Research Affairs: Researcher's Alert for September 11, 2020

Coming on Sept. 30 - Pointers for Grant Writers: Part 1 Specific Aims

Research Affairs Presents — Thu, 10 Sep 2020 18:13:06 -0700

An Informal Presentation by Successful LLU Grant Writers

How do They Create and Compose Specific Aims
Learn the Do’s and Don'ts

Presentations from these Experienced and Successful PI’s

Marino DeLeon
Penny Duerksen-Hughes
Bill Pearce
Julia Unternaehrer
Lubo Zhang

Register in Advance for this Webinar:

https://llu.zoom.us/webinar/register/WN_1__dPauRRmiExtzr3qQtXw

Please Note: Zoom Link will be sent to you on day of event

Announcing a 10% Decrease in Per Diem Fees at the Animal Care Facility

Research Affairs — Fri, 11 Sep 2020 08:44:15 -0700

We are pleased to announce that per diem fees at the Animal Care Facility will decrease by 10% this fiscal year. As such, this decrease will be applied to all per diem fees incurred beginning July 1, 2020.

New Institutional Review Board Module Go-Live and Training

Human Research & Compliance — Thu, 10 Sep 2020 17:56:35 -0700

The Human Research & Compliance office within Research Affairs is excited to announce that a new electronic research administration software, iRIS by iMEDRIS, is scheduled to Go-Live on October 15, 2020. This new software will allow for fully electronic submissions, meeting management and paperless reviews.

In order to transfer seamlessly into the new system, the LLUH IRB will not be accepting any submissions October 3rd-October 14th. Starting October 15th, all documents will be submitted through iRIS. Training announcements for PIs and study personnel will be announced in the next week.

Enforcement Procedure for ClinicalTrials.gov Reporting Requirements Finalized

Human Research and Compliance — Thu, 10 Sep 2020 20:25:59 -0700

On August 17, 2020, the FDA announced final guidance on the enforcement procedure for ClinicalTrials.gov reporting requirements. Penalties of up to $10,000 per violation plus an additional $10,000 per day until the violation is corrected, have been confirmed by the final guidance. This applies to those who fail to report applicable clinical trials (ACTs) or submit false or misleading information. The guidance also allows for the possibility of civil injunction and/or criminal prosecution. The FDA will also post violator’s notices of noncompliance on its website and the National Institute of Health (NIH) will upload the notices to clinicaltrials.gov. The FDA states they will identify violators using information gathered during the routine inspections conducted by the Bioresearch Monitoring (BIMO) program. Per CenterWatch, The NIH issued new rules on July 30,2020 that mandate clinical trial sponsors submit missing data for studies conducted between 2007 and 2017. Those sponsors who fail to submit the required results information may be subject to monetary penalties as well as the withholding of remaining grant funds.

The full CenterWatch articles may be found here:

https://www.centerwatch.com/articles/24915-fda-finalizes-enforcement-procedure-for-clinicaltrialsgov-reporting-requirements

https://www.centerwatch.com/articles/24908-nih-instructs-drug-and-medical-device-manufacturers-to-post-missing-trial-data

The final guidance may be found here: https://www.fda.gov/media/113361/download

A ten-minute podcast that discusses the legal implications for investigators may be found here:

https://www.natlawreview.com/article/kl-gates-triage-qa-what-sponsors-and-investigators-need-to-know-about-fda-s

For questions regarding clinicaltrials.gov, please contact:

Jerri Mendivel, Research Compliance Manager

(909) 558-9408 Extension 49408

jmendivel@llu.edu