It’s an exciting time for the life sciences industry, with technology driving greater levels of efficiency, effectiveness and patient engagement and satisfaction in clinical trials.
Electronic informed consent (eConsent) is quickly gaining a reputation for being the next big technological innovation in clinical trials. With both regulators and industry groups advocating the impressive benefits of eConsent, it is no surprise that 66% of top 50 pharma companies are engaged or planning an eConsent initiative in the near future, with all 10 of the top 10 already having an eConsent strategy in place.
In order to benchmark current eConsent use, gauge experiences and expectations, better understand adoption hurdles and challenges, and anticipate how eConsent use will grow in the future, CRF Health conducted the first-ever State of eConsent Industry Survey. Following that survey, CRF Health released its site edition of the survey, gathering site staff opinions on the impacts of paper-based informed consent and eConsent.
During this webinar, Sandra “Sam” Sather from CRF Health and special guest, Giga Smith, from Coastal Carolina Health Care (CCHC), reveal the results of CRF Health’s “Electronic Informed Consent: 2017 Industry Survey Results – Site Edition.” This site-specific survey gathered feedback from 105 respondents in roles including study coordinator, clinical research associate (CRA), investigator, and researcher. Topics covered include:
- Participant compliance
- Time to complete the consent form
- Participants’ most frequently asked questions
- Negative impact of paper consent forms
- Reasons for refusing consent
- Reasons for dropping out of a consent
- Impact of eConsent on drop outs
- eConsent usefulness
- Effects of eConsent on participant recruitment
- Current eConsent use
- Perceived impact of eConsent
Plus, Giga Smith provides insights into the responsibilities of a site and how adding eConsent technology brings challenges and benefits. Giga’s experience with a variety of consent formats provides a real-world view into how to successfully implement strategies to adopt eConsent with minimal issues. A checklist of items to consider gathering from sponsors and vendors will also be discussed.
The input from a site perspective can prevent some major issues when implementing a new technology. Whether your organization is just starting to consider eConsent or looking to expand adoption, these survey findings will provide valuable insight and context into the perspectives of site staff.
Sam Sather, Quality and Regulatory, TrialConsent, CRF Health
Sam’s current focus of consulting is to promote clinical quality systems for Sponsors/CROs, Investigators and clinical research institutions. She has over 30 years of clinical experience, a Bachelor of Science degree in Nursing and a Master of Science degree in Education with a Specialization in Training and Performance Improvement.
Sam has served many roles in clinical research, including site study coordinator and manager, sponsor and CRO monitor, quality assurance auditor, risk manager, trainer, and performance management consultant. She has held clinical research industry certifications for over 15 years by the Association of Clinical Research Professionals (ACRP). Sam is a current member of the ACRP Academy Board of Trustees, and Regulatory Affairs Committee (RAC). She is a frequent subject matter expert for GCP regulation and a speaker at industry conferences. Sam has authored dozens of competency based curriculums for various clinical research stakeholders.
Giga Smith, Director of Research, Coastal Carolina Health Care
Giga Smith is the Director of Research for Coastal Carolina Health Care and Research, a large multi specialty, private practice and research site in New Bern, NC, where she was responsible for starting their research program in 2015.
Giga has worked in clinical research since 1991 in roles such as study coordinator, project manager for CROs and pharmaceutical sponsors, and business development for CROs and patient recruitment providers.
As the executive Director of Research at Greenway Health, Giga managed studies and sites that utilized technologies to facilitate direct data entry into EDC systems.
Who Should Attend?
- Clinical Operations
- Data Management
- Clinical Innovation
- Medical Director/Clinical Sciences
- Patient Recruitment
- Academic Research
- Clinical Site Management
- Executive Leadership
- Health Economics
- Outcomes Research
- Regulatory/Risk Management
- Quality Assurance
- Outsourcing/Vendor Relations/Procurement
- Adherence and Compliance
- Clinical Research Associate
- Principal Investigator
- Study Coordinator
- Site Physician
- Site Clinician
CRF Health is the leading provider of patient-centered eSource technology and service solutions for the life sciences industry. With experience in more than 800 trials, over 100 languages and across 74 countries, CRF Health’s TrialMax® platform consistently demonstrates the industry’s highest data accuracy, patient and site compliance, and patient retention.
CRF Health’s eSource solutions improve trial engagement by fitting into the lives of patients and seamlessly integrating into sites to maximize protocol compliance. The integrated TrialMax® platform includes eCOA solutions for collecting PROs (Patient Reported Outcomes), ObsROs (Observer Reported Outcomes), ClinROs (Clinician or Rater Reported Outcomes), and PerfOs (Performance Outcomes), and features TrialConsent™, an electronic solution for collecting informed consent in clinical trials.