The CTSI is responding to Institutional Policies and Guidelines in response to COVID-19. For the foreseeable future, some CTSI services will be limited or only available electronically. Please view the CTSI's COVID-19 Response page before submitting a request. Date of Request* must provide value
Today M-D-Y
Name of Individual Requesting Service* must provide value
* must provide value
Department (Organization if outside of Wake Forest) * must provide value
* must provide value
Administration Assistant Professor Associate Professor Biostatistician Community Member Community Org. Representative Fellow Instructor Nurse Nurse Practitioner/Physician Asst Professor Programmer/Analyst/Engineer Research Support Staff Resident Student-Graduate Student-Medical Student-Undergrad Visiting Clinician
Which of the following CTSI services or areas do you need? Not sure? View document below (CTSI Services Definitions) for more information on each service/area listed below to help you select.* must provide value
I don't know / I want to ask a question BERD | Biostatistical Support Clinical Research Workshops ClinicalTrials.gov Support Community Engagement Consultation, General Data Extraction Editing (Grants) FDA Support (IND/IDE) Health Equity/Special Populations I-DSMB Implementation Science Consultation Primate Program Consultation QPRO Recruitment REDCap Research Navigation Research Studio Study Coordinator Team Effectiveness Consultation I don't know / I want to ask a question
BERD | Biostatistical Support
Clinical Research Workshops
ClinicalTrials.gov Support
Community Engagement
Consultation, General
Data Extraction
Editing (Grants)
FDA Support (IND/IDE)
Health Equity/Special Populations
I-DSMB
Implementation Science Consultation
Primate Program Consultation
QPRO
Recruitment
REDCap
Research Navigation
Research Studio
Study Coordinator
Team Effectiveness Consultation
CTSI Services Definitions How can we help?* must provide value
Is your request related to a specific research study/project or proposal?The answer can be changed, but most often will be 'yes'. * must provide value
Yes
No
Study/Project Title* must provide value
Principal Investigator Name* must provide value
* must provide value
* must provide value
* must provide value
Professor Associate Professor Assistant Professor Instructor Non-Faculty PI
* must provide value
Resident Fellow Physician Assistant Nurse Practitioner Pharmacist Physical Therapist (DPT) Nurse Researcher Research Associate Physician
Have they/you ever been a PI of a research award exceeding $100,000 in direct costs per year? * must provide value
Yes
No
Is the PI an active Translational Research Academy Member?* must provide value
Yes
No
Active Translational Research Academy Members Is the PI currently supported by a career development award (e.g. K23, K08)? * must provide value
Yes
No
Please provide the grant number of your active career development award. * must provide value
How is the PI classified? * must provide value
Faculty Researcher - EARLY CAREER
Faculty Researcher - EXPERIENCED
Non-Faculty Researcher
Faculty Researcher - EARLY CAREER
Faculty Researcher - EXPERIENCED
Non-Faculty Researcher
Proposed/Awarded Funding Source* must provide value
Institution/Internal/Departmental Federal Industry Foundation/Association Center Pilot CTSI Pilot
If Federal, please select the Funding Mechanism* must provide value
R01 R03 R15 R21 R24 R25 R34 R56 U01 K99/R00 P01 P20 P30 P50 X01 Other
If 'Other' federal funding source, please describe* must provide value
Is this study funded by an institutional pilot? (Example: Cancer Center, Pepper Center, CTSI, etc.) * must provide value
Yes
No
Please select the primary funding source of the pilot.* must provide value
Center for Biomedical Informatics Comprehensive Cancer Center Critical Illness, Injury, and Recovery Research Center Center on Diabetes, Obesity and Metabolism Center for Healthcare Innovation Hypertension and Vascular Research Center Center for Integrative Medicine Maya Angelou Center for Health Equity Center for Precision Medicine Center for Redox Biology and Medicine Center for Research on Substance Use and Addiction Sticht Center for Healthy Aging and Alzheimer's Prevention Center for Vaccines at the Extremes of Aging Other
If another funding source, please specify.* must provide value
Is the pilot in the application process or already received funding notification?* must provide value
Application process
Received funding
Application process
Received funding
Please upload the approved funding award documentation for the Pilot.
Do you have IRB approval?* must provide value
Yes Pending Need IRB approval, but not yet started No IRB approval needed for project
IRB Number* must provide value
Do you have IACUC approval?* must provide value
Yes Pending Need IACUC approval, but not yet started No IACUC approval needed for project
IACUC Number* must provide value
The option "
Below are a list of elements that align with the principles of an Academic Learning Health System. CTSI is interested in capturing studies or projects that encompass these elements. The information you provide below will not impact service provided. only elements that describe your study or project.
* must provide value
Addresses a "real" problem facing WFBH system or patient population
Development of practices, treatments, tools or approaches that have the potential to improve care at WFBH
Inclusion of a skilled researcher AND a clinician
A balance of scientific rigor and practicality
A plan for timely dissemination of results
Clinical data analysis as a central aspect of the study or project
A plan to disseminate results of the learning process throughout the organization in a manner that leads to better patient care and improved organizational practices and policies
An evidence-based intervention
An implementation plan utilizing principles and practices of Implementation Science
None of the above
Addresses a "real" problem facing WFBH system or patient population
Development of practices, treatments, tools or approaches that have the potential to improve care at WFBH
Inclusion of a skilled researcher AND a clinician
A balance of scientific rigor and practicality
A plan for timely dissemination of results
Clinical data analysis as a central aspect of the study or project
A plan to disseminate results of the learning process throughout the organization in a manner that leads to better patient care and improved organizational practices and policies
An evidence-based intervention
An implementation plan utilizing principles and practices of Implementation Science
None of the above
The option "
Please select the sections of the study you would like assistance with.* must provide value
Pre-Site Selection Coordinator Services (available for Industry Sponsored studies only)
Regulatory related to IRB (Wake Health) submissions
Regulatory related to Grant/Sponsor submission
Start-up
Screening/Recruitment
Patient Management
Data Management
Specimen collection
Study Close-out
Record Retention
Pre-Site Selection Coordinator Services (available for Industry Sponsored studies only)
Regulatory related to IRB (Wake Health) submissions
Regulatory related to Grant/Sponsor submission
Start-up
Screening/Recruitment
Patient Management
Data Management
Specimen collection
Study Close-out
Record Retention
This option is not available for Non-Industry Sponsored studies If Study Coordinator support is needed after your site is selected for study participation, then you will need to submit a new request for Study Coordinator services. Pre-site Selection Coordinator Services include: By checking this box, I confirm that I read and understand the activities that are involved with Pre-Site Selection Coordinator Services.* must provide value
I agree
Anticipated hours per week* must provide value
Final decision will be made upon consultation
Anticipated Service Start Date The date you plan to start receiving support from the CTSI. This typically is before the anticipated study start date * must provide value
Today M-D-Y
Anticipated Study Start DateThe date the actual study starts. * must provide value
Today M-D-Y
Anticipated Service End DateThe date you anticipate no longer needing CTSI services. * must provide value
Today M-D-Y
Anticipated Study End DateThe date the study is expected to end. * must provide value
Today M-D-Y
Please upload a copy of the protocol (Only full protocol drafts will be reviewed***)* must provide value
Does your study require services/support outside of the main medical center campus?* must provide value
Yes
No
Where will the study activities take place (e.g., Miller Plaza, Shepherd St, VAMC, etc.)? Please include all locations.* must provide value
Please review the FAQ Guide. By checking this box, I confirm that I read and understand the policies as indicated in the FAQ document.* must provide value
I agree
What area do you need the biostatistics core for?* must provide value
Grant development | Study Design
Data analysis
Grant development | Study Design
Data analysis
What is the deadline for biostatistics input?While we will work to honor all requests, please allow 60 days’ notice for biostatistical support.
* must provide value
Today M-D-Y
Please describe in more detail what your needs are.* must provide value
Please provide a chartfield for this work.* must provide value
Was this a consultation during open office hours?* must provide value
Yes
Date and Time of Office Hours* must provide value
Now M-D-Y H:M
Please select the workshop you are interested in.* must provide value
Industry-Initiated Budget Management
WakeOne Research Navigation
Industry-Initiated Budget Management
WakeOne Research Navigation
What specific areas in ClinicalTrials.gov are you interested in?* must provide value
Consultation
Training
New record registration
Results submission
Solve record problems
Open/edit user accounts
Other
Consultation
Training
New record registration
Results submission
Solve record problems
Open/edit user accounts
Other
If other, please specify.* must provide value
What specific areas in REDCap are you interested in?* must provide value
Project Build (Fee-for-Service)
General Consultation
REDCap Basics Class
REDCap Advanced Class
Other
Project Build (Fee-for-Service)
General Consultation
REDCap Basics Class
REDCap Advanced Class
Other
Was this a consultation during office hours?
Yes
What type of scientific editing do you need?* must provide value
Grant/Proposal
Manuscript
What type of proposal?* must provide value
New
Resubmission
Pre-proposal/Letter of Intent
New
Resubmission
Pre-proposal/Letter of Intent
Is there a submission deadline?* must provide value
Yes
No
Agency Deadline* must provide value
Today M-D-Y
Please upload a copy of the RFA (if applicable)
Please select what you specifically need for your grant proposal.* must provide value
Editing Text
Drafting Letters of Support
Boilerplate/Facilities & Resources
Introductions for resubmissions
Other
Editing Text
Drafting Letters of Support
Boilerplate/Facilities & Resources
Introductions for resubmissions
Other
What is your preferred time by which to receive editorial feedback?* must provide value
Today M-D-Y
Journal Submission Deadline* must provide value
Today M-D-Y
Full Journal Name* must provide value
Full Manuscript Title* must provide value
Is this request related to an existing system?* must provide value
Yes
No
Please provide a description of the programming support requested (including system if it already exists).* must provide value
What does your IDSMB request relate to?* must provide value
Consultation prior to IRB submission Letter of Support I-DSMB Review Other Consultation prior to IRB submission
Letter of Support
I-DSMB Review
Other
If other, please describe.* must provide value
Study Origination* must provide value
Cancer Center Pepper Center (OAIC supported studies) Not from one of the Centers listed Cancer Center
Pepper Center (OAIC supported studies)
Not from one of the Centers listed
Since your study is supported through the Pepper Center, additional assistance is available from the Pepper Center DSMB. Please contact Kim Kennedy at (336) 713-8567 or kkennedy@wakehealth.edu. Is your data extraction request related to a Quality Improvement (QI) project?* must provide value
Yes
No
What is your deadline to receive your data?Requests may take a minimum of two weeks to process. Please consider the amount of time it will take to verify and clarify criteria/data elements, pull the data, and review for accuracy. * must provide value
Today M-D-Y
What initiative will the data be supporting?Examples include, but are not limited to, hypothesis testing, * must provide value
Is this request specifically related to data for recruitment or feasibility?* must provide value
Feasibility Numbers
Recruitment
Other
Feasibility Numbers
Recruitment
Other
Do you only need summary numbers / cohort identification?You will only receive a number regarding how many patients meet your criteria if you select 'Yes'. This request will not include patient level data. (Example of information supplied through this type of request: 2000 patients meet inclusion/exclusion criteria) * must provide value
Yes
No
Do you have an existing patient list for this data query?* must provide value
Yes, I have a patient count from a previously ran i2b2 query.
Yes, I can provide a collected patient list of MRNs.
No, I want help generating a patient list based on my inclusion/exclusion criteria.
Yes, I have a patient count from a previously ran i2b2 query.
Yes, I can provide a collected patient list of MRNs.
No, I want help generating a patient list based on my inclusion/exclusion criteria.
Someone from the Data Team will e-mail you with a folder location to provide your identified patient list in a secure manner. Please list your Inclusion Criteria.Please consider the following elements: * must provide value
Please list your Exclusion Criteria (if none, please enter n/a).Please consider the following elements: * must provide value
Please provide the name(s) of your query in i2b2.* must provide value
What data elements do you want pulled associated with queried patients?all data elements that you want included in your result file. We do not automatically include data associated with inclusion/exclusion criteria; if this is data needed, please make sure to specify.* must provide value
Is your studio request for a proposal submission?* must provide value
Yes
No
Proposal Deadline* must provide value
Today M-D-Y
Please select the type of support you are looking for.* must provide value
Biostatistics
Informatics
Grantsmanship
Content Expertise
Process/Methods Expertise
Ethics
Epidemiology
Career Development
Implementation
Study Design
Hypothesis/Aims
Response to reviewer critiques
Networking (for newly hired Investigators)
Other
Biostatistics
Informatics
Grantsmanship
Content Expertise
Process/Methods Expertise
Ethics
Epidemiology
Career Development
Implementation
Study Design
Hypothesis/Aims
Response to reviewer critiques
Networking (for newly hired Investigators)
Other
If 'Other', please describe.* must provide value
Please provide a list of your mentors.* must provide value
Is there any specific area of expertise that you would like included in your studio? * must provide value
Please list specific questions you want addressed by the expert panel.* must provide value
How can the Program in Community Engagement help you?* must provide value
I have a question or an idea I'd like to discuss
I want to arrange a speaker for an event
I have a question or an idea I'd like to discuss
I want to arrange a speaker for an event
Please describe what you need help with.* must provide value
What expertise do you want the speaker to have?* must provide value
Cancer Cardiology Diabetes Genetics Gerontology Head and Neck Mental Health Neurology Obesity Ophthalmology Osteology Patient Care Pediatrics Physical Activity Pulmonary Regenerative Medicine Sleep Sports Medicine Urology Women's Health Other
Please provide additional information we might need to help organize your requested talk.* must provide value
Please provide any further details regarding your Implementation Science consultation request.
What are your recruitment needs?* must provide value
Advertisement Design and Marketing
Be Involved support
Recruitment Plan Consultation
General Information
Advertisement Design and Marketing
Be Involved support
Recruitment Plan Consultation
General Information
Is this a new posting request for a study not currently on Be Involved? * must provide value
Yes
No
Is this a request to edit an existing posting?* must provide value
Yes
No
Provide the name of the contact to be displayed on Be Involved for this study
Provide the phone number to be displayed on Be Involved for this study
Provide the email address to be displayed on Be Involved for this study
Please complete the BeInvolved Study Add/Change Request Form . Is this request specific to any of the following special populations?* must provide value
Youth (17 and younger)
Older Adults (65 and older)
Racial/ethnic minorities
N/A, this request is unrelated to a special population
Youth (17 and younger)
Older Adults (65 and older)
Racial/ethnic minorities
N/A, this request is unrelated to a special population
Please provide additional information.* must provide value
If your needs involve receiving animals, tissues/samples, or data from the Vervet Research Colony, Please complete the Vervet Colony Request Form . Please provide some information on what you are interested in discussing.* must provide value
How did you hear about our services?* must provide value
What type of service(s) are you interested in?* must provide value
Research Participant Navigation
Consultation
Training
Language Services
Other
Research Participant Navigation
Consultation
Training
Language Services
Other
Please upload any supporting documentation (if applicable - translation)
What type of Research Participant Navigation do you need?* must provide value
Participant consenting (Spanish)
Participant follow up
Participant recruitment
Participant consenting (Spanish)
Participant follow up
Participant recruitment
What type of consultation are you interested in?* must provide value
Data/Feasibility Review
Study Design
Pipeline Education
Data/Feasibility Review
Study Design
Pipeline Education
What type of training are you interested in?* must provide value
Health Literacy
Implicit Bias
Cultural Humility
Other
Health Literacy
Implicit Bias
Cultural Humility
Other
If Other, please specify.* must provide value
What type of language services are you interested in?* must provide value
On-site language interpretation
Document translation
Video remote interpreting
Contact/Consent with study subject
Participant follow-up
On-site language interpretation
Document translation
Video remote interpreting
Contact/Consent with study subject
Participant follow-up
Please describe your health equity research needs.* must provide value
If you are interested in the Voucher Program to support a special population with a transportation, care-giving, or advertisement need, please complete a Voucher Program Application . What is the research mission of your team?* must provide value
Are you seeking an individual consultation to help you work with your team more effectively, or a team-based consultation?* must provide value
Individual Consultation Team-Based Consultation Individual Consultation
Team-Based Consultation
How many members are on the team?* must provide value
Please provide a brief description of the team development need. What kinds of developmental opportunities and challenges does the team have?* must provide value
Is the study PI a Cancer Center member?
No Yes - CPC Member Yes - CGM Member Yes - NRO Member Yes - SBT Member No
Yes - CPC Member
Yes - CGM Member
Yes - NRO Member
Yes - SBT Member
Is the project cancer-focused?
Yes No
Which of the services are you requesting?
Patient-Reported Outcomes Consultation Qualitative Research Consultation Patient-Reported Outcomes Consultation
Qualitative Research Consultation
Are the services for:
Funded Project Grant Proposal Preparation Manuscript Preparation Funded Project
Grant Proposal Preparation
Manuscript Preparation
When is the grant due date?
Today M-D-Y
When is the anticipated start date of QPRO service?
Today M-D-Y
Additional Notes:
Yes
No
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