1. New Competitive Application to Say … the Chamber Music Society of America testing whether chamber music orchestra members are more calm and composed than heavy metal artists? Due tomorrow, but not getting funded for a year?  Wait before you submit that IRB application! GCO’s got an easier initial step.

Include a compliance waiver form signed by the PI with your InfoEd application, which explains that if the project will be funded, the PI will submit to the PPHS Office at a later time, and of course not rush the PPHS Office for immediate review if the PI forgets.  If this project were, say, with chimpanzee and zebrafish musicians, you can use the waiver form for the down the road IACUC submission too.

For additional criteria for the use of the waiver form refer to the Compliance (PPHS/IACUC) section of the Application Submission Checklist Instructions.

Got any other useful advice for your fellow investigators?  Feel free to send to to include in a future GCO Helpful Hints column.


Helpful Hints: What the GCO Doesn’t Need in Your InfoEd Application

MessyDesk_2Here’s a list of the Top 6 Items the GCO doesn’t need in your InfoEd application, which should reduce some cyber clutter and save you time.


  1. IRB Forms

Thanks but no thanks.  GCO has enough of its own forms.  If your application is a yearly continuation of an unfunded human subject project, please feel free to copy the progress report (HRP 212), which you need for the IRB submission, and submit it in the Progress Report tab in the InfoEd application.  However, please don’t send the GCO consent forms, etc. unless the funding agency is requesting you send these items to them.

  1. Biosketches

That place in the Personnel tab sure looks like a requirement. But no, only include the Biosketch if this is a System to System (S2S) application and in that case only for key personnel, Other Significant Contributors and Consultants.  Otherwise ignore.  Sorry, it is not possible to deactivate the button.

  1. Other Support

That place in the Personnel tab sure looks like a requirement too. But no.  Ignore. Only include if it is a requirement for a S2S application, which would be a rarity.  Sorry, it is not possible to deactivate the button.

  1. Extra InfoEd Budget Data Entry

Submitting a multi-million dollar NIH ASSIST project? Tons of work! Awesome and good luck! GCO only needs Y1 data entered in the InfoEd budget tab.  More budgeting shortcuts can be found in the Budgeting section of GCO’s Application Submission Checklist Instructions.

  1. InfoEd Projects Where the GCO Doesn’t Need a Budget Tab – GCO Also Doesn’t Need to Know About TBN Positions or Consultants

That’s right, less data entry on the Personnel tab. For applications that don’t need an InfoEd budget tab (e.g., any unfunded project, no cost extensions, pharma sponsored studies where the pharma company pays per subject), don’t spend time adding TBN positions or Consultants.

GCO will add this shortcut to the Application Submission Checklist Instructions.  In the meantime, take note of this shortcut.

  1. InfoEd Projects That are Non System to System – GCO Doesn’t Need to Know about Other Significant Contributors (OSC)

Got an OSC on a NIH non-competitive application?   OK, leave him or her off the Personnel tab in the InfoEd application.

GCO will add this shortcut to the Application Submission Checklist Instructions. In the meantime, take note of this short cut.

NIH Changes to Application Forms – Phase 1 Now in Effect

The NIH updates for competitive research grants and most career development award applications for due dates of 1/25/16 to 5/24/16 are now in effect. Another round of changes, which will apply to deadlines on or after 5/25/2016, is expected to be released by the NIH by 3/25/2016. Highlights of the changes are summarized below.

The major changes from Phase 1, which are now in effect, are as follows:

  1. Change to Significance and Approach Sections in Research Strategy of Research Plan: Rigor and Reproducibility requirements
  2. New Authentication of Key Resources Document (for applicable projects)
  3. Change to Human Subjects Section in Research Plan: NIH Lowers the Age Individuals are Defined as Children from under 21 to under 18
  4. Change in Vertebrate Animals Section in Research Plan

For more information, refer to NIH’s updated Application Submission Guide (FORM C 11/25/15 version), the Rigor and Reproducibility webpage, Rigor and Reproducibility FAQs,  and NIH’s Open Mike Blog.

The NIH is planning a Phase 2 of application changes, including the release an updated Application Guide in a new FORMS D version by 3/25/16.  The major changes center around new forms and other clarification and highlights are as follows:

  1. New Data Safety Monitoring Plan Form
  2. Updated Inclusion Enrollment Forms
  3. New PHS Assignment Request Form
  4. Change to Font Guidelines to Add Flexibility
  5. Biosketch Clarifications
  6. Appendix Changes

The above is not an exhaustive list of NIH application changes. If you would like more information, please e-mail for GCO’s “Special Series” e-mails or refer directly to NIH Notices NIH-OD-16-004, NIH-OD16-008, NIH-OD-16-009.


MediTract Software Launch at FACTS

The Financial Administration of Clinical Trials Services (FACTS) office is getting ready to launch MediTract, a contract life cycle management software. MediTract enables researchers to know where their contracts are located in the negotiation process.

FACTS will implement this new software to facilitate quicker turnaround time in negotiation and assist their team with Metrics reporting along with full transparency of the contract process flow.

If you would like additional information about this exciting new venture, please contact Rosaria McEntee.