Crf Design Embraces Several Different Disciplines

By Author: LydiaDaisy
Total Articles: 13
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As per ICH GCP guidelines, the Case Report Form is a printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.

CRF design is an initial step in translating the protocol into Standard questionnaires using CDISC standards.

One of the components of well-designed CRFs is an informative header and footer. Typical headers and footers contain information such as Sponsor ID, Protocol number, Subject ID, Subject initials, date of printing, and page number, all of which uniquely identify a CRF page. Although these fields are sufficient in managing data, additional information such as protocol label, visit ID and label, form ID, CRF version and date printed, as well as sequence number make database design easier and a better link to the study database. The protocol and visit labels are informative features that provide brief descriptions of the study and the schedule of assessments. The form ID is used to identify how the CRF page ...
... is linked to the database. The visit ID identifies how observations are archived in the database, and also acts as a unique identifier of time dependent data when it is compiled into a dataset as per schedule of assessments. The CRF version number is a critical field that not only prevents using an incorrect CRF page but also confirms that there is no change made to the page. If a different version number is used, it warns users about possible changes within the page and the database should be redesigned to accommodate the change. All pages of the CRF booklet should be numbered in sequential order. This helps in identifying queries from data validation and manual review. It is essential to organize CRF pages in a structural order, reflecting the schedule of assessments specified in the protocol. A table of contents acts as a reference for the sequential order of CRFs. Not only does it provide site personnel with a quick reference to specific pages (for recording the study data) but it also helps define the database in a structural manner.

At Makrocare we have skilled and dedicated team for designing the CRF which includes multi disciplinary team efforts or can use client corporate standards for all the therapeutic areas.CRF design can be the beginning of electronic data capture and database design as well.

Makrocare preserves a strong cross-functional relationship between the CRF design team, Clinical, Medical, Data Management, Clinical Programming and Biostatistics. This established relationship ensures database design, while ease of data entry and statistical output are equally considered during the creation of each CRF.

For traditional paper CRFs, we can liase with printers, organize proof copies for your approval and ensure that the right numbers of CRFs are ship to the right centres, on time.

We use electronic tools such as mEDC and other CDMS which includes the design, development, integration, and implementation of many leading technologies in over hundreds of global clinical trials. By combining both our clinical and technical expertise we are capable of providing customers with superior technical and logistical solutions which are tailored to meet each study's specifications.

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At Makrocare, the standard CRF modules in compliance with the CDISC SDTM and the validation rules incorporated in developing the paper and eCRF will generate an informative and structured CRF which simplifies database design and data validation processes as well as during statistical analysis.