PI Name
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(Last, First, Degrees)
Email
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Phone
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Title
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Department or Division and Institution
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Area of Expertise
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(Last, First, Degrees)
Department or Division and Institution
(Last, First, Degrees)
Department or Division and Institution
Primary Contact if we have questions about the application (if not PI)
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Last, First
Are you the study coordinator?
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Yes
No
Email
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Phone
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Coordinator #2 Name
(if applicable)
Last, First
Other Research Team Member
(if applicable)
Last, First
Role (Other Team Member):
Email (Other Team Member)
Phone (Other Team Member)
Regulatory Coordinator Name
(if applicable)
Last, First
Will the study coordinator be primary billing contact?
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Yes
No
Primary Billing Contact
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Last, First
Email
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Phone
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Must be the same as the IRB title.
NCATS and NIH will use this title for indexing. It should include information on drug(s), population, disease, technique, and/or the device being studied. You may include an abbreviation or number, if applicable.
End of Enrollment Date
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Today D-M-Y
as listed for award
Funding Source:
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Grant/Contract Number or Work Tags (GU):
IRB of Record
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GHUCCTS IRB
Georgetown University IRB
Howard University IRB
MedStar Health Research Institute IRB
Washington, DC Veteran's Affairs Medical Center (WVAMC) IRB
Central IRB:
Other:
GU or HU IRB Number
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Please specify which Central IRB:
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ex. Chesapeake, Western, etc.
Please specify:
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Implementation sites:
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Georgetown University Clinical Research Unit
Howard University Clinical Research Unit
MedStar Health Research Institute
Washington, DC Veteran's Affairs Medical Center (WVAMC)
Other
Check all that apply
Other, please specify:
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Category Description:
|| Budget Considerations ||
Investigator-initiated, federally-funded, and foundation funded studies: all subjects' visit costs are the financial responsibility of the investigator's research funds. A cost-share in the form of a 25% discount will be granted to qualifying studies.
Industry-sponsored studies: all costs are the responsibility of the PI through their industry-sponsored research grant/award.
Investigator-initiated pilot study
Investigator-initiated collaborative study (GHUCCTS-funded)
Federally funded study (e.g. R01 with NIH funding)
Foundation funded study
Industry-sponsored study
Multicenter study (e.g. cooperative group or industry-sponsored)
Check all that apply
Further investigator-initiated pilot funding source:
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No other financial support
GHUCCTS-funded
Other financial support
Other, please specify:
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Observational
Pilot
Clinical Trial
AIDS-related
Pediatric-related
Addressing Health Disparities*
Affecting Minorities
*Addressing Health Disparities is defined as: "a particular type of health difference that is closely linked with social, economic, and/or environmental disadvantage"
Please select clinical trial phase:
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Phase I Phase I/II Phase II Phase II/III Phase III Phase III/IV Phase IV
Does this project make special effort to recruit any of the following populations?
Veterans
People with a disability
People age 65 years or older
Youth (birth to 21 years)
People from a racial or ethnic group other than non-Hispanic Whites
Listed above are priority GHUCCTS populations
Please describe which disabilities:
Americans with Disabilities Act (ADA) currently defines a person with a disability as "a person who has a physical or mental impairment that substantially limits one or more major life activities, a person who has a history or record of such an impairment, or a person who is perceived by others as having such an impairment."
Please indicate special efforts made to accommodate people with a disability?
Racial or ethnic groups this project makes a special effort to recruit
White
Hispanic or Latino
Black or African-American
Native American or American Indian
Asian/Pacific Islander
Other
Are special efforts made to include people with limited English proficiency (LEP) for this study? (i.e. bilingual staff, translated ICF)
* must provide value
Yes
No
Please provide rationale:
Indicate languages (other than English) of participants you seek to recruit for this study:
Which language assistance services are being used for inclusion of people with LEP into this study?
(select all that apply)
Bilingual or multilingual study staff
In-house hospital interpreters
Contract interpreters
Volunteer interpreters
Translation company/professional
Telephone interpretation services
Study participant family member or friend
Other
No language assistance services will be used
*Language assistance services: all oral and written language services needed to assist individuals with LEP communicate effectively with staff and/or contractors and gain meaningful access and an equal opportunity to participate in studies.
Other language assistance services, please specify:
Which written research documents are translated into a non-English language(s)?
(select all that apply)
Study advertisement
Consent form
Surveys/Assessments
Other
None
Other translated research documents, please specify:
During CRU onboarding, GHUCCTS offers consultation services to support recruitment and inclusion of diverse populations. Please indicate topic areas of interest:
Enhancing current recruitment strategies
Expanding recruitment to diverse populations
Engaging people with limited English proficiency
Providing accommodations to meet needs of participants with a disability
Learning more about GHUCCTS services (i.e training, funding)
Other topics
Total estimated enrollment at GHUCCTS site(s)
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Inpatient
Outpatient
Off-site Visit (not on the CRU)
Lab processing only (no participants, sample drop off only)
Check all that apply
Please specify:
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ex. specific unit in the hospital, off-site in community space, etc.
(e.g. 10)
Visits Requesting Support
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(e.g. V2, V5, V6 & V10)
(e.g. V2 & V5 = 1 Day; V6 & V10 = 2 Days)
(e.g. 10)
Visits Requesting Support
(e.g. V2, V5, V6 & V10)
(e.g. V2 & V5 = 1 Hr; V6 & V10 = 3 Hrs)
(e.g. 10)
(e.g. V2, V5, V6 & V10)
(e.g. V2 & V5 = 1 Hr; V6 & V10 = 3 Hrs)
Yes
No
Frozen (day of collection)
Ambient (day of collection)
Batch ship frozen
Batch ship ambient
Check all that apply
Yes
No
Budget Note: storage for less than 1 week is not charged a fee; storage fees are incurred on a monthly basis (please reach out for current fee schedule)
Reason(s) your study requires CTSA Support
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Study requires CTSA's specialized research staff and specialized research facilities
Pilot study with no other funding
Primary funding does not cover all subject costs
Research-only use of patient rooms
Other:
Check all that apply
If other, please explain:
Please specify special testing/procedures/other:
Will outpatient subjects require a regular meal?
Yes
No
Breakfast
Lunch
Dinner
If you are requesting special meal or meal preparation, please specify:
Special Equipment:
Please check all that apply
Note: *Available at HU only **Available at GU only
Stow Away Electronic Wheel Chair Weight Scale (weight up to 450 lbs) *
Electronic standing scale (weight up to 400 kgs)
Wall mounted stadiometer
Portable stadiometer **
Portable Marquette EKG machines
Telemetry *
Centrifuge ambient with multiple speeds, temp, & gravity
Sub zero freezer currently set to -70 to -80
Microcentrifuge with variable speed (ambient)
Specimen Rocker **
18" Ductless Containment Hood
Energy Expenditure Unit
BOD POD for total body measurement of fat / BMI *
Dexa Scan **
Vital Signs Machine with Pulse Oximetry
Marquette Dash 3000 Vital Signs monitor with Sao2 / EKG*
Energy Expenditure (sensor 2900) *
Cybex Treadmill *
Cybex Stepper *
Cybex Exercise Bikes *
Cybex ARC Trainers *
Neurometer *
Glucometer
Infusion Chairs with recumbent and trendelenberg positions
Sphygmacor Pulse Wave Velocity and Anaylsis
Biosafety Cabinet **
Other
Please specify:
* must provide value
Special Room:
Please check all that apply
Cognitive Testing **
Exercise Room
IV infusion room **
Sleep room *
Note: *Available at HU only **Available at GU only
GHUCCTS offers the following specialized services. Please check any that are relevant to your research, and click the link to learn more about what is available through these other GHUCCTS modules.
Full Protocol and IDB
* must provide value
IRB Application
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IRB Site Supplement Document (required for GU and MedStar)
CV of the Investigator
* must provide value
IRB Informed Consent Form (draft or approved)
* must provide value
Original IRB Approval Memo
Budget from Funding Source
Assent Form as Approved by or Submitted to the IRB
Summary Statement or Notice of Award
Responsibility for Scentific Conduct
As Principal Investigator or Designee, I affirm that:
• All information in this application is complete and true to the best of my knowledge.
• All key personnel (Principal Investigator, Study Coordinators, Co-Investigators, Trainees) on this protocol have completed approved training in Human Subjects Research and have proof of training record with appropriate Office of Regulatory Affairs.
• I will ensure that the protocol is conducted as approved by the SEPCOM and IRB.
• I will provide the SEPCOM Administrative Offices with the IRB-approved status reports and modifications, including updated consents (if applicable) in a timely manner.
• I will provide information requested by the CRU in a timely manner.
• I will notify the SEPCOM if the study is suspended for any reason.
• I will credit the NCATS CTSA grant 1UL1RR031975 in any publications resulting from research performed with CTSA support.
* must provide value
Responsibility for Medical Conduct
As Principal Investigator or Physician of Record or Designee, I affirm that:
• I will supervise and accept responsibility for the medical conduct of this protocol.
• I will accept responsibility for the safety of human subjects on this protocol.
• I will ensure every subject meets eligibility criteria.
• I will report adverse events to SEPCOM and my IRB.
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