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INDUSTRY-SPONSORED CLINICAL TRIAL FEASIBILITY FORM

I. Background

Study teams should complete this form after reviewing the study synopsis, protocol, and other sponsor materials, but before the sponsor site feasibility assessment. Information from the checklist will be reviewed by a Feasibility Review team within 5 business days and should also be used as a tool for preparing the budget. The intention of this needs assessment is to mitigate resource waste, increase efficiencies, develop reporting metrics, and successfully and equitably enroll participants in research studies occurring at BMC.

Name of Person completing the form

Email

Phone

1. Protocol #

Please upload the protocol

2. IRB # (if applicable)

3. Brief Protocol Title

4. Brief Description

5. Home Institution

6. Are you working with BMC Development on the proposal development?

7. Sponsor Name

8. Sponsor Type

IndustryFederal GovernmentFoundationInvestigator Collaboration/Jointly Other

Other

9. Principal Investigator Name

10. PI Email

11. PI Home Department

12. PI Division

13. Area of Medical Specialty

14. Select the experience range of the PI leading clinical research studies

Less than 5 years 5 to 10 years More than 10 years

Link to Glossary

See available trainings here

How many clinical trials has the PI led?

15. Do you have a Co-Investigator serving on your protocol?

Please provide the name of your Co-I

16. Do you have a mentor serving on your protocol?

Please provide the name of your mentor

17. Does this study have dedicated staffing support?

Select all that apply

Clinical Research Coordinator RAStudent 3rd Party Temporary Service Provider or staffing vendor (e.g. ThreeWire)Data AnalysisResearch Nurse Other

Other

Please refer to the CRN

18. Select the average experience range of study staff working on the clinical research study (if applicable)

Less than 5 years 5 to 10 years More than 10 years

Link to Glossary

See available trainings here

19. Do you plan to cede IRB review to a Single IRB?

Note: If the request is to rely on a commercial IRB, the study must either be an industry-sponsored, multi-site trial involving an IND or IDE held by the industry-sponsor or a federally-supported multi-center trial where the commercial IRB has been selected as the IRB of record.

Useful Links:
IRB Resources

20. Do you anticipate the involvement of a non-BMC employee (3rd party) in the conduct of this study? (e.g. monitors on-site or remote, EMR remote access, 3rd party study staff)

YesNo

Please indicate the 3rd party

Study Coordinator Regulatory Assistance/Central IRBHome Health Provider Laboratory Services PharmacyMonitorOther

Other

Please describe the role that such 3rd party will assume

21. Type of research study, select all that apply.

Industry-Initiated

Drug*Device Chart Review Repository Observational Animal Research Tissue CollectionRetrospective Data AnalysisSurvey/Interview/Focus GroupWet Lab Dry Lab Non-drug or device clinical research *includes investigational products

Please select all applicable phases of the study

Phase I Phase IIPhase IIIPhase IVNot a clinical trial

Enter drug type or modality

Will you need access to Pharmacokinetic (PK) or Pharmacodynamic (PD) draws?

Pharmacokinetic Draws (PK)Pharmacodynamic Draws (PD)None

Please describe the who will be conducting the draws

Please describe the location procedures would occur

Please describe the anatomical location of IV placement

Frequency of PK Draws

Number of hours

Number of draws

Frequency of PD Draws

Number of hours

Number of draws

Will this study require observation time?

Yes No

How long is the expected observation time?

What is the phase of the study?

Pilot/Early FeasibilityPivotal Post Market

Select device category

Experimental/Investigational (Category A)Non-experimental/Investigational (Category B)Humanitarian Device Exemption (HDE)Other

Other

Hospital location of device administration (e.g. clinic name)

PI-Initiated

Please select all applicable phases of the study

Phase I Phase IIPhase IIIPhase IVNot a clinical trial

Enter drug type or modality

Will you need access to Pharmacokinetic (PK) or Pharmacodynamic (PD) draws?

Pharmacokinetic Draws (PK)Pharmacodynamic Draws (PD)None

Please describe the who will be conducting the draws

Please describe the location procedures would occur

Please describe the anatomical location of IV placement

Frequency of PK Draws

Number of hours

Number of draws

Frequency of PD Draws

Number of hours

Number of draws

Will this study require observation time?

Yes No

How long is the expected observation time?

What is the phase of the study?

Pilot/Early FeasibilityPivotal Post Market

Select device category

Experimental/Investigational (Category A)Non-experimental/Investigational (Category B)Humanitarian Device Exemption (HDE)Other

Other

Hospital location of device administration (e.g. clinic name)

Sub-award

Please select all applicable phases of the study

Phase I Phase IIPhase IIIPhase IVNot a clinical trial

Enter drug type or modality

Will you need access to Pharmacokinetic (PK) or Pharmacodynamic (PD) draws?

Pharmacokinetic Draws (PK)Pharmacodynamic Draws (PD)None

Please describe the who will be conducting the draws

Please describe the location procedures would occur

Please describe the anatomical location of IV placement

Frequency of PK Draws

Number of hours

Number of draws

Frequency of PD Draws

Number of hours

Number of draws

Will this study require observation time?

Yes No

How long is the expected observation time?

What is the phase of the study?

Pilot/Early FeasibilityPivotal Post Market

Select device category

Experimental/Investigational (Category A)Non-experimental/Investigational (Category B)Humanitarian Device Exemption (HDE)Other

Other

Hospital location of device administration (e.g. clinic name)

Other

Other

IPS involvement is required for drug studies. Click here for more information.

Please complete the CTO Intake Form

22. Identify research visit locations(s). Select all that apply

Please identify research visit locations

Clinic Location

Clinic Name

Determination of research coverage. Select all that apply

Research visits includes no routine careResearch visits includes some routine careResearch is chart reviewing on routine care visits

Please describe the routine-related care related to the research protocol

Please identify research visit locations

Inpatient Location

Inpatient Unit Name

Will you need access to any of the following?

Pediatric Code Cart Adult Code Cart Infusion Capability InterviewOvernight Observation Space PhlebotomyPharmacokinetic (PK draws) Pharmacodynamic (PD draws) Other

Other

Is the inpatient admission occurring for routine care and research is piggybacking on the admission?

YesNo

Please identify research visit locations

GCRU: General Clinical Research Unit

For additional information on the GCRU, proceed to page 2, question #1

Useful Links:
GCRU Resource

Please identify research visit locations

CRU: Clinical Research Unit

Useful Links:
CRU 1-pager
CRU Resource

Please identify research visit locations

Outside of BMC Medical Campus

Provide Location Outside of BMC Medical Campus

Please identify research visit locations

Dedicated Department Assigned Research Space

Provide Location of Dedicated Department Assigned Research Space

Please identify research visit locations

BU Medical Campus

Provide Location within BU Medical Campus

Please identify research visit locations

BMC Affiliated Community Health Centers

Identify research visit locations(s). Select all that apply

Boston Health Care for the Homeless Program Codman Square The Dimlock Center Dot House Health East Boston Neighborhood Health Center Geiger Gibson Community Health Center Greater Roslindale Medical and Dental Center Manet Community Health Center Mattapan Community Health Center South Boston Community Health Center Upham's Corner Community Health Center Whittier Street Health Center

Access BHN/Community Health Center Resources or Click the individual CHC links above for a CHC summary

Please provide a brief description of the role Community Health Centers will play.

Please identify research visit locations

Other

Please identify research visit locations

N/A

II. Clinical Services and Research Workflows

1. Select all clinical services required to complete this protocol

InfusionSubcutaneous InjectionClinic SpacePhlembotomyLab ProcessingClinical Visit SupportOther

Other

2. Does this protocol require non-GCRU hospital nursing services?

Select the nursing services needed

CRUBMC floor/unit nurses

Useful Links:
CRU 1-pager
CRU Resource

Useful Links:
BMC Nursing Resource

Do you require inpatient or outpatient hospital nursing?

Inpatient Outpatient

Please describe the responsibilities of the hospital nursing service role (e.g. vital signs, blood draws, administration of drugs, IV placement, etc.)

Please provide further details and contact the Primary Care Manager (PCM) for a support letter

3. Does this protocol require study team hired research nursing services?

Please describe the responsibilities of the study team hired nursing role (e.g. vital signs, blood draws, administration of drugs, IV placement, etc.)

4. Does this protocol require study team or research nursing support services? Select all that apply.

CRUGCRUCRNNot applicable

CRN selected -

CRN staffing modelCRN community engagement supportCRN community engagement consultations

CRN Services Requested

IRB Preparation and Regulatory Oversight Budgeting and Financial Management Clinical Research Coordinator Community Engagement Planning Other

Other

5. Will special procedures require evaluations or testing outside of regular clinic hours?

Please comment on specific facility requirements, if any

6. Will this study require a pediatric or adult code cart?

7. Do you plan on utilizing BMC clinical services, clinical core services, or infrastructure, such as ancillary service departments?

Some ancillary service providers may require additional intakes. Please refer to the clinical services or infrastructure resource through this link:

If "Yes", please select all that apply to your study:

Epic Billing will occur (Training Resource)No Epic billing but want to track research participants in the systemsInvestigational Pharmacy Service (For study drug maintenance and dispensation. Follow IPS policy. No offsite study drug storage allowedInvestigational Device (IDE) implantsMarketing Observational StudiesExpanded Access/Compassionate Use/Emergency Use protocols/Single-PatientHumanitarian Device Exemptions and Humanitarian Use DevicesInfusion services Lab Medicine (Processing or Providing Analysis of blood/tissue samples)Pathology (e.g. Histology Slides)Cardiology Performing Physical Exam in BMC clinical spaceDrawing Blood in BMC clinical space (Phlebotomy Sample Collection for Research)Radiology (e.g. MRI, CT/PET/MUGA Scans)Ophthalmology (e.g. Retinal Exams)

Infusion Services: Please indicate the location

Radiology: Please indicate the location:

Lab Medicine: Please indicate the location

Pathology: Please indicate the location

Ophthalmology: Please indicate the location

Performing Physical Exam in BMC clinical space: Please indicate the location

Drawing Blood in BMC clinical space: Please indicate the location

Will you be performing echocardiographies?

YesNo

Cardiology: Please indicate the location

You may need to fill out the Echocardiography Research Study Form.

Useful Links

Epic Billing Resource

IPS Resource

Marketing Resource

Lab Medicine Resource

Pathology Resource

Phlebotomy Resource

Radiology Resource

Ophthalmology Resource

8. Does the protocol have any data informatics needs from Clinical Data Warehouse for Research (CDW-R)?

Useful Links:
CDW-R Website
Clinical Data Warehouse for Research (CDW-R) Request Form
CDW-R Resource

9. Does your study include any of the following?

Technology that is being used at BMC to further the care of BMC patients as part of the research study; or
Technology that is used to gather data from BMC patients for research purposes; or
Software that is used as part of the research study that is integrated with existing software hosted by BMC.
Examples include, but are not limited to, Epic EHR build(s), use of new servers, data integrations for research, and study-specific 3rd party software use-case review.

(Note that these criteria pertain to the use of proposed *new* technology or *new* software that is not currently being used at BMC; rather, the new technology or software is being implemented for the purpose of this research study)

Link to Research Technology Programs (RTP)

Does your study include any of the following?

Please elaborate on services needed

III. Enrollment

1. Are you considering the enrollment of BMC patients for your research study?

YesNoPlanning to enroll both BMC and non-BMC patients

Do you have other patient sources (e.g. registry)?

YesNo

Explain

Please provide BMC’s aggregate patient population that can enroll in this protocol to justify performing this study at BMC. Visit TriNetX resource for support to run aggregate data based on the protocol’s inclusion/exclusion criteria.

Please identify ICD-10 diagnoses for accurate reporting.

What non-BMC populations do you plan to enroll? Provide high level strategies on who and how you are targeting those you intend to enroll.

Useful Resources:
Community Engagement Resource
Community Health Centres Collaboration
Communications and Marketing

2a. Based on the information supplied in #1 above, provide a reasonable projected number of participants to enroll at BMC/BU.

2b. How many participants does the sponsor anticipate enrolling at BMC/BU?

2c. Please describe any expected barriers to enrollment, if any.

*Please note that you will be held accountable for not meeting enrolment expectations

3. Share the actual or anticipated date that the first site has begun or will begin enrollment

4. How many sites are expected to be selected for this study?

5. What is the total expected enrollment for all sites?

6. When do you anticipate enrolling your 1st participant?

7. What methods does the study anticipate using to reimburse participants? Select all that apply

Not applicable/No compensation Exemption for use of gift cards, checks, eCredits Travel: Uber Health, Taxi Vouchers, MBTA, Gas, Parking Childcare Flight HotelFood Voucher Managed by sponsor ClinCard

Guidance on Participant Compensation

FDA Guidance
“Perceptions of Reimbursement for Clinical Trial Participation”
“Who’s Doing the Math? Are We Really Compensating Research Participants?”
“Paying Research Subjects: An Analysis of Current Policies”

ClinCard Resources:

ClinCard Training
Card Pickup Request Form

Travel Compensation Guide:

Uber Health Guide

Community Engagement Planning

1. 33% of BMC patients speak a primary language other than English. What resources do you anticipate your team needing to engage this population? Select all that apply.

Of the 33% -

50% speak Spanish
15% speak Haitian Creole
9% speak Portuguese
5% speak Vietnamese

33% of BMC patients speak a primary language other than English. What resources do you anticipate your team needing to engage this population? Select all that apply.

Staff training to support multilingual enrollment

Non-medical interpreter training certificate Medical interpreter training certificate Other

Other

33% of BMC patients speak a primary language other than English. What resources do you anticipate your team needing to engage this population? Select all that apply.

Funding and support in hiring multilingual staff Language justice workshops Interpreter Services Study documentation translation services Certification or review of translated materials for cultural relevance and accuracy Other

Other

Useful Resources:

Interpreter Services

Study documentation translation services

2. 70% of BMC patients identify as a racial or ethnic minority. What resources do you anticipate your team needing to engage this population? Select all that apply.

Please see resources here

70% of BMC patients identify as a racial or ethnic minority. What resources do you anticipate your team needing to engage this population? Select all that apply.

CRN website for community engagement materials and support services Community partnerships and outreach CTSI Community Engagement Core

Useful Resources:

CRN website for community engagement materials and support services

Community partnerships and outreach

3. It is recommended to request financial support from the sponsor to provide recruitment resources. Please, select which support services this study will need to successfully enroll non-primary language English speakers.

Consent and study document translation Study staff interpreter training or certification programs Time to enroll and complete study visit for non-primary language English speaker Other

Other

4. What collaborations do you anticipate needing (i.e. community engagement, academic partnerships) to successfully enroll the populations selected above? If unknown, it is best practice to create a community engagement plan - preferably informed by individuals the study anticipates enrolling - to successfully meet the accrual targets through inclusive practices.

Useful Resources:
It is recommended to use the Equity in Research Rubric, provided by the Health Equity in Research Community Advisory Board (CAB), to support the drafting of your outreach protocol. See resource for additional support.

Acknowledgements

I certify that the answers provided are true and accurate to the best of my knowledge. I understand the importance of and agree to notify Research Operations of any changes.

Link to Central Research Toolkit

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