Rating Scales: Mastering Copyright Permissions for Clinical Trials
3 Things That Impact Your Efficiency
By Monika Vance
Part 1: Your Copyright Licensing Purpose and Situation
Your purpose for securing a copyright permission is to use a specific rating scale, or several of them, in a pharmaceutical clinical trial. In some licensors’ lingo, in a commercial (or industrial) research study.
Your situation is extremely demanding right now…you’re on a tight deadline and looking at 12-hour days for the next few months.
In the introductory part of this series, I mentioned that it takes about 6 hours in total to manage the life cycle of a license for a single rating scale. In CNS trials, in particular, the number of PROs and ClinROs in a single protocol ranges from 3 to 10, or so. As you know, licensing of rating scales often begins before the study protocol is approved by all review committees. This means that changes to rating scale line-up and quantities can and do occur.
When changes to the rating scale line up and quantities happen, that 6-hour time frame can easily double in early phase trials, and triple for late phase trials. It’s a domino effect whenever the protocol changes, or when you need to revise license terms, chase unresponsive and slow licensors, audit and amend uses, or resolve ownership claims. That can add up to about three weeks of working full-time just on getting copyright licenses for a single trial, depending on phase and complexity.
It doesn’t feel like it takes that long, because you’re doing fifty other things in between, so who is paying attention to it? What is that kind of turnaround inefficiency costing your study?
Licensors, of course, don’t see this part of your world.
Your relationship with licensors, knowing what resources you have at your disposal to find copyright owners, and the level of skill and experience that you bring to the discussion and bargaining table also influences your efficiency.
In Part 2, I summarize what skills are helpful in becoming highly efficient in licensing rating scales.
Your Copyright Licensing Experience and Skill
Licensors – Authors, Publishers and Collectives
Rating Scales: Mastering Copyright Licensing
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