Research Area:
Clinical pharmacology
KeyWord:
case report form (CRF), electronic case report form (ECRF), database, case report form designing, standard template, software
Abstract:
The case report form Case Report form (CRF) is a specialised clinical research document, to gather the research relevant data. A Case Report Form (CRF) should be study protocol oriented & robust in content. Electronic Case Report Form (E-CRF)’s are preferred over Paper Case Report Form (CRF)’s, as they provide, improved data quality, management of online differences and faster locking of databases, etc. Preserving data quality and integrity are the key goals behind Case Report Form (CRF) growth. To meet the needs of all users, such as investigator, site planner, research monitor, data entry workers, and statistician, the Case Report Form (CRF) architecture should be standardised. Data should be structured in a way that promotes data processing and simplifies it. The collection of vast volumes of data results in the collection of wasted resources. Standard guidelines should be followed while designing the Case Report Form (CRF). The site workers should be supplied with the Case Report Form (CRF) completion manual to facilitate correct data entry by them. These steps would result in decreased generation of queries and improve the integrity of data. In the below article we have performed an observational study to find about two major concepts of Electronic Case Report form (E-CRF) designing.