April 15, 2008

The Office of Grants Management (OGM) and the Office of Industry Contracts (OIC) have revised various forms and contract templates used in the initiation and management of research projects. The updated versions of these documents should be used in place of older versions.

Effective dates for forms that have been revised are:

4/15/2008      Proposal Clearance Form (PCF)
3/15/2008      PCF Clinical Attachment
3/15/2008      Transmit for Review and Initial Assessment (TRIA)
3/15/2008      Multi-Institutional Research Application (MIRA)
3/15/2008      PCF/MIRA Additional Signature Page
4/02/2008      Guarantee/Preaward Request
3/15/2008      OIC NDA Review
3/15/2008      OIC Investigator, Budget, End Date (IBED) Revision

Major revisions to the forms include:

• PCF and MIRA budget sections to provide separate enumeration of direct costs and modified total direct costs, and to accommodate a change in the F&A rate used for industry-sponsored research
• New five-day submission deadline to OGM/OIC for review of all proposals (electronic or paper) being submitted to sponsors
• New references to Multiple PIs to accommodate a change in NIH designations of study personnel

Contract templates used by OIC have also been revised. The Clinical Trial Agreement (CTA) template has been changed to meet re-accreditation recommendations made by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) including notification to the institution regarding research results that could affect the safety or medical care of subjects. The Sponsored Research Agreement (SRA) template has been revised to better address compliance matters when institutional committees are involved, confidentiality obligations and publication, notice of export control issues and general notice provisions.

Because these documents are periodically updated, OGM and OIC recommend that researchers download the latest versions at the time of each research submission in order to ensure use of the most recent forms and templates. The new documents are available on the Executive Vice President for Research (EVPR) website. Visit http://stage.louisville.edu/research/for-faculty-staff/forms.html to download the revised forms. Visit http://stage.louisville.edu/research/offices/industry-contracts/offices/ industry-contracts/common/cra-temp/industry-contracts-forms-and-templates.html to download the revised contract templates. For additional information, contact OGM at 852-8367 (Belknap) or 852-3788 (HSC), or OIC at 852-8359.