A PDT is a committee of multidisciplinary researchers who

assist investigators in developing ideas/hypotheses into

well-designed translational projects. This goal is

accomplished by helping investigators with protocol

development; pilot funding; facilitation of collaboration

with other investigators; and access to Core Resources on

IUPUI and Purdue campuses.

TRAC1 – Basic/PreClinicalTRAC2 – Adult ClinicalPediatrics – Pediatrics ClinicalTRIP - Community–Based ResearchBehavioral/Population Sciences - Epidemiological

Studies & Clinical Intervention StudiesPurdue – Basic and Clinical

http://www.indianactsi.org/programs/pdt

Translational research: Research that transforms scientific discoveries arising in the lab, clinic, or population into new clinical tools and applications that reduce incidence, morbidity, and mortality.

TRAC 1

Provide investigators a point of access to multidisciplinary

research expertise, biostatistics, regulatory and infrastructure

support, and pilot funds.

The Review Committee meets twice a year, Spring and Fall.

TRAC 2

Pediatrics

Interface with basic and clinical scientists to design and implement high quality, feasible, fundable clinical/translational research projects.

Providing investigators access to multidisciplinary research expertise, biostatistics, IRB/regulatory and nursing support, and pilot funds.

Not simply a review group, but is a team that will discuss ideas and concepts with investigators and fully assist in developing research projects.

The committee meets on Monday of each week.

TRIP (Translating Research Into Practice)

Multidisciplinary teams to assist and guide in the development of projects that are specifically translating research into practice through implementation, system redesign, patient safety, human factors engineering, or medical informatics.

The TRIP PDT seeks to expertly foster research in the following areas:

New strategies adapted for implementation, system redesign, and dissemination of evidence-based practice

New treatment approachesincrease in evidence-based patient care

System redesign health issues

Increasing awareness of the importance of studying and improving processes for effectively translating research into practice

The team meets the second Wednesday of each month.

Behavioral/Population Sciences

Basic research on methods and theories, epidemiological research, testing of clinical interventions, and translation of results to patients, families and communities.

Research can address various areas across the life/disease continuum including prevention, early detection and treatment of diseases, management of chronic health conditions, healthy life style choices, community and environmental research, public health, and end of life care.

The Behavioral/Population Sciences PDT meets the first Monday of the month

Go to http://www.indianactsi.org/programs/pdt and download either

the PreClinical Request Form or the Human Subjects Request Form

INDIANA CLINICAL TRANSLATIONAL SCIENCE INSTITUTEREQUEST FORM FOR PROJECT DEVELOPMENT ASSISTANCE FOR RESEARCH INVOLVING HUMAN SUBJECTS*

*Note: Human Subject Projects might include, but are not limited to: Specimen collection, chart reviews, surveys, health services research, clinical trials and/or new drugs or devices for humans. Section I: Personnel Information

Name:Date:Department: Faculty Rank:Years at Rank: Referred to CTSI by: Help Desk PDT Committee Member Colleague Other:      

Division: Protocol Title: Co-investigators:

Section II: Project DescriptionConcept Status (Check all that apply)

First Concept/Idea Partial Protocol Complete ProtocolGrant Submission Planned Unfunded Grant Submission/Need more dataOther (Please explain)

Please provide a 1 page concept protocol in the space below.If you have a more extensive protocol or grant submission you can attach that document, however, please ensure all points below are included.

Points to include are:Background and Rationale for Pilot Study (Note: Make sure to include why you feel this project is ‘translational’ in nature). Hypothesis Potential study population Plans to submit for external funding and external funding sourceLead investigator Biosketch or CV

SECTION III: RESOURCES REQUESTED

_______New Protocol Development _______Budget Development _______Pilot Funding _______Feedback on Current Protocol _______Nurse Coordinator/Res Assist_______IRB Support

Please send the Completed Request Form to tsajdyk@iupui.eduIf you have any questions regarding this form please contact Tammy Sajdyk at 278-7488 or via the above e-mail address.

Faculty submits Request for PDT Assistance

Request Form

Version 10.09.08

PDT Scheduling Workflow*Project is triaged (Scott, Linda, Tammy, Lucy, Jody) to determine whether ready for PDT scheduling

YESNO

Translational Officer notifies faculty or requests more information if needed

Translational Officer schedules project and PI for PDT meeting

PI gives a 15-20 min. presentation, including PI’s expected timelines, what has occurred to date, and potential resources needed.

* For projects involving human subjects; not applicable to CReFs and HORFFs.

PI leaves PDT meeting

PDT discusses project, assigns PDT contact member(s), and determines next steps.

Project Map initiated (Tammy).

PDT contact member(s) provide feedback to PI, including outline of comments, concerns, timelines, responsibilities, etc.

PI invited to subsequent meeting to respond to PDT’s feedback.

Source: IUSCC ITRAC

Pediatric PDT Pediatric basic scientist makes an in vitro observation of the effect of

glucose on endothelial progenitor cells.

Meets with PDT to explore extending studies to pregnant women and their babies

Clinical design and protocol written by PDT, including biostatistics

PDT supports IRB submission and approval

Research nurse assigned to obtain sample for pilot. Pilot funds provided by PDT ($10K)

R21 submitted and funded. Manuscript published in Diabetes

Information from R21 leads to R01 submission. Favorable score but resubmission necessary.

Second R01 from this project also being prepared.

TRAC 1 PDT Basic Scientist contacts translational officer to

fill out PreClinical request form.

A meeting is arranged to discuss the PI’s project regarding an animal model of panic disorder.

The translational officer and the PI work together to create a map of the project.

The PI presents to the review committee in November and receives partial funding for the project by December 1.

The PI submits a K99/R00 grant to NIH in Feb.

TRAC 2 PDT

Clinician fills out request form and is scheduled to present to the committee.

The PI in infectious disease presents evidence showing that investigating multidrug resistant gram negative bacteria in obese pts is critical to the health of these pts.

The Committee provided extensive feedback and assigned a mentor to the PI

The PI worked with the mentor and returned to the committee in the beginning of Feb. The committee redesigned her study and determined the new direction was a better fit for the TRIP PDT

The committee contacted the TRIP project manager and the PI will be presenting her new protocol on March 11.

TRIP PDT

Basic scientist (geologist) studying soil samples for lead finds a potential connection with lead poisoning in children and soil levels. Contacts Peds PDT member for mentoring.

Works with mentor and comes toPediatric PDT to present. Committee discusses the proposal extensively with the PI and determines a collaboration with Health Services Research is important. In addition, they reroute the proposal to the TRIP PDT.

TRIP PDT hears the collaborative presentation and following a detailed discussion determines that this project is important for the community and provides funds and assistance with mining the Regenstrief Database.

Behavioral/Population Sciences PDT Junior VA Faculty in Occupational

Therapy interested in gait for stroke patients.

The PI and Co-PI presented to the committee in Jan. The committee provided extensive feedback.

The committee met with the PI again in Feb and provided additional assistance in protocol development.

The protocol will be reviewed and discussed for funding in the next couple of weeks.