Electronic Data Capture (EDC) Case Report Form (CRF) in Clinical Trials

 

Introduction: 

A case report form (CRF) is an important document that is designed during a clinical trial by the Clinical Data Management Team. It consists of the evaluated patient data. A CRF can be a paper document or electronically recorded data used to record the protocol and required information about every subject in the trial. It is a very efficient method of collecting, analyzing, and reporting of data. Traditionally, a clinical investigator would collect patient data which might include the patient’s demographic details, characteristics, results of the treatments, and adverse events in paper format at the site. Later they are boxed and shipped to the sponsor's study site where it is entered into the computer database before analysing the data. Such a CRF is known as a paper-based CRF. 

What is an e-CRF?

Paper CRFs have been standard practice in clinical trials for decades. But nowadays many companies are prioritizing digitally collected data. Such a CRF is known as the Electronic Case Report Form (e-CRF). It is a digital version of the paper-based CRFs. It consists of a list of questionnaires framed by the researchers and given to the participating subjects to collect the data. In e-CRFs, the data is collected and uploaded to the cloud and is much secure compared to the paper format of the CRF which requires physical storage and transportation which increases the risk of damage and alteration of the data. Thus many companies are opting for electronically collected data since they are collected in less time, have less risk, and require low cost. 

Electronic Data Capture (EDC): 

E-CRF and Electronic Data Capture (EDC) are like two sides of the same coin and are related to the collection of data in clinical studies. Even though they are used interchangeably by clinicians perhaps they are not the same. An EDC is a system software solution designed for the collection of data in clinical trials. EDC allows the data manager to design an e-CRF and provide a graphical interface. 

 EDC enables the collection of data from electronic health records from a hospital directly. Plus, they also control the data and access to it, which ensures that the data is accurate, authentic, and securely collected and stored.  EDC has decreased the time of collection of data and is very economical for studies of drugs and medical devices.  

 

 EDC allows the sponsor to form a customized e-CRF that has been collected by the researchers during the study. EDCs are programmed and configured by Data Managers making them more secure and accurate. 

Difference between e-CRF and EDC

 Electronic data capturing (EDC) is a software application used for processing, collecting, securing, and storing clinical study data where electronic. The EDC refers to the software itself. Whereas a Case Report Form (e-CRF) is the digital collection of case report form (CRF) used by researchers to collect subject data in the trial. 

Types of data being collected in an EDC system. 

EDC is built to collect data with much accuracy and in an organized fashion for an easy user interface for the researchers. Which includes e-CRF documents and results of medical devices. 

An e-CRF consists of information such as: 

-         Patient demographic details 

-         Patient’s vital signs, medical history, and physical examination. 

-         The effect of treatment.

-         Lab data of the patient 

-         Dosing details 

-         Adverse Events 

A Clinical Study is carried out mainly to answer the research hypothesis. Thus data regarding variables that are relevant to it are gathered. Thus EDC software ensures that the e-CRF is customized and necessary data is being collected. 

 Data collection in an EDC Software. 

There are three methods by which researchers use to input their data into an EDC Software: 

 1. Direct Data Entry: The researchers log into their EDC software using their credentials and access the e-CRF into which they want to input the data and enter the clinical data into the system. 

2. Automatic Transmission: Data is being transmitted through e-PRO instruments to the EDC Software making it an automatic transmission. 

3. Directly Transcribe the Paper CRFs into the e-CRFs in the EDC Software System.

Advantages of using EDC Software in collecting data in clinical studies: 

 

 The main advantages of using electronic data captures are that it facilitates a streamlined data collection process, improves the quality of the data being collected since it is digitally collected, enhances data authenticity and security since the data is stored in software is protected by private credentials only known to the researchers involved in the study, the data has become more accessible. Furthermore, it has accelerated the pace of completing a clinical study and finally, it has reduced the clinical operations costs. 

Conclusion

In clinical research collection of patient data is a very crucial process and requires proficient skills in collecting, securing, maintaining accuracy, reviewing, and storing the data in a safe and tidy manner. For the smooth functioning of the clinical trial, the collection of data should be user-friendly making it more easily accessible. Any minor mistake or unreported data can affect the result of the study. To prevent this risk there have been significant transformations from paper-based to electronic-based CRF. To make data collection more easy and eliminate any risk of alteration in the data and affecting the clinical study.

References

Basics of case report form designing in clinical research:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4170533/

https://www.pharmaceutical-technology.com/contractors/clinical-trials/clindox-pharma/

Student Name: Mohammed Junaid Pasha 

Student ID: 164/082023

Qualification: Pharm D