CTSI Designated Core Application

Core Name

Core Director

Core Director Campus Address

Core Director e-mail

Core Director phone number

Is there an Associate Director or Facility Manager?

Name(s) and title(s) of Associate Director / Facility Manager (if applicable)

Please upload current biosketch(es) for the Associate Director and/or Facility Manager, as applicable.

Please list all Core Personnel (Name and Role)

Campus where your core is located

If other, please provide campus location

Core Location - Building and room number

Narrative Description of the Core:

Definition of a CTSI Core: A CTSI Core is a facility that provides a needed service to CTSI investigators from more than one department enabling them to conduct their funded individual research projects more efficiently and/or more effectively. Cores should be designed to furnish a group of investigators with materials (but not materials that should be acquired and/or purchased by the investigators), training, determinations, data analysis, instrumentation, and/or quality control to enhance research and contribute to cost effectiveness. Cores should be open to all CTSI investigators and clearly demonstrate available staff and equipment devoted to the core work and the commitment to core services.

To show how your core supports science from more than one department, please describe:

1. Services provided (high level) and the reason for providing these services in a core setting (example: specialized equipment and/or distinctive expertise that would be difficult to duplicate in multiple labs).

2. What percentage of Core resources (personnel, equipment, etc) is available to users paying user fees versus that from specific projects, investigators, or centers that provide funding directly to the core?

3. Core Users - reported in the next section

Purdue CURRENT Users
(# of Users / Departments)

Univ. of Notre Dame CURRENT Users
(# of Users / Departments)

IU South Bend CURRENT Users
(# of Users / Departments)

IU Bloomington CURRENT Users
(# of Users / Departments)

IUPUI, IU School of Medicine (IUSOM) CURRENT Users
(# of Users / Departments)

IUPUI, Outside IUSOM CURRENT Users
(# of Users / Departments)

Other (provide institution, city, state) CURRENT Users
(# of Users / Departments)

Alternatively, you may upload a Word, PDF, or formatted Excel report of CURRENT USERS (to fit on one page when converted to PDF) containing this information:

-- Campus (Purdue, Notre Dame, IU South Bend, IU Bloomington, IUPUI - IUSOM, IUPUI - Outside IUSOM, or Other (including Institution, City, State))
-- # of Users per Institution
-- Departments of Users per Institution

Purdue ANTICIPATED Users
(# of Users / Departments)

Univ. of Notre Dame ANTICIPATED Users
(# of Users / Departments)

IU South Bend ANTICIPATED Users
(# of Users / Departments)

IU Bloomington ANTICIPATED Users
(# of Users / Departments)

IUPUI, IU School of Medicine (IUSOM) ANTICIPATED Users
(# of Users / Departments)

IUPUI (outside IUSOM) ANTICIPATED Users
(# of Users / Departments)

Other (provide institution, city, state) ANTICIPATED Users
(# of Users / Departments)

Alternatively, you may upload a Word, PDF, or formatted Excel report of ANTICIPATED USERS (to fit on one page when converted to PDF) containing this information:

-- Campus (Purdue, Notre Dame, IU South Bend, IU Bloomington, IUPUI - IUSOM, IUPUI - Outside IUSOM, or Other (including Institution, City, State))
-- # of Users per Institution
-- Departments of Users per Institution

Describe regulatory considerations for your Core and your approach to ensuring regulatory compliance within the Core.

(e.g. Environmental Health and Safety, HIPAA, Biosafety, Animal Care and Use, Human Subjects, Research Integrity, Radiation Safety, etc.)

1. Confidentiality

2. Cost Recovery/Payment -
Including:
---- If/when partial payments will be accepted
---- If/when payments will be waived altogether
---- If/when refunds will be given, such as when Core resources are utilized but the requested service cannot be completed.
---- Must include method of collecting payment from external users or when university account numbers are not available

3. Prioritization of work

4. Acknowledgement, publication and authorship expectations -
Including:
---- Guidelines for justifying work that is above technical expertise that warrants authorship
---- Crediting the Core in the acknowledgement section of any publication
---- Providing the Core details of any publications or grants arising out of work that uses Core resources

5. Conflict resolution -
Describes how the following issues will be handled:
---- Scheduling difficulties
---- Technical problems
---- Authorship disagreements
---- Quality issues
---- Other applicable

6. Submitting Material in Compliance with Regulatory Requirements -

States that material or health-related information submitted to a Core for analysis was obtained in compliance with current regulatory and legal requirements, that users comply with all safety standards (e.g. IRB, IBC, IACUC, etc.) and fully disclose the potential hazards of materials submitted to a Core.

Examples of acceptable core policies available upon request.

Please provide the following information for your Core Advisory Committee Chair?

- Name
- Home campus, School, Unit, or Department

Is the Chair of your Committee outside of the core?

Your core advisory chair is required to be outside of your core. If there is reason that you cannot modify your advisory committee to meet this requirement please explain.

Is the Chair of your Committee a Core User?

Please list the following for all other committee members (including Core Associate Director/Facility Manager, if applicable):

- Name
- Role, including:
---- Core Associate Director
---- Core Facility Director
---- Committee Member
- Home campus, School, Unit, or Department
- Within the core or not
- Core user or not
- Technical adviser or not

The Advisory Committee must meet at least annually.

What is the frequency of Advisory Committee meetings?

The Advisory Committee must review the following items. Please provide a sample agenda for your meetings demonstrating that you discuss each of the following:

i) Core utilization
ii) Core quality assessment/user satisfaction
iii) User fees
iv) Suitability of new services and equipment
purchases
v) Funding opportunities for the Core (Equipment
grants, Core Pilot grants, etc.)

The Committee's findings must be communicated to the Department Chair / Center Director in which the Core is based, and to the CTSI Oversight Committee (annually via the Renewal Application).

Please describe your method for ensuring that the Advisory Chair and/or Director communicates a summary of the above advisory committee items to the responsible Department Chair / Center Director at least annually.

Please upload a document demonstrating a quality and user satisfaction survey.

Please name the Business Office and/or University Official that approves your rates.

Provide a document listing your menu of services and rates (internal and external, if applicable) for each.

Are rates for services on your website current and/or readily available to users?

Please explain

Have your rates been SUBMITTED to your Business Office and/or University officials?

If rates have not been submitted, please describe your plans for submission.

Which School, Division, Department or Center will be ultimately responsible for the financial shortfalls of the Core, if any?

Please upload (template attached above) a document containing printed names and signatures for the following:

1. Core Director attestation that the application is accurate

2. Core Advisory Chairperson attestation that the Core Advisory Committee will provide oversight as directed in the Core Advisory Committee section of this application

3. School, Division, Department, or Center attestation accepting fiscal responsibility for the Core