Please note, this tool is intended to help departments assess the resources necessary to safely and compliantly conduct the study in question. This includes consideration of whether or not the investigator has enough potential participants, appropriate staffing, facilities, and adequate funding. In order to avoid delays in study implementation it is strongly encouraged that study teams complete this form and get it approved and signed prior to submission to any central office. A copy of this checklist signed by both the PI AND Departmental Official (Chair/Director/Division Chief), and will be required to upload at the time of the CTA submission in TRAcs.
Email of individual completing this form:
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A copy of the completed checklist will be sent to this address for signature.
Today's Date:
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Today M-D-Y
Principal Investigator
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Departmental Official:
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(Chair / Division Chief)
Project Title
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Please provide a short summary or description of the purpose of this study and your motivation for opening this study at UMass Chan:
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Primary Study Coordinator Name:
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Primary Study Coordinator Email
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Department Administrator name:
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Department Administrator email:
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Sponsor Protocol No.:
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If not applicable, please enter "N/A"
Protocol Version No.:
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If not applicable, please enter "N/A"
ClinicalTrials.gov NCT #: here .
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If not applicable, please enter "N/A"
Which IRB will this protocol be submitted to for approval?
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UMass
CIRB (NCI)
WCG (aka Western IRB or WIRB)
Advarra
Other
If other IRB, please specify:
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Will this protocol be peer reviewed?
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Yes
No
Will any other departments be involved in this research study?
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Yes
No
If yes, indicate the collaborating department(s):
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The expectation is that study teams have worked with the appropriate member of any collaborating department to ensure that the requirements of the protocol are feasible,. OCR and/or UMMH may request documentation of collaborating departments approval if necessary.
Do you intend to utilize services from the Department of Medicine Core (DOM Core)?
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Yes
No
Do you intend to utilize services from the Cancer Research Office (CRO)?
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Yes
No
Will the CRO be the primary coordinating team?
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Yes
No
Will this study involve the following?
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Which Health Alliance locations will be involved in the study?
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If not applicable, please enter "N/A"
Will any of the following ancillary review committees be needed for this protocol?
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Sponsor:
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If internal, please enter "UMass Chan"
Primary Funding Source:
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NIH
Other Federal
Internal UMass Funding
Industry
Foundation / Nonprofit
Other
Speedtype (Required for all Internally Funded Research):
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Speedtype will need to be obtained from your department administrator
Is the sponsor fully funding this study?
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Yes
No
If no, who will be funding this study?
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Observational or Interventional Study?
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Observational
Interventional
Study Phase:
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If other, explain:
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Does this study involve patients under the age of 18?
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Yes
No
Does this study involve healthy volunteers?
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Yes
No
Total (maximum) accrual for study at UMass Chan:
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How many patients have been identified with this diagnosis based on PI knowledge/estimation:
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Please indicate # patients/appropriate period of time (e.g. 5 patients/week)
How many patients have been identified with this diagnosis based on a data lake query or other method:
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Please indicate # patients/appropriate period of time (e.g. 5 patients/week)
Because this study is using the CRO, please provide how many patients have been identified with this diagnosis based on the cancer registry:
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Please indicate # patients/appropriate period of time (e.g. 5 patients/week)
More information regarding the available recruitment resources at UMass Chan CCTS including "Just-in-Time Alert" (JITA) - Real Time Patient Recruitment Application, Data Lake Extraction, i2b2, etc, can be accessed here .
Anticipated duration patients will be on study, including follow-up:
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Is this study utilizing any UMass Memorial Health Facilities, Staff, or Services?
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Yes
No
Where will the study be conducted? (Check all that apply)
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If only using the Clinical Research Center (CRC), mark "We are not using any of the above".
Which UMass Member Hospital location:
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If other, please explain:
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Please describe exactly where clinical study visits will be conducted:
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Will UMMH staff (other than IDS) require specific protocol training?
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Yes
No
What specific protocol training will be required?
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Do you intend to utilize any of the following for research purposes?OCR-202 .
Please note: The first floor ACC, Clinical Research Center is a school facility and does not need to be indicated in this question.
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If imaging services, list any non-routine imaging and which provider will be performing them.
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If laboratory services, list any non-routine local labs.
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If infusion center, list specific non-routine services, including how many infusions and over what length of time.
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If infusion, is this a substitution for a standard infusion drug?
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Yes
No
If infusion, do you anticipate this taking a longer amount of time than the standard therapy infusion?
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Yes
No
If 'other', please explain:
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Will hospitalization be required as part of this research study?
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Yes
No
Do not include hospital stays related to unanticipated emergencies or symptom management.
What specific service AND hospital unit will the study subject be admitted to?
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(e.g. Neurology AND 4th floor)
If yes, how long will subjects be hospitalized?
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If yes, has the unit been made aware of the study?
Please confirm that you have notified the impacted unit and that they have been made aware of the study?
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Yes
No
Please note that study teams are expected to have notified the involved unit(s) and that a failure to do so may result in delays in the study start up process up to and including intake and setup by OCR.
Please reach out to the involved unit prior to submitting this form.
Will any study specific drug(s)/biologic(s)/device(s) be used in this research (check all that apply):
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Has the Investigational Drug Service (IDS) been made aware of this study?
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Yes
No
If any drugs/biologics/devices will be used, does the UMass Chan Principal Investigator hold the IND/IDE?
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Yes
No
If yes, specify:
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Does the UMass Investigator have a current MCSR Researcher License?
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Yes
No
The Massachusetts law, Title 105 CMR 700.009, requires that every principal investigator (PI) who is conducting research involving any drug must be covered by a Massachusetts Controlled Substances Registration (MCSR) research license. This means that drug research should not commence until a MCSR research license is obtained from the Massachusetts Department of Public Health (MDPH). here .
In which setting will the study drug, biologic, or device be administered (check all that apply):
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If drug or biologic, please provide the route of administration:
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if "Other", please specify:
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If device, describe how the device will be transported, stored, utilized:
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Is the device being provided by the sponsor at no cost?
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Yes
No
Is the device being used off label?
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Yes
No
Yes
No
Has the department approved the purchase of the device through UMMH and arranged for the appropriate Epic coding of the device?
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Yes
No
Has the department approved the purchase of the device through UMMH?
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Yes
No
Has the department worked with UMMH and built the coding of the device into Epic?
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Yes
No
If the department has not worked with UMMH to get the device code added to Epic, you will not be able to proceed with your OnCore shell record build, negotiations, or move forward with accrual from an institutional perspective until this is resolved. Your department administrator will need to work with the study team in order to assist with this.
If "No", you will not be able to proceed with your OnCore shell record build, negotiations, or move forward with accrual from an institutional perspective until this is resolved. Your department administrator will need to work with the study team in order to assist with this. This will likely include ensuring that there is a billing code for the device that may not already exist (as this is a research device).
Please upload the documentation for the Epic coding of the device (if available).
What is the clinical code for the device:
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Clinical codes should be obtained from revenue integrity or the UMMH department. TBD or Pending are not acceptable responses.
Is this study considered gene and/or cell therapy?
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Yes
No
Is this an urgent request?
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Yes
No
Please provide a summary of the gene/cell therapy study, including why this study should be conducted at UMass Chan?
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Please provide a list of possible side effects or adverse events and risks related to the proposed gene/cell therapy.
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What clinical services would be needed to support any anticipated adverse events? Please provide a detailed list.
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Please provide the following information for 4 individuals who you believe could be called upon to serve as external reviewers for this study. These individuals, to the best of your knowledge, should be free of conflicts of interest (including serving in any other capacity on this protocol).
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The study team is not required to contact these individuals in advance. The Gene and Cell Therapy Advisory Committee will reach out to these individuals directly.
Are there any competing studies currently active at UMass Chan?
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Yes
No
If yes, please explain:
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How many active studies does the PI currently have?
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How many studies is the primary coordinator working on?
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Please provide a brief list of personnel who you anticipate will be working on this study team. This includes sub-investigators, coordinators, research assistants, and research nurses, AND the number of years of research experience for each team member. This is intended to help ensure appropriate staffing.
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As a reminder, all clinical research that meets any of the following criteria must be entered into OnCore:
Has an external fund source. Uses or purchases a service from UMass Memorial Health Care or any of its affiliates, including UMass Memorial Medical Group. Has or requires registration on ClinicalTrials.gov (has a NCT number). Uses the UMass Center for Clinical and Translational Science Clinical Research Center. Uses the services of the UMass IRB or Investigational Drug Services. Flags patients in Epic or uses Epic for recruitment. Requires access to https://www.conqueringdiseases.org/ recruitment tools. Please provide the names of the staff members who will be responsible for entry of data into OnCore.
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An "Interest" is any form of remuneration, payment, or equity interest such as ownership of stocks, bonds, stock options, warrants, partnership or other equity interest, and rights to patent, royalty payments or any uncompensated relationships with the sponsor and/or a product or service involved in the study outside of your UMass Chan responsibilities .
Examples of interactions outside of your role with UMass Chan that create Interests include the following, regardless of compensation:
Officers or Board of Directors Scientific Advisory Board Teaching (outside appointment, lecturer) Sponsored Travel and/or Reimbursement Other (any activity leveraging your professional experience)
Please list all 'study team' individuals responsible for the design, conduct, or reporting of research.
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Does any member of the study team (as listed above) have or does a member of their immediate family have a current or pending financial interest in the sponsor or any entity affiliated with the study?
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Yes
No
If so, please indicate each member of the project team with financial interest.
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Please provide a copy of the study protocol.
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Please provide a copy of the consent form (if available).
Please upload a copy of the study investigator brochure.
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Upon submission, a copy of this checklist will be provided to the individual completing this form (as completed above). The study team will be required to upload a copy that has been signed by both the Principal Investigator AND departmental Chair/Division Chief at the time of the CTA submission / OnCore shell build request in TRAcs .
The study team and/or person completing this form is responsible for the collection of signatures. Signatures can be via wet signature or collected via DocuSign. If you do not alreayd have a DocuSign account, one can be requested by IT via ServiceNow here .
PI Name:
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By signing this form you are acknowledging that the information contained in this form is accurate.
Because it has been indicated that there is a review of Conflict of Interest for this study, by signing, you ______ are certifying that:
i. I confirm that this form has been completed accurately and in full. I have consulted with each member of the project team to ensure that all financial interests have been disclosed and that each team member's Conflict of Interest (COI) Disclosure is current.
Departmental Chair / Division Chief Name:
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By signing this form you are acknowledging that the information contained in this form is accurate and that this protocol is approved to move forward by the department/division.
Please note that this has been flagged as an internally funded study to be billed to the provided speedtype: ______
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