JCTO Fees

Fee Type

Fee Amount

Fee Required

Rationale

JCTO

$5,000

Industry-Sponsored (initiated and funded by industry)

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)

Fee Type

Fee Amount

Fee Required

Initial

$2500

Industry Sponsored (initiated and funded by Industry)

Renewal

$1250 per year

Amendment

$750 per amendment

Local Context Review

$2500

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 Pharmacy Maintenance Fee (Drug)

$1701 per drug per year

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 annual maintenance fee begins when inventory is received and continues until study close-out and study drug(s) are destroyed or returned to Sponsor. This fee applies to each drug/drug item (including different strengths) provided by Sponsor. This fee does not include dispensation costs.Please refer to the above table for task descriptions (*).

Investigational Pharmacy Maintenance Fee (Supply)

$408 per supply per year

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 annual maintenance fee begins when inventory is received and continues until study close-out and supply are destroyed or returned to Sponsor. This fee applies to each item that the pharmacy must order and track and is not part of the pharmacy’s standard inventory/supply.

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

Fee Type

Fee Amount*

Fee Required

Per Envelope

$10

Industry Sponsored (initiated and funded by Industry)

Per Envelope

$5.50

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