C2 CRF Designer

Case Report Form (CRF)

The CRF is the tool use to collect pre-defined data from a Subject in a clinical trial. A printed, optical document designed to record all of the protocol required information to be reported to the Sponsor on each trial Subject.

The CRF is a very specialized form. This form collects data, but the use of the data varies based on the study protocol defined. Forms are composed of structured questions. Questions are designed based on the study protocol by CRF Designer.

Electronic Case Report Form (e-CRF) means an auditable electronic record designed to record information required by the clinical trial protocol to be reported to the sponsor on each trial subject.

CRF Designer is a utility tool used to create the metadata of the study protocol questionnaires. This metadata are then used by the CompleteClinica system to generate e-CRF. It allows designing essential elements of CRF like Safety and Efficacy modules questionnaires. Generally
A CRF Designer team (includes Project Clinician, Lead CRA, Lead Statistician, Lead Programmer, Lead Data Manager) together can work on the study protocol and design the CRF questionnaires.

Features:

• Easy to Create, Modify, and Maintain metadata of protocol questionnaires.
• Allows Importing and Exporting metadata of CRF questionnaires in C2 e-CRF compatible Excel and XML format. Excel and XML form can be further used as guidance in creating future CRF questionnaires.
• Web based CRF builder for easy access
• Security using Authorization, ACL and Roles