EFS Contracting

EFS Contract Language Library* & Negotiation Tool

Leveraging feedback obtained from the 2017 EFS Performance Metrics Baseline, MDIC’s EFS working group formed a Contracts subgroup tasked with developing (a) EFS-specific contract clauses and templates, and (b) Identifying and publishing Best Practice tools and processes for EFS contracting.  In response, this MDIC EFS Contracts subgroup published the MDIC Early Feasibility Study Contract Resource (October 2017). This Resource contains tools and best practices focused on those clinical trial agreement (CTA) clauses identified as the most time-consuming to negotiate, and accounts for considerations unique to EFS trials including: the novel nature of device; procedural advancements, such as surgical technique or sample acquisition; and EFS-specific (vs. other trials) clinical operations.

Specific EFS Contract Impact Areas include, but are not limited to:

  • EFS Contract Best Practices: Proactive identification of EFS Contract Negotiation Ranges
  • EFS Contract Language Libraries: Subject Injury, Indemnification, 3rd Party Payers, and Intellectual Property

EFS Master Clinical Trial Agreement (MCTA)*

Building on the 2017 EFS project success, in 2018 the EFS Contracts working group set out, for the first time, to (A) develop an EFS-specific Master Clinical Trial Agreement (MCTA), and (B) make that EFS MCTA publicly available on the MDIC website for both medical technology and care provider EFS participants.  With engagement of diverse stakeholders including industry, care provider organizations, and regulators, the goal of releasing this MCTA is to facilitate efficiencies in the EFS contracting process by developing an EFS MCTA providing (1) a starting point for contract negotiations with a priori agreement of 90% or greater, and (2) allow both parties to focus remaining legal resources on the remaining 10% (or less) of the EFS MCTA requiring negotiation.

The Early Feasibility Study Master Clinical Trial Agreement (MCTA)* can be found here:

(A) EFS MCTA in MS Word format

(B) EFS MCTA in .pdf format (use link to see authorship team)

The authorship team acknowledged differences among state and local laws, as well as organization policies, when setting the 90% acceptability minimum threshold for the above EFS MCTA.  To provide complimentary efficiency for the remaining 10% (or less) of EFS Sponsor and Institution MCTA negotiations, the authorship team recommends focusing legal resources on the following MCTA sections, and/or addressing trial-specific items in a corresponding statement of work (SOW):

  1. Section 11.5: Record Retention
  2. Section 15.3: Inventions
    • SPONSOR Intellectual Property
    • Other Inventions
    • Option Period
  3. Section 18.3: Sponsor Review timeline(s)
  4. Section 20.x: Indemnification, Insurance and Limitation of Liability
    • 20.1: Indemnified Parties (definition)
    • 20.2: Indemnification by Institution
    • 20.3: Obligation to reimburse, timeframe, and fair market value standards
    • 20.5: Insurance
      • 20.5.1: Amounts and/or types
      • 20.5.2: Term length
  5. Section 22.5: Institution Audit timeline

*The Early Feasibility Study (“EFS”) Master Clinical Trial Agreement template and EFS Study Contract Language Library are provided by The Medical Device Innovation Consortium (“MDIC”) as educational tools.  They are neither intended, nor should be considered, to be legal advice.  Applicable laws may vary in different states.  Also, federal and state laws governing clinical studies are subject to change and to varied interpretations by courts in different jurisdictions.  Each Institution and Sponsor entering into a clinical study agreement should consult with its own counsel to obtain legal advice on contracts for clinical studies.