Protocol Amendments And Electronic Consent: Overcoming The Challenges To Reap The Benefits

By Kate Godwin-Smith, Director, Client Services, Patient Consent Solutions, IQVIA Technologies

In a recent article, five steps to achieve greater eConsent adoption by clinical research sites were shared:

Step 1: Develop your country strategy for eConsent.

Step 2: Include eConsent in trial planning.

Step 3: Optimize your informed consent form digitization timelines.

Step 4: Train and communicate.

Step 5: Build a monitor advocacy program.

Many found the article helpful and had further questions around the topic of handling protocol amendments in an eConsent deployment. Some had found that eConsent lacked the agility necessary to make quick changes to the electronic informed consent form (ICF) when protocol amendments occurred. Thus, learn about some insights that have been gleaned from experience deploying eConsent on diverse trial types around the world.