COMPARISON BETWEEN PAPER CRF AND eCRF

ABSTRACT

Now-a-days every field Business, Banking, Transport, Government sector.. and so on has moved from manual to on-line services, to gain huge efficacy for suppliers and potential financial value to the company. Suppliers that have failed to modernize their business strategies have slowly vanished from the market place.

In this decade, going digital can improve the quality of clinical trials in many ways. The present paper is a narrative review of comparison on the percentage of clinical trials performed using the simple pen and paper to record the data with the trials that are performed by smart data entry us electronic case report forms (or eCRF)

“ Source or eSource – is the grapevine of this era clinical trials ”

INTRODUCTION

One of the core documents in clinical trials is the case report form (CRF). A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. The Case Report Form is the tool used by the sponsor of the clinical trial to collect data from each participating site. All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events.

According to FDA

On page 11, the FDA adds: "The eCRF is the electronic document containing all data elements on a study subject that the investigator has reviewed prior to release to parties in Tier 3 (e.g., the sponsors, CRO, institutional review board)." The word "all" is used again.

On page 3, the guidance states: "The eCRF is a vehicle used to assemble all the data from different electronic- and paper-based systems and makes it possible to capture and organize these diverse data in a manner that satisfies the study protocol and that enables the data to be systematically reviewed and analyzed." Got it? The key word there is "all." Are all of your organization's eCRFs "vehicles"?

 In the past decade, the classical paper case report forms are surprisingly entrenched against the digital age. As clinical trials are considered as business process, the sponsor’s main objective will be to compare pros and cons of paper CRF and eCRF so as to estimate the values of data quality parameters and performed cost calculations for a sample clinical trial.

Paper CRF Vs. eCRF

Many of the studies have shown that electronic subject data collection yielded higher quality then the simple paper collection with great study compliance. The studies have also proved that electronic data capture has significantly reduced the overall expenses of the trial. Hence it is no wonder that companies have an interest in cost cuttings.

However, some clinical researchers argue regarding the “flexibility”. According to them Paper CRF is a flexible tool that can record the free-form information using pen and paper at any point of time. Whereas in case of eCRF, it is very hard to predict in advance the kind of data that needs to be captured. Paper CRF can never fail to accommodate the data but what happens to the eCRF if there is a power break up or short circuit goes down?

But if the digital tools are properly managed, the above mentioned lack of flexibility also become s the greatest strength of the electronic case report forms. eCRF can be a truly inter-responsive tool that can provide information to the investigators as soon as the data is entered and with very less frequency of errors.

“An intellectual eCRF – is like acquiring brainy scientist at the clinical site”

ADVANTAGES OF eCRF

Lowered Chances Of Errors: Electronic case report forms are designed in such a way that it will send an “ALERT” to the investigator, if any wrong entries are made. In this way eCRF provide a check to the investigators and prevents errors before it happens.

Reduced Data Entry Time: Increasing EDC computerization has enabled a paperless environment where key study variables based on protocols and electronic querying are directly entered into the clinical trials application.

Eliminating Duplicate Data Entry: In eCRF the repetitive data in clinical trials such as- Subject ID, Study Number, Site ID, Date - are automatically replicated from the first form to the last form. Hence eliminating duplicates.

Accurate Data: Since eCRF are configured to check for and prevent errors and omissions, data collected is accurate.

Facilitate Analysis: Data collected in eCRF are linked with one form to another from for analysis.

Improved Document Management: Advanced electronic record-keeping systems with basic features like document version control, full text indexing, metadata templates, data storage, security access etc., have improved the document management system.

Dashboards: Electronic case report forms provide features such as color-coded dashboards for each subject visit that provide information to the clinical investigator at a glance. Hence dashboards remain the outstanding as well as user-defined options to display the data that can be visualized and identified with an ease imagination.

CONCLUSION

Although EDC technology and e-clinical systems have been implemented to enhance various aspects of the data management process, implementation not been without difficulty nor has it been improved as rapidly as many has anticipated. But, EDC acceptance seems, strong and there are few instances where sponsors have gone back to PDC studies when they have had the experience of EDC.

However, competitive pressure in today’s market place is forcing the CRO’s to seek better ways of reducing drug development times and increasing productivity. Electronic case report forms that are shortening the clinical trial lifecycle by collecting quality data more quickly and accelerating the availability of data are solutions to a critical path bottleneck that the industry has been working on for many years.

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Written by
Vanitha
vanitha.archana@clinzen.com