Getting Your Site Ready for eSource
Many large academic centers (e.g., Princess Margaret 1) have been using customized EHR (electronic health records) systems or even homegrown eSource systems for clinical research. However, most research sites do not have the resources to build or customize their own applications, and many find existing EHR systems too cumbersome for use in clinical trials. As a result, paper remains the customary way of capturing source data.2
This practice will change in the coming years, as lower technology costs and the ubiquity of mobile applications have given rise to a wave of new eSource software vendors offering site-specific solutions at affordable prices. Current FDA guidelines make it clear that principal investigators have the responsibility to "prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation"3,4 and may deploy electronic instead of paper source.3,4 A growing number of research sites indicate they value this option, with 87% of sites stating they would find eSource "helpful" or "very helpful" if integrated with EDC.2
Why should sites consider eSource?
Technology unlocks efficiency and streamlines and standardizes workflow processes. For these reasons, virtually every industry has transformed itself through technology. The same will hold for clinical research sites. Here are five ways eSource can contribute to site goals:
- Efficiency eSource has the ability to save time. Coordinators do not have to print out and manage paper templates, fill in subject headers, or initial and date for attribution purposes. A well designed eSource template is interactive, providing real-time alerts as the user completes source, thus ensuring nothing is missed. By streamlining the data capture process, eSource makes the visit go by more quickly, and saves time on downstream error correction. One case study found a 20% overall time savings.5
- Compliance While the real-time alerts create efficiency, they also prevent errors and improve data quality. Many protocol deviations occur because of simple human oversight or miscalculation. For example, a coordinator may miscalculate BMI and randomize someone who should not be randomized. The real-time nature of eSource catches and prevents these errors from happening in the first place, thus improving quality. One report from ClinPharm Networks found that a well-designed eSource system can safeguard against 50% of the most common deviations found in site audits.6
- Principal investigator oversight With eSource, principal investigators (PIs) can have immediate access to source data wherever they are, thus enabling faster response times on lab sign-offs, serious adverse event assessments, etc. Information is easier and quicker to retrieve. A PI no longer has to be physically present in the office to review and sign off on source, enter progress notes, pull up a patient's medical history, etc.
- Remote management of sites With eSource, completed source data is instantaneously available online for viewing, editing and/or quality control review (QC). That means site management can have full visibility into the operations of remote site operations -- an extremely important enabler for site management organizations. Processes such as electronic data capture (EDC) or QC can now be centralized across locations, leading to greater network efficiencies.
- Hiring and onboarding new employees With interactive eSource, it's easier for a junior coordinator to complete visits as they are walked through the workflow in real time. Even an experienced coordinator who is new to a given protocol (e.g., serving a back-up role) can benefit from this real-time engagement. This allows sites to hire and successfully integrate new coordinators more easily, and allows more cross staffing on studies.
What are the challenges to moving to eSource?
There are some important factors for sites considering the transition to paperless data collection.
- New/different workflows Electronic source is a different medium than paper. It will present itself differently, and require a different way of collecting data. A well designed eSource system should be intuitive and easier to populate than paper, but no matter how thoughtfully designed the system, staff will have to adjust their workflows from the familiar to the new. Not all staff members are equally open to change. Besides the data collection process itself, other workflows may require revision, such as source creation, study start-up, EDC entry, or Quality Control. Sites will need to be prepared to redefine many elements of their overall process.
- Template design quality Well-designed eSource templates can greatly streamline the data collection effort while increasing accuracy and decreasing deviations. Poorly designed templates can do the opposite: it can hamper the collection of data and lead to more, not fewer, deviations. It's critical, therefore, that sites have a plan to develop, or to outsource, a strong eSource template creation capability.
- Stakeholder education Shifting from paper to electronic source data collection can be a big behavior change. Sites are advised to inventory each of their stakeholders, from investigators to scheduling personnel, to identify who is ready and willing to embrace change. For each stakeholder, it's critical to craft the right messages to communicate the benefits of eSource and reasons for change. Sometimes a single, important stakeholder is all it takes to undermine the success of the entire transition.
What do sites need to do to implement eSource?
As with any system, it's important to understand how to implement eSource. Some sites start with a pilot study and then, if the experience is positive, expand to the full portfolio of studies. Others decide to jump right in and ramp up as quickly as possible.
Your implementation plan should include, at minimum, the following milestones:
- Compliance documentation
- Sponsor notifications
- Staff training
- Rollout by study
Sites often ask if they should switch existing studies over. The answer is that there is no particular reason not to switch. For the most part, it's as simple as filing a Note to File in the regulatory binder, then performing all future visits in eSource instead of on paper.
Ultimately, the principal investigator (not the vendor) is responsible for compliance with 21 CFR Part 11 guidelines, which are the FDA guidelines governing the use of electronic systems in clinical trials.
To demonstrate compliance, sites should obtain documentation from their vendor. Such documentation may take the form of a certification, or a description of features and how those features fulfill specific 21 CFR Part 11 requirements.
Sites should inquire about the vendor's track record being vetted by sponsors and CROs, many of whom have their own vendor qualification processes. Sites with technology resources may want their internal resources to "vet" the vendor by reviewing the vendor's security, back-up, and disaster recovery processes.
Sites need to document staff training on the system. They should also implement an eSource SOP that will address site usage, the importance of safeguarding log-in credentials, and the definition of what constitutes "source."
If the software is not going to be used for e-consenting or patient reported outcomes, then IRB approval is generally not required. However, hospitals and other sites with their own IRBs should check their local IRB requirements first.
Sites subject to HIPAA requirements should have a Business Associate Agreement (BAA) in place with their vendor. They need to ensure they apply the same safeguards in the eSource system as they would in their own EHR system.
Finally, as eSource becomes commonplace, interoperability will likely become an issue. Therefore, sites may want to ask their vendor about current and planned interoperability with other systems and the vendor's adherence to CDISC standards, which are a set of protocols that govern the transference and presentation of data within the clinical research industry.
You do not need to ask if your sponsors will "accept" it
Unless the sponsor has pre-selected a specific vendor and mandated use of that technology for the study, they have no right to prevent you from adopting an electronic source system. Sponsors and CROs, at most, can review and vet the system for regulatory compliance.
Ultimately what sponsors care about is PI oversight- if your electronic system furthers that, then your sponsors will be happy.
Of course, any good eSource system should have some means for CRAs to review and QC source data, so the quality of experience of the CRA should be one of your important feature considerations.
eSource is likely to be the next big technology wave in the industry. Even if you're not ready to adopt it now, consider investing the time to get ahead of the curve. Start by inventorying electronic source options and comparing the pros and cons to your current process. Develop a list of required features and think about what your prerequisites would have to be for you to move forward. Be ready to catch the wave.
- Cole H, et al. Mobile electronic solution for clinical research documentation. Association of American Cancer Institutes. 2016. Accessed August 2017 from: http://www.aaci-cancer.org/cri_meeting/pdf/2016abstracts/Cole_UHN.pdf
- Society for Clinical Research Sites. Why is clinical source data still collected on paper? May 2017. Accessed August 2017 from: http://myscrs.org/learningcampus/white-papers/
- Food and Drug Administration. Drugs for human use: Investigator recordkeeping and record retention. 21 CFR Sec.312.62(b). [April 1, 2017.] Accessed August 2017 from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.62
- Food and Drug Administration Center for Drug Evaluation and Research. Guidance for industry: Regulatory assessment of investigator responsibilities. August 2016.
- CRIO. [Case report on Palm Beach Research Center.] Unpublished raw data. 2016.
- ClinPharm Networks. [Letter to CRIO.] Unpublished letter. November 21, 2016.
*To see the original version of this article, please visit the full-issue PDF of InSite Fall 2017.