Basics of case report form designing in clinical research

Abstract

Case report form (CRF) is a specialized document in clinical research. It should be study protocol driven, robust in content and have material to collect the study specific data. Though paper CRFs are still used largely, use of electronic CRFs (eCRFS) are gaining popularity due to the advantages they offer such as improved data quality, online discrepancy management and faster database lock etc. Main objectives behind CRF development are preserving and maintaining 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 statistician. Data should be organized in a format that facilitates and simplifies data analysis. 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. Apart from that, standard guidelines should be followed while designing the CRF. CRF completion manual should be provided to the site personnel to promote accurate data entry by them. 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. This article is an attempt to describe the methods of CRF designing in clinical research and discusses the challenges encountered in this process.

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“…For this purpose, prognostic models must predict risks for patients in the absence of a certain treatment—which can prove challenging in non-RCT data, because of the non-random use of treatments by patients,28 and because advanced statistical methods might be needed to correctly account for this 2930. In the case of RCT data, the effect of treatment use can be solved by simply developing or validating the prognostic model in the control trial arm (control treatment, untreated, or placebo treated) or by including the randomised treatment as a predictor in the model, along with terms for any other treatment-predictor interactions (model development only) 24. However, the placebo arm of a placebo controlled trial might not represent truly untreated patients in usual practice (as discussed later), whereas the control arm of a randomised pragmatic or comparative effectiveness trial better reflects daily practice.…”