Today's Date
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Cancer Prevention and Control (CPC) Breast Cancer Program (BC) Molecular and Experimental Therapeutic Research in Oncology (METRO) Hackensack (HUMC) Other
Email
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Brief overview of the project
Is there another contact person for this proposal aside from the PI?
No
Yes
Today M-D-Y If unsure of specific start date, please select the first of projected start month.
Today M-D-Y
Exempt
Plan to submit
Submitted and pending review
Approved
Use GMR2 protocol, if applicable
Funded Research
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Funded research
Unfunded research
Not yet funded (project planning stage)
National Institutes of Health
Department of Defense
Department of Veterans Affairs
American Cancer Society
Georgetown University (Internal Funds)
MedStar Health Research Institute (Internal Funds)
Other
Please specify the NIH instituteeg: National Cancer Institute(NCI), National Center for Advancing Translational Sciences (NCATS), National Institute of Dental and Craniofacial Research (NIDCR) etc
Funding Agency Project Number:
Formal Grant Title (if different from title above)
Yes
No
GMS Cost Center (CC)
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GMS Fund Code (Fund)
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GMS Purpose Code (PP)
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GMS Program Code (PG)
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GMS Grant Code (Starts With GR)
GMS Assignee Code
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Expiration Date
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Today M-D-Y
What is the main purpose of your request for SRBSR?
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Project planning - obtain number of available cases for planning purposes
Recruitment of new subjects for patient-level data collection and/or biospecimen data collection
Accessing stored biospecimen for analysis
Database programming for survey and subject tracking
Data Management and other consulting services (no recruitment or access to existing data)
Medical Record Abstraction
What type of data are you interested in? Please check all that apply.
Biospecimen
Survey (Georgetown Medstar Registry Study)
Medical Record
Do you plan to use existing data or do you want new data?
Existing data
New data
Please describe your request:
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Cancer cases
Non-cancer cases
Institutions Participating
MGUH
MWHC
What is the target enrollment size for cancer cases ?
What is the target enrollment size for non-cancer cases ?
All Cancers
Breast
Colon
Rectal
Leukemia
Lymphoma
Ovarian
Cervical
Lung
Pancreatic
Prostate
HCC
Other
Type of subjects [non-cancer cases]
Patients at high risk of cancer (genetic mutation carriers)
Primary care patients/internal medicine
Other specialty clinic populations
If high risk: For which cancer types?
If high risk: Which mutation carriers?
If specialty clinic: Which clinics or departments? (e.g. Gastroenterology, Endocrinology, Neurology, Psychiatry)
Age at Diagnosis [cancer cases]
Years of Diagnosis [cancer cases]
Age at Specimen Collection (if applicable)
Male
Female
Non-Hispanic Whites
Non-Hispanic Blacks
Hispanic
Asian
Other
All patients
Only alive
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Newly diagnosed
Within 1 year
Within 3 years
Within 5 years
Other
Do you want SRBSR to screen and identify eligible patients for your project?
Yes
No
Do you want SRBSR to recruit eligible patients for your project?
Yes
No, I will use someone else to do the recruitment
When do you want to initiate recruitment services?
01 02 03 04 05 06 07 08 09 10 11 12
2021 2022 2023 2024 2025 2026 2027 2028 2029 2030
Do you want SRBSR to consent subjects and/or administer the surveys to them for your project?
Only consent subjects
Only administer surveys for subjects
Consent and administer surveys for subjects
No consenting or administrating of surveys needed
Do you want SRBSR to assist you with designing a patient-level survey for your project?
Yes
No
What type of survey would you like to use?
Web
Paper
Phone
What general domains or variables will be included in the survey?
Sociodemographics
Clinical
Behavioral
Quality of life
Symptoms
Function
Other
If quality of life, did you have a specific scale or instrument you want to use? PROMIS
SF-36
Other
Other scale or instrument:
How many timepoints will the survey cover?
1
2
3
4
5 or more
Do you want SRBSR to create a database to manage survey data for assessment and tracking purposes?
Yes
No
Do you have a preference for which program? REDCap
Qualitrics
Tonic
Other
Do you want biospecimen samples?
Yes
No
Blood
Urine
Stool
Saliva
Bone marrow aspirate
Type of Blood Collection Tubes
Red
Green
Purple
Mouthwash
Urine
Other
[Red] Number of tubes requested
[Green] Number of tubes requested
[Purple] Number of tubes requested
[Mouthwash] Number of tubes requested
[Urine] Number of tubes requested
[Other] Number of tubes requested
Plasma
Serum
Whole blood
Blood clot
Buccalcells
RBC
Buffy coat
[Plasma] Number of samples
[Serum] Number of samples
[Whole Blood] Number of samples
[Blood Clot] Number of samples
[Buccalcells] Number of samples
[Buffy Coat] Number of samples
Additional data and/or information
Do you want SRBSR to obtain data from the EMR for your project?
Yes
No
Do you have an abstraction form?
Yes
No
Do you need help from SRBSR to create an abstraction form and manual?
Yes
No
Please select all applicable variables to be abstracted from the EMR for your study.
Cancer diagnosis of interest, as applicable
Cancer status at recruitment
Sex
Race/ethnicity
Vital Status
Stage
Grade
Histology
Biomarkers
Comorbidities
Treatment
Disease status
Other
Please specify other variables you want to abstract from the EMR record
Please specify biomarker(s) needed:
HER2
ER/PR
Other
Please specify treatment(s):
Surgery
Radiation
Chemotherapy
Other
(No recruitment required)
Do you need data management consultation services to discuss best practices and how to support your projects specific data needs?
Yes
No
Do you need consultation on survey applications to use, such as REDCap, Qualtrics, Tonic, etc.?
Yes
No
Do you need consultation on survey measures to use?
Yes
No
Do you want SRBSR to assist you with designing a patient-level survey for your project?
Yes
No
What type of survey would you like to use?
Web
Paper
Phone
What general domains or variables will be included in the survey?
Sociodemographics
Clinical
Behavioral
Quality of life
Symptoms
Function
Other
If quality of life, did you have a specific scale or instrument you want to use? PROMIS
SF-36
Other
Other scale or instrument:
How many timepoints will the survey cover?
1
2
3
4
5 or more
Do you want SRBSR to create a database to manage survey data for assessment and tracking purposes?
Yes
No
Do you have a preference for which program? REDCap
Qualitrics
Tonic
Other
Do you need SRBSR to help with instrument scoring (e.g. PROMIS)?
Yes
No
Do you need data cleaning and preparation for self-collected or secondary data?
Yes
No
Please describe the data that you have:
Survey data
Medical records
Claims
Other
Do you need SRBSR to help with data reporting (NCI reporting, external site reports, accrual reports, etc.)?
Yes
No
Do you need SRBSR to conduct educational development, training, workshops?
Yes
No
Please upload the following documents for SRBSR to review.
Please email Colleen McGuire (mcguirec@georgetown.edu) or Tania Lobo (tania.lobo@georgetown.edu), SRBSR Directors of Operations, with any questions or concerns that you'd like address immediately.
2. IRB Approved Study Protocol (if applicable)
3. IRB Approved Study Consent (if applicable)
Acknowledgement
Publications and/or grants arising from research projects using SRBSR specimens and/or data must acknowledge this support by stating "Samples and/or data were provided by the Survey, Recruitment and Biospecimen Shared Resource of Lombardi Comprehensive Cancer Center, which is partially supported by National Institutes of Health Grant P30-CA-51008 (Cancer Center Support Grant to Lombardi Comprehensive Cancer Center). "
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