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Regulatory aspects on EDC systems

Regulatory aspects on EDC systems

Investigator-independent copy of the data

There is regulatory concern whether data collection in the EDC systems of today meets the requirement of a contemporaneous, certified copy that is not under the exclusive control of the sponsor. The requirement originates from the EMA eSource reflection paper: EMA/INS/GCP/454280/2010 “Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials” (June 2010).
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/08/WC500095754.pdf

The FDA also explains this requirement on Electronic Source Data: “Guidance for Industry – Electronic Source Data in Clinical Investigations” (September 2013).
https://www.fda.gov/downloads/drugs/guidances/ucm328691.pdf

Both the EMA and the FDA have stated publicly that the EMA eSource reflection paper and the FDA eSource guidance are equivalent to each other and place the same requirements on clinical trial data, and that any differences between formulations in the documents are merely due to the different judicial climates that the authorities must cater to in Europe and the US.

The requirement was also further emphasized with the recent update of GCP (June 2017).
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf

Before explaining how Viedoc assures an independent, contemporaneous copy of the data, one should understand how data has been recorded historically and what led to this requirement. With that background in mind, one will see that the requirement is more accurate today than ever.

How the data collection process has changed over the years

In the past, before ICH-GCP was established, CRFs consisted of a single, master copy – on paper. Thus, tracking changes and data edits was practically impossible. When ICH-GCP was introduced it required that a copy of the data should be kept at the investigators’ site, and the original at the sponsor. The No Carbon Required (NCR) CRF was developed to ensure an exact copy of the CRF. The NCR CRF consisted of three papers: one white (the original, normally sent to the data management department for performing data entry), one yellow (the sponsor’s copy), and one pink (the investigators’ copy, which stayed at the site).

Although the NCR CRF was indeed an improvement, the process to complete, collect, transfer and enter the CRF data at the sponsor was very time consuming (especially if the ink from the white copies didn’t bleed through to the yellow ones – a constant problem requiring clarification). To get faster access to data and to decrease the number of errors/clarifications, Remote Data Entry (RDE) systems were developed. In these systems, investigators, nurses, and study coordinators entered data directly at the site. The RDE systems were installed locally on a computer and data was periodically transferred to the sponsor. While the RDE systems had their own shortcomings: deployment, installation, support, usability and cost, this was certainly an improvement over the slow, fallible, and messy paper records. A copy of the data was also always available on the local RDE machine used for data entry.

Soon after the internet opened for general use, web-based EDC software was introduced. This improved the data entry process even further, as sites could simply use their own computers and send data directly to the main database. The EDC landscape has continued to evolve, and today data is available as soon as the investigator hits save, and data can be reviewed, queried, clarified, locked and signed off almost instantly (i.e., in real time).

Regulations state that the archiving of eCRF data is the responsibility of the investigator. The current practice of archiving is to burn a PDF copy of the data on DVDs or Blu-rays and then mail the disc to the site. The investigator must then approve and verify that this disc does indeed contain the data that was entered. The problem with this approach is that the disc doesn’t contain a copy of the originally-entered data but rather a print-out (essentially a screenshot) of the database in the form of a PDF. Regulators from governing bodies around the world have variously been uncertain that such copies truly reflect reality (i.e., match what was physically entered/approved by the site).

How is Viedoc different?

Viedoc provides a contemporaneous PDF copy of the data at the same time as the data is saved. Moreover, the data is not stored on a server under the sole control of the sponsor, but within Viedoc’s servers, where the investigator can access it at any time (the legal equivalent of storing it at the investigator site). Alternatively, generating PDFs at a later date (which is done by many other EDC systems) means that they are not contemporaneous, and thus do not fulfil this requirement.

Furthermore, the requirement applies to all data within the eCRF – not just a subset of data, (e.g., what some consider “eSource”). Because Viedoc provides contemporaneous capture of the entered data on PDFs at the time of data entry, the sponsor does not need to involve other systems in the capture and archiving of source data that is entered or transcribed to the eCRF.

For more information on Viedoc’s regulatory compliance, please contact us.

Top 6 things customers love about Viedoc

Top 6 things customers love about Viedoc

We’ve assembled a list of the top 6 things customers around the world love about Viedoc.

Starting with the most popular comment:

    
 

1

   User friendly/Easy to navigate
Viedoc looks and acts like a modern web application (because it is!). Viedoc was designed to be intuitive for all users, and save time performing any day-to-day activity.
    
 

2

 Ease of set up, quick eCRF setup
Through Viedoc Designer, the time to build and setup a study from start to completion is done in days rather than months. Being a certified study builder allows you to control and perform this process in-house, saving both time and money.
    
 

3

 Viedoc is built to facilitate the work for all users
Whether you are responsible for a Clinic, Admin or Designer activity, Viedoc makes you fast, accurate, and efficient. All workflows are developed to enable maximum output with minimum effort.
    
 

4

 Best value for the money
Our motto is, “Everyone wants to (and can) use Viedoc!”. That motto includes the price. Whether you’re a start-up, a university, or a large CRO – we want you to have the best EDC system money can buy.
    
 

5

 Fast performance
Viedoc is modern technology running on modern hardware and built for handling all kinds of data. Thus, you can depend on the highest speed your internet connection will allow, without lag or waiting for the system to save your actions.
    
 

6

 Minimal required training
With access to a prototype environment, text-based eLearning, and even video tutorials, a standard user can be fully-functional within an hour, and a study-designer within days.

 

There are many more appreciative comments about our EDC system and we are grateful for all the reviews our customers give us.

We add features to our product on a near-monthly basis. This is because in addition to our team of study builders and support staff, we employ an entire development team specializing in making Viedoc better. We also host active User Group meetings to listen to our customers about their needs, as well as show them what’s new. All of the above and more is what makes Viedoc the #1 EDC product in the world.

Interested to know more? Contact us for a demo.

BYOD, App, Web-based Application?

Things to consider when collecting data from patients using ePRO

Patient self-reported data is playing a key part in efficacy, quality of life assessment and safety data collection in clinical trials. Bring Your Own Device, aka BYOD, enables a patient to capture such data on a device the patient is already familiar with, e.g. a smartphone, tablet or computer.

ViedocMe, our web-based ePRO solution, is an integrated part of our EDC platform Viedoc and allows patients to report clinical trial information directly from their mobile devices into the eCRFs available in Viedoc. Thanks to the integration, deploying a study diary and/or questionnaire in ViedocMe is not only more cost-effective than traditional ePRO trials, but can also be done in much less time.

ViedocMe builds on our vision of the future for how to handle patient reported data. For more information and a comparison between different solutions, see our white paper “The Future of ePro Platforms”, written in 2015 and still accurate.

For more info about ViedocMe, read here.

Why nominate for the Viedoc Most Valuable Professional Award?

Viedoc Most Valuable Professional

The passion born from improving electronic data capture for clinical trials is still our greatest goal and this has made us a leading provider in the industry. This goal can only be accomplished by the communication and collaboration we have with our users. That is why we have now introduced the Viedoc Most Valuable Professional (Viedoc MVP) award. The Viedoc MVP is given for outstanding contributions within the Viedoc community and to acknowledge those who are willing to share their passion, technical expertise and real-world knowledge of Viedoc, electronic data capture or clinical trials. A Viedoc MVP is awarded for individual contributions and the nominees are selected exclusively by the PCG Solution’s management team based on a review of accomplishments and achievements.

This year, we have given our first Viedoc MVP award to Makoto Yokobori at the User Group Meeting held in Tokyo on 13 June. Mr Yokobori was the first user to get our back end set up training back in 2008. Since then, he has gained and shared in-depth knowledge from all aspects of conducting clinical trials using Viedoc. Mr Yokobori is a true ambassador for good clinical practice and includes this thinking in the study design and how systems can best be incorporated to support and raise the quality of the study. He is full of ideas and has a strong interest in improving and developing the industry, much like why Viedoc was born.

Learn all about the award and how to get nominated in our Viedoc MVP page.

White Paper: Preparing for the EU GDPR in Clinical and Biomedical Research

On the 25th of May, 2018 the new European Union (EU) General Data Protection Regulation (GDPR) comes into effect. Everyone who does business within the EU must follow this new regulation. PCG Solutions is a European company, and is subject to GDPR.

GDPR requires companies to have control of their information management and its governance. In the Clinical Research sector this has long been vital for the success of clinical drug development, so it is not a pivotal change to how companies work. Instead companies need to ensure that their internal policies are aligned with the regulations defined in GDPR.

This white paper explains what GDPR is, the responsibilities and obligations it entails and how it affects you in your dealing with the EU and with PCG Solutions. PCG Solutions customers cover the entire range of companies from those active in the EU with natural persons based in the EU in their studies, to the opposite extreme where the only contact with the EU is PCG Solutions itself. This white paper covers all scenarios so that no matter what your connection to the EU is you can easily see how you are affected.

Download White Paper: Preparing for the EU GDPR in Clinical and Biomedical Research