Preparing for eConsent - A Step by Step Guide for Site Personnel

Sandra "SAM" Sather

Electronic informed consent, or eConsent, is one technological advancement introduced to clinical trials that is escalating in its adoption. This blog highlights findings from a recent survey which sought to understand the impact of the consent process in clinical trials. The result: sites are interested in the development of eConsent.

Read on to learn more about the survey and Sam Sather’s top tips for site personnel on developing an eConsent process.

Preparing for eConsent - A Step by Step Guide for Site Personnel

 By Sandra "SAM" Sather, Regulatory and Quality, TrialConsent®

Recruitment and retention are key to the success of a clinical trial. Low rates of recruitment and retention result in longer study durations, delayed completion and higher costs. Over 40% of studies face challenges in meeting predefined enrollment goals, leaving sponsors and sites struggling to conduct trials effectively. Furthermore, 85% of clinical trials fail to retain enough patients, with the average dropout rate being as high as 30%.1

A recent survey2 of 105 people across site-based roles sought to gather opinions on informed consent related to participant understanding, subject recruitment and retention. Top line results included:

  • 12% of survey respondents indicated that 50% of subjects were unable to finish paper consent forms in a reasonable timeframe
  • More than one-in-five respondents spent more than 30 minutes discussing questions with subjects
  • 25% of respondents found that subjects still had questions about the purpose of a study even after reading the informed consent form (ICF)
  • 85% felt the technology would be useful in their roles
  • 61% felt that eConsent would enable them to recruit more subjects

The survey data indicated that sites are interested in the development of eConsent. So, what can site personnel do in preparation of adopting an eConsent solution in a study? Take a look at these top 5 tips:

  1. Evaluate business processes

Look at workflows / understand how study start-up is operated in terms of informed consent. How would the use of eConsent change the procedures and associated processes? This can include, but is not limited to, preparing for consent sessions, scheduling consent sessions, documentation requirements, management of monitors and auditors, ethics committee communications, and much more.

  1. Establish what needs to be documented

Sites need to build an understanding of what information an eConsent solution can automate versus what will still need to be documented manually and develop plans for how this will be managed. For example, documenting the informed consent process related to the date, who was present during consent, ensuring all questions were answered, etc.  An audit trail of the consent process steps performed by the system vs. manually performed by a site personnel should be generated and supplied to the site for source documentation.

  1. Determine training provisions are in place

Ensure provisions are in place to train study staff and study participants on the use of eConsent technology prior to use. Clearly understand the plan to train new staff members that join the study later.

  1. Ensure inspection readiness

Plan how you would be able to provide direct access to the eConsent system if requested by a regulatory authority.

Ensure system generated copies and audit trails are downloaded and easily readable after study close for inspections that occur after study closure and the eConsent system is deactivated for the study. Be sure to know how long the eConsent vendor holds any study data on their servers after study end.

  1. Certify data security

Protect patients’ private health and personal information. Be informed how the system protects the security of this information. Ensure institution requirements and restrictions are followed related to sponsor remote and onsite monitoring, 

With regulators, academic research centers and industry groups advocating eConsent’s impressive benefits, it is no surprise that many of the major pharma companies are engaged in or are currently planning an eConsent initiative. It’s important to remember that site personnel are not bystanders in the move toward eConsent, but pivotal to developing an eConsent process that benefits all stakeholders in research.

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  2. State of eConsent 2017 Report. CRF Health.

About the Author

Sandra "SAM" Sather

Sandra “SAM” Sather, MS, BSN, CCRA, CCRC, 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. She 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. SAM has held clinical research industry certifications for over 15 years by the Association for Clinical Research Professionals (ACRP). She is a current member of the ACRP Academy Board of Trustees, and Regulatory Affairs Committee (RAC). SAM is a frequent subject matter expert for GCP regulation and speaker at industry conferences. Sam has authored many competency-based curriculums for various clinical research stakeholders.

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