Welcome to the Duke Primary Care Research Consortium (PCRC) Research Advisory Board (RAB) Application for Study Submission and Review.
The PCRC RAB meets monthly on the 4th Tuesday of the month. Submissions must be received by the 3rd Tuesday of the month to be considered by the RAB that month.
To have your study reviewed by the PCRC RAB, please complete the submission form below.
Next available RAB meeting at which your study can be reviewed
(select the next occurring 4th Tuesday of the month at which your study is eligible for review)
NOTE: if there are less than 7 days until the next RAB meeting, please select the 4th Tuesday in the following month
Today M-D-Y Please use the calendar to select the next RAB meeting date
What are you requesting from the PCRC?
* must provide value
Specify other recruitment efforts involving clinics
Is this a submission for a pediatric or adult study?
* must provide value
Adult
Pediatric
Both
select one
What type of study is this submission for? Select all that apply.
* must provide value
Please explain what type of study this submission is for:
* must provide value
Age range of participants
Principal Investigator Last Name
* must provide value
Last Name
Principal Investigator First Name
* must provide value
First Name
What is your email address?
* must provide value
Which academic clinical department are you with?
* must provide value
Anesthesiology Family Medicine and Community Health Dermatology Medicine Neurology Neurosurgery Obstetrics and Gynecology Ophthalmology Orthopaedic Surgery Pathology Pediatrics Psychiatry and Behavioral Sciences Radiation Oncology Radiology Surgery Not applicable
What Division in the Department of Anesthesiology are you with?
* must provide value
Ambulatory Basic Sciences Cardiothoracic Community Critical Care Medicine Pain Medicine Pediatric Regional VA Service Women's
What Division in the Department of Family Medicine and Community Health are you with?
* must provide value
Community Health Family Medicine Occupational and Environmental Medicine Division of PA Studies Student Health CFM research unit
What Division in the Department of Dermatology are you with?
* must provide value
General Dermatology Pigmented Lesions Immunodermatology Laser/Wound Treatment MOHS Surgery Hair Disorders
What Division in the Department of Medicine are you with?
* must provide value
Cardiology Endocrinology, Metabolism, and Nutrition Gastroenterology General Internal Medicine Geriatrics Hematologic Malignancies and Cellular Therapy Hematology Infectious Diseases Medical Oncology Nephrology Pulmonary, Allergy, and Critical Care Medicine Rheumatology and Immunology
What Division in the Department of Neurology are you with?
* must provide value
Epilepsy and Sleep Multiple Sclerosis & Neuroimmunology General & Community Neurology Headache and Pain Memory Disorders Critical Care and Vascular Neurology Neuromuscular Disease Parkinson's Disease And Movement Disorders Stroke
What Division in the Department of Neurosurgery are you with?
* must provide value
Pediatrics Brain Aneurysm Stroke Brain Tumors Spinal Disorders Neurological Disorders Skull Base Tumors Minimally Invasive Neurosurgery
What Division in the Department of Obstetrics and Gynecology are you with?
* must provide value
Gynecologic Oncology Maternal Fetal Medicine Urogynecology Minimally Invasive Gynecologic Surgery (MIGS) Reproductive Endocrinology and Infertility (REI) Reproductive Sciences
What Division in the Department of Ophthalmology are you with?
* must provide value
Comprehensive Ophthalmology Cornea, External Disease, and Refractive Surgery Duke Vision Rehabilitation and Performance Glaucoma Neuro-Ophthalmology Oculofacial Plastic Surgery Pediatric Ophthalmology and Strabismus Vitreoretinal Disease
What Division in the Department of Orthopaedic Surgery are you with?
* must provide value
Adult Reconstruction Division of Foot and Ankle Division of Hand and Upper Extremity Division of Orthopaedic Oncology Division of Pediatric Orthopaedics Spine Division Division of Sports Medicine Trauma Division
What Division in the Department of Pathology are you with?
* must provide value
Anatomic Pathology Clinical Pathology
What Division in the Department of Pediatrics are you with?
* must provide value
Allergy and Immunology Blood and Bone Marrow Transplantation Cardiology Child Abuse and Neglect Critical Care Medicine Endocrinology Gastroenterology, Hepatology and Nutrition Global Health Healthy Lifestyles Hematology-Oncology Hospital and Emergency Medicine Infectious Diseases Medical Genetics Neonatology Nephrology Neurology Primary Care Pediatrics Pulmonary and Sleep Medicine Quantitative Sciences Rheumatology
What Division in the Department of Psychiatry and Behavioral Medicine are you with?
* must provide value
Addiction Behavioral Medicine Brain Stimulation and Neurophysiology Child and Family Mental Health and Development Neuroscience General Psychiatry Geriatric Behavioral Health Social and Community Psychiatry Translational Neuroscience
What Division in the Department of Radiology are you with?
* must provide value
Abdominal Imaging Breast Imaging Cardiothoracic Imaging Community Radiology Interventional Radiology Musculoskeletal Imaging Neuroradiology Nuclear Medicine Pediatric Radiology
What Division in the Department of Surgery are you with?
* must provide value
Abdominal Transplant Surgery Advanced Oncologic and Gastrointestinal Surgery Cardiovascular and Thoracic Surgery Emergency Medicine Head and Neck Surgery and Communication Sciences Metabolic and Weight Loss Surgery Pediatric General Surgery Plastic, Maxillofacial and Oral Surgery Surgical Sciences Trauma and Critical Care Surgery Urology Vascular and Endovascular Surgery
Principal Investigator's Email address
* must provide value
Study Coordinator's Email Address
Study Name/Title
* must provide value
What stage is your study currently in?:
Concept
Grant writing
Submitted
Funding notice/ contracting
Start-up
Enrolling
Other
Other study stage, please explain:
Research Topic:
(purpose of the study)
You may upload your abstract, research plan or IRB Research Summary below but please provide 2-3 sentences describing your study.
* must provide value
please DO NOT type "see attached"
Upload your abstract, research plan, IRB summary, etc.
Why is this study important to primary care?
Please include a summary of clinical issues relevant to the study setting and potential impact on, for example, survival, quality of life, or proof of principle.
* must provide value
Study Overview:
Please describe the specific hypotheses, study objectives, primary endpoints and feasibility -- 3-5 sentences is adequate
* must provide value
please DO NOT type "see attached"
Study Design:
Please describe if this is a randomized trial, survey, focus group, chart review, etc.
* must provide value
please DO NOT type "see attached"
If you've already reached out to any clinic directors about this study, please describe the discussion or interaction.
* must provide value
Enter N/A if not applicable
Involvement of participating practices:
If you are obtaining consent or conducting any study visits/procedures in clinic, please describe the activities taking place, and estimate how much time it will take.
If applicable, please also describe how you have or will engage providers/staff/patients of the clinic(s) in the design and/or conduct of the study.
* must provide value
What are you asking of the community or primary care site(s)?
* must provide value
Select all that apply
Specify other
* must provide value
Describe the process for obtaining informed consent, including who will be responsible for obtaining consent and where consent will be obtained.
* must provide value
Are there any "costs" to the clinic from a financial or logistical perspective?
For example, disruption of clinic flow, duplication costs, nurse or staff time, loss of income by referring patients rather than treating them, use of clinical staff, or any other expenses the clinic may incur.
* must provide value
Yes
No
If yes, please specify the costs
* must provide value
Please address any potential concerns our clinicians might have about their own participation or the participation of their patients.
* must provide value
Is there a way clinicians can opt out for their patients or for themselves?
* must provide value
Yes
No
Does the study provide any benefit for scholarly enhancement of primary care faculty or clinicians?
For example: CME hours, acknowledgement in manuscripts, opportunities to collaborate on publications.
* must provide value
Yes
No
Please list the scholarly activities:
* must provide value
Does the project include funding to pay for clinic overhead and/or a stipend to clinicians, faculty or staff?
* must provide value
Yes
No
If yes, please specify the amount and describe.
* must provide value
Is there any training provided or required for staff, clinicians or faculty?
* must provide value
Yes
No
If yes, please describe.
* must provide value
Please provide the full inclusion criteria.
* must provide value
Please provide the full exclusion criteria.
* must provide value
Please estimate the numbers needed for recruitment.
* must provide value
Have you run a DEDUCE query for this population?
Yes No Not yet but plan to
If yes, how many Duke patients might be eligible?
Of those, how many are seen in primary care?
Does the project include payment to participants (reimbursement, remuneration, etc.)?
* must provide value
Yes
No
If yes, please describe the amount.
* must provide value
Anticipated start of participant enrollment
* must provide value
Enter N/A if not applicable
Anticipated end of patient enrollment
* must provide value
Enter N/A if not applicable
Duration of participant treatment/intervention
* must provide value
Enter N/A if not applicable
Duration of follow-up
* must provide value
Enter N/A if not applicable
Anticipated end of participant follow-up
* must provide value
Enter N/A if not applicable
Today M-D-Y
Is this an internal or external (sponsor) due date?
Internal External N/A
What is your funding status?
* must provide value
Funding confirmed Applying for funding No external funding (pilot project, using departmental funds, etc.)
If applicable, please describe the potential or actual Sponsor/Funder Name
What is the likelihood of successful funding?
* must provide value
What is the estimated or actual budget?
* must provide value
Has the study received IRB approval?
* must provide value
Yes
No
Submitted, pending review
Anticipated date of IRB submission
Name of the IRB that approved the study or where study will be submitted
Will this study be used for a regulatory submission?
* must provide value
Yes
No
Will this study involve the administration of an investigational drug, device or biological product, or an approved product for an unapproved indication or dose?
* must provide value
Yes
No
If yes, who will hold the IND/IDE for this product?
Proposed Recruitment Locations:
Which clinics are you most interested in recruiting participants from?
* must provide value
select all that apply
Have you already been discussing this study with a specific clinic(s)?
Yes, I have discussed with a specific clinic(s) or plan to in the future
No
Please list specific clinic(s):
Proposed Recruitment Locations - Pediatrics
Proposed Recruitment Locations (Family Medicine)
Proposed Recruitment Locations (Internal Medicine)
Proposed Recruitment Locations - Urgent Care
Proposed Recruitment Locations - Primary Care
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