General Feasibility Questionnaire-Update Aug 2024

General Feasibility Questionnaire-Update Aug 2024

We are identifying investigative sites that are interested in participating in clinical trials. To assess feasibility, we need to collect some basic site and investigator information. During this feasibility survey we will ask you to provide your name and the institution location that you are affiliated with. Kindly please provide information regarding the investigators and staff at your site, and their credentials. We will keep all information confidential and protected, and the evaluation of your information may be shared with study sponsors for the express purpose of site selection. This survey should take approximately 10 minutes to complete.

Date feasibility completed

Principal Investigator/Lead PI (option to add additional PIs below)

PI First Name

PI Last Name

Please indicate if you agree or disagree with the following statement: I understand the information above, and I agree with sharing information about myself and the institution. I have received permission to share investigator information for this purpose. If you do not wish to participate in this feasibility survey, please decline participation by selecting Disagree. If preferred, an electronic copy of the questionnaire can be sent to you and returned by email. Please contact us if you wish to proceed in this manner.*

Select

What is the name of the person we should reach out to with information regarding new studies?

Role

Email Address

Phone Number

Your name, if the contact above is someone other than yourself

Your email, if the contact above is someone other than yourself

PI and Site Details

Principal Investigator (listed above) Area of Specialty

Select or enter value

Institution

City/Town

State/Province

ZIP/Postal Code

Country

Institution Phone Number

Institution Email Address

Do you have other investigators at your site who function as Principal Investigators?

Select or enter value

Additional PI 1 First Name

First Name

Last Name

Additional PI 2 First Name

First Name

Last Name

Additional PI 3 First Name

First Name

Last Name

Additional PI 4 First Name

First Name

Last Name

Does your site have access to a network of referring physicians?

Select

Is your site part of a site network/site management organization?

Select or enter value

Please provide us with the name of the site network/site management organization

How many experienced Study Coordinators would you have available to work on new studies?

What is the name of the person who would be the main point of contact during feasibility and start-up?

Can you describe what your core clinical study team looks like?

Do all of your site staff receive formal ICH-GCP training and re-certify, at minimium, every 3 years?

Select

What are the most prominent barriers for trial participation at your site in general?

Select or enter value

If other, please explain.

What recruitment strategies and/or specialized resources does your site utilize to increase recruitment at your site?

For diversity of the trial can you please specify the patient populations treated at this site (for example how many African American, Asian, Hispanic etc)? (%)

INDICATIONS

Ulcerative Colitis

Does your site have experience conducting trials in patients with Ulcerative Colitis?

Select or enter value

How many years of experience does the Principal Investigator have conducting trials in Ulcerative Colitis?

How many clinical trials has your site completed in Ulcerative Colitis?

Select

How many trials in Ulcerative Colitis are currently ongoing at your site?

Select

How many trials are in Mild to Moderate UC?

Select

How many trials are in Moderate to Severe UC?

Select

Are you in a position to take on new studies in Ulcerative Colitis?

Select or enter value

How many patients in your practice have Ulcerative Colitis?

Select

How many patients with Ulcerative Colitis does your practice see monthly?

Select

Crohn's Disease

Does your site have experience conducting trials in patients with Crohn's Disease?

Select or enter value

How many years of experience does the Principal Investigator have conducting trials in Crohn's Disease?

How many clinical trials has your site completed in Crohn's Disease?

Select

How many trials in Crohn's Disease are currently ongoing at your site?

Select

Are you in a position to take on new studies in Crohn's Disease?

Select or enter value

How many patients in your practice have Crohn's Disease?

Select

How many patients with Crohn's Disease does your practice see monthly?

Select

Does your site have experience conducting studies with Biologic treatments?

Select

What proportion of your UC or CD patients are currently treated with advanced therapies (biologics or small molecules)? Please use percentage.

Pouchitis

Does your site have experience conducting trials in patients with Pouchitis?

Select or enter value

How many years of experience does the Principal Investigator have conducting trials in Pouchitis?

How many clinical trials has your site completed in Pouchitis?

Select

How many trials in Pouchitis are currently ongoing at your site?

Select

Are you in a position to take on new studies in Pouchitis?

Select

How many patients in your practice have Pouchitis?

Select

How many patients with Pouchitis does your practice see monthly?

Select

What is your most prominent barrier for recruitment in Pouchitis?

Select

If other, please specify.

Liver Disease

Does your site have experience conducting trials in patients with liver disease?

Select or enter value

Does your site have experience conducting trials in patients with Primary Sclerosing Cholangitis?

Select or enter value

Does your site have experience conducting trials in patients with Primary Biliary Cholangitis?

Select or enter value

Does your site have experience conducting trials in patients with auto-immune hepatitis?

Select or enter value

Does your site have experience conducting trials in patients with Alcoholic Liver Disease?

Select or enter value

What is your most prominent barrier for recruitment in liver disease?

Select or enter value

If other, please specify.

Eosinophilic Esophagitis (EoE)

Does yout site have experience conducting trials in patients with EoE?

Select or enter value

How many clinical trials has your site completed in EoE?

Select

How many trials in EoE are currently ongoing at your site?

Select

Are you in a position to take on new studies in EoE?

Select or enter value

How many patients in your practice have EoE?

Select

How many patients with EoE does your practice see monthly?

Select

What is your most prominent barrier for recruitment in EoE?

Select

If other, please specify.

Celiac Disease

Does your site have experience conducting trials in patients with Celiac Disease?

Select or enter value

How many clinical trials has your site completed in Celiac Disease?

Select

How many trials in Celiac Disease are currently ongoing at your site?

Select

Are you in a position to take on new studies in Celiac Disease?

Select or enter value

How many patients in your practice have Celiac Disease?

Select

How many patients with Celiac Disease does your practice see monthly?

Select

What is your most prominent barrier for recruitment in Celiac Disease?

Select

If other, please specify.

Additional Indications

If you have experience in other indications, please share.

Select or enter value

Years of experience in other indications

Study Phases/Types

Does your site have the ability to participate in Phase I studies?

Select

Does your site have the ability to participate in Phase II studies?

Select

Does your site have the ability to participate in Phase III studies?

Select

Does your site have the ability to participate in Phase IV studies?

Select

Does your site have the ability to participate in pediatric studies?

Select

Intestinal Ultrasound and MRE

Is your site able to perform intestinal ultrasound, or are you affiliated with a site that can perform intestinal ultrasound for a clinical study?

Select or enter value

How often does your site perform IUS for IBD (cases/week)?

Please enter number only

Does your site have the ability to record IUS cineloops of each bowel segment (longitudinal, cross-sectional, colour Doppler) for central reading?

Select or enter value

Does your IUS machine meet all the following requirements?

Have 2 transducers connected
Export files in DICOM format
Set and display Colour Doppler flow speed to 5-7 cm/s
Annotate scan location
Measure length
Mid/high- and low-frequency probes, according to ultrasound devices. Essential probe frequency should ideally be between 2-12 MHz, and minimum 5-8 MHz to optimize bowel imaging.

Select or enter value

Are you able to send two test ultrasound images to Alimentiv for parameter veriﬁcation to ensure consistency across all sites? (i.e., de-identiﬁed Standard of Care images)

Select or enter value

Does your site have MRE (Magnetic Resonance Enterography) capabilities?

Select or enter value

If yes, is this on-site or contracted third party?

Select or enter value

Have you worked with this MRE department/imaging facility for a clinical trial before?

Select or enter value

Do you require a separate contract with the department/imaging facility per study?

Select or enter value

Site Capabilities

Is your site able to prepare IP using aseptic technique?

Select

Is your site equipped to administer IV medications?

Select

Does your site have experience with clinical trials that require an unblinded pharmacist (or other trained personnel) for drug preparation?

Select

Does your site have experience with the following solutions:

Electronic consent?

Select or enter value

Electronic investigator site file?

Select or enter value

Remote CRA access to electronic patient records and source data?

Select or enter value

Home health care, i.e. conduct of study assessments/visits at patient home?

Select or enter value

What is the typical turnaround time for contract execution at your site?

Select

Does your site use Central, Local or Hybrid IRB?

Select or enter value

Are you required to obtain any additional approvals? If yes, please explain type of review required and typical timeline for approvals

Comments

We welcome any feedback you may have. If you have questions, please email us at ALMV-GenFQ@alimentiv.com and we will contact you.

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