Clinical Research Management & Support Office Study Intake Form

Did you know that CRMSO has a Study Intake Form? The CRMSO study intake form is a valuable resource for investigators. This form can be used to prepare a high-level and comprehensive study concept that can also be presented to funding sponsors at the time of the proposal. 

The data collected from this form allows the CRMSO team to develop a preliminary approach to manage the project and identify the necessary resources to implement the study.

The Study Intake form can be found at this link: CRMSO Study Intake Form.

Beware of Compliance Issue

ChatGPT is Not HIPAA Compliant

ChatGPT is not HIPAA compliant, and the University does not permit its use with any patient data. We are in the process of developing a policy to ensure appropriate use within the University setting. OpenAI, the company behind ChatGPT, also warns against inputting confidential data into the platform, which could constitute a public disclosure and lead to a loss in our ability to protect University information, including intellectual property.

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Effort Certification Period Opens July 10, 2023

Effort Certification Reminder

The effort certification period for the second half of fiscal year (FY) 2023 will be open July 10, 2023.

This certification is required by the Federal Government and must be completed within 60 days. Therefore, the deadline will be September 8, 2023.

Unless there is an approved exception from ORA, effort must be certified timely. Please send exception requests prior to the end of the certification period to Gloria Gari at ggari@miami.edu.

Late exceptions will not be granted. Compensation not certified will be removed from the sponsored account and moved on a non-sponsored account.

 
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Important NIH Notices

NIH Notices

• eRA Information: Select Withdrawn NIH Applications Will Display a Grant Number Appended with a "D" in eRA Commons Effective April 26 - A new process to go into effect tomorrow, April 26, 2023, will tag a resubmission or renewal application that is withdrawn prior to review with a ‘D’ in the grant number. The tag will only appear when a subsequent version is submitted.

  This will allow NIH staff to assign the original grant number of the withdrawn application to the subsequent version and preserve information related to the withdrawn application in the eRA Commons.

  Applicants will see the withdrawn application listed on the Status Information screen (also called Grant Folder) with a D% (D1, D2, D3) at the end of the grant number.  An example is 1R01CA12345-01D1. The Status will state ‘Application withdrawn.’

• Reminder: NIH Policy for Data Management and Sharing Plan Effective January 25, 2023. The National Institutes of Health issued a notice (NOT-OD-23-053) to remind the community of the effective date of the NIH Policy for Data Management and Sharing (DMS Policy) and summarize available key resources.

  As noted in the Final NIH Policy for Data Management and Sharing (NOT-OD-21-013), the effective date of the DMS Policy was January 25, 2023 for competing grant applications submitted to NIH on or after January 25, 2023 and subsequent receipt dates; proposals for contracts  submitted to NIH on or after January 25, 2023; NIH Intramural Research Projects conducted on or after January 25, 2023; and other funding agreements (e.g., Other Transactions)  executed on or after January 25, 2023, unless otherwise stipulated by NIH.

  The DMS Policy applies to all NIH research, funded or conducted in whole or in part by NIH, that results in the generation of scientific data. Note that the DMS Policy does not apply to research and other activities that do not generate scientific data, for example: research training, fellowships, infrastructure development, and non-research activities. See Research Covered Under the Data Management & Sharing Policy for more details. 

• Notice for the NIGMS Grant Writing Webinar Series for Institutions Building Research and Research Training Capacity The National Institute of General Medical Sciences (NIGMS) will host an informational webinar series for faculty and sponsored programs/research development personnel from institutions building research and research training capacity. During the webinars, suggestions will be shared for navigating the process of seeking NIH funding. Attendees will learn considerations for determining research idea and grant writing readiness, selecting opportunities to apply for, effectively writing a grant application, and seeking appropriate feedback. Registration is required to attend.
• Do you have questions about the National Institutes of Health (NIH) Inclusion Plans?  In Part 1 of this NIH All About Grants podcast mini-series, NIH's Inclusion Policy Officer, Dawn Corbett, discusses how to consider inclusion plans when putting together your application (MP3 / Transcript). Part 2 of the podcast covers inclusion plans during peer-review and post-award (MP3 / Transcript). NIH's All About Grants episodes can also be heard on iTunes and Spotify. Read the article in the Extramural Nexus.
• Updated Requirements for NIH Notification of Removal or Disciplinary Action Involving Program Directors/Princial Investigators or other Senior/Key Personnel. Section 239 now requires that, “[t]he Director of the National Institutes of Health shall hereafter require institutions that receive funds through a grant or cooperative agreement during fiscal year 2022 and in future years to notify the Director when individuals identified as a principal investigator or as key personnel in an NIH notice of award are removed from their position or are otherwise disciplined due to concerns about harassment, bullying, retaliation, or hostile working conditions.” Therefore, effective 60 days from the publication of this Notice, NIH recipient institutions are required to notify NIH when individuals identified as PD/PI or other Senior/Key personnel in an NIH notice of award are removed from their position or are otherwise disciplined by the recipient institution due to concerns about harassment, bullying, retaliation or hostile working conditions. Notification must be provided by the Authorized Organization Representative within 30 days of the removal or disciplinary action and must be submitted to NIH through a dedicated web form.
• NIH NIAID Technology Transfer Fellowship Program. Fellows will be mentored by professionals that work side-by-side with with world-renowned NIAID and Centers for Disease Control and Prevention (CDC) scientists and will be part of the team that helps transfer innovations from the lab to commercial products (including vaccines, therapeutics, and diagnostics) that benefit global public health.
• Childcare Funding Available for Pre/Post Docs Full-time appointed predoctoral  and postdoctoral NIH-NRSA supported trainees are eligible to  receive $2,500 per budget period for childcare costs provided by a  licensed childcare provider. For households where both parents are eligible full-time predoctoral or postdoctoral NRSA trainees, each parent is eligible to receive $2,500.
• Guidance on Salary Limitation for Grants and Cooperative Agreements  This Notice provides information regarding the salary limitation for NIH grant and cooperative agreement awards and extramural research and development contract awards.Since 1990, Congress has legislatively mandated a limitation on direct salary for individuals under NIH grant and cooperative agreement awards (referred to here as a grant). The mandate appears in the Consolidated Appropriations Act, 2023 (Public Law 117-328), signed into law on December 29, 2022, which provides authority for NIH to incur obligations for Fiscal Year 2023. The Consolidated Appropriations Act, 2023 restricts the amount of direct salary to Executive Level II of the Federal Executive pay scale. The Office of Personnel Management recently released new salary levels for the Executive Pay Scale. Effective January 1, 2023, the salary limitation for Executive Level II is $212,100.