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 [email protected] [email protected]
Gwyn Kropp: CRCM Administrative Director 313-745-5889 [email protected] Pilarski Karen Cason 5th floor Carls BuildingAngela Moore Johanna DeponioBrenda Mansfield Maria Braum
Jackie Parker: Clinical Research Center Director 313-745-5837 [email protected] 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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