Benefits of Using an EDC

System

INTRODUCTION: Some of the biggest challenges that clinical research sites often face are staying on budget, keeping accurate track records, working according to rules and regulations (in compliance), and finally – trying to do all of this in as little time as possible. Managing to achieve this goal is impossible without the help of a proper organizational system.

For this reason, nowadays more and more sites decide to implement an EDC (electronic data capture) System, as a new technology that will help sites save a lot of time and money.

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● Explain what an EDC System is;

● Choose the best EDC System for your site;

● Know what problems can be solved by using EDC;

● Use an EDC System;

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After this presentation, you’ll be able to...

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An EDC System (electronic data capture system) is a web-based software system that stores collected data in clinical trials.

The participant data related to a certain clinical trial is first recorded on paper-based documents. After that, this data is transcribed into the system and saved in an eCRF or electronic case report form.

Although just some years ago, an EDC was considered to be a thing of the future, today the use of an EDC is preferred and sometimes even required.

An EDC is a software that can be used in practically all research phases, and regardless the complexity/simplicity of the trial.

Defining an EDC System

- Cloud-hosted;

- User permissions;

- Designing eCRFs;

- Data Entry;

- Managing Queries;

- Audit Trail;

- Export of data;

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Common Functions of an EDC System

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Function: Cloud-Hosted

Being cloud-hosted means that the data entry is made on the interface of a website.

You’ll be able to access this data from all devices as long as you have internet access.

Apart from the ease of access, being in the cloud is also important for having a backed up and protected data.

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Each user account that has an access to the system has its own unique username, password, and permissions.

User permissions put a clear limit to the data that each user is allowed to see and access.

A feature such as this reinforces patient confidentiality and strengthens data integrity. Role-based user permissions will provide the most secure access to data and affect your whole trial positively.

Function: User Permissions

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eCRFs are electronic case report forms, which are the forms in which we save data in the EDC system.

One common feature of EDC systems is the ability to choose from different design options of eCRFs. We can choose the best eCRF design form that best suits for data entry and export and the one that will allow a replication of some complex tasks such as questionnaires. These eCRFs are also saved in a shared library which allows us to re-use them.

Another great advantage that this eCRF designer gives you are edit checks.

Function: Designing eCRFs

- Data entry is another area that can be simplified and improved with the use of an EDC system.

- When you're entering data the system performs real-time data checks based on the edit checks that you previously programmed into the saved eCRFs.

Function: Data Entry

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- All queries in an EDC system must have a feedback and response, and must be solved in order to lock the data.

- EDC systems have automatically generated queries which are the result of previously programmed edit checks, and the possibility to add queries manually.

Function: Managing Queries

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- Every EDC system that works in compliance with 21 CFR Part 11 has to have the suitable technical controls. One such control feature is the audit trail whose main responsibility is to track the histories of eCRFs.

- The history of a saved eCRF includes: the used that made the change, the reason for making the change, both old and new values, the date of change, and the time of change.

Function: Audit Trail

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Most Common Problems Solved by an EDC System

- Working in compliance;

- Saving time;

- Reducing mistakes;

- Easy access

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- All clinical research has to be conducted in compliance with FDA regulations and according to Good Clinical Practice.

- Every study that is supposed to be submitted to the FDA has to be conducted by using the appropriate EDC system that works in compliance with 21 CFR Part 11.

- The EDC system that you're going to choose has to possess the appropriate technical controls for working in compliance with FDA regulations. The most important feature for this is the audit trail function which tracks every change that's been made to data.

*21 CFR Part 11 – The criteria that have to be met in order to consider electronic records and signatures trustworthy, valid, reliable, and with equal value as paper records.

Solved Problem: Working in Compliance

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Saving time and effort is one of the biggest challenges in the conducting of a clinical trial. Inefficiencies and miscommunication are some of the biggest culprits for wasting valuable time and resources on a site.

With an EDC system, you can do everything at once, in the same system: build eCRFs, enter data, solve queries, and lock data. As soon as everything's finished and you lock the database, you can immediately have the data exported for analysis and review.

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Solved Problem: Saving Time

Our Portfolio

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- The amount of data related to a clinical trial is enormous, so it's virtually impossible not to make a mistake without using a proper system.

- An EDC will help you reduce these mistakes by using standardized eCRFs which have programmed edit checks. These edit checks will prevent invalid and wrong data to be entered in the eCRFs.

Solved Problem: Reducing Mistakes

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EDC systems have the feature of being cloud-hosted which means that all the eCFRs are stored in a central location that can be easily accessed from anywhere – any device that has internet access.

These eCFRs are standardized which means that they can be reused across many different protocols.

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Solved Problem: Easy AccessSolved Problem: Easy Access

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When making this decision, it's important to do some research beforehand. Purchasing the right EDC system for your organization is important if you wish to use all the benefits that such a system can offer.

There are many factors that have to be considered in order to find your best fit. These factors are not only regarding the EDC features, but also the vendor behind it.

How to Choose the Right EDC System

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Does the total cost of the system fit your budget?

What features do you need?

Is the system user-friendly and easy to use?

Will you submit your clinical research data to the FDA?

Ask which expenses are included and which aren't. What if you change your study? How are they going to charge you for additional sites? Is this a one-size-fits-all contract or is it a pay-as-you-go? Is hosting included in the price? Do they offer support and training included or will you have to pay extra?

If you're conducting a simple study or trials, then you don't need many complex features but only the most basic ones. You shouldn't pay money for features that you're never going to use!

An EDC system has to have an intuitive interface design and a straightforward protocol setup. This will make users learn the system more quickly and easily. When we say 'easy to use', it means that it should be easy to use for ALL users.

If you're plan is to submit your research data to the FDA, then you'll have to make sure that the EDC system you're going to purchase supports validation and works in compliance with 21 CFR Part 11.

How to Choose the Right EDC System

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How long is the implementation process?

What is the vendor company history?

Do they offer training, assistance, and support?

What’s the vendor’s opinion regarding implementing new features?

These timelines can be important for organizing and managing the timeline and deadlines of your trial in general. When we're talking about implementation timing, you should also consider the time needed for your staff to learn the system. Some EDC systems can be really easy to learn and use, while others might require more time.

You'll need to find out if the vendor has any good references, stability, respect, etc. Learning the history of the vendor company will help you decide if that company is a good fit to be your future partner or not.

Some vendors include technical and customer support within the system cost, while other will charge you extra for such services. That's why it's important to know the vendor's policy regarding assistance and support.

Will the vendor take into consideration your feedback and needs regarding future upgrades? Is the vendor open for suggestions and collaboration? The second thing you'll need to know is implementation of these future upgrades and enhancements. How will these changes be implemented? Will you have to pass through a validation process again?

How to Choose the Right EDC System

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user interface75%

support and service 68%

ease of implementation 68%

Percentage of trials using EDC systems went from 13% in 2001 to 58% in 2009

When compared to paper-based methods, EDC can bring from 49% to 62% of savings

Reduction in queries time86%

Decrease in study duration30%

cost 47%

Reduction in time to lock the database

43%

Global annual growth expected through 2018

13%

Facts and Statistics About EDC Systems

EDC USERS EVALUATION OF IMPORTANCE

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Myth #4: Only the vendor is responsible for validation.Truth: The responsibility of vendors regarding validation of EDC systems is only to build the technical controls into the system that meet the requirements of 21 CFR Part 11. Sponsors must have the right procedures that will validate the system for its intended use.

Myth #3: Implementation of an EDC system takes too long.Truth: Again, the complexity of the implementation process greatly depends on the EDC system you decide to use. Some systems can be implemented in a relatively short time (some weeks), while others may take longer.

Myth #1: An EDC system is only needed for large and complex trials.Truth: These systems are used for complex as well as simple trials, and in every research phase. There are many different EDC systems that provide different features depending on the needs and complexity of your trials.

Myth #2: An EDC system is complicated to use.Truth: Some EDC systems are complicated, and others are really easy to use. The simplicity/complexity of the system will mostly depend on the features that you'll need.

EDC Myths and Truths

The advantages that an EDC system offers when compared to other methods are countless. Such advantages are having a cleaner and more accurate data, faster trial completion, improving compliance in conducting the study, increased data security, easier and faster access to data, and saving your time and resources in general.

An EDC system will improve the overall functionality of your clinical research, providing help and support in areas where traditional methods are lacking. This system will help you save your time and resources that would have been otherwise wasted on trivial tasks, and allow you to focus your efforts elsewhere.

Conclusion

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