Though paper CRFs are still used largely, use of electronic CRFs (eCRFS) are Moreover, for studies with large sample size if traditional method of data. Electronic Case Report Form (eCRF) Completion Guidelines (eCCGs) provide assistance in .. example, cysts, benign and malignant tumors. Entrypoint i4 comes with electronic case report form templates for demographics, inclusion/exclusion criteria, laboratory test results and more, which can be used.

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The electronic case report from eCRF played a pioneering role in the digitalization and introduction of ever new technologies into clinical research, and enjoys great popularity. National Center for Biotechnology InformationU. Collection of large amount of data will result in wasted resources in collecting and processing it and in many circumstances, will not be utilized for analysis.

Filing a sample of eCRF at Investigator Site | Research Quality Association | RQA

The structure and data validation plan. However, this method may not require user training and system validation as in the case of EDC systems, where such things are essential before implementing it.

For that purpose, a structure plan is created which is reviewed and approved — by all involved parties — before set-up and validation of the eCRF structure within the development environment of the EDC system. When the study administrators or automated mechanisms process the CRFs that were sent to the sponsor by local researchers, they make a note of queries.

This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.

This article is an attempt to describe the methods of CRF designing in clinical research, discusses the challenges encountered and measures to be taken to prevent the occurrence of issues in its development. After review and approval by all involved parties, the manuals are handed out to the users of the EDC system.

In some circumstances, data can be obtained using derivation procedures; collection of derived data again on the CRF should be avoided to minimize calculation errors. For ordinal data, to ensure uniformity and clarity among raters, adequate explanation should be provided adjacent to the CRF fields.


Objectives should be defined clearly before designing. The language used should be simple with clear instructions, concise, and easy to understand. Data should be organized in a format that facilitates and simplifies data analysis.

The development of an electronic Case Report Form (eCRF)

This article is an attempt to describe the methods of CRF designing in clinical research and discusses the challenges encountered in this process. Table 1 provides the comparison between well-designed and poorly designed CRF.

Therefore, majority of samlle cleaning activities will take place during the completion of the eCRFs, thus reducing the time and effort required by data management personnel. It should be study protocol driven, robust in content and have material to collect the study specific data. Depending on variables relating to the nature of the study, e. Clear instructions should be provided to ecdf user where ever necessary; otherwise, it will have a significant impact on the data management activities like database designing, data cleaning, data validation, and data extraction due to poor understanding of the site personnel about the expected responses.

A case report form CRF is designed to collect the patient data in a clinical trial; its development represents a significant part of the clinical trial and can affect study success.

Designing user-friendly CRF to reduce data entry errors is again a challenge. Usually, boxes are used for entering dates and the date format i. Queries are non-sensible or questionable sampe that must be explained.

User feedback mechanism should be built into the CRF design and maintenance process. In other words, CRF should collect data in sufficient detail without ambiguity and dample the same time, should avoid redundancy and avoid capture of unwanted details. Providing CRF completion guideline aids in minimizing the challenges in data capture and data entry. The supervising Institutional Review Board IRB oversees the release of any personally identifiable data to the sponsor.

The training requirements are described in the data management plan. User and access management. However, because of human and machine error, the data entered in CRFs is rarely completely accurate or entirely readable.


These templates are of great help while conducting multiple studies in the same saple area.

As soon as the aim of the study and its contents are determined, the structure of the eCRF can be defined, i. Each query has to be resolved by the individual attention of a member of each local research team, as well as an individual in the study administration. The data management plan. We use cookies to give you the best user experience and to analyze the usage of this site. For that purpose, the workflow definition document is created and, upon review and approval by all involved parties, the workflow is implemented and validated within the development environment of the EDC system.

Case report form insanity. If it is included as part of the CRF, it is advisable to print instructions on the page facing the CRF page back side of the previous page as the investigator can easily take instructions and simultaneously fill the CRF page. Author information Copyright and License information Disclaimer.

By Team Data Management T On the other hand, separate lines and boxes are provided in the well-designed form, which gives the visual cues about what is expected fcrf a response and thereby, reduces the unnecessary queries. The sponsor of the clinical trial develops the CRF to collect the specific data they need in order to test their hypotheses or answer their research questions.

It can be prepared either concurrently along with the protocol development, but may result in many versions, and hence needs to be version controlled. Hence, it is advisable to have a standard operating procedure for CRF preparation and to follow best practices of CRF designing.