JCTO Fees

Fee Type

Fee Amount

Fee Required

Exempt From Fee

Rationale

JCTO

$3,000

Industry-Sponsored (initiated and funded by industry)

Investigator-Initiated and Funded by a Federally Supported Research Center (e.g. CTSC)

Funded by a Private Foundation or Federal Grant Investigator-Initiated and Industry-Funded

The Joint Clinical Trials Office provides comprehensive oversight of clinical trial agreements and many other types of legal agreements. Indirect cost recovery offsets a portion of the on-going management costs, but does not fund the substantial front-end investment made in negotiating clinical trial agreements and setting up clinical trial accounts. The one-time JCTO administrative management fee partially offsets the following costs:

• Contract review, negotiation and execution
• Financial accuracy and feasibility review
• Monitoring and electronic storage of legal agreements
• Invoicing and accounts receivable management of initial set up costs
• Compliance with applicable institutional and legal requirements
• Quality control and industry sponsor relationship management

$1,500

Industry-Sponsored (initiated and funded by industry)

The Clinical Study Evaluation Committee (CSEC) is a scientific and feasibility review committee. All clinical research protocols require review and approval by the committee prior to submission to the Institutional Review Board (IRB). The committee provides bio-statistical and bioethics resources to physician researchers. The committee consists of a multidisciplinary team of physicians, biostatisticians, pharmacists, and other health professionals.

Fee Type

Fee Amount

Fee Required

Exempt from Fee

Initial

$2500

Industry Sponsored (initiated and funded by Industry)

Funded by private foundation, federal grant, or investigator – initiated

Renewal

$1250 per year

Amendment

$750 per amendment

Local Context Review

$1500 (Initial);
$1000 (Continuing Review)

Fee Type

Fee Amount

Fee Required

Contact JCTO for Guidance

Rationale

Initial Investigational  Pharmacy Fee

$3375.00 (inclusive of IDC)

Industry-Sponsored (initiated and funded by industry)

Investigator-Initiated and Funded by a Federally Supported Research Center (e.g. CTSC)

Funded by a Private Foundation or Federal Grant Investigator-Initiated and Industry-Funded

This is a one-time fee that includes study initiation and closing costs.  The fee reimburses the investigational pharmacy for the time that is required of the pharmacist (PharmD) and/or pharmacy technician (PT) to perform non-dispensing related tasks included but not limited to:

• Site qualification visit and site initiation visit
• Review of the protocol prior to pharmacy approval and assessing feasibility
• Reading the pharmacy manual and preparing the Protocol data sheet for IDS use
• IT work up to upload the study
• Meeting with the sponsors/monitors
• Logging all required info in accountability logs*
• Receiving shipments and stocking IP*
• Managing extended expirations and drug recalls*
• Randomization management*
• IWRS and IVRS Submission*
• Communication with drug sponsor and data coordinators throughout the study*
• Close out visit
• Budget and Billing

(*) Also applies to maintenance fee

Investigational Maintenance Fee

This fee may be paid to the Investigational Pharmacy either on a monthly or annual basis:

Monthly: $128.25

Annually: $1,539 (Inclusive of IDC)

Industry-Sponsored (initiated and funded by industry)

Investigator-Initiated and Funded by a Federally Supported Research Center (e.g. CTSC)

Funded by a Private Foundation or Federal Grant Investigator-Initiated and Industry-Funded

This fee is assessed monthly starting when inventory has been received until study close-out and study drug(s) are destroyed or returned to sponsor. This fee may also be paid on an annual basis

Please refer to the above table for task descriptions (*).

Fee Type

Fee Amount

Fee Required

Card

$4 per card

Pharma/Biotech/Device for all other projects please contact Clincard@med.cornell.edu  

Load

$1.25 per card load