PLEASE ATTACH PROTOCOL TO WEBFORM
IF YOU DO NOT HAVE A PROTOCOL, IT IS TOO SOON TO SUBMIT THE STUDY TO ONCORE AND INFOED
(You will still need to upload your protocol in InfoEd for IRB review)
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Requestor Date:
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Requestor Name:
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Requester Email:
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PI Last name:
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PI First Name
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PI email
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PI department
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Does this study involve cancer patients, their caregivers or relatives or cancer prevention or assessing cancer epidemiology, imaging or biomarkers for detection or risk stratification?
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Yes No
Non-Oncology Protocol Type Definitions: Click here
Non-Oncology Type
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Clinical Trial Data: Review, Sets or Repository Expand. Access/Compassionate Use Non-Trial Interventional Study Observational Other Registry with/without Specimen Collection Specimen/Lab Only Survey/Questionnaire with/without Specimen Collection Collection=Registry with/without Specimen Collection
Oncology Type
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Basic Science Cancer - Specific Biorepositories or Tissue Banks Data: Review, Sets or Repository Device Feasibility Diagnostic Economics of Care Related to Cancer Care Genetic Studies Health Services Research Other Patient Registries (With Underlying Cancer Research Focus, Includes Epidemiological Studies) Prevention Screening Supportive Care Treatment
Study Title
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Short Title
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Short title is a shorter version of full title or, if applicable, the study acronym or nickname. Primary Objectives
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Protocol Phase
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N/A Phase I Phase I-II Phase II Phase II-III Phase III Phase IV Pilot/Feasibility
UTMB Investigator Initiated Protocol
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Yes No
Multi Site: Is the study being conducted at any NON-UTMB sites?
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Yes No
Participant Age Range
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Adults (18 and older) Children (17 and under) Both
Who is responsible for data monitoring?
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Data Safety Monitoring Committee (DSMC) External (Sponsor or other) PI
Is an Investigational Drug being used?
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N/A Yes No
If no drug is part of the study, select "N/A" A drug is investigational if it is being used outside the FDA-approved indication, route of administrtion, dosage or population. If a drug is being used as part of the study, select "YES" or "NO". Is an Investigational Device being used?
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N/A Yes No
If no device is part of the study, select "N/A" If the device is part of an IDE or is being used outside of it's FDA-approved indication/labeling, select "Yes" If the device is being used according to it's FDA-approved indication/labeling, select "No" Will artificial intelligence (AI) be used in any aspect of this study (e.g., study design, recruitment, data collection, data analysis, decision-making, participant-facing activities or as part of the intervention)?
Yes No
Which of the following describes your study?
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Standard of care Research Combination of Standard of care AND Research No tests, medications, clinic visits, or other procedures take place
Standard of care - (test, medication, clinic visit, etc. that occurs even if the subject is not on the study - is considered routine care) Research - (only occurs because they are on the study - would not occur if they were not on the study) Combination of Standard of Care AND Research -(some events will be standard of care and some events will be research only) No tests, medications, clinic visits or other procedures take place Are there any lab tests performed for research?
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Yes No
Will you be utilizing the UTMB clinical lab for processing?
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Yes No
Should lab test results be available to view in Epic?
(Keep in mind that anyone outside of the research study with Epic access can see them)
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Yes No
Are there any OTHER study events or procedures (non-lab) done solely for research that will generate charges in EPIC? Examples may include ECG, imaging, or clinic visits.
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Yes No
Please List
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What location/space is being used?
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Will the Clinical Research Center (CRC) be utilized for any aspect of this study?
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Yes No
Does this study test a process or action (drug, device, behavior modification, etc.) to evaluate the effect of the intervention?
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Yes No
An intervention is a process or action (drug, device, procedure, AI, education, diet/exercise modification, behavior modification, etc.) that is assigned to a participant as described in a protocol to evaluate the effect of the intervention(s). Are these subjects assigned to an intervention prospectively?
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Yes No
Prospectively means to assign an intervention prior to carrying out the intervention on a participant. Do any of the objectives/aims examine the effect of the intervention on a health-related biomedical or health-related behavioral outcome?
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Yes No
Outcomes may also be called Aims or Endpoints. Are any of the outcomes examining how an intervention effects a health-related biomedical or health-related behavioral outcome? National Clinical Trial (NCT) # enter numbers only, 8 digits total:
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Study Account Department:
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A submitter account must be created. OCR will assist and contact you later. You may use the paper lab requisition form.
Where will the lab tests be performed?
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Will you be enrolling individual participants?
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Yes No
Enrollment means a person participates in the study. Data analysis and chart reviews are examples of studies without enrollment. Will WRITTEN consent be obtained from the participants?
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Yes No
Please list study members needing access in OnCore for Subject Management:
How many participants does the UTMB Investigator plan to enroll?
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Approximately how many MONTHS are planned for enrollment?
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Will you use MyChart to send study invitations to participants who chose to be contacted for research in MyChart?
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Yes No
Epic Research Module Recruitment MyChart: Click the link to download the file
Will you use Our Practice Advisories (OPAs) for study recruitment?
OPAs are specialized advisories to clinicians within Epic that identify potential participants meeting specific study inclusion/exclusion criteria.
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Yes No
Epic Research Module Recruitment OPA (click to download the file)
Sponsor Type
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Federal Non-Profit Industry Department/School
Will the study account be setup in the department that the PI belongs to?
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Yes No
UTMB Study Sites where study activity will take place
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Angleton Danbury Campus
Bay Colony
Clear Lake Campus
Clinical Research Center
Community Clinics-Local (Dickinson, TC, CL, etc.)
Community Clinics-Regional (Alvin, Pasadena, Bay Town, Pearland, etc.)
Galveston Campus
League City Campus
Town Center
TDCJ
Other (if study does not involve enrollment OR all study activity is remote/virtual OR occurs at a site not listed, such as St. Vincent's, community center, etc.)
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