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 sponsor is responsible for designing a CRF that accurately represents the protocol of the clinical trial, as well as managing its production, monitoring the data collection and auditing the content of the filled-in CRFs.

In order to check compliance with the DTS and technical feasibility, a test data transfer should be performed before the first planned data transfer. Incorporation of an indicator question and skips are shown in Figure 1. Findings and comments have to be documented by each testing person within the user acceptance test report.

Therefore, majority of data cleaning activities will take place during the completion of the eCRFs, thus reducing the time and effort required by data management personnel.

Therefore, the finalized structure plan is amended with the data validation plan. On the other hand, separate lines and boxes are provided in the well-designed form, which gives the visual cues about what is expected as a response and thereby, reduces the unnecessary queries. Figure 5 shows sample page of CRF completion guideline. Sometimes, external laboratory data or data from an electronic patient-reported outcome ePRO have to be incorporated within the eCRF.

Consistent design is a crucial aspect as it reduces the number of mistakes in data entry. Most commonly used standard CRF templates are inclusion criteria, exclusion criteria, demography, medical history, PE, AE, concomitant medication and study outcome modules, whereas, the modules which captures efficacy data are not unique.

These templates are of great help while conducting multiple studies in the same research area. As a last step before Go-Live, once the EDC system is approved by all involved parties, the EDC system is transferred from the development environment to the productive environment. In conditions where same parameters are to be recorded at multiple visits, it is recommended to use the same CRF module for each visit to reduce the number of query generation.


A CRF completion guideline is a document to assist the investigator to complete the CRF in a step by step manner and is drafted concurrently in line with the CRF and protocol.

Clear guidance about skip patterns like what to skip and what not to skip should be mentioned at appropriate places. Apart from the structure and check criteria within the EDC system, it is important to define the project-specific EDC rolestheir individual rights and workflows e. This is an open-access article szmple under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.

CRF design should be standardized to address the needs of all users such as investigator, site coordinator, study monitor, data entry personnel, medical coder and statistician. Shantala BellaryBinny Krishnankutty1 and M. Abstract Case report form CRF is a specialized document in clinical research.

Case Report Form Templates – ICTR – UW–Madison

Open Access J Clin Trials. The DTS are created in collaboration with the external data provider before the first planned data transfer occurs. There is no standard template for CRF completion guidelines as it is study specific. Usually, also user manuals are created within the project-specific EDC system, in accordance with the different existing user roles e. In case of poorly designed CRF, by placing a single line for required response results in variations in the investigator’s responses from site to site.

Clinical data acquisition Clinical research associate CRA Clinical trial protocol Data clarification form Data collection system Drug development Electronic data capture Patient diary Patient-reported outcome.

Retrieved from ” https: By Team Data Management T External electronic data — if applicable. Use instructions including page numbers where data has to be entered e. Important part of the CRF is an informative header and footer, which ssample be customized.

Moreover, the regulatory authorities are readily accepting submissions in which validated electronic data capture EDC systems are used. We would like to acknowledge the technical support offered by Mr. But recently there is a changing trend to perform clinical studies using an electronic case report form eCRF.

eCRF development: How an electronic case report form is formed

Standard CRF should be designed in such a way that it helps the collection of consistent and valid data, ultimately resulting in submission of data to regulatory authorities and its acceptance. For example, vital Signs and body systems in the physical examination PE module can be collected in the same order each time. The fields like protocol ID and visit labels are informative features as they provide brief descriptions of the study and the schedule of assessments, respectively. Capturing the same piece of data in more than one place duplication on the CRF should also be avoided.


For example, if exact date is unknown, then use a preferred notation in the place of missing value i. The data transfer specifications DTS describe the content, structure and frequency of the external electronic study data transfers.

Global Medical Affairs, Dr.

This page was last edited on 21 Novemberat Click “More information” to read our privacy policy. Primary objective of CRF designing is to gather complete and accurate data by avoiding duplication and facilitating transcription of data from source documents onto the CRF.

February 15th, 0 Comments. Providing CRF completion guideline aids in minimizing the challenges in data capture and data entry. The structure and data validation ecrd.

Case Report Form Templates

To facilitate ongoing study and patient management, study-specific status reports are programmed and validated on demand e. Latha Global Medical Affairs, Dr. Designing a CRF is an art that should to be based on scientific practices and the design should be implemented keeping the end-user the one who enters data in the CRF in mind.

A case report form CRF is designed to collect the patient edrf in a clinical trial; its development represents a significant part of the clinical trial and can affect study success. Originally all case report forms were made on paper. This way of working has many advantages:. For ordinal data, to ensure uniformity and clarity among raters, adequate explanation should be provided adjacent to the CRF fields.

Collecting the data in the coded form whenever possible is ideal as it facilitates data entry at CRF and dcrf the database levels and helps the statistician in data interpretation and analysis. To combat these errors monitors are usually hired by the sponsor to audit the CRF to make sure the CRF contains the correct data.