Electronic Data Capture EDC system in clinical trials

A software which is used for collecting clinical trial data is termed as Electronic data capture, EDC. An eCRF or electronic case report form is a web-based questionnaire for collection of data based on a study participant.

eTMF in Clinical Research

eTMF in Clinical Research are server applications and software to regulate the complete stage of the clinical trials. Electronic Trial Master File is the full form of eTMF. Many set up  clinical trials around the world use this system to store, guide, and trace data and lengthy documents relevant to the trial. 

How does EDC work in clinical trials?

The sponsors of a clinical study are allowed by the EDC system to make personalised electronic CRF (eCRF) forms that can be accomplished by the researchers who are doing the study. To validate user inputs the configuration and programming of  EDC systems can be done, making sure that the collection of data must be complete and exact.

The features of electronic data capture in clinical trials

For data entry,a data authentication component and a reporting tool, the EDC system involves a graphical user interface. Features of EDC system involves: Quality electronic case report forms (eCRF) Data entry with instantaneous data authentication.

What is electronic data capture used for?

Recently, the majority of initiation of clinical trials are made using electronic data capture software. Site, CRO’s, sponsors are the three main categorisation of EDC software users.

• Sites 

The collection and coordination of data from the clinical trial patients by the entity, usually clinic or hospitals is referred to as a site. The site will employ nurses or other designated study “coordinators” and will give them the task of data entry into the study’s EDC system. 

The investigator of the site-the in charge of the patient’s data and patient’s care is answerable for signing the data electronically and reviewing.

• Sponsor

The organisation that owns the trial is the sponsor of the clinical trial. The life science companies like biopharma, device in order to get the approval of regulatory authorities (like the FDA) before they can enter to market with their product compulsorily sponsor clinical trials. The employment of a variety of people who use the EDC system in several roles is done by the sponsors.

For verification of source data, inspection of data source documents and verification of the validity of corresponding data in the EDC system, the visitation of monitors working on behalf of the sponsor to the clients can be considered. In the planning and analysing of the collected data biostatisticians are of immense  help.

• CRO

The entity that does the contract part with the Sponsors for facilitating the planning and commencement of a clinical trial is a CRO, or contract research organisation. The CROs may efficiently work on the trial on behalf of the sponsor in some of the trials but in other trials they will only take on some of the main roles. According to this,CROs may consist of  several of the similar types of EDC system users as sponsors.

CROs are often termed as Clinical Trials Units, AROs (Academic Research Organizations), or Data Coordinating Centers. Their management and cooperation functions are mostly similar to their commercial peers in academia.

In addition to the users mentioned above, the study patients directly through a specifically designed role in the software can also give data to the EDC system. 

The benefits of electronic data capture (EDC)

• With its uncomplicated and inbuilt interface without any reliance on programming the configuration of studies in days is allowed by the ClinVigilant EDC system and helps in easing the set up.
• ClinVigilant EDC system enhances data quality
• Helps in accelerating study completion
• Helps in making it uncomplicated to find what you need
• ClinVigilant EDC system is more secure

Why use electronic data capture software?

Recently, electronic data capture software is used by the majority of new clinical trials. Few of the most common motivations for using ClinVigilantEDC involves:

• Cleaner Data 

In enforcing specific aspects of data quality ClinVigilant EDC software is a good choice. The assurance that the data meets specifically needed formats, ranges, etc. prior to accepting the data into the trial database is given by edit checks and source data authentication programs.

• More Efficient Processes

ClinVigilant EDC software can aid in guiding the site through the sequence of study events, asking for the data that is required for the particular patient’s situation at a specific time. It aids in declining the number of personal site visits needed throughout a trial and it faculties the procedure of clarifying data inconsistencies with tools for finding and solving data issues with sites.

• Faster Access to Data

ClinVigilant EDC systems can offer near instantaneous ingress to data in a clinical trial. 

Faster decision making can be achieved through this insight, and adaptive trial decisions can be supported. For using ClinVigilant EDC each of the above mentioned reasons addresses issues of effectivity and productivity, and hence can also minimise the cost of clinical trials.

What is the difference between EDC and eCRF?

There is a distinction between eCRF and EDC. A software used for collecting clinical trial data is Electronic data capture, EDC. On the other hand a digital questionnaire for collection of data about a study participant is electronic case report form, or eCRF. eCRFs live inside the EDC, allowing other clinical research stakeholders and clinical data managers to arrange better data, quickly.

Trends in EDC

“Remote data capture” (RDC) was used for referring to electronic data capture in the 1990s.

These systems were quite archaic if compared with today’s technologies.

Recently, with other kinds of software in the eClinical spectrum system the integration of EDC software is quite beneficial and practical. The capacity to swift and dependable import of data from different sources is also becoming common. Through the rise of independent standards for characterising and sharing data  and open source EDC software it is now easy to accelerate productivity and decline the cost relevant to the clinical trials.

Patient engagement in clinical trials 

Patient engagement in clinical trials is necessary for successful clinical trials. In the recent ClinVigilant series many of the panel members spotlighted the requirement for improving patient engagement in clinical trials at every possible stage of the clinical journey and why it is a necessary thing to do.  

There are several chances for the industry to involve more efficiently with patients at each touchpoint because of an increase in awareness of chances to take part in studies. Efficient patient involvement is more important than ever as fully virtual trials become more ordinary and home healthcare replacing site visits and with technologies replacing personal communication.

Raising Public Awareness of Patient Engagement In Clinical Trials

Through research it is clear that the willingness of the public to participate in clinical trial studies is in general more than 75%. If this is so then why do so many studies still find it difficult to meet their enrollment targets? More efficient engagement with volunteer populations and  eligible patients is required. 

One of the biggest barriers to engage worldwide is the lack of clinical trial awareness among the public. Generally many people are not aware of the term clinical trial, what it involves, why it is necessary, or in which way they can make a contribution. It has been seen that most patients are not aware that they are eligible to participate in these clinical trials.

Why would the patients engage with the industries if they are not fully aware about what clinical trials are, what are the benefits of involving or taking part in these clinical trials?

Some of the ways in which we can enhance participation in clinical trials among the patient populations and the wider public are as follows:

• Using easy language to communicate in clinical trials with the patients about their needs, concerns, about the goals, and necessarily about the risks and commitments.
• A straightforward and jargon-free method of communication is sharing information with media and healthcare practitioners and it also helps in ensuring that the information that is reaching to the public is clear and exact.
• By asking trial participants to share their experiences via online patient forums, social media or word of mouth we can encourage volunteer advocacy or patients.

Conclusion

In this guide, we have looked into all aspects of patient engagement over the complete clinical trial journey, and why it’s necessary to make sure of diversity between participants and looking after patients’ intellectual welfare. We had also seen why efficient communication is important in conveying a memorable patient experience, and how to make conversation with patients in a way that keeps them involved across the complete process. Overall, An important part of the picture is raising awareness and knowledge about the clinical trials among Health Care Practitioners (HCPs).

Hope this guide to Electronic data capture system was useful to you guys. For more details contact clinvigilant.