Research Affairs: 2017 IRB and IACUC Notices

Clinical Trial Specific Parent R01 and Parent R21 Funding Opportunity Announcements (FOA)

Cindy Dickson — Mon, 13 Nov 2017 14:14:00 -0800

Beginning November 2017 the NIH plans to publish Parent R01 Clinical Trial Required and NIH Exploratory/Developmental Parent R21 Clinical Trial Required Funding Opportunity Announcements (FOAs). Some NIH Institutes and Centers will join these parent FOAs and others will jointly or alone publish specific Clinical Trials. You will not be able to apply for a Clinical Trial grant unless the FOA states it can be used for Clinical Trials.

Click on the link for more NIH information.

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-010.html

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-001.html

Reminder: NIH definition of a Clinical Trial

Mon, 13 Nov 2017 14:15:42 -0800

NIH defines a clinical trial as “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”

Click on the link for more NIH information

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html

Changes and updates related to NIH grant submissions

Cindy Dickson — Mon, 13 Nov 2017 14:01:51 -0800

We have some exciting new announcements related to grant submissions. Below is a preview of updates/information included in this Researcher’s Alert.

Procedural Change for grant agreements sent directly to Industrial Relations
New eTransmittal and eRouting for approvals
New FORMS-E for NIH submissions with Human subjects
New RFAs for Clinical Trial submissions
Reminder: NIH definition of a Clinical Trial
Protect the credibility of published research

IRB: New Protocol Template for NIH-FDA Phase 2 and 3 IND/IDE Clinical Trials

Research Protection Programs — Wed, 05 Jul 2017 11:25:37 -0700

This new clinical trial template (See IRB Toolkit for Investigators) will assist NIH-funded investigators with preparing protocols conducted under Food and Drug Administration’s Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application. This tool will help both IRBs and the FDA perform speedy reviews. NIH has also released a web-based Electronic Protocol Writing Tool that investigators can use to form a “protocol writing team” composed of different individuals to write and review documents. Call Research Protection Programs at x44531 if you have any questions.

May 10 IRB meeting cancelled

Anu Diekmann — Mon, 13 Mar 2017 11:17:24 -0700

The only IRB meeting in May will be held on 5/24, with the deadline on 5/15. The first meeting of the month is cancelled since staff will be attending an IRB accreditation conference. Plan accordingly and submit renewals early so they don’t expire. Feel free to call the Investigators Help Desk at x43042 for any questions.

Revised IRB application forms

Anu Diekmann — Tue, 21 Feb 2017 15:46:37 -0800

Revised IRB application forms

The IRB application forms below were revised on 2/16/17 to add questions about using materials that may require review by the Institutional Biosafety Committee. Be sure to download the latest versions from the IRB Toolkit for Investigators to avoid delays in the approval process. Contact us at x44531 or e-mail IRB@llu.edu if you have any comments/feedback.

Newly Approved LLEAP Training for Clinical Research

Lila Dalton — Tue, 24 Jan 2017 08:00:36 -0800

The Clinical Trial Center and the LLEAP training team are happy to announce that two new courses have been created to support the training needs of our clinical research community. These two courses have been developed to not only include research specific training in LLEAP, but also decrease the current training time.

The two courses represent a unique approach by combining training across modules in LLEAP that are used to support enrollment, documentation, charge capture and billing activities for clinical research.

LLEAP Ambulatory: Research Coordinator will cover documentation and charge capture for both inpatient and outpatient research activity. LLEAP Cadence: Research Orientation will cover enrolling research subjects, associating encounters in research and working the research work queues. Both are required courses to receive LLEAP access for research activity and are highly recommended as a refresher course to those who still have challenges using LLEAP.

Please note that LLEAP View Only: 2017 (S000032119) (M:X:ORNT:EX71) must be completed prior to enrolling in the two required research courses. Individuals must register using the OWL Portal for all courses. Once the registration occurs, the trainers will contact the employee to schedule the training time. Please contact the training department at Trainingdepartment@llu.edu or the individual trainers listed below with any questions you may have.

COURSE INFORMATION

LLEAP View Only: 2017 (S000032119) (M:X:ORNT:EX71)

Location: Online Classroom (Moodle)

*LLEAP Ambulatory: Research Coordinator ORNT (S000032215) (X:ORNT:CL1394)

Location: FMO B100

Time Commitment: 4 hours

Contact Information: Greg Dickinson at gdickins@llu.edu or via cell phone 405-990-3975 OR Tracey Lesch at tcappelletty@llu.edu

*LLEAP Cadence: Research Coordinator ORNT (S000033955) (X:ORNT:CL1417)

Location: TBD

Time Commitment: 3 hours

Contact Information: Adam Smith at adasmith@llu.edu or 405-371-2354

*Course scheduled as needed

REDCap available for LLU Researchers

Lila Dalton — Tue, 24 Jan 2017 11:22:57 -0800

The Clinical Trial Center is happy to announce that REDCap is now available for use at Loma Linda. For those that are not familiar with it, REDCap is a mature, secure web application for building and managing online surveys and databases.

Using Redcap’s streamlined process for rapidly developing projects, you may create and design projects using 1) the online method from your web browser using the Online Designer; and/or 2) the offline method by constructing a 'data dictionary' template file in Microsoft Excel, which can be later uploaded into REDCap. Both surveys and databases (or a mixture of the two) can be built using these methods.

REDCap provides automated export procedures for seamless data downloads to Excel and common statistical packages (SPSS, SAS, Stata, R), as well as a built-in project calendar, a scheduling module, ad hoc reporting tools, and advanced features, such as branching logic, file uploading, and calculated fields.

The use of the database is free to LLUH researchers. However, any assistance needed for the project creation and form development will be billed and discussed as part of the project review. Researchers at many institutions are able to construct their own databases. For additional information about REDCap please visit https://redcap.llu.edu/redcap/.

To request the use of REDCap for your research please submit the attached request form to redcap@llu.edu.