Is this a Duplicate entry?
Yes
No
Identify corresponding duplicate record.
Yes
No
COVID-19 Applications v0.1 Record Number
Select your Management Center
* must provide value
MNMC (SOM/SON)
PAMC (Campus)
Enter PI First Name
* must provide value
Enter PI Last Name
* must provide value
Enter PI NetID
* must provide value
Enter PI Email Address
* must provide value
Are you filling this form out on behalf of the PI?
* must provide value
Yes
No
Submitter First Name
* must provide value
Submitter Last Name
* must provide value
Enter Submitter Email Address
* must provide value
Email address of operations/staff person(will receive notifications and may be contacted for more info)
Select School/Department/Clinical Research Unit Name
* must provide value
Divinity School Fuqua School of Business Law School Pratt Engineering Sanford Public Policy Trinity A&S - Natural Sciences Trinity A&S - Social Sciences Trinity A&S - Arts &Humanities Other Campus Department Anesthesiology Biochemistry Biostatistics & Bioinformatics Brain Imaging and Analysis Center Cell Biology Center for Genomic and Computational Biology Center for the Study of Aging & Human Development Dermatology Duke Cancer Institute Duke Clinical and Translational Science Institute Duke Clinical Research Institute Duke Forge Duke Global Health Institute Duke Human Vaccine Institute Duke Molecular Physiology Institute Family Medicine And Community Health Heart Center Head and Neck Surgery and Communication Sciences Immunology Marcus Center for Cellular Cures Medicine Molecular Genetics & Microbiology Neurobiology Neurology Neurosurgery Obstetrics & Gynecology Ophthalmology Orthopaedics Pathology Pediatrics Pharmacology & Cancer Biology Population Health Science Psychiatry Radiation Oncology Radiology RASR School of Nursing Surgery
Other Campus Department - Please Specify
* must provide value
In what stage are you with regard to planning or executing your COVID-19 research or activities?
* must provide value
I have an idea, but may need help finding collaborators, samples, or other resources
I am submitting or have submitted a new grant application or proposal for new/supplemental funding
I will be seeking approval to move forward my research/development activities (e.g., IRB, IACUC, IBC, RBL)
I have already started up my research or activity and I am simply registering
I have submitted one of these COVID-19 activity/research registration forms before, while at an earlier stage; I am updating
Other
Provided IRB, IACUC, etc. number if in progress (if not; pending)
Other - Please specify
* must provide value
Please provide SPS number if applicable/available.
Please provide SPS number if applicable/available.
Please provide SPS number if applicable/available.
Project or activity title
* must provide value
Would you describe your COVID-19 research or activity as ....
* must provide value
Other - Please describe
* must provide value
Please provide a brief description, abstract, or specific aims of your COVID-related research or activities
* must provide value
Project anticipated start date
Today M-D-Y
We want to encourage collaboration, resource/expertise matching, and sharing of ideas. Please indicate if you are willing to have your COVID 19 research or activity posted on this PAGE , visible only to researchers in the Duke community.
* must provide value
Yes
No
List any Duke collaborators, as well as collaborators at other institutions.
Are you open to new collaborators?
* must provide value
Yes
No
Services/resources you CURRENTLY need
Study design support (e.g., methodologic, operational planning)
Core Facilities
Recruitment Support
Proposal development assistance (e.g., proof-reading, administrative assistance [tables, figures, biosketches, administrative data collection, etc.], budget assistance)
FDA Regulatory support (e.g., guidance on investigational drugs, biologics, and medical devices, questions about manufacturing products, current FDA guidance)
Operational resources (e.g., project management, data management, lab technicians, clinical research coordinators, meeting/videoconference facilitation)
Community engagement support (e.g., patient advisory panels, community input, marketing/promotion to community)
Data science resources (e.g., computing resources, machine learning expertise)
Data/IT needs
Samples
Reagents, media, etc.
Something else?
Select all that apply
Core Facilities - Please Specify
* must provide value
Data/IT needs - Please specify
Samples - What Kind? - Please specify
Reagents, Media, etc. - What Kind? - Please specify
Something else? - Please be specific
Will this research or activity involve any transfer of materials into or out of the US?
* must provide value
Yes
No
Will you be conducting research involving human subjects?
(This includes in-person and remote activities, as well as surveys)
* must provide value
Yes
No
Not sure
Does this project involve laboratory/animal work with live SARS-CoV-2 (COVID-19) virus or work with specimens derived from infected subjects/animals?
* must provide value
Yes
No
Does the proposed project require live animals?
Yes
No
BASIC RESEARCH
Â
Note: submission of this form does not signify approval to start or restart on-campus research activities. All on-campus wet-lab research activities must be approved by the Vice Dean for Basic Science. Please use this form to register interest, make your research visible for possible collaborators, and to allow leadership to understand details of proposed activities/research.
Please have the PI and Investigative team review the Duke OESO Biosafety Guidelines surrounding SARS-CoV-2 when preparing this section:
Duke OESO Biosafety Guidelines
Provide all locations where current or proposed research is or will be conducted if approved (Laboratory, Animal, Duke Core Labs etc.). If you don't know the location of a Core Lab, list the name of the Core Lab in the Building Name field.
Building Name:
* must provide value
Room Number:
* must provide value
Yes
No
Building Name:
* must provide value
Room Number:
* must provide value
Yes
No
Building Name:
* must provide value
Room Number:
* must provide value
Yes
No
Building Name:
* must provide value
Room Number:
* must provide value
Yes
No
Building Name:
* must provide value
Room Number:
* must provide value
Please describe how COVID-19 specimens will be managed and stored.
* must provide value
Please State N/A if not applicable.
Add another Biosafety SOP document?
Yes
No
Additional Biosafety SOP Upload
Add another Biosafety SOP document?
Yes
No
Additional Biosafety SOP Upload
Add another Biosafety SOP document?
Yes
No
Additional Biosafety SOP Upload
Will this fall under IRB Oversight?
* must provide value
Yes, Duke Health IRB Oversight
Yes, Campus IRB Oversight (must not involve patients, samples, or DUHS space; PI must have campus affiliation)
No
Not sure
Where are you identifying/enrolling participants?
Outpatient - Identify Where
Please provide DUHS IRB Protocol Number or enter "pending"
Will you need to obtain informed consent from research participant?
Yes
No - We expect this to be exempt
No - We expect to receive a waiver
Not sure
Does this study involve patients who are positive for SARS-CoV-2 or COVID-19?
* must provide value
Yes
No
Will this research involve collection of human biospecimens?
* must provide value
Yes
No
Not sure
Select all that apply
Please provide name of Duke collaborator that will be providing biospecimens . If the protocol name and/or IRB number for the biospecimen collection is readily available, please include.
Provide name and institution for specimens to be received from non-Duke collaborators.
If you are seeking biospecimens from a Duke collaborator, please describe the type and quantity of biospecimens you will need
Duke has standardized Duke REDCap architecture to collect data across all Duke Health research participants. Will your study use this?
Yes - We plan to use the Duke REDCap template
No - Using external data collection tool
No - This is not applicable to my research
Please let us know anything else about your planned or active research or activity that may not have been addressed in previous items.