Resources for Research

Children’s Research Center of Michigan (CRCM)

Purpose

To facilitate and advance child health research in terms of identification of funding, grants administration, regulatory and IRB issues, research design and analysis, conduct of both clinical and basic science research, research education, and dissemination of research results

CRCM Organizational Chart

Physicians Research Concerns DMC submission process, requirements and approval

times

WSU IRB submission and approval times in relation to DMC approval

Resources available in Children’s Hospital of Michigan to facilitate research Staff to help conduct the trial

Help to submit to the IRB and DMC

Dedicated space to conduct research

Resources

CRCM

Grants Management

Clinical Trial Management

Biostatisticaland Research

Writing Support

CRCM Research Resources: Grants Grant Management (Pre/Post Award)Budget development & agency forms submission Account reconciliation & expenditure approval Travel Wayne (travel booking and expensing)

Epidemiology & Biostatistical Consulting Research study design New grant submission Data cleaning and analysis

Research Writing & Editing Development of collaborative research Grant preparation, scientific writing, editing and mentoringManuscript preparation and editing

CRCM Research Resources: Clinical Trial Confidentiality Agreements, Budgets and Contracts Budget negotiation & Sponsored Programs submissionSubmit documentation to sponsored programs

Regulatory Institutional review board (IRB) submissionsFood and Drug Administration (FDA)Investigational New Drug (IND) submissionsDetroit Medical Center (DMC) submissions

Dedicated Support StaffNursing support to conduct study procedures Study coordinators to implement/coordinate studies

CRCM Research Resources: Clinical Trial Study Management and Setup Coordinate study visitsOncore clinical trials management software Study monitoring for investigator initiated studies Create study data forms

Space/Equipment/LaboratorySpecimen processing & shipping laboratoryClinic rooms to conduct research study visits

EducationGood Clinical Practice (GCP) training Study coordinator and investigator training Clinicaltrials.gov registration support

Clinical Trial

Sponsor

Inquiry

Receive Protocol

Submit IRB & DMC

Create Billing

Initiate Trial

Conduct Study Visit & Enter Data

Close Study

Reconcile Account

Grant

RFA

Develop Budget

Complete Agency Forms

Submit SPA

Receive Award

Set up Account

Expense Monitoring

Reconcile Account

CRCM: Grant or Clinical Trial Processing

PI meets with Gwyn Kropp & Staff

DMC and IRB submitted simultaneously

Register participant, send consent to DMC

PI meets with Jackie Parker & staff

CRCM & CHM Enhancements to Research Support • Contract between DMC-CHM and Wayne State University

has been signed and processing times have decreased to the contracted 2-3 month turn around time

• Additional nurses, coordinators and regulatory staff to facilitate clinical trials

• Additional staff to assist with grant preparation and submission

CRCM Leadership & StaffSteven Lipshultz, MD Jay Wilkinson, MDInterim Director CRCM Associate Director CRCMslipshultz@med.wayne.edu jwilkins@med.wayne.edu

Gwyn Kropp: CRCM Administrative Director 313-745-5889 gkropp@med.wayne.eduKaren Pilarski Karen Cason 5th floor Carls BuildingAngela Moore Johanna DeponioBrenda Mansfield Maria Braum

Jackie Parker: Clinical Research Center Director 313-745-5837 jparker@med.wayne.eduJulie McQueeney Ginger Steinhilber Research Center

3rd floor Children’s Hospital

Study Coordinators & Research NursesJamal Ameli Nancy SullivanAhlam Saleh Deanna Sypula Mae Nordin Brittany AllanDale Couey Tammy OsentoskiJoslyn Westphal Jason CzachorHiedy Razoky Ashley HillXin Lu (laboratory coordinator)

Biostatistician Medical EditorRon Thomas, PhD Thomas Lang, M.A.Ahmad Farooqi, M.S.

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