Monitoring eConsent: An Exclusive Interview with the Webinar Speakers

February 27, 2018

Webinar speakers discuss the upcoming eConsent webinar, providing attendees a sneak peek at the webinar agenda.  Ready to register?  Click here.


Full Transcript

JACKIE BRUSCH

Hello everyone, thank you for joining today’s podcast. Today we have an exciting panel of speakers. We are interviewing our webinar presenters for our upcoming webinar on March 8, Monitoring Clinical Trials with Electronic Informed Consent. Today we have Sam Sather here with me. You may know her from some of our other podcasts and videos. We also have two of our esteemed guest presenters as well. And today really is just to talk about what you can expect to hear on the webinar, and just to get to know the presenters a little bit better and hear what they’re looking forward to in regards to the presentation. So without further ado, I’d like to pass it over to Sam now to give us a little bit of her background, have us understand who she is and how she fits into the electronic informed consent and informed consent area. And so Sam, I’ll pass it over to you.

SAM SATHER

Great, thanks Jackie. So again I go by Sam, so Sam Sather, and I have been in the industry a long time, first as a nurse, as a research study coordinator, and had the opportunity to work with a lot of patients on very complex studies and consent. And not seeing a lot of differences between the consents that I helped patients with then. Then I became a monitor and then auditor, and the idea that we have effective and really supportive consent in the paper world is something we’ve really struggled with, from a patient point of view and also from an ethical standpoint. So I’m really excited, I’ve been working with eConsent for a couple years now and really this is the topic that I think I’ve been waiting for the most, because it really I think is touching the participant, the patient, a lot. But man, the ability to monitor I think will really change. So I’m really excited because we have two wonderful guest speakers that are going to be there with us on the webinar on March 8. And I’m going to let them introduce themselves, and first I want to go to Debbie. Debbie, if you don’t mind, introduce yourself and kind of bring into the listeners context on why this is an important topic for you.

DEBBIE ROSENBAUM

Sure. Thank you Sam. My name is Debbie Rosenbaum. I’m a consultant and President of Sarrison Clinical Research. I’ve served as a consultant not only to the pharma industry but also to sites, so I’ve kind of been on both sides of the fence. And I’m also a trainer and author and a subject matter expert. I find this particular topic very exciting because it’s moving us into more of the electronic technical phase of doing clinical trials and definitely a direction that we’re going in. I think that this offers an opportunity not only for the participant to be more informed, but also for those who are also involved in the study, in this case the monitor, to have more involvement in that actual process and to be able to review the consenting process remotely as it is ongoing or in a more timely manner rather than waiting until your once-every-three-months site visit where you go through the paper documents. I really do think that it’s going to give us a whole lot more insight into the consenting process at the site.

SAM SATHER

Great. I agree, and there’s so much to really expand upon that we’ll do in the webinar. And Elizabeth, let’s introduce you, and talk about yourself in the context of informed consent and what you’re excited about about this topic.

ELIZABETH WEEKS-ROWE

Sure, and thank you very much for having me and Debbie, nice to meet you finally. Elizabeth Weeks-Rowe, I’ve been in clinical research for 18 years. I am a CRA, CRA trainer, author. I am very passionate about patient education and clinical research education in clinical trials, and it’s a lot of the topics that I’ve written and presented on. And I’ve monitored on and off for 17-18 years. And I saw consent issues back when I first started as a study coordinator, and I’ve seen consent issues through the years with paper versions and signature questioning. And I’m excited about eConsent in this context because this is the way to make sure not only a patient has an interactive informed experience, but that the patient was given the correct version of the informed consent, that we’re not just seeing documentation that patients given version of the informed consent, questions asked and answered, but we’re going to have the opportunity to actually verify and validate. And I’ll kind of go on to what Debbie said also, how exciting to be able to start the ball on reviewing consent and resolving issues prior to the next monitoring visit and making sure the patient safety and informed consent are being done in a manner compliant with GCP. So I’m really excited about that.

[05:45]

SAM SATHER

What two great speakers, and a lot of breadth of great experience. And it’s interesting, if I think about a day in the life of a monitor, and when you’re talking to sites, and think about some of the challenges when you approach a site about questions or things that you think are deficiencies in consent, what are some of the most common areas, Debbie, that you find that in the paper world that just keep not getting better? Any insight on that?

DEBBIE ROSENBAUM

Sure.

ELIZABETH WEEKS-ROWE

Probably a lot!

DEBBIE ROSENBAUM

From the early days until recently, I’ve been very involved with clinical operations manager of a clinical trial, we’re seeing the same type of issues. For example, the site picks up the wrong version of the consent form, instead of the amendment one, it’s the original version. And you know, you come in months later and you pick this up, well in the meantime they’ve not only picked up the wrong version but they did it for the next four or five patients. So you know, we really are seeing the same thing. We’re seeing that signatures aren’t obtained or the date is entered incorrectly. Not all of the pages are there as part of the consent. So we’re seeing those still happening. I don’t know that we’ve made much improvement over the years. And there’s the whole consenting process itself is taking so long. You know, 24-page consent, and we’re seeing that in the 15 minutes as the patient is reviewing it that they’ve actually had a good comprehensive review. So I think that, you know, this offers so much more for us. It eliminates the opportunity of making some of those mistakes.

SAM SATHER

Yes, that’s really very very packed full of some of the challenges like you said that we just haven’t really seen any change in the ability to get improvement. Even though a lot of sites have created some QC or, you know, quite a few sites we’ve seen that before the patent leaves another coordinator—there’s a lot of burden—another coordinator goes behind them to see if all those checkboxes have been done. And Elizabeth, you said you’re very passionate about the participant, the patient. So how do you think, in general, just some key things, how will it change with eConsent, what do you think we might be able to serve them better?

ELIZABETH WEEKS-ROWE

I think it’s going to very much change patient interactions. Interaction and education. if you have a patient going through an eConsent, and they’re reading the pages in order, and they have the opportunity to stop and think and ask questions and have more information at their fingertips, I think it’s going to make them have a better opportunity to make a more informed and better decision about being a participant. I also feel like speaking to what Debbie said a little bit, informed consent signature authenticity issues is what I have seen a lot monitoring. Coordinators who feel like they can print a patent’s name on an informed consent if it’s missing. And, no truly, monitoring findings like that. And getting rid of paper is going to help make it a more credible process as far as signatures and education. So that’s what I’m excited about.

[10:00]

SAM SATHER

Wow. And think about all the benefits. And this webinar when you come on the 8th, what Debbie and Elizabeth and myself will talk about is then pulling it into what are the items to consider from the monitoring perspective and how this is going to change how you would monitor, how you would interact with sites, how you would look for documentation, and what would be the manual things versus non. So in the presentation, the main part, what we’re going to spend a lot of time on, is what are the things to consider and the impact to the monitoring role and pre-study—so qualification visit, site initiation visits—during the study, and then at study close. So taking you through the GCP stages and phases that we go through, and really practically what are the key things for you guys to think about. So we’re really excited for you to come to this webinar on March 8. So Jackie, anything else that you’d like to tell our listeners before they attend on the 8th. And thank you Elizabeth and Debbie very much for being here.

JACKIE BRUSCH

Yes thank you all so much, this was really really informative. And I’m really looking forward to joining this webinar alongside everybody else and learning myself about all the expertise that you all have in that monitoring world, especially now that the industry is really starting to see that shift to electronic. So thank you all so much for giving us a little taste of what we can expect when we attend the webinar. So thank you all so much, thank you Sam, thank you Debbie, thank you Elizabeth. We’re really looking forward to the webinar. And if you’d like to register for the webinar, you can click the link that will follow this podcast, and you’ll be able to register to attend. So thank you all so much, and I hope you have a great rest of your day.

 

 

 

 

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