Clinical Trials - SPA Procedures 

Confidential Disclosure Agreements (CDA)

SPA Guide to Clinical Trials

How to Negotiate a Clinical Trial Budget with a Sponsor

Clinical Trial FAQs

Helpful Links for Clinical Trials

Clinical Trial Closure Checklist

• Clinical Trial Fees

Research Contracts - Other Key Documentation 

Statement of Work Guidance

SPA Procedure for Processing Contracts (non-clinical/pharmaceutical) (pdf)

Contract Checklist 

Affirmation Memo Non MTA 

WSU Research Policy 

Request for Waiver of WSU Research Policy

Researcher's Dashboard

School of Medicine Research Administrative Services

Patty Yuhas Kieleszewski
Associate Director
M-F, 9:00-5:30
313-577-9227

Shaterra Childs
Grant & Contract Officer - Clinical Trials: Post-Award, All Confidentiality and Non-Disclosure Agreements for Sponsored Programs
M-F, 7:00-3:00
313-577-3275

TBD
Grant & Contract Officer - Clinical Trials, Investor-Initiated Agreements
M-F, 7:30-3:30
313-577-3726

Mike Maher
Grant & Contract Officer - Subcontracts
M-F, 6:30-3:00
313-577-9490

Karen Tomlinson
Grant & Contract Officer - Non-Clinical Trials Agreements, Federal and Pass- Through Contracts, Data Use Agreements, Confidentiality Disclosure Agreements (All Others)
M-F, 9:00-5:00
313-577-0192

What is a Subaward?  

A subaward is when a portion of Wayne State's sponsored project is passed through to another entity in order to complete a portion of the sponsored project's scope of work. It does not include payments to a contractor or payments to an individual that is a beneficiary of a program.

A subaward agreement is formal written contract made between Wayne State University and another institution or organization to perform an intellectually significant portion of Wayne State's SOW (Statement of Work) under a Wayne State University sponsored project.

Key Terms

• Pass-Through Entity: Non-federal entity that provides a portion of an award it has received to a subrecipient to carry out a specific program
• Subrecipient: Non-federal entity that expends federal awards received from a pass-through entity to carry out a federal program, but does not include an individual that is a beneficiary of such a program. A subrecipient may also be a recipient of other federal awards directly from a federal awarding agency.
• Tier One: of a series of rows placed one above another, it defines the relationship when awards have subawards in their respective budgets.
• Privity of Contract: a doctrine of contract law that prevents any person from seeking the enforcement of a contract, or suing on its terms, unless they are a party to that contract.

Subaward Characteristics

The Subrecipient:

• Makes programmatic decisions
• Must adhere to compliance requirements
• Uses sponsored funds to carry out portion of entire work scope

Uniform Guidance: 2 CFR section 200.331

• Federal award: Characteristics indicative of a federal award received by a subrecipient are when the organization:
  • Determines who is eligible to receive what federal financial assistance;
  • Has its performance measured against whether the objectives of the federal program are met;
  • Has responsibility for programmatic decision-making;
  • Has responsibility for adherence to applicable federal program compliance requirements; and
  • Uses the federal funds to carry out a program of the organization as compared to providing goods or services for a program of the pass-through entity.

Considerations Prior to Proposal Submission

• A need for additional expertise is identified by PI
• Subrecipient selection process is decided
• Proposal package from subrecipient is collected
• If the proposal is going to be a PHS agency the Financial Conflict of Interest review must take place
• PI assesses potential recipients PI documents decision based on evaluation criteria. Some important criteria used in the decision process include:
  • Past scientific and financial performance
  • Technical/financial resources
  • Strength of the proposed scope of work
  • Reasonableness of proposed costs
• The proposal package from the subrecipient includes:
  • Statement of work
  • Budget and associated budget justification
  • Signed commitment letter
  • Biosketches, other support, and other associated information as required by the sponsor
  • Other documentation as requested based on sponsor requirements
• The subrecipient selection process entails
  • Subrecipient competitive bidding: A process whereby a potential subrecipient submits a bid to the PI. The PI considers all bids and decides based on the quality of the science, the best price, and the contract terms.
  • Sole source procurement: The PI's documentation of selection criteria is used.

Roles & Responsibilities

• Department/Principal Investigator (PI)
  • Request proposal package from proposed subrecipient and evaluates selection.
  • Verify FCOI policy and/or obtain FCOI Forms 1 & 2 if sponsor uses PHS FCOI regulations
  • Indicate subawards on PRF.
  • Prepare proposal and sends to SPA
  • Provide additional information required for subaward issuance
  • Monitors subrecipient technical progress and performance
  • Monitor subrecipient's adherence to terms and cost sharing requirements
  • Verify compliance approvals are current for subrecipient's portion of statement of work (human subjects, animal subjects, biosafety)
  • Monitor receipt of invoices and reviews that expenses are aligned with technical progress and all required reports are received
  • Review, sign, and dates invoice (PI)
  • Send approved invoice to SPA mailbox subkinvoices@wayne.edu for processing or returns to subrecipient for more detail or documentation
  • Assesses need to modify statement of work or budget (PI)
  • Plan for timely closeout and obtain prime no cost extension if needed (follow up on missing reports, receipt of final invoice)
  • Promptly alerts SPA when problems arise (inability to obtain satisfactory invoice, non-performance).
• Sponsored Program Administration
  • Reviews and submits proposal
  • Verifies FCOI policy and reviews Forms 1 & 2
  • Works with COI office to verify FCOI training and disclosures
  • Negotiates with sponsor and accepts prime award
  • Follows-up with PI / Dept. to obtain any additional required documentation/data required for subaward
  • Reviews risk levels and, if necessary, modifies subaward agreements
  • Prepares, negotiates, issues and distributes subaward agreement
  • Collects, maintains, and reports FFATA data
  • Activates/encumbers subaward funds in financial system
  • Assists PIs and departments with monitoring subawards
  • Requests and reviews annual audit reports
  • Verifies corrective action plans are implemented (if necessary)
  • Notifies department administrators if the invoices are incorrect
  • Tracks and processes invoices with PI approval
  • Prepares, negotiates, issues, and distributes amendments
  • Modifies subaward encumbrances in the financial system
  • Completes closeout
  • Resolves problems that arise during performance

Subrecipient vs. Contractor Guidance

• Vendor vs. Subrecipient: Guidance on Appropriate Classification of Legal Relationships
  • Under the OMB Uniform Administrative Requirements, Cost Principles and Audit Requirements for Federal Awards, which went into effect on 12/16/2014, the term "vendor" was replaced with "contractor." The terms vendor and contractor substantially have the same meaning and may be used interchangeably in other guidance. For consistency purposes, when Wayne State provides funds from a federal award to a non-federal entity, the non-federal entity receiving these funds is classified as a subrecipient or a contractor based on the nature of the agreement and the criteria in 2 CFR §200.331.
• Subrecipient
  • A subrecipient relationship is appropriate when:
    • Substantive, programmatic work or an important or significant portion of the research program or project is being undertaken by the other entity. 
    • The research program or project is within the research objectives of the entity.
    • The entity participates in a creative way in designing and/or conducting the research.
    • The entity retains some element of programmatic control and discretion over how the work is carried out.
    • The entity commits to a good faith effort to complete the design or conduct of the research.
    • The entity makes independent decisions regarding how to implement the requested activities.
    • A principal investigator has been identified at the entity and functions as a "Co-Investigator".
    • There is the expectation that the entity will retain ownership rights in potentially patentable or copyrightable technology or products that it produces in the course of fulfilling its scope of work.
    • Publications may be created or co-authored at the entity.
    • The entity provides cost sharing or matching funds for which it is not reimbursed by Harvard.
    • The entity regards itself, and/or is regarded by Harvard, as "engaged in research" involving human subjects under the Common Rule and therefore requires approval for its interactions with human subjects.
• Contractor (Vendor)
  • A contractor (vendor) relationship (including that of an individual acting as a vendor of consulting services) is appropriate when:
    • The entity is providing specified services in support of the research program.
    • The entity has not significantly participated in the design of the research itself, but is
    • implementing the research plan of the Harvard investigator.
    • The entity is not directly responsible to the sponsor for the research or for determining research results.
    • The entity markets its services to a range of customers, including those in non-academic fields.
    • Little or no independent decision-making is involved in the design and conduct of the research work being completed.
    • The agreement only specifies the type of goods/services provided and the associated costs.
    • The entity commits to deliverable goods or services, which if not satisfactorily completed will result in nonpayment or requirement to redo deliverables.
    • The entity does not expect to have its employees or executives credited as co-authors on papers that emerge from the research.
    • The expectation is that the work will not result in patentable or copyrightable technology or products that would be owned by the entity.
    • In the case of an individual vendor of consulting services, the person has no employment relationship with Wayne State, either academic or administrative in nature.