6 Guidelines on How to Select Electronic Data Capture Software

If you want clinical data collection to be much easier and faster you should check out best electronic data capture software reviews. These reviews will enlighten you and will point you towards the right direction in selecting a software. Carefully check out different features as well as the cost so you know which software you can considerably use for collecting data.

To help you more, I’m going to point out 6 important guideline when choosing EDC, but before that let me first talk about what electronic data capture software is.

Electronic data capture (EDC) replaces the traditional way of collecting data which is mostly paper-based. With EDC, clinical data are collected using an electronic format thus making process much faster. The software is usually web-based which means that it runs completely using a web-server. You just have to be connected to the internet to be able to access it.

More and more clinical trials are using EDC to replace the paper records with electronic records. The 3 major users who utilize the electronic data capture software are sites, contract research organization (CRO) and sponsor.

A site is an entity that organizes and gathers data from clinical trial patients or subjects. This information typically comes from clinics or hospitals. There will be individuals who are employed in the hospital like nurses who will enter data into the electronic data capture software for clinical trials. The doctor who is in-charge of the patient will then view the data and electronically sign it.

People or organization who facilitates the planning and execution of the clinical trials are called contract research organization (CTO). The CTO are sometimes responsible for data management, monitoring, and data examination. The CTO oftentimes uses the same EDC system as the sponsors.

The sponsors of the clinical trial are organizations who own and are responsible for the study. The trials are needed before innovations of products get approved by regulatory authorities. With the use of electronic data capture software, all groups participating in the trial will use one platform ensuring that they get the same accurate data.

What to Look for In Electronic Data Capture Software?

There are many circumstances where electronic data capture software can be used, but it does not mean that it will work for you too. You should learn the different features that come with the software so you know if indeed it is a wise investment. Assess within your organization how electronic data capture software can be used efficiently.

Quick, Accurate and Efficient Data Capture Process

Data can be captured through different methods like letters, emails, invoices, fax, etc. If these data are available in electronic form, the data capture accuracy is considerably higher. If the data is not in the electronic form it needs to be printed and scanned before it will be accepted. The data will then be entered into the software through manual, automatic, optical character recognition, optical mark reading or magnetic stripe cards.

The moment the procedure is set-up in the system, the information gathered will be entered into the applicable forms. When the data is collected through EDC you are assured that assured it is precise and organized even when those providing the information have not gone through extensive training.

Importance of Electronic Case Report Form Designer

Electronic data capture software for clinical trial has a designer feature in order to create an electronic case report form (eCRF). An electronic case report is generated to get patient information for the clinical study. The progress in the report will determine the success of the trial hence it is vital that the design of the case report is carefully made.

Designing of case report form requires extensive planning and attention to small details. The CRF is crucial in the trial because it will aid in determining the effectiveness and safety of the product. When doing the CRF manually or using paper, there is increased the chance of the data getting mixed up which eventually affects the results gathered. On the other hand, when electronic data capture is used, you can be confident that you get correct results.

The main goal when creating case form design is to collect complete and accurate data by avoiding duplication. The form should be easy to fill out without needing too much assistance that is why it should be structured properly.

Using eCRF will make linking of data between two associated pages quicker and easier. It has built-in edit checks attached to different data fields so data cleaning is automatically done even while it is still entered into the system. As a result, clean data is produced faster.

If you want to avoid spending countless hours designing case report form and you want a hassle free approach to collecting data, the electronic data capture software is the key. The software already contains designs that imitate the one in paper form and it also allows you to create your own. As you build the form, it will perform edit checks to prevent invalid data entry.

Available Information and Query Management

There are instances when a variable contains an error or when a question is raised; this is referred to as containing discrepancy or query. To address this problem EDC software created a discrepancy tool called validation check and this is encoded into the system.

The moment the validation check detects a problem with the information provided, it generates a query. When a page is saved, an automatic validation check is done by the system. Detecting these errors at the early phase of the trial prevents contaminating the results later on.

To resolve queries, you can either manually correct the error by re-entering the correct data. There are EDC which offers an option to further raise the query. When this happens the question is directed to the people involved in the clinical trial like the coordinators, site, sponsor or CRO.

Hassle-Free Data Export From Various Databases

Clinical trials would usually need data from other platforms and if your EDC has limited data export capabilities you will have a hard time merging the information in your system. When your software has extensive data export functionality it should be able to filter based on form status. Most common data exported are MS excel and SAS.

If you are planning to use EDC but still undecided which one to get, there are guidelines that you can check to help you with your decision.

Requirement

Before you purchase a software, first look into the clinical trial and find out what factors need to be researched and measured. The expected length of time wherein the study will be conducted should also be considered. There are softwares you can utilize for a long time while others only for short period of time.

The more feature and the longer the EDC will be used the higher its price will be.

Complexity

EDC come in all shapes and sizes. Some involve complex functions while others just the basics. Training are usually provided by vendors when the software is multifaceted. So, if it’s really necessary to get the complex one, don’t get intimidated and get in touch with the dealers.

FDA Compliance

This is needed when you collect and gather data to be submitted to FDA. This is not always needed but the majority of trials have the FDA as a regulatory authority.

Do your research and don’t just rely on what the vendor tells you. This is a crucial requirement if you want your data to count. Check if the software adheres to the current standards and if its features are up-to-date.

FDA-compliant software means that it has technical controls in place to assure data accuracy at all times. To properly sustain an EDC system, standard operation procedures are needed to guarantee that the organizational policies and regulations are attained.

Availability of Resources

Ask the seller if they will give further training aside from the one given for the hardware. It would be beneficial to you if someone in your organization will be trained regarding troubleshooting in case technical problems occur. This way you can repair the system right away if needed. Sometimes waiting for vendor replies can take a while and this can delay the trial.

Budget

When getting an EDC software, other than knowing the price, also check if there are other additional fees for installation, support, hosting and extra sites. You wouldn’t want to be surprised when you receive your total bill.

Software Enhancement

Find out from vendors with they have scheduled enhancement and if there are other software that they are planning to release.  This way you can keep your software up-to-date if the need arises.

Acquiring EDC is a great investment that can offer various benefits. However, if you don’t know how to fully utilize its features, you are putting a limit on what it can do. Make sure that you do more research on the different software available. Carefully study different vendors and compare their packages.

Reading best electronic data capture software reviews should also be included in your research. Find out what other people have to say about the different EDC software and get insights from them.

To get a list of top selling EDC, visit CrowdReviews.com. You can also check out our electronic data capture review for more information.