August 30, 2023

In the complex world of clinical trials, ensuring real-time access, accuracy, and transparency is paramount. Viedoc elevates these standards by instantly generating and storing a PDF of every data capture screen as investigators input data. This innovative approach not only mirrors exactly what investigators see during data entry but also strictly adheres to Good Clinical Practice guidelines.  
 

In this article, we'll dive into the unique advantages Viedoc’s contemporaneous data capture brings to the EDC ecosystem. 


 

Real-time data capture 

Viedoc creates PDFs at the exact moment of data entry by the investigator. Once the “save” button is clicked, it generates a document, ensuring the authenticity of data capture. 
 

Regulatory compliance 

Electronic data capture in clinical trials must meet the requirements of Good Clinical Practice and other regulatory authorities. Viedoc’s contemporaneous feature ensures compliance with these standards. 

Transparent record keeping 

With Viedoc, anyone reviewing the PDFs later can see precisely what the investigator viewed on their screen at the time of data entry. This transparency is vital for audits, investigations, and quality checks. 
 

Market differentiation 

While many EDCs generate PDFs at the conclusion of a study, Viedoc emphasizes capturing data in its original state through real-time PDF generation. This unique approach provides an added value to the data capture process. 

Addressing common misunderstandings 

Confusion regarding a patient’s randomization number on initial visit PDFs may arise because the number wasn’t yet assigned. However, with Viedoc’s contemporaneous PDFs, you can see the exact data state at the time of input.
 

Ensuring data integrity after amendments 

Making changes to study protocols can complicate data representation. Viedoc’s feature takes the guesswork out of data history by capturing it as it was at the time of entry. 

Upholding high-quality standards 

Viedoc treats any inability to generate contemporaneous PDFs as a serious fault, ensuring the highest commitment to quality and accuracy. 
 

Protecting against unauthorised data cleaning 

Viedoc prevents unauthorised ‘data cleaning’ to make data look better. Such practices can lead to significant regulatory findings and jeopardize study integrity. 

Assured compliance 

Clinical trials have received critical feedback from regulatory bodies for not producing contemporaneous PDFs. By choosing Viedoc, sponsors and researchers ensure they meet the highest standards set by regulatory authorities. 
 

 

Join the transformation 

Viedoc's approach to electronic data capture isn't just innovative; it's transformative. Generating PDFs at the exact moment of data entry is a testament to our commitment to authenticity and accuracy. Viedoc’s contemporaneousness feature It reinforces the integrity and accuracy contemporaneousness of clinical trial data, setting a gold standard for electronic data capture in modern trials. 

Discover first hand how Viedoc can elevate your data integrity

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