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INFORMATION FOR

Protocol Activation & Lifecycle Management (PALM)

PALM was developed for the sole purpose of optimizing the trial activation process at YCCI.

PALM supports any investigator and research study team who conduct clinical research at Yale.

We aim to make the study startup process smooth and efficient for all stakeholders, while ensuring Yale remains financially sustainable and compliant.

Ready to submit a new study?

BEFORE you submit a new study to our team for review and processing, please make sure that you have the following documents & information available:

General Study Information

  • Make sure you have been officially selected as a site before your submission to PALM. You should have received an official email notification from the Sponsor/CRO.
  • An IRES-IRB HIC # must be created and provided to our team
  • The department business office must submit the budget & CTA to OSP via the IRES Agreements Module
Study Documents
  • Protocol (final version – not draft)
    • The final Protocol must be inclusive of a Schedule of Events (SOE)
  • Informed Consent (Sponsor draft version)
  • Budget (draft)
  • Manuals, if available (lab, pharmacy, imaging, etc.)
Support Decisions to be Made
  • Who is doing what on the study – your study team or YCCI?
    • Who will handle the submission to the IRB, initial regulatory document processing & ongoing regulatory management?
    • Are central labs involved? Who will collect the samples (phlebotomy)? Who will process and ship the samples?
    • Where will study visits occur – your office or do you need space at a YCCI research unit?
    • Are any ancillaries required? Radiology? Ophthalmology?

Frequently Asked Questions

On this page
How do I submit a new study?
Request Service
What is the current indirect cost rate?
  • Industry sponsored trials is 35% and for Federal trials it is 67.5%
  • For more information see: https://ysph.yale.edu/myysph/faculty/research-support/resources/indirect-cost-policy/
What documents and/or information do I need before I can submit a new study to YCCI?
  • HIC #
  • Protocol (final version, inclusive of a schedule of events)
  • Informed Consent(s)-Sponsor draft version(s)
  • Budget (draft)
  • Manuals, if available (lab, pharmacy, imaging, etc.)
What fees will be charged by the YCCI?
  • YCCI FY25 Service Rates
  • Fees that your study will be charged regardless of YCCI services requested include:
    • QCT/Coverage Analysis
    • OnCore Calendar Build
    • OnCore Financial Console Build
    • CTMS licensing fee
What if my department is handling the budget and regulatory? Will I still have to pay YCCI?

No, the funding will follow the services. If your team is negotiating the budget and/or doing their own regulatory, the associated fees negotiated in the budget will come back to your department.

NOTE: regardless of who is negotiating the budget, your department will be charged for (1) QCT/Coverage Analysis, (2) OnCore Calendar Build, (3) OnCore Financial Console Build and (4) CTMS licensing fee. Make sure your budget analyst includes these fees in the budget with the sponsor.

Request Service Now!