Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Susan Brink

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 should you 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

Dr. Brink co-founded ConsentSolutions, Inc. in 2006 to further the development of media-based approaches to informed consent for clinical trials. She is the CEO and President. The company grew out of Phase II SBIR NCI funding for the development of an online informed consent process for clinical trials, on which she was the PI. Dr. Brink has authored articles in peer-reviewed publications discussing the effect of media on the patient experience, the need for e-consent, and the pathways to implementation of electronic informed consent in clinical trials. She has conducted research and reported on patient decision-making processes, and patient knowledge outcomes when using e-consent compared to a paper-based consent. Dr. Brink has presented on electronic informed consent at DIA, DIACanada, PRIMR, ACRP, NIH and SoCRA, focusing on the benefits for patients, clinical sites and sponsors.