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Tell us about your project:
	Select the CTSU most appropriate for your project: * must provide value Acute, Critical Care, Surgery & Transplant Ambulatory & Chronic Disease Behavior, Function, & Pain Children's Heart, Vessel, Blood Neurosciences & Sensory Michigan-CTSU Oncology-CTSU Not Sure reset
	Oncology Clinical Research Team * must provide value Bone Marrow Transplant Breast Oncology Cancer Control and Prevention Childhood Cancers Connective Tissue Oncology Cutaneous Oncology Experimental Therapeutics Gastrointestinal Oncology Genitourinary Oncology Gynecology Oncology Head, Neck, and Endocrine Malignancies Hematological Malignancies Neurological Oncology Thoracic Oncology reset
	Project Short Title: * must provide value
	Select the Funding Source Under Consideration: Industry Federal Foundation Other University / Institution Investigator Self-Funded (e.g., discretionary; start-up funds) Internally Funded (e.g., pilot) I do not yet have this information available Other reset
	Other Funding Source:
	Select the Type of Trial: Sponsor-Initiated, Single-Site Clinical Trial Sponsor-Initiated, Multi-Site Clinical Trial Investigator-Initiated Clinical Trial, Sponsored Investigator-Initiated Clinical Trial, Self Funded or Internally Funded I do not yet have this information available reset
	Select the Type of Protocol: Diagnostic - Clinical trials directly testing the efficacy of devices, techniques, procedures; or tests for earlier or more accurate detection or diagnosis of disease. Treatment - Clinical trials with therapeutic intent using drugs, radiation, surgery, other biological agents, or behavioral or other interventions. Other I do not yet have this information available reset
	Select the Trial Phase: Phase 0 - Exploratory study to determine whether an agent behaves in humans as pre-clinical testing indicated Phase I - Evaluate safety, dose range, and identify side effects in healthy volunteers or in patients with the disease of interest Phase I/II - Safety, dosage levels, and efficacy of new treatment; device pilot study Phase II - Evaluate safety and efficacy of selected dosage levels and duration of treatment Phase II/III - Larger study to confirm safety and efficacy of selected dose(s) and duration of treatment Phase III - Larger, controlled trial to confirm efficacy compared to a standard treatment regimen or to no treatment; device pivotal study Phase IV - Post-market study to provide additional information on risks, benefits, and optimal use I do not yet have this information available Other - A clinical trial that does not fit into the phases listed above. A comment is required if this option is selected reset
	If "Other", please explain:
	Do you plan to use a CTSU Study Coordinator?	Yes No Unsure reset
Important Deadlines:
	Does your project have a specific deadline you are trying to meet? * must provide value	Yes No reset
	Deadline Date: * must provide value	M-D-Y
	Reason for deadline: Sponsor Deadline for a Proposal Submission (NIH, American Heart Association, etc.) Target First Enrollment Date Competitive Enrollment Other reset
	Other Reason for deadline:
	Please enter a brief description about the deadline, as needed. (e.g. Website of sponsor proposal announcement, information about competitive enrollment process)
Principal Investigator responsible for Human Subject Activity (HUM) Information:
	First Name:	PI First Name
	Last Name:	PI Last Name
	Email:	PI Email
	Telephone:	PI Phone Number
	Academic Rank:	Assistant ProfessorAssociate ProfessorProfessorLecturer PI Academic Rank
	Department / Division	AnesthesiologyBiomedical Engineering - MSCancer CenterCardiac SurgeryCollege of EngineeringDermatologySchool of Dentistry-ProsthodonticsEmergency MedicineFamily MedicineInt Med-AllergyInt Med-Allergy MNiMBSInt Med-CardiologyInt Med-GastroenterologyInt Med-General MedicineInt Med-Geriatrics & Palliative Med.Int Med-Hematology/OncologyInt Med-Hospital MedicineInt Med-Infectious DiseasesInt Med-Institute of GerontologyInt Med-MetabolismInt Med-MI Diabetes Research TrainingInt Med-MI Metabolical & Obesity CtrInt Med-Mich Comprehen Diabetes CntrInt Med-Molecular Med&GeneticsInt Med-NephrologyInt Med-Pulmonary/Critical CareInt Med-RheumatologyLearning Health SciencesNeurologyNeurosurgerySchool of NursingObstetrics/GynecologyOphthalmology & Visual SciencesOrthopaedic SurgeryOtolaryngologyPathologyPediatrics-Adolescent MedicinePediatrics-Ambulatory Care PgmPediatrics-Biochem Gen./Metab.Pediatrics-CardiologyPediatrics-Developmental BehavioralPediatrics-EndocrinologyPediatrics-GastroenterologyPediatrics-General ServicesPediatrics-GeneticsPediatrics-Hematology/OncologyPediatrics-HospitalistsPediatrics-Infectious DiseasesPediatrics-Intensive CarePediatrics-Neonatal/PerinatalPediatrics-NephrologyPediatrics-NeurologyPediatrics-Pediatric & Communicable DiseasesPediatrics-Primary CarePediatrics-PsychologyPediatrics-Pulmonary MedicinePediatrics-RheumatologyPharmacologyCollege of PharmacyCollege of Pharmacy-Clinical PharmacyPhysical Medicine & RehabilitationPsychiatrySchool of KinesiologySchool of Public Health-Health Behavior & EducationRadiation OncologyRadiologySurgery-Acute Care SurgerySurgery-ChelseaSurgery-Colorectal SurgerySurgery-Endocrine SurgerySurgery-GastrointestinalSurgery-Minimally InvasiveSurgery-Oral & Maxillofacial SurgerySurgery-Pediatric SurgerySurgery-Plastic SurgerySurgery-Surgical OncologySurgery-Thoracic SurgerySurgery-Transplant SurgerySurgery-Vascular SurgeryUrology HUM Department
	Is this a multiple Principal Investigator trial?	Yes No reset
Additional Principal Investigator Contact
	First Name:	PI First Name
	Last Name:	PI Last Name
	Email:	PI Email
	Department / Division	AnesthesiologyBiomedical Engineering - MSCancer CenterCardiac SurgeryCollege of EngineeringDermatologySchool of Dentistry-ProsthodonticsEmergency MedicineFamily MedicineInt Med-AllergyInt Med-Allergy MNiMBSInt Med-CardiologyInt Med-GastroenterologyInt Med-General MedicineInt Med-Geriatrics & Palliative Med.Int Med-Hematology/OncologyInt Med-Hospital MedicineInt Med-Infectious DiseasesInt Med-Institute of GerontologyInt Med-MetabolismInt Med-MI Diabetes Research TrainingInt Med-MI Metabolical & Obesity CtrInt Med-Mich Comprehen Diabetes CntrInt Med-Molecular Med&GeneticsInt Med-NephrologyInt Med-Pulmonary/Critical CareInt Med-RheumatologyLearning Health SciencesNeurologyNeurosurgerySchool of NursingObstetrics/GynecologyOphthalmology & Visual SciencesOrthopaedic SurgeryOtolaryngologyPathologyPediatrics-Adolescent MedicinePediatrics-Ambulatory Care PgmPediatrics-Biochem Gen./Metab.Pediatrics-CardiologyPediatrics-Developmental BehavioralPediatrics-EndocrinologyPediatrics-GastroenterologyPediatrics-General ServicesPediatrics-GeneticsPediatrics-Hematology/OncologyPediatrics-HospitalistsPediatrics-Infectious DiseasesPediatrics-Intensive CarePediatrics-Neonatal/PerinatalPediatrics-NephrologyPediatrics-NeurologyPediatrics-Pediatric & Communicable DiseasesPediatrics-Primary CarePediatrics-PsychologyPediatrics-Pulmonary MedicinePediatrics-RheumatologyPharmacologyCollege of PharmacyCollege of Pharmacy-Clinical PharmacyPhysical Medicine & RehabilitationPsychiatrySchool of KinesiologySchool of Public Health-Health Behavior & EducationRadiation OncologyRadiologySurgery-Acute Care SurgerySurgery-ChelseaSurgery-Colorectal SurgerySurgery-Endocrine SurgerySurgery-GastrointestinalSurgery-Minimally InvasiveSurgery-Oral & Maxillofacial SurgerySurgery-Pediatric SurgerySurgery-Plastic SurgerySurgery-Surgical OncologySurgery-Thoracic SurgerySurgery-Transplant SurgerySurgery-Vascular SurgeryUrology Financial Department
Study Team Contact Information:
	First Name:	Study Team Contact First Name
	Last Name:	Study Team Contact Last Name
	Email:	Study Team Contact Email
	Telephone:	Study Team Contact Phone Number
Department / Division (i.e., non-CTSU staff) Pre-Award Research Administrator:
	First Name:	Department Pre-Award Administrator Contact First Name
	Last Name:	Department Pre-Award Administrator Contact Last Name
	Email:	Department Pre-Award Administrator Contact Email
	Telephone:	Department Pre-Award Administrator Contact Phone Number
Department / Division (i.e., non-CTSU staff) Post-Award Research Administrator:
	Do you know your Post-Award Administrator?	Yes No reset
	Is your Department Post-Award Administrator the same as your Pre-Award Administrator?	Yes No reset
	First Name:	Department Post-Award Administrator Contact First Name
	Last Name:	Department Post-Award Administrator Contact Last Name
	Email:	Department Post-Award Administrator Contact Email
	Telephone:	Department Post-Award Administrator Contact Phone Number
Sponsor Information:
	Are you responding to a specific sponsor request or announcement?	Yes No reset
	Does the sponsor have published directions?	Yes No reset
	Please provide website for directions:
	Sponsor Name:
	Sponsor Contact Name:
	Sponsor Email:
	Sponsor Street Address:	Expand
	Sponsor Telephone:
	Sponsor Fax:
File Upload:
	Does your trial require a CDA?	Yes No reset
	Please upload an editable confidentiality agreement so the CTSU can create a UFA and PAF.	( MB) Upload file
	Please attach Draft Agreements, Protocol, Sponsor Instructions/Correspondence, etc.	( MB) Upload file
	Upload additional files?	Yes No reset
	Please upload additional instructions, draft agreements, and key correspondence from sponsor.	( MB) Upload file For the CTSU to process a Non-disclosure UFA or Clinical Trial Routing Form in eResearch a draft contract must be uploaded.
	Upload additional files?	Yes No reset
	Please upload additional instructions, draft agreements, and key correspondence from sponsor.	( MB) Upload file For the CTSU to process a Non-disclosure UFA or Clinical Trial Routing Form in eResearch a draft contract must be uploaded.
	Upload additional files?	Yes No reset
	Please upload additional instructions, draft agreements, and key correspondence from sponsor.	( MB) Upload file For the CTSU to process a Non-disclosure UFA or Clinical Trial Routing Form in eResearch a draft contract must be uploaded.
	Upload additional files?	Yes No reset
	Please upload additional instructions, draft agreements, and key correspondence from sponsor.	( MB) Upload file For the CTSU to process a Non-disclosure UFA or Clinical Trial Routing Form in eResearch a draft contract must be uploaded.
	Upload additional files?	Yes No reset
	Please upload additional instructions, draft agreements, and key correspondence from sponsor.	( MB) Upload file For the CTSU to process a Non-disclosure UFA or Clinical Trial Routing Form in eResearch a draft contract must be uploaded.
Comments:
	Please provide additional instructions or information that can assist us in supporting you.	Expand
Form Completed By:
	Are you the Study Team Contact listed above?	Yes No reset
	First Name:	Your First Name
	Last Name:	Your Last Name
	Email:	Your Contact Email
	Telephone:	Your Contact Phone Number
Contact Us:
	For more information, please contact the Acute Critical Care, Surgery and Transplant CTSU at 734-936-1432 or by e-mail at CTSU.AcuteCriticalCareSurgeryTransplant@umich.edu
	For more information, please contact the Ambulatory Chronic Disease CTSU at 734-998-9992 or by e-mail at CTSU.AmbulatoryChronicDisease@umich.edu
	For more information, please contact the Behavior, Function, Pain CTSU at 734-998-9979 or by e-mail at CTSU.BehaviorFunctionPain@umich.edu
	For more information, please contact the Children's CTSU at 734-998-9979 or by e-mail at CTSU.Childrens@umich.edu
	For more information, please contact the Heart Vessel Blood CTSU at 734-998-9976 or by e-mail at CTSU.HeartVesselBlood@umich.edu
	For more information, please contact the Neurosciences & Sensory CTSU at 734-936-1788 or by e-mail at CTSU.NeurosciencesandSensory@umich.edu
	For more information, please contact the Oncology CTSU at 734-763-4073 or by e-mail at CTSU.Oncology@umich.edu
	For more information, please contact the Clinical Trials Support Office at CTSOgroup@umich.edu
	Submission Date:	TodayM-D-Y
	Select all needed assistance: * must provide value Confidentiality / Non-disclosure Agreement ? Clinical Trial Agreement / Contract ? Full Proposal Submission? Budget Development / Trial Cost Estimate Study Coordinator Services? Other Strategic Partnership: Michigan Institute for Clinical & Health Research (MICHR) Biostatistician Consultation Clinical Trial Design Consultation Database Development Electronic Case Report Form IND/IDE Assistance MCRU Recruitment Consultation Study Monitoring Services Strategic Partnership: Regulatory Affairs ClinicalTrials.gov Reporting Consultation or Results Reporting Consultation
	Other assistance needed: * must provide value
	Confidentiality / Non-disclosure Agreement Target Execution Date: * must provide value	TodayM-D-Y
	Clinical Trial Agreement / Contract Target Execution Date: * must provide value	TodayM-D-Y
	Full Proposal Submission Published Deadline: * must provide value	TodayM-D-Y
	HUM Number (if available):	e.g., HUM00012345
	Please attach the Clinical Trial Agreement / Contract	( MB) Upload file
Submit