electronic-data-capture-in-clinical-trials-boost-study

Clinical Research is continuously growing all over the world and due to which huge amount of data collected related to each and every drug, location, patient, trials etc. For the collection and maintenance of this bulk data, many IT companies developing very powerful and highly optimized system for data collection and management, which is know as Electronic Data Capture Systems or EDC for Clinical Trials.

If you are a Clinical Research professional then you well aware about these systems. But if you are new in this domain, then don’t worry I will share some information about these EDC systems with you.

What is Electronic Data Capture in Clinical Trials

Electronics data capture in clinical trials is just a process through which we collect data from different location for different studies and for specific patients in a centralized system. Centralize system because it connect with all the centers located in all over the world and due to study member, you can easily access your data from any location.

Few years ago and today also we are doing data collection task in paper format. But If we talk about today’s condition then we have replaced most of the paper work with electronic format.

Electronic data capture is fast, secure, cost saving and fast in analysis prospectus.

Right Now most of the Sponsor companies, Pharmaceutical companies and CROs are adopting Electronic Data Capture in Clinical Trials. Well, process is same as previous method. First, most of the data captured in paper format and site coordinator responsible for this primary task.

Then he/she send all the data direct into the system or send it to Clinical Data Management team for further process. This simple task is know as Electronic Data Capture.

Advantages of Electronic Data Capture in Clinical Trials

As we know that today in this hi-tech world, you can send your message within few seconds and send anywhere in the world. Same phenomenon with EDC system, you can capture bulk data from any location in the world and save your money and time, which is I think most important for any project.

Below are some advantage of EDC system, if you have any suggestion then you can share with me via comment I will add your point with below list:

Instant Access: If you are working both paper based study and EDC based study then you analyze that EDC less consume your time and give you instant results. If you submitted data have any issue or error then you will get the popup message within few seconds or hours. Submitted data easy available for analysis purpose, while in paper based study it take lots of time for analyzing.

Data Accuracy: Electronic data always more accurate than paper based study. Because you can easily check your errors and issues with running study and rectify you issue instantly. Study designer make many edit checks or error message pop-up for errors which helps you to check what’s wrong with your data. Example:

If Study protocol said Patient of Age 40-60 should be included into Clinical Trial. According to which study designer make a edit check which appears, when you enter Age less then 40 and great then 60.

Means you get your error message during data entry of patient. It automatically reduce error and rectification time for you.

Data Security: Electronic Data Capture in Clinical Trials is completely web based and it is not a application loaded in specific computer system. Server administrator installed this EDC system in centralized server and give unique access for specify authority. All access details are different for different person and locations.

Server administrator check all data process and backed up in regular basis for data protection.

Cost Saving: Most Important thing is EDC systems are not free but you can say one time investment. Every CROs or Clinical Organization pick yearly based licenses for particular EDC and use same EDC system for multiple studies.

That’s why it is one time investment. EDC reduces your mailing charges like couriers, It reduces your transport charges etc.

Well Organized: Due to EDC system your all study data stored in well format and you can easily find your data with search functions. Normally when you are working paper based project and searching for some specific files and documents then it take more time and sometime cause headache for you.

But in EDC system your all data organized in proper format and study based folder. If still your are unable to fine your document then you can use search function and your data appears within few seconds.

Compliant with Regulatory: Most of the EDC systems are compliant with regulatory requirements. Software should be well formatted, structurally powerful and follow regulatory requirement like 21 CFR Part 11. Well software like Oracle RDC Onsite, Medidata Rave, Informs are most popular and perfect system for Electronic Data Capture in Clinical Trials.

Why System like Electronic Data Capture in Clinical Trial is Important : Some Features

Clinical Trials process  is overall combination of many division and working as a network from different locations. So EDC system make it easy in many aspects like Developing designs for study, Data Capture, Data Migrations, Data Reporting, Data analysis and many more.

Main Task of Electronic Data Capture in Clinical Trials:

eCRF Designing: CRF or Case Report Form is just a simple form made in MS Word for paper based study. But if you are entering the same data into the system, then you design it into CDMS or Clinical Data Management System. All sections in eCRF are same as Paper CRF. After completion of eCRF design, one of the Data Manager verify it and approve for trials.

eCRF or complete study is based on study protocol and we collect only required data as per study protocol.

Data Entry: After eCRF approval from study team, They send it to operation team and distributed to all trials center for data entry.  Data entry in eCRF done by site coordinator or send it to CDM department for data entry by Data coordinator.

Query Management: Electronic Data Capture in Clinical Trial provide a streamline path between study data managers, study coordinator and study monitors. Most or the queries are auto generated or system generated. But some query are manually generated by Data managers or monitors.

Before study lock, all data should be validated and all queries should be resolved.

Data Export for Analysis: After successful study completion, all locked data send for analysis purpose to analytics department. They use different analytical tools for analysis like SAS. I will tell you more about SAS in my next post.

Well finally, Analysis department analyze the data and generate Table, Listing ad Graphs from Clinical Data. Final analyze data send to sponsor for FDA submission or authority approval.

List of Some EDC System in Clinical Trials

Below Tools are combination of Electronic Data Capture and Clinical Data Management System.

Medidata Rave

Oracle RDC Onsite

Oracle Inform

Phase Forward

Electronic Data Capture in Clinical Trials is really a smart and fast technique and It boost the overall process of clinical trials. It reduces overall cost and time in Clinical Trial completions.

EDC software makers still developing and improving the system for more accuracy and fast process. If you have any query and suggestion then share with me and other readers via comments.

What is your opinion about Electronic Data Capture in Clinical Trials.

Reference: Forteresearch, Wikipedia