Volume IV, Issue 7
July, 2004
Research and Sponsored Programs
ERA
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ERA Release Adds Functionality
A new release of the Electronic Research Administration (ERA) System Budget Module was successfully deployed on June 23, 2004 providing the user enhanced functionality with a copy over and inflation feature for non-personnel expenses. Enhancements to the Routing Form and the Maintenance modules were also included in this release.
Complete Details

Corporate Contracts
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Why MTA? Top Three Reasons Researchers Want an MTA
Are you using unauthorized materials? Using a patented material in your research from another party without a proper Material Transfer Agreement (MTA) or other formal written permission could potentially result in a patent infringement action against you and the University. Read on to learn the top three reasons why researchers want to use MTAs.
Complete Details

Proposals and Awards
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New Budget Option for NIH Modular Grant Applications
In April 2004, Indiana University announced a new budget option for NIH modular grant applications. In place of a detailed or simplified budget you may complete the Indiana University Budget Information Sheet for NIH Modular Applications.
Complete Details

Human Subjects
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New VA Research Submission Forms
In an effort to provide guidance and more streamlined research study submission documentation, the VA Research and Development Committee approved a new research submission packet on May 20, 2004. Read on for form access information and submission date requirement.
Complete Details

What's New
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Pervasive Technology Labs Issue Call for Proposals for Fellows Program
The Pervasive Technology Labs at Indiana University are soliciting candidates for consideration to join the PTL Fellows Program in 2004-05. Proposals are due no later than 5:00 PM on Friday, July 16, 2004. Complete details are available at http://www.ptl.iu.edu/fellows/.

Clinical Research Positions Revised
At the request of the Office of Clinical Trials Program and Human Subjects Research and Education Training Committee (HUBREC), the guidelines to establish clinical research positions and minimum qualification requirements were re-visited and revised for both biweekly and monthly clinical research positions.
Complete Details

Research & Sponsored Programs (R&SP) Staffing Updates:
Anita Camic has been promoted to a new Team Leader position that was created within Research Compliance Administration. Anita's new role as Team Leader was effective July 1, 2004.

Laura Fucio has been hired as a Grants Assistant for the Sponsored Program Administration office. Laura will provide clerical and administrative support to the office.

Alicia Gahimer recently joined Sponsored Programs Development as the Grants Development Coordinator. Alicia will be responsible for consulting with faculty, staff, and students to identify potential funding sources and advise on proposal development. She will also administer the internal grants programs and assist Sponsored Programs Administration with the processing and submission of external grant proposals. For the past seventeen years, Alicia was employed by the State of Indiana and has extensive knowledge of grants management/administration and program coordination.

Mark Reichel has assumed additional responsibilities as Assistant Director of Corporate Contracts Administration effective July 1, 2004. In addition to his regular duties, Mark will assume primary responsibility for processing of material transfer agreements, confidentiality and miscellaneous agreements and amendments, as well as the negotiation of additional master agreements. Mark is a graduate of the Indiana University School of Law - Indianapolis, holds an MBA from the IU Kelley School of Business and is a registered patent attorney.

Please join us in congratulating Anita and Mark and welcoming Alicia and Laura! To view the complete R&SP organization chart, see: http://www.iupui.edu/~resgrad/org-chart/spon-org.htm.
Events
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Jul 13 ACRP Circle City Chapter Meeting
Topic / Speaker: “HIPAA Requirements for Clinical Research- One Year Later”, Danelle Marks, JD, Attorney for the firm Baker & Daniel’s, Specializing in Health Care and Medical Technology
When: July 13, 6:00 - 7:30 PM
Where: Indiana Cancer Pavilion, Room 101 Auditorium, 535 Barnhill Drive, Indianapolis, IN 46202
CEU: 1 will be requested for this program
Questions: Contact Joni S. Hoop, 317.274.2745, jhoop@iupui.edu

Jul 23 Source Documents & Case Report Forms: If it’s not documented - it didn’t happen
Note: This represents a date and place change
When: July 23, 2004, 12:00 - 1:30 PM
Where: Riley Outpatient Center (ROC) Classrooms A&B
Cost: None
Registration: Register at the door
CMEs: 1.5
Presenters: Gail Douglas, Clinical Trials Program and Mary Arnould, CRA, Bristol Myers Squibb
Content: Methods and requirements for creating, collecting, and organizing source documents and case report forms in paper and electronic formats.

Aug 18 IUPUI Full and Part Time New Faculty Orientation
When: Aug 18, 2004 (Wednesday), 8:30 AM – 3:15 PM
Where: IUPUI University Library Auditorium
Register:
http://www.opd.iupui.edu/register/nfo/
Aug 20 Quality Improvement Strategies
What: Implementation of quality improvement activities in your research area; how to catch your own problems before someone else does; how to prepare for an audit; and advice from your peers and from industry regarding “best practices”. Presenters: CTP staff and external representative TBD.
When: Aug 20, 2004 (Friday), 12:00 - 1:30 PM
Where: Tudor Auditorium - Wishard Outpatient Wing 5th floor
Cost: None
Registration: At the door
CMEs: 1.5

Sept 10 Industry-Sponsored Research Budgets and Contracts: Your Need-To-Know Guide to Success
What: Developing an appropriate study budget; identifying hidden costs; establishing appropriate billing mechanisms to prevent insurance fraud; making sure sponsors pay you what you are due; preventing contractual problems; and developing communication and tracking tools. Presenters: Sharon Moe, MD and Pam DeWeese.
When: Sept 10, 2004 (Friday), 12:00 - 1:30 PM
Where: Tudor Auditorium - Wishard Outpatient Wing 5th floor
Cost: None
Registration: Contact Michelle Murray at mimurray@iupui.edu or 278-2868
CMEs: To be determined

  Sept 14 NCURA Video Conference: Conflict of Interest Management
When: Sept. 14, 2004 (Tuesday), 10:30 AM - 2:30 PM
Where: Riley Outpatient Center (ROC) – Auditorium
Registration: Coming Soon

Sept 18 ACRP Exam
What: The ACRP (Association of Clinical Research Professionals) exam will be offered in Indianapolis on 9.18.04. The application deadline is 7.30.04.
When: Sept 18, 2004
More info: http://www.acrpnet.org/certification/fda/index.html
Note: At the discretion of each department, a salary increase for certification has been endorsed by HR and SOM if the exam is passed.

Sept 22 – 24 Clinical Research Education Program
What: This course is designed to introduce all clinical research staff to issues related to clinical research management and to provide specific guidance as to how to appropriately budget, conduct and coordinate clinical research studies at IUPUI/Clarian. This course is mandated for all new clinical research nurses, coordinators and specialists in the School of Medicine with less than 2 years of clinical research experience at IUPUI.
When: Sept 22, 2004, 9:30 AM – 5:00 PM, Sept 23 and 24, 2004, 8:00 AM – 5:00 PM
Where: Riley Outpatient Center (ROC), A&B
Cost: $320
Registration: TBD
CME’s: 21.6 CEUs through IU School of Nursing (CMEs TBD)
Presenter: Various - including both internal and external expertsSept 18 ACRP Exam

Submissions
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Submit Your News to the R&SP Communicator
We want to hear about what you are doing!
Complete Details

Send COMMENTS, QUESTIONS to:
RSPCOMMU@iupui.edu.


Research and Sponsored Programs
UN 618
General - 317 274-8285
Research Compliance - 317 274-8289
Sponsored Program Development - 317 278-0249