Correlative studies may include:

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• Additional samples from existing subjects
  Expanded testing of study samples
  A full additional arm of the study
  A new funding entity
  A new PI
  New patient pool
  A full, separate research project
  A full, separate service agreement
  A reference to a separate protocol without clear separation from the current protocol

 
Key Considerations

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• Forcing a separate project (that would not by itself be considered a clinical trial) into an IIT protocol does not make it a clinical trial and will result in significant delays. It is often necessary to remove the separate project from the protocol at a later time, which can result in major budget, contract and compliance issues.
   

• You should describe the correlative study in the protocol if the project is part of the clinical trial and if the correlative project uses all of the same:

  • Funding as the clinical trial      

  • Funding entity as the clinical trial

  • PI as the clinical trial

  • Study subjects as the clinical trial

  • Study team as the clinical trial
     

• The following types of correlative projects should NOT be described in the protocol:

  • Independent research projects that involve different patients, a different PI or different funding (even partially).      

  • Projects that will be done off site by other entities (i.e. services or subcontracts)

  • Projects that are sponsor initiated (under a sponsor written protocol)

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• If you must reference a separate correlative project in an IIT protocol that will use other funding, staff, patients or facilities, the IIT protocol should reference, but not describe, the correlative activity clearly. For example:

        “Correlative Study: The de-identified samples will be analyzed along with samples from similar studies
         under a separate, state-funded grant.  The results of the correlative study will be published, and all
         rights, payments and services will be handled, exclusively in accordance with the terms of that grant.”
 
Reminders

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• Describe a correlative study in the protocol if you want incorporated into the protocol. Merely referring to a correlative study does not mean that it is part of the protocol.
   

• Funding for correlative studies may require separate grant terms, agreements, or protocol.  This should be made clear to the funding entity in communications, and included in the budget and the contract to ensure that there are no conflicting commitments.

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