First Name
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Last Name
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Email
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Phone Number
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Anesthesiology Campus Oversight Organization Central Administration (E.G., IRB, SOM Finance, DOCR, OCRC, etc.) Clinical And Translational Sciences Institute (CTSI) DCI/Oncology Dermatology/Pathology Duke Clinical Research Institute (DCRI) Duke Early Phase Research Unit (DEPRU) Duke Global Health Institute Oversight Organization Duke Human Vaccine Institute (DHVI) Duke Office Of Clinical Research Oversight Organization Emergency Medicine Family Medicine And Community Health Head And Neck Surgery And Communication Science (HNSCS) Heart Center Medicine Neurology Neurosurgery OB/GYN Office Of Curriculum Oversight Organization Ophthalmology Orthopedic Surgery Pediatrics Pharmacy Services Oversight Organization Population Health Sciences Psychiatry Radiology School Of Nursing Surgery Urology Other
Specify Other
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Are you the PI or the Designee?
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Yes No
First Name
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Last Name
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Email
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First Name
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Last Name
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Email
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First Name
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Last Name
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Email
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Do you have a written protocol for the study?
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Yes No
Please upload the protocol provided
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Protocol/Project title
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Protocol/Project short title
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Therapeutic Target Area
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Allergy/Immunology Anesthesiology Cardiology Clinical Pharmacology Dermatology Endocrinology Gastroenterology Gerontology/Aging Health Service Delivery Hematology Infectious Disease Medical Genetics Neuropharmacology (Including Neurology, Psychiatry, Behavioral Health, And Pain Control) Nutrition Obstetrics/Gynecology Oncology Ophthalmology Orthopedics Pulmonary Rheumatology Urology Other
Specify other therapeutic type
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Do you have a DUHS protocol number?
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Yes No
IRB number
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Primary Funding Source
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NIH/Federal (for DOD or other federal funding to apply) Industry sponsor Department Funds Foundation Other
Specify other funding source
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How many participants do you hope to enroll?
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Week Month Year
How many total participants will be enrolled at Duke?
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estimate
Participant Type (Select all that apply)
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Select all that apply
Pediatric age
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Select all that apply
Location
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Other location, specify
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Approximate Service Duration
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Duration
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Weeks Months Years
How soon do you need someone to start working on your project?
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M-D-Y
The service agreement process takes approximately two weeks. This includes time to complete an estimate, send the estimate for your review, and request signatures on the completed agreement. If CRC services are required, a separate meeting will be required after the agreement is signed to allow that manager to make sure she is assigning staff with the best qualifications.
You may download a Facilities and Resources here .
In what locations will coordinator services be required?
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Inpatient (hospital and unit - indicate specific location)
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Outpatient (clinic, home, etc - indicate specific location)
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Does this study require or prefer visits that must occur at the DEPRU location?
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Yes No
Why must the visits occur at DEPRU location?
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If you have a Schedule of Events, highlight the visits and procedures you are requesting and attach.
If you do not have a Schedule of Events, please complete the Visits page.
When are services needed?
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Special equipment required
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Yes No
Specify equipment used:
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The option " " can only be selected by itself. Selecting this option will clear your previous selections for this checkbox field. Are you sure?
Participants physical limitations
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Specify other limitations
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Do any of your study visits include administration of investigational product?
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Yes No
Which of the following types of investigational products will you need administered?
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Specify Other
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Do you have local DUHS clinical labs?
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Yes No
Do you have central labs for safety labs and/or PK/PD (Lab Corp, PPD, etc.)?
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Yes No
Which of the following will you need for central labs?
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Has a lab manual been provided?
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Yes No
Please upload the lab manual provided
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If you do not provide a lab manual, the estimate will be based on our interpretation. Subject to change.
Which IRB of record will you be using:
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Duke IRB
Central IRB (multi-site)
External IRB (single site)
Other
Other IRB - specify
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How will your regulatory file be managed?
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Other file management - specify
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Does this study require a Clinical quality management plan (CQMP)?
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Yes No
Do you want DOCR to provide an estimate to complete?
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Yes No
How many sponsor portals will we need access to (EDC, training portals, IRT, etc.)?
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Please specify number of portals
How often do you anticipate monitoring visits?
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Monthly
Quarterly
Other
Specify Other
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What services do you need assistance with recruitment for?
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Provide a protocol synopsis
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Inclusion criteria to include (example) age, gender, BMI and Exclusion criteria to include (example) all medical conditions, location/address (Do you want to exclude those out of state, or certain cities or zip codes in state?)
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IRB approved email template, Number of study subjects, Study enrollment timeframe, Estimated number of email blasts, Estimated frequency of email blasts
Note: Number and frequency of sends dependent on the number of subjects needed within a certain timeframe. Can start with one, two or three send(s) per week to test response, and 'dial in' from there.
Spanish services required
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How many documents do you need to be translated?
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1 2 3 4 5+
Please attach a Word document
Please attach the document
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Please attach the document
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Please attach the document
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Please attach the document
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Please attach the document
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Interpretation needed
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Location
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In-person: Number of visits
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In-person: Length of each visit
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in minutes
Please enter the number and length of each in-person visit
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Virtual: Number of visits
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Virtual: Length of each visit
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in minutes
Please enter the number and length of each virtual visit
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Do you require transcription of visits?
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Yes No
Transcription: Number of visits
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Transcription: Length of each visit
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in minutes
Please enter the number and length of each transcribed visit
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Today M-D-Y
Submit
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