While transitioning source documents from paper to eSource, implementing standard templates across the organization for everyone to realize can be helpful, especially when using an intelligent electronic data capture system. When searching for inconsistencies across studies, using two buckets is recommended: therapeutic lines and research categories.
Research categories consist of components like ICFs (informed consent forms), device tracking methods, AE (adverse event logs), or SAE (serious adverse event). Therapeutic lines comprise lab draws, vitals, or head-to-toe assessments.
While there may be a lot more consistencies than stated above, this offers a decent basis for what goes into electronic source forms. By developing simple and short form templates, you can further save time on repetitive tasks by reusing the templates from study to study.
Here, our intelligent electronic data capture system expert expands on some key considerations from transitioning from paper to eSource!
Maintaining compliance in eSource
When transitioning to an eSource system, remember the system requires 21 CFR Part 11 validation and conformance. If you’re going to maintain an FDA (Food and Drug Administration)-regulated essential record, like a signed ICF that the FDA may require during an audit, 1572, or a delegation of authority, the system must be validated. Incorporating electronic signatures on the program and signature process also needs to adhere to 21 CFR Part 11 requirements per regulation guidelines.
Remember, there are two parts to the Part 11 regulation:
The first part requires the digital and electronic signatures piece. This part outlines the requirement of the FDA for non-repudiation, authentication of the signature, meaning it should be the legally binding equivalent to the manual signature. When making a transition to an eSource system, the institution employing the eSignature needs must notify the FDA in their Part 11 regulation of their intent to use eSignatures in place of paper signatures.
The second part covers electronic records – if any FDA-regulated information is developed, maintained, or stored in electronic format, Part 11 applies.
Don’t ignore the assessment flow
Thanks to electronic systems, there’s no need to flip through pages to find the documentation you’re looking for. Instead, you can set up an assessment flow, making sure you fill out the right documents in the right order. With eSource, staff can set up requirements around documents – dictating which documents to fill out in a specific order, which are optional, and which are essential to fill out. In addition, embedding certain fields as ‘required’ may also help, ensuring critical information is gathered, ultimately helping you avoid deviations.
Sending documents to the PI (principal investigator) is easier via eSource once everything is filled out. This is because all you need to do is send them a link, which will direct them to the documents they need to review and put their signatures on. This doesn’t just ensure that everything needing their signatures is properly filled out but saves time on their end as well.
While there are a lot of parts to consider during the transition from paper to eSource, the transition allows researchers to do their research more efficiently by letting them focus on tasks that matter most to them: advancing science and interacting with participants.
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