Definitions

A Case Report Form or CRF is a questionnaire specifically used in clinical trial research. The CRF is the primary data collection tool from the investigator site. The trial sponsor is responsible for development of a CRF that accurately represents the protocol of the clinical trial, management of CRF production, monitoring of data collection, and auditing of the content. All data, information and results on each patient, participating in a clinical trial, are held and/or documented in the CRF.

With eCRF, or electronic CRF, the traditional paper based collection of Case Report Forms is defined as a set of computer forms. Today these forms are mostly accessible over a secured internet connection using a standard web browser.

eCRF differs from Electronic Data Capture or EDC in that EDC comes as a remote data entry device which does not necessarily need to be connected to a public or private network infrastructure (off-line or near-line data entry systems). The most common appearance of EDC is a laptop with preconfigured software for a single trial of a single sponsor distributed to study sites.

EDC vs eCRF

EDC is the most commonly used solution deployed by pharmaceutical industry. TENALEA services are targeted to Academic trial centers which - in general - cannot afford the distribution of a laptop to each study site for each study. In addition the disadvantages of the one laptop for each study approach are obvious to the study sites: cupboards full of laptops, slow and tedious compared to paper, etc.  As an alternative to the laptop, the EDC application could be installed on local PC's at the study sites, but this introduces an unmanageable computer system validation effort. Therefore, eCRF is considered an affordable yet comprehensive alternative to EDC.

Several TENALEA Randomisation Service users are already using InferMED's MACRO as an EDC tool. This product is a preferred candidate for the provision of EDC services in the TENALEA framework.

TENALEA-ID and eCRF

Taking into account the advantages and opportunities of eCRF to the TENALEA Academic target users, the feasibility of deployment of an eCRF service is being investigated in the framework of TENALEA-ID. Following the service implementation procedure defined for the TENALEA Service Framework, the requirements of eCRF have been compiled, and a product review is being conducted. The selection criteria will be compiled, followed by a proposal within the TENALEA consortium for a vendor selection.