Electronic Informed Consent for Clinical Trials: Why, What and How

Overview:

An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.

In this webinar we will discuss recent FDA observations in the laboratory and how this knowledge can be used in the laboratory to prevent or reduce regulatory observations in the future.

Why you should Attend:

• Why are you considering e-consent
• • Need to put the patient at the center of the trial process
  • Lack of patient interest in trial participation
  • Need for greater patient involvement during trial
  • Need to explain complex terms and protocol
  • Need to implement remote monitoring
• What concerns you the most
• • Reaction of the IRB
  • FDA non-acceptance of the consents
  • Patient inability to use technology
  • Lack of acceptance by clinical staff
  • Cost
  • Timelines

Areas Covered in the Session:

• Using an e-consent to assist low literacy patient populations understand your trial
• Using e-consent to assist patients in understanding their role in a complex clinical trial.
• Working with an IRB in the review of a e-consent
• Understanding the cost drivers of an e-consent process
• Features of an e-consent. Deciding what is important to your trial.

Who Will Benefit:

• Clinical Trial Innovation teams
• VP, Clinical trials
• Clinical Operations (VP, Senior Managers, Trial Managers)
• IT innovation
• Managers, VPs Research Portfolios
• Others who may benefit - Biobank Managers