ClinicalTrials.gov Spotlight Series: Understanding ClinicalTrials.gov Registration and Reporting Dates

As of January 17th, 2018 the new NIH penalties for non-compliance with Clinicaltrials.gov registration and reporting went into effect. The potential penalties are financial, at over $11,000 per day of non-compliance, and may impact continued funding of both existing and future NIH awards.

What you need to know to achieve compliance:

Understanding the Date & Deadline requirements

When registering a study in ClinicalTrials.gov, specific dates must be provided – if the PI is uncertain about an exact date, the best anticipated date must be provided until an actual date is available.  Dates cannot be left blank.

What are the dates that must be provided?
*A primary outcome measure is the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one. For more information see, ClinicalTrials.gov Outcome Measures & Statistical Analyses Module.
Source: https://clinicaltrials.gov/ct2/about-studies/glossary

NOTE:

  • In some cases the primary completion date and study completion dates are the same.
  • In other cases, the primary outcome measures may be collected much earlier than the secondary. And yes, results for the primary outcome measure must be posted within 1 year of this date.

Other deadlines to remember

  • Records must be updated every 12 months.
  • Records must be updated within 30 days of Recruitment Status changes or amendments that affect information in ClinicalTrials.gov record, especially recruitment status, location and contact information.
  • Records must be updated within 30 days after the completion date (last data collection).
  • After initial submission of registration data, the ClinicalTrials.gov Quality Assurance team may respond with queries. The PI has to respond within 15 days (yes, this includes weekends).
  • After initial submission of Results, the ClinicalTrials.gov Quality Assurance team may respond with queries. The PI has to respond within 30 days.

All unmet dates and deadlines trigger errors in ClinicalTrials.gov  and a status of “non-compliance” in ClinicalTrials.gov.

Questions? Please open a ticket via the ORS Research 411 Portal’s ClinicalTrials.gov Assistance form.

 

Occupational Health and Safety Questionnaire “Renew Button” Introduced

As you are aware, for all personnel having direct or indirect exposure to laboratory animals, the Public Health Service Policy on Humane Care and Use of Laboratory Animals IVA.1f requires Institutions involved in biomedical research to have an Occupational Health and Safety Program (OHSP) aimed at protecting the health of personnel who have direct or indirect exposure to laboratory animals. The Occupational Health and Safety Questionnaire that exists online via Sinai Central must be completed annually.

In an effort to facilitate annual renewals, a “Renew Button” has been introduced. The renew button will allow all members of the research team to:

  1. Submit the form ‘B’ to the Employee Health Service (EHS) annually for review
  2. ‘Renew’ option will be available for the life of the protocol (until final report is submitted).

As a reminder, non-compliance in the timely filing of the OHSQ could delay the approval of IACUC Applications.

If you have any questions regarding the Occupational Health and Safety program or the Questionnaire please contact the Employee Health Service (212-824-7014), the Biosafety Officer (212-241 -5169) or the IACUC Office at 212-241-0153.

PPHS Reaches Out to the Research Community for Feedback on their Next Update to the Consent Template

The Program for the Protection of Human Subjects (PPHS) has announced a March 14th event, at which members of the research community are asked to provide their opinions and expertise regarding the informed consent template that will become active in the near future. Stemming from their desire to update the template according to proposed changes to the Common Rule, this revision will address both the PPHS’ own concerns and the feedback provided in this open forum workshop.

For more information about the specific terms under consideration to review in preparation to participate, please view the PPHS Master Consent Template Revisions Workshop calendar event.

Announcements and updates about this forum will be made via the Research Listserv via the Human Subjects Research Events category. If you are not (or are not sure if you are) subscribed to this list, please enter your email under Research Listserv on the Research Portal Getting Started page (within the MSHS firewall) to check your current subscriptions and subscribe if needed.

Changes to Human Subjects Certificates of Confidentiality

As previously indicated in communication from the Program for the Protection of Human Subjects (PPHS), all NIH funded protocols that were active on December 31, 2016 (or commenced after that date) and involve human subjects, activities using or generating identifiable human subject data or samples, or the generation of individual level, human genomic data was automatically granted a certificate of confidentiality (CoC) by the NIH, effective October 1, 2017 (Please see the PPHS announcement for details).

In order to assure that the affected participants in qualifying protocols have been, or will be, notified, the PPHS requires that the Principal Investigator submit a copy of the Investigator’s CoC Notification Form for each protocol that received a CoC on October 1, 2017. While it is not required that the plan be fully executed at this time, it is important that the form(s) acknowledging that the plan is being implemented are sent to IRB@mssm.edu as soon as possible, if not done so already.

The PPHS has drafted a letter describing the pertinent information for participants (Spanish translation available upon request); however, research teams that choose to mail/email the letter to participants must also draft a cover letter reminding participants of the study and providing contact information for the study team in the event the participants may have questions. Please note that the original deadline for sending the letter to all participants, or notifying the PPHS that the task has not yet been completed was October 31, 2017.

If you have chosen to contact participants directly (e.g. phone, in-person), you should still complete the Investigator’s CoC Notification Form as soon as possible, if not done so already. If you have not spoken with all participants by November 30, 2017, you will need to re-contact the PPHS with an update on your progress.

If you have not already completed the above mentioned steps, please submit the Investigator’s CoC Notification Form upon receipt of this email, and reference the Guidance and Policies section of the PPHS website for additional details.

 

InfoEd Instructions For Submissions Started Prior to Upgrade

The Grants and Contracts Office conducted a major upgrade of InfoEd on Friday, November 17, 2017, and it may have affected some users’ submissions. Researchers may need to take additional steps to ensure that their submissions are properly completed.

If you started your project in InfoEd prior to the upgrade, which began at 5 pm of 11/17, and it has not already been received by the GCO, please be aware that finalizing, routing and sign off may be impaired since the old template will not convert to the new template properly without a manual intervention.  Below are the steps to fix it:

  1. Go into the Setup Questions > Please select a Submission Mechanism/Screen Template.  In this drop down, select any choice.  Then re-select yours. This refreshes the program and creates the correct InfoEd application.
  2. You must re-upload your Lay Summary, Research Plan, Progress Report, and/or Final Report in the appropriate tabs.
  3. You should now see the eForm as a stand alone tab.  If it’s new, the eForm is called “New/Competitive Renewals/…”.  For other projects, it is called “Non-Competi Cont/Supplement…”
  4. On the eForm, please answer q. 16 re: location again.

Technical support for InfoEd applications is available by opening a Ticket with Research IT.

 

InfoEd Upgrade Prompts GCO Advice to Research Community

Some of us may strive to be like a robot achieving our goals in the most efficient and systematic way possible. Others may resemble this robot before drinking their morning coffee. Wherever we may fall in this inner and outer robotic spectrum, please be aware that with the new version of InfoEd that went live on Tuesday, November 21, adjustments need to be made in our inner auto-robotic settings as some of the InfoEd fields and tabs have changed. You may also be pleasantly surprised with InfoEd’s enhanced functionality in the budget section.

The below highlights significant changes and increased functionality. In addition, Research Information Technology posted a slide set with screenshots and a corresponding podcast. They plan on updating training material as needed, so please do check back on the Research IT InfoEd Instructions web page for the latest updates.

  • Initial Set Up Tab: “Step 3 Selecting a Sponsor”
    Removal of sponsor drop down menu and “Preferred” box with simple typing data entry box.
  • Tabs that Remain the Same or Little Change
    • Brief Lay Summary
    • Research or Program Plan and Progress Report Tabs
    • Classification Codes
    • Finalize
  • Tabs that Are Different
    • Set Up
    • Personnel
    • Budget
    • Internal Documents: Location of the “eForm” Moved to a Stand Alone Tab
  • Personnel Tab: When Adding Personnel, the Default is Key Personnel
    Please be sure to change the default in the provided drop down menu if you are adding someone other than key personnel.
  • Subawards Are Added Differently
  • Budget Tabs: Option to Enter Entire Budget onto the Main Budget Tab or into Individual Tabs by Period
  • Budget Tab > Personnel: Defaults to “Person Months” Rather Than “% Effort”
    You can change the default to “% effort” if you wish.
  • Budget Tab > Personnel > Fringe Benefits: Option to Use Sinai’s Rates or Manually Data Enter the Amount
  • Budget Tab: Entry of $ Amounts in Y1 in “Personnel” and “Non-Personnel” sections -Automatically Adds the Same Costs to Future Years if Future Years are Included.
    Easy to remove or change the costs if needed.
  • Modular Budget Tab – Defaults to Increments of 10, that is 10 Modules x $25,000 = $250,000
    If your modular budget is not a request for $250,000 in direct costs per year, please do change to the appropriate number of modules.

Please open a Ticket with Research IT if you need technical assistance with your proposal.

 

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
    and/or
    –  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.

Less InfoEd Data Entry – Elimination of Requirement to Enter Non-Key Personnel on Select Submission Types

Effective August 18, 2017, if researchers are submitting an InfoEd proposal for which the budget tab is not required, they no longer need to data enter non-key personnel in the InfoEd Personnel tab.

Below are project types that do not require a budget tab:

  • ISMMS funded
  • Projects in which the extramural funding agency provides funding by per subject payments (e.g.,  Pharmaceutical sponsored multi center clinical trial, NIH CALGB protocol)
  • No cost extensions

Examples of typical non-key personnel positions are research coordinators, research assistants and technicians.  Please review GCO’s Glossary of Common Terms for  additional information.

Also, please be aware that this policy change is for GCO InfoEd submissions only.  This policy neither applies to documentation submitted to PPHS or IACUC nor personnel data entry on Sinai Central, Ideate, or any other software system. Please contact the GCO at grants@mssm.edu, if you have questions about this change.

ISMMS IRB to Review Beth Israel Human Research

As part of the continuing efforts of the Icahn School of Medicine at Mount Sinai (ISMMS) to streamline and unify the submission process to the Institutional Review Boards (IRBs) throughout the system, the Program for the Protection of Human Subjects (PPHS) is pleased to announce that effective May 30, 2017, all Beth Israel human research applications will now follow the ISMMS submission deadline schedule found on the Researcher page on the PPHS website.  With this integration, the ability for the IRB to review projects weekly rather than monthly will assist in improved turn-around times.

As a reminder all initial applications require an e-submission through Ideate.  If the project was originally submitted in Ideate, its continuation application, any modification submissions, and its final report will also be submitted through Ideate.

For projects that did not begin in Ideate, they will continue to be submitted to IRB@mssm.edu.

As always, the PPHS appreciates your attention to this matter and all that you do to protect the research volunteers who agree to take part in the research conducted by investigators working within the Mount Sinai Health System.

If you have any questions related to the changes above please call the PPHS/IRB office at 212-824-8200.

 

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.