According to ICH guidelines for GCP, CRF can be defined as 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 development is one of the most crucial steps in Clinical trials as it preserve and maintains quality and integrity of data. 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 biostatistician.
CRFs can be classified into two types i.e. Paper CRF (pCRF) and Electronic CRF (eCRF). Though paper CRFs are still used largely, use of electronic CRFs (eCRFS) are gaining popularity due to the advantages such as improved data quality, online discrepancy management and faster database lock etc. eCRF has minimal chance of errors and it also avoids data redundancy. On the other hand, pCRF designing is time consuming, involve large amount of papers which add to the total expense.
While designing CRF, one should always keep in mind that the CRF must be user friendly, follow the standard operating procedure (SOP). A well referenced CRF should be structured, concise and must be able to capture high quality data. The header and footer of the CRF should reflect information about the study. Data discrepancies should be avoided during CRF designing by making an un-crowded CRF layout. CRF layout has basically three types i.e. time dependent and time non-dependent and cumulative layout. The use of fonts, formats, layouts, queries should be uniform and appropriate. CRF pages should be systematically ordered and should follow specific protocols. Data should be organized in a format that facilitates and simplifies data analysis. CRF completion manual should be provided to the site personnel to promote accurate data entry. These measures will result in reduced query generations and improved data integrity. It is recommended to establish and maintain a library of templates of standard CRF modules as they are time saving and cost-effective.
CRF designing is actually a very challenging task as designing should be consistent and data should be precise. Objectives should be defined clearly before designing. Consistent design is a crucial aspect as it reduces the number of mistakes in data entry. To overcome these challenges, the designing should be well planned by the clinical data management team. For different responses different font styles can be used in a well designed CRF. For multiples answers for a query check box can be used and if single answer is required for a query buttons should be used. For easy statistical analysis, pre-coded responses are used. One should also need to pay attention on date format while designing CRF to avoid misinterpretation. All these points should be kept in mind while designing well structured CRFs which are performed under “best practices”.
WorkSure® involves well trained team for Clinical Data Management including data management personnel, biostatisticians, clinicians and medical writers. CRF designing is performed in a planned manner and as per disease specific SOP. At WorkSure® we believe in designing a concise, well structured and user friendly CRF. WorkSure has capability of developing CRF for all Phases of clinical trials (i.e Phase I to Phase IV), Investigator initiated studies, Hospital/clinic qualitative healthcare studies, Pharmacoeconomic and Health Budget Impact studies.