Clinical trial consent: Using automation to get it right —every time

“We have 20,000 samples and don’t know what they’re for or where they’re from!”


It is a phrase no clinical trial sponsor ever wants to hear, yet it is not uncommon when consent tracking is a manual process. Sponsors and CROs can better protect patients’ rights and reduce risk by moving to fully automated solutions.


Consent in clinical trials is more than a signature on a form. Each subject's consent informs research teams on precisely what they can do with the samples, the consequences if the subject withdraws consent, future-use consent, and when samples expire based on predefined retention dates.


The Federal Drug Administration offers guidance for Institutional Review Boards (IRBs), clinical trial sponsors and contract research organizations (CROs). More than simply permission to participate, informed consent includes providing a potential subject with the following:


  • Thorough information to make an informed decision about participating, aiding in their comprehension of the clinical study goals;
  • Time to ask questions and discuss research protocol with loved ones about whether they should participate;
  • An opportunity to voluntarily agree to participate; and
  • Continuous information as the study progresses.


The FDA expects researchers to run all studies in the United States with several essential informed consent elements. Research teams will describe the investigation, risks, discomforts and benefits; alternative procedures or treatments; confidentiality, compensation and medical treatments in case of injury; study contacts; and the fact that participation is entirely voluntary.


How do study amendments impact informed consent?


Consent standards in the United States and globally may differ, with potential customization based on country or region, according to Jitu Manjunath, Director of Product Management at BioFortis, a Q2 Solutions company.


“There must be some sort of process and documentation in place to demonstrate that the subject understands all of the information about the study, why they’re participating and side effects,” Manjunath said. Research teams “often forget there needs to be a process for consent that includes providing information about the trial as it changes.”


These amendments may include changes to visit plans, samples or clinical considerations.


The subject must understand what biological samples researchers will collect and when and how often researchers plan to use the samples. The clinical trial sponsor or CRO will use informed consent to define when they will provide the testing results to subjects and whether researchers can use samples for purposes outside of the study.


Moving to a digitized, e-consent model informs researchers of the subject’s enrollment for each country and site, the subject consent type and date, and attributes for each country and site for each sample type.


Moving from paper to automation


Research teams have historically captured consent to collect and analyze biological samples from clinical trials on paper, but “patient consents are designed as a set of documents intended for human interaction,” Manjunath said. “It is critical that the subject knows where their personal biological material (will) be.”


Consent tracking on paper is challenging to analyze when it is not in a digitized database using technological advances. The information enables investigators to determine which samples can be used for what purpose more efficiently.


“What is the impact of not capturing this information somewhere? If an investigator can’t find pieces of paper, they can’t get ahold of the data because it’s not captured (digitally),” Manjunath explained. “If they (cannot) review (consent) before running the test and storing samples, and not knowing if proper consent was even collected, this can be a huge noncompliance issue. This creates quite a bit of downstream risk for the trial and organization.”


Manjunath said that researchers must amend nearly every protocol at some point in clinical trials. These may include changes to testing procedures, additions or cancellations of visits, changes to sample collection, and additions of new labs or sites.


Digitizing data: Simplifying CTST is the future in clinical studies


Sponsors know their data, and the ability to understand and access it is crucial to getting things right from an ethical perspective, Manjunath said. “They can make this easier by having a more global template to start with — something that is digitized with basic elements for each consent at a global perspective, and deviations from the template for countries or sites are minor changes that can also be digitized.”


Q2 Solutions offers Labmatrix® Clinical Trial Sample and Consent Tracking (CTST), an industry-leading, robust CTST software solution that tracks samples through their lifecycles across sites, labs, biorepositories and other trial partners. Q2 Solutions’ work is rooted in research, grounded in collaboration, and guided by its passion for turning the hope of patients and caregivers worldwide into the help they need.


The Director of Clinical R&D IT at a global pharmaceutical company shared a scenario his team addressed with Labmatrix®:


“We didn’t know where or what was happening with our clinical trial biospecimens, and it would take weeks to compile a report,” they said. “Using Labmatrix, we’ve established an immediately accessible, single source of truth and accountability hub for all our clinical samples.”


The Director of Clinical Operations at a global biologics R&D company agreed. “After putting Labmatrix in service, we gained new abilities to review and analyze sample data,” they said. These opportunities included trends by site, country, or vendor; entire chain of custody across vendors; sample expiry; and other consent-driven activities.


Q2 Solutions listened to industry leaders when developing Labmatrix® 10, the latest rendition of the technology that helps users accomplish more with new dashboard capabilities, improved performance, enhanced features and more.


  • Labmatrix® takes the guesswork out of specimen management by:
  • Providing clear visibility into workflows;
  • Ensuring sample usage corresponds with the subject's consent; and
  • Offering a well-annotated subject and sample database to support research.


SCOPE 2023 with David Kaye: ‘Clinical Trial & Consent Management: Too Important to Leave to Chance’


With collection plans, a better understanding of samples’ current and future value, technology to simplify data collection and other best practices, clinical trial sponsors and CROs can reduce risk and increase compliance while building a strategy for samples.


For more information, visit Booth No. 913 at the 2023 SCOPE Summit for Clinical Ops Executives. Don’t miss BioFortis Vice President and General Manager David Kaye’s SCOPE presentation, “Clinical Trial & Consent Management: Too Important to Leave to Chance,” at 12:30 p.m. Tuesday, Feb. 7.