1. Do you have funding in place for your new project?
* must provide value
Yes
No
1a) Do you have departmental funding for this project?
Yes
No
1b) Is this funding from a research grant award?
Yes
No
1c) Is this funding from an industry sponsored clinical trial?
Yes
No
1d) Do you have a Clinical Trial Agreement (CTA) in place for this project?
Yes
No
2a. Do you plan to apply for a grant?
Yes
No
3. Have you identified a sponsor for this project?
Yes
No
3a) Is your project Basic Science/Animal Research?
Yes
No
3b) Is your project Human Research?
Yes
No
3c) Is your project human research and you need help building a protocol and a budget?
Yes
No
4. Will your project involve human subjects?
* must provide value
Yes
No
4a) Do you have Institutional Review Board (IRB) approval in place for this project?
Yes
No
4b) Will your project involve clinical services?
Yes
No
5. Will you be using animal subjects in your project?
Yes
No
5a) Do you have IACUC approval in place for this project?
Yes
No
6. Will you be using radioactive, biological, or chemical materials/agents in your project?
* must provide value
Yes
No
6a) Do you have approval from the Biological and Chemical Safety Advisory Committee (BCSAC) to conduct research using the following hazardous materials/agents:
• pathogenic/infectious microorganisms/materials including virus, bacteria, fungi, protozoan, or prions?
• bio-toxins, carcinogens, mutagens, teratogens, or highly toxic chemicals?
• human material?
Yes
No
6b) Do you have approval from the Radiation Safety Committee and the Radiation Safety Officer to conduct research using radioactive materials?
Yes
No
7. Will you be using Organisms/Materials classified as Select Agents or Toxins? If so, are these agents registered with the Responsible Official (RO) for the UT Southwestern Select Agent and Toxin Program and approved for use by the Biological and Chemical Safety Advisory Committee (BCSAC).
* must provide value
Yes
No
8. Will you be using recombinant DNA or does your project involve the genetic modification of organisms? If so, do you have approval from the Institutional Biosafety Committee (IBC) to conduct research with recombinant DNA or to genetically modify organisms?
Yes
No
9. Does the study involve any of the following: 1) cancer patients, their caregivers or relatives; 2) cancer prevention; 3) assessing cancer epidemiologic, imaging or biological markers for early detection or risk stratification?
* must provide value
Yes
No
10. Does your project involve work, materials, or collaborations outside of the United States?
* must provide value
Yes
No
11. Will you be performing any activities at University Hospitals and/or Clinics, Parkland or Childrens Medical Center?
* must provide value
Yes
No
12. Are you sure that there are a sufficient number of research subjects within the UT Southwestern patient population that meet your draft study enrollment criteria?
Yes
No
13. Do you plan on utilizing either a survey or Electronic Data Capture (EDC) forms in your project to gather study-related data?
Yes
No
NOTE: Please Print your results before you submit to save a record of your materials.
To learn more about conducting research at UT Southwestern, please visit:
The UT Southwestern Research Portal
To learn more about Research Programs offered at UT Southwestern, please visit:
The UT-STAR Portal FUNDING 1: You indicated that you have departmental funding for this project. If you need to have a new account set-up, please contact your Department Administrator to set-up a new account with the Office of Post Award Administration. If you do not need to have a new account set-up, nothing else is required.
FUNDING 2: You indicated that you have outside funding already in place for this project, nothing else is required.
FUNDING 4: You indicated that you have identified an industry sponsor for your human research. To initiate a new Clinical Trial Agreement you will need to complete the OGM1 (Research Contract) form and Clinical Trial Worksheet in the ERGO system. Please click here, ERGO to access these forms. If you have additional questions, please contact the Office of Research Grants and Contracts at ClinicalTrials@UTSouthwestern.edu . More information about Research Contracts can be found at http://utsouthwestern.edu/utsw/cda/dept238840/files/320770.html .
FUNDING 5: You indicated that you need to apply for a grant for a non-human research project. You will need to complete the OGM1 form in the ERGO system. Please click here, ERGO to access the OGM1 form. More information about the Office of Research Grants and Contracts can be found at http://www.utsouthwestern.edu/utsw/cda/dept29530/files/41331.html .
PROTOCOL: You indicated that your project involves humans and that you need assistance in building a protocol or budget. These can be built in the Velos Clinical Trial Management System. Please click here, VELOS to access the Clinical Trial Management System. More information about Velos can be found at HERE . IRB 1: You indicated that you already have IRB approval for this project. Please note, if you need to make any changes to your original IRB protocol, you will need to submit a modification of your protocol to the IRB for approval. IRB approval of your modification can be done via the eIRB system. Please click here, eIRB to access the eIRB system. More information about the IRB can be found at http://www.utsouthwestern.edu/utsw/cda/dept31018/files/41623.html .
IRB 2: You indicated that you do not have IRB approval for this project. You will need to get IRB approval by submitting the details of your project via the eIRB system. Your project must first be registered in Velos before it can be submitted through eIRB. Please click here, VELOS to register your study in Velos. More information about Velos can be found at HERE .
For more information about current IRB procedures please go to http://www.utsouthwestern.edu/utsw/cda/dept31018/files/41623.html .
COVERAGE ANALYSIS 1:You have indicated that your project will involve clinical patient services. You will need to submit a Clinical Trial Coverage Analysis for this project. For more information about the Coverage Analysis process please contact a coverage analyst within the Central Coverage Analysis Group: Mary Jo Cascardo (214) 648-2238, Sharon Haynes (214) 648-6081, Ann Heard-Sakhaee (214) 648-2242, Marsha Roberts (214) 648-6111.
COVERAGE ANALYSIS 2: You indicated that there will be no clinical patient sevices associated with your project. No further action is needed.
IACUC 1: You indicated that you already have IACUC approval for this project. Please note, if you need to make any changes to your original IACUC protocol, you will need to submit a modification of your protocol to the IACUC for approval. IACUC approval of your modification can be done via the eSIRIUS system. Please click here, eSIRIUS to access the eSIRIUS system through ERGO. More information about the IACUC can be found at http://www.utsouthwestern.edu/utsw/cda/dept41600/files/54634.html . IACUC 2: You indicated that you do not have IACUC approval for using animals in this project. You will need to get IACUC approval by submitting the details of your project via the eSIRIUS system. Please click here, eSIRIUS to access the eSIRIUS system through ERGO. More information about the IACUC can be found at http://www.utsouthwestern.edu/utsw/cda/dept41600/files/54634.html . EHS6a: You indicated that you already have the appropriate BCSAC approval(s) in place for this project. Please note, if you need to make any changes to your original submissions to the BCSAC or if your registration has expired, you will need to submit a modified Hazard Registration to Environmental Health and Safety (EH&S). You can obtain approval by submitting the details of your project via PDF forms, which can be found at:
http://www.utsouthwestern.net/intranet/administration/environmental-health-safety/safety/biological-chemical/hazardous-agents/hazard-registration-assistance.html
If you will need to acquire these hazardous materials/agents, you must have the required UDSA permit(s) and MTA(s). If you do not and you need assistance acquiring a USDA permit please contact the Biosafety Officer (214) 645-8341.
EH&S 2: You indicated that you do not already have Environmental Health and Safety (EH&S) approval(s) for this project. You will need to get those approvals by submitting the details of your project via paper forms which can be found at http://www.utsouthwestern.edu/utsw/home/admin/ehs/ .
EHS7: You have indicated that, you have notified the RO and obtained BCSAC approval. Please note, if you need to make any changes to your original submissions to the BCSAC or if your registration has expired, you will need to submit a modified Hazard Registration to Environmental Health and Safety (EH&S). You can obtain approval by submitting the details of your project via PDF forms, which can be found at:
http://www.utsouthwestern.net/intranet/administration/environmental-health-safety/safety/biological-chemical/hazardous-agents/
If you will need to acquire the Select Agents or Toxins, you must have the required Division of Select Agents and Toxins (DSAT) transfer forms, UDSA permits, and MTA. If you do not and you need assistance acquiring these documents please contact the RO (5-8341) .
TECH DEV: You indicated that you will be transferring research materials in relation to this project. You will need to submit the details of your transfers to the Office for Technology Development, Cooperative Research via the MTA (Material Transfer Agreement) form found in iAIM. Click this link, MTA , log in with your UT Southwestern ID and password , and proceed through the forms submission there. More information about Cooperative Research can be found at http://utswtechdev.org/index.php/cooperative-research/material-transfer-agreements . REGULATORY: Your responses indicate that you have no regulatory approvals or compliance submissions to be filed prior to the initiation of this project.
EXPORT CONTROLS: Please consult with Institutional Compliance to determine whether an export controls license is necessary for your research project. PERFORMANCE SITE: Performance Site Approval is required Please submit an NR3 form via ERGO . utCRIS1: You indicated that you are unsure whether or not you may have a sufficient number of research subjects at UT Southwestern. You may utilize the utCRIS Study Feasibility application via the Clinical Research Data Warehouse (i2b2) to review your criteria to determine how many potential subjects may be eligible.
You may also wish to consult with the Division of Biostatistics in The DCS and link for estimation of sample size requirements.
utCRIS2: You indicated that you plan on using a survey or Electronic Data Capture (EDC) forms in your project to gather participant health information. You should consider using either Velos or REDCap to gather this information. For additional information and to compare the two applications, please review Choosing a Data Management System for Research to determine the best choice for your project. NOTE: Please Print your results before you submit to save a record of your materials. Printing to PDF will keep links intact.
Print to PDF in Windows
Requirements: Adobe Acrobat Standard or above (Reader will not work)
1. On the keyboard, hit 'Ctrl+P'
2. In the Print window, select "Adobe PDF"
3. Click 'Print'
4. In the "Save PDF File As" window, choose where to save the file (i.e. Documents)
5. Either use the default filename or rename it
6. Click 'Save'
Print to PDF on a Mac
1. Go to File Menu select Print
2. Select the little triangle to drop additional choice
3. Select "Save as PDF"
4. Provide a meaningful name in the Title area
5. Click Save