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Considerations for Transitioning from Paper to eSource

In the fast-paced clinical research industry, time is of the essence. Maximizing the time you have to efficiently meet with participants, collect data, and organize it is key to keeping your study on track.

Oftentimes, keeping paper records of study visits, participant data, and the like can cause significant delays during research. This may result in added labor hours, misplaced documents, or an increased risk of error. A solution for these roadblocks may be transitioning from paper source to an eSource solution. Knowing the benefits of using eSource, tips for implementing eSource, and maintaining compliance in your eSource solution may make all the difference in an efficient trial.

Benefits to Using eSource

As the research industry continues to move into a more decentralized, electronic age, there are many benefits to transitioning from paper to eSource. Top benefits include:

Saving Time

Switching to eSource can improve a study’s accuracy, compliance, quality, safety, and decrease deviations – all of which add up to significant time saved on protocol. Additionally, electronic source records decrease time and effort for source and electronic data capture (EDC) data entry verification. This leverages real world direct data entry and remote monitoring capabilities.

eSource also has the ability to leverage standardized research assessment templates, such as informed consent process documentation templates and clinical research assessment forms. In addition to standard healthcare outcome assessment forms and standard questionnaires utilized across all clinical trials, this also decreases time and effort recreating paper source documents per study.

Adapting standardized templates and forms, and implementing standard research questionnaires strengthens the site’s quality and safety outcomes. In turn, this will decrease protocol deviations and enhance the validity of source data collections.

Easier Data Interpretation

Switching from documents with hand-written notes to everything electronic standardizes writing, making it easier to read for everyone, since no time is spent trying to interpret what’s written out.

Additionally, eSource allows staff to put in order sets, which, due to the shift from paper to electronic workflows, will decrease deviations.

Increased Organization

With paper source, it’s easy to misplace necessary documents for a study, or to lose them altogether. Staples may come loose, or papers may get thrown out on accident. Not only would staff have to spend time retrieving documents if this happened, but it also accounts for the missing organization piece of paper source. Through eSource, everything is in one place, eliminating the risk of misplacing documents or not having everything you need as you collect data.

Additionally, using electronic patient reported outcomes (ePRO) with eSource further automates and improves data quality. Utilizing ePRO to its fullest extent also contributes to increased organization because it holds everything for a study subject, including standard forms they need. This not only keeps everything organized for study staff, but for participants as well, since everything is in one spot for them.

Tips for Switching Over to eSource

When transitioning source documents from paper to eSource, it can be helpful to implement standard templates across the organization for everyone to utilize. When looking for consistencies across studies, it’s helpful to use two buckets: research categories and therapeutic lines. Research categories include components such as serious adverse event (SAE) or adverse event (AE) logs, device tracking methods, or informed consent forms (ICFs). Therapeutic lines include head-to-toe assessments, vitals, or lab draws.

While there may be more consistencies than just the ones listed above, this provides a good basis for what goes into electronic source forms. By making short and simple form templates, you can reuse the templates from study to study, further saving time on repetitive tasks.

Think About the Assessment Flow

Keeping everything electronic eliminates the hassle of flipping through pages to find the correct documentation. Rather, you can set up a documentation flow, ensuring you fill out the correct documents in the correct order. eSource enables staff to set up requirements around documents – dictating which documents are essential to fill out, which are optional, or which ones to fill out in a specific order. Additionally, you can embed certain fields as “required”, ensuring critical information is collected, ultimately helping you avoid deviations.

Once everything is filled out, sending documents to the principal investigator (PI) is easier via eSource, because all you will have to do is send them a link, directing them to the specific documents they need to review and sign. This saves time on their end, and ensures everything needing their signature is filled out properly.

Maintaining Compliance in eSource

When transitioning to an eSource system, it’s imperative to remember the system needs 21 CFR Part 11 validation and conformance. If you are going to store and maintain a Food and Drug Administration-regulated (FDA) essential record, such as a delegation of authority log, a 1572, or a signed ICF that the FDA can ask for during an audit, the system needs to be validated. Incorporating electronic signatures on the signature process and program also need to meet 21 CFR Part 11 requirements per regulation guidelines.

Keep in mind, there are two parts to Part 11 regulation. The first part covers electronic records – if any FDA-regulated information is created, maintained, or stored in electronic format, Part 11 applies.

The second part entails the electronic and digital signatures piece. This second part outlines the FDA’s requirement for authentication, non-repudiation of the signature, meaning it has to be the legally binding equivalent to the manual signature. When transitioning to an eSource system, the institution employing the eSignatures needs to notify the FDA in their Part 11 regulation of their intent to use eSignatures in lieu of paper signatures.

While there are many parts to consider during the transition from paper source to eSource, the transition enables researchers to conduct their research more efficiently by allowing them to focus on tasks that matter most to them: interacting with participants and advancing science.

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