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SEPCOM Application

Returning?

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Application for the Use of CTSA Resources

Application for submission to SEPCOM

(Scientific Evaluation and Prioritization Committee)

If unable to complete in full, you may click 'Save & Return Later'. At time of completion and submission, you will receive a confirmation email.

We recommend you submit all relevant information, whether listed below or not, that would provide context for the committee to evaluate the scientific rationale and merit for the proposed study.

Application Checklist

Please upload the following required documents:

Full protocol
IRB application
IRB site supplement document (required for GU and MedStar)
CV of the investigator
IRB Informed Consent Form (draft or approved)

If applicable or available, please also upload the following:

Original IRB approval memo
Budget from funding source
Assent form as approved by or submitted to the IRB
Lab Manual
Investigator's Brochure
Summary statement or notice of award
Investigational Drug Branch documentation

All investigators submitting protocols to request CTSA resources should meet with the CRU administration to discuss budget and study feasibility prior to submission of their application. Such pre-review discussions will allow management to become familiar with these studies, enabling them to better understand anticipated CRU use.

Additional GHUCCTS Resources and Services

The following resources are also available to investigators. Click the links for more information.

Research Participant Advocates provide clinical research safety oversight and advocate services to the research participants. Link: https://cru.gumc.georgetown.edu/resources/rpa/
Biostatistics, Epidemiology and Research Design -The goal of this component is to provide the integrated infrastructure for the design and conduct of research that is innovative and statistically sound. Link: http://www.georgetownhowardctsa.org/research/programs-resources/biostatistics-epidemiology-and-research-design
Biomedical Informatics - This component provides analytical and computational support with the goal of promoting clinical and translational research. Link: http://www.georgetownhowardctsa.org/research/programs-resources/biomedical-informatics
Community Engagement - The goal of this component is to develop a program of community-centered collaboration. Link: http://www.georgetownhowardctsa.org/research/programs-resources/community-engagement

For more information on available GHUCCTS resources, please visit the following website: http://www.georgetownhowardctsa.org/research/programs-resources

PI Name

* must provide value

Phone

* must provide value

Title

* must provide value

eRA Commons User Name

Department or Division and Institution

* must provide value

Area of Expertise

* must provide value

Co-I #1 Name

Phone

Title

eRA Commons User Name

Department or Division and Institution

Area of Expertise

Co-I # 2 Name

Phone

Title

eRA Commons User Name

Department or Division and Institution

Area of Expertise

Primary Contact if we have questions about the application (if not PI)

* must provide value

Are you the study coordinator?

* must provide value

Yes

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Role of Primary Contact

* must provide value

Phone

* must provide value

Coordinator #2 Name
(if applicable)

Phone

Other Research Team Member
(if applicable)

Role (Other Team Member):

Email (Other Team Member)

Phone (Other Team Member)

Regulatory Coordinator Name
(if applicable)

Phone

Will the study coordinator be primary billing contact?

* must provide value

Yes

reset

Primary Billing Contact

* must provide value

Phone

* must provide value

Project Title

Expand

Short Title

End of Enrollment Date

* must provide value

D-M-Y

Principal Investigator:

Funding Source:

* must provide value

Grant/award end date:

Total Funding Amount:

Grant/Contract Number or Work Tags (GU):

Title of Grant/Contract

IRB of Record

* must provide value

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

* must provide value

Please specify which Central IRB:

* must provide value

Please specify:

* must provide value

Implementation sites:

* must provide value

Georgetown University Clinical Research Unit

Howard University Clinical Research Unit

MedStar Health Research Institute

Washington, DC Veteran's Affairs Medical Center (WVAMC)

Other

Other, please specify:

* must provide value

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)

Further investigator-initiated pilot funding source:

* must provide value

No other financial support

GHUCCTS-funded

Other financial support

Other, please specify:

* must provide value

Type of Study

Observational

Pilot

Clinical Trial

AIDS-related

Pediatric-related

Addressing Health Disparities*

Affecting Minorities

Please select clinical trial phase:

* must provide value

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

Please describe which disabilities:

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

reset

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

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

Other

Total estimated enrollment at GHUCCTS site(s)

* must provide value

Type of Visit Requested

Inpatient

Outpatient

Off-site Visit (not on the CRU)

Lab processing only (no participants, sample drop off only)

Please specify:

* must provide value

Inpatient Days:

Total # of Visits / Pt.

Visits Requesting Support

* must provide value

Expand

Duration of each Visit

Expand

Outpatient Visits:

Total # of Visits / Pt.

Visits Requesting Support

Duration of each Visit

Expand

Off-Site Nurse Hours:

Total # of Visits / Pt.

Visits Request Support

Duration of each Visit

Expand

Laboratory Services Only

Sample shipment needed?

Yes

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Sample shipment type

Frozen (day of collection)

Ambient (day of collection)

Batch ship frozen

Batch ship ambient

Sample storage needed?

Yes

reset

Reason(s) your study requires CTSA Support

* must provide value

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:

If other, please explain:

Comments on support need, if any:

Expand

Outpatient Visit

Inpatient Visit

Off Site Visit

Blood/Serum Collection

Blood/Serum Processing

Urine Collection

Urine Processing

Blood Glucose Monitoring

Other, please specify in section D.5.

Outpatient Visit

Inpatient Visit

Off Site Visit

Vital Signs

Weight, Height

Other Anthropometrics (waist, hip)

EKG

Serial BP Monitoring

Assistance with Examinations/Procedures (NP/PA coverage):

a. Physical Examination/Procedures

b. Gynecologic Examination

c. Lumbar Puncture

d. Other, please specify in section D.5.

Outpatient Visit

Inpatient Visit

Off Site Visit

Glucose Monitoring

Medication Administration

Other, please specify in section D.5.

Outpatient Visit

Inpatient Visit

Off Site Visit

Intensive Physiologic Monitoring (frequent VS, EKG monitoring, etc.)

Pulse Oximetry

Sleep Observation

Psychomotor/Cognitive Testing

Telemetry/Cardiac Monitoring *at Howard only*

Activity Monitor

Intake and Output

Other, please specify in section D.5.

Outpatient Visit

Inpatient Visit

Off Site Visit

Please specify in field below

Please specify special testing/procedures/other:

Expand

Outpatient Visit

Inpatient Visit

Off Site Visit

Oral

IM/SC

Intravenous Infusion (< 1 hour)

Intravenous Infusion (> 1 hour)

Stock Medication Dispensing

Other, please specify in section D.5.

Outpatient Visit

Inpatient Visit

Off Sit Visit

Administer Questionnaires

Administer Computer Tasks

Other, please specify in section D.5.

Will outpatient subjects require a regular meal?

Yes

reset

Meal Type:

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 *

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.

Attachment:

GHUCCTS_services flyer.pdf

Full Protocol and IDB

* must provide value

Upload file

IRB Application

* must provide value

Upload file

IRB Site Supplement Document (required for GU and MedStar)

Upload file

CV of the Investigator

* must provide value

Upload file

IRB Informed Consent Form (draft or approved)

* must provide value

Upload file

Original IRB Approval Memo

Upload file

Budget from Funding Source

Upload file

Assent Form as Approved by or Submitted to the IRB

Upload file

Lab Manual

Upload file

Investigator's Brochure

Upload file

Summary Statement or Notice of Award

Upload file

Case Report Form (CRF)

Upload file

Signature Page

Attachment:

CRU SEPCOM Application Signature Page.pdf

Responsibility for Scentific Conduct

As Principal Investigator or Designee, I affirm that:

â€¢ All information in this application is complete and true to the best of my knowledge.
â€¢ 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.
â€¢ I will ensure that the protocol is conducted as approved by the SEPCOM and IRB.
â€¢ I will provide the SEPCOM Administrative Offices with the IRB-approved status reports and modifications, including updated consents (if applicable) in a timely manner.
â€¢ I will provide information requested by the CRU in a timely manner.
â€¢ I will notify the SEPCOM if the study is suspended for any reason.
â€¢ I will credit the NCATS CTSA grant 1UL1RR031975 in any publications resulting from research performed with CTSA support.

* must provide value

Upload file

Responsibility for Medical Conduct

As Principal Investigator or Physician of Record or Designee, I affirm that:

â€¢ I will supervise and accept responsibility for the medical conduct of this protocol.
â€¢ I will accept responsibility for the safety of human subjects on this protocol.
â€¢ I will ensure every subject meets eligibility criteria.
â€¢ I will report adverse events to SEPCOM and my IRB.

* must provide value

Upload file

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