Clinical Outcome Assessments (COAs) are scientifically validated instruments and copyrighted material unless they are placed in the public domain by the developer or copyright holder. Therefore, to administer a COA in a clinical trial, sponsors must secure permission to use it through a study-specific license.

COA licensing best practices

  • Seek for copyright and licensing requirements before using COAs

  • Identify and mitigate upfront any potential risks to COA / eCOA implementation

  • Consider all dependencies when building study timelines for your COA implementation

  • Optimize success by involving appropriate stakeholders for their individual area of expertise

Why partner with Mapi Research Trust for the licensing of COAs?

Mapi Research Trust acts as a single point of contact for study teams to secure all licensing agreements, reducing the burden for sponsors.

We provide the largest global catalog of COAs, acting as the distributor for more than 700 of the industry’s most widely used COAs on behalf of their developers and/or copyright holders.

Our deep experience and relationships with COA developers allow us to navigate complex licensing agreements even for COAs not managed by Mapi Research Trust.

  • COAs distributed by Mapi Research Trust

For a list of all the COAs distributed by Mapi Research Trust on behalf of their copyright holders, along with the conditions of use specific to each COA, please consult our COA catalog.

  • COAs not distributed by Mapi Research Trust

If the COA that you wish to use is not listed in our catalog, Mapi Research Trust may offer to handle the licensing process on your behalf. Acting on your behalf, Mapi Research Trust can obtain official permission from licensing authorities (e.g. developers, publishers, distributors, etc.) so you can access, use, and translate COAs for your project.

 

A streamlined licensing process for any COAs, distributed by Mapi Research Trust or not.

  1. Agreement; Terms and conditions of this service: enabling Mapi Research Trust to negotiate and manage the licensing process on behalf of our clients.
  2. Study details; Nature and scope of the licenses required: study information (e.g., study title, # of expected patients, # of administrations, mode of administration for each instrument, etc.) to support the licensing process.
  3. Information search: For COAs not distributed by Mapi Research Trust, an in-depth search is completed to obtain all needed information (already available for distributed COAs), such as conditions of access and use, availability of derivatives and gap analysis (translations, electronic versions), measure-specific information, etc.
  4. Permission to use: Upon approval of the conditions of use (legal and financial) by the client, Mapi Research Trust facilitates the exchange between the client and the licensing authorities until all parties are in agreement and until the contracts are finalized: license agreements*.

*It should be noted that Mapi Research Trust does not perform legal reviews of the license agreements. The clients handle discussions on legal clauses with the licensing authorities directly.

 

What do you get from our licensing services?

Upon receipt of your request via ePROVIDE™, our licensing team will first assess the complete list of COAs with you (confirming the original versions intended for use in the study), countries and languages required for the research project. Our services include:

  • Complete gap analysis of available versions and translations
  • Investigation of the requirements of the COAs to be used for the study (electronic implementation, linguistic validation, rater training, etc.)
  • Provision of official available translations
  • Scoring guides and manuals
  • Tracking of the status of your requests through the ePROVIDE™ system
  • License agreements and copies of English source versions
  • Verification that the versions used are the original ones or approved derivatives (certified eCOA and/or translations)
  • Audit of COA usage versus licensing terms (# of patients, schedule of events, translations, mode of administration)

Complementary services:

  • Partnering with ICON Language Services for translations not yet developed
  • Screenshot reviews for eCOA implementation and validation with relevant parties (eVendors, sponsors)
  • Distribution of paper COAs to sites as needed

 

Search our PROQOLID™ COA database of over 5,900 COAs and contact us for help with COA management and licensing.

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