MDIC’s EFS Contract Language Library* & Negotiation Tool
This resource was created from 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.
The tools contained intend to drive efficient and consistent contracting processes among clinical sites and sponsors collaborating in clinical trials gaining IDE approval through the EFS program within CDRH. This Resource begins by outlining a proactive EFS Negotiation Range process encouraging sponsors and sites to:
1) Initiate EFS contracts from a reasonable starting point, and consider acceptable backup positions,
2) Empower Contract negotiators to efficiently finalize contracts within acceptable negotiation ranges, and
3) Engage Legal subject matter experts through a “right time, right scope” approach
In addition to the EFS Negotiation Range process, this tool set includes EFS Contract Clause Language Libraries. Each Library contains several clause language examples which have proven acceptable to both the sponsors funding EFS trials and clinical sites conducting EFS trials. Importantly, in addition to language examples, these EFS Language Libraries provide commentary describing the considerations and negotiation points relative to each party during the EFS contract negotiation.
This MDIC EFS Contracts subgroup published the MDIC Early Feasibility Study Contract Resource which can be found here:
MDIC Early Feasibility Study Contract Resource (October 2017)
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, 3rdParty Payers, and Intellectual Property
*The Early Feasibility Study (“EFS”) Study Contract Language Library is provided by The Medical Device Innovation Consortium (“MDIC”) as educational tools. It is 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.