Below is a list of the NBRCIT user documentation. We will expand this list over the next coming months.
1. OpenClinica – Best Practice v1.9: this document provides guidelines for each of the Rare Diseases studies to conform to the NBRCIT standards which will allow the data to be stored in a secure, accessible, extendable and sustainable way. The focus of this document is OpenClinica study setup and it is aimed at Principal Investigators and persons responsible for setting up and configuring a study in OpenClinica.
2. OpenClinica – StudySetupGuide v1.8: this document is a step-by-step guide (screenshot-based) on how to set up your study in a way that conforms to the NBRCIT best practice standard. This document should be read in conjunction with the Best Practice Guide.
3. OpenClinica Import & Export Guide V2.3: this document provides instruction and best practice guidelines’ for the import and export of study data into and out of OpenClinica.
4. DataPlanDesignV1.1: this document provides guidelines for the creation of a NBRCIT approved data plan and describes how to integrate clinical coding into a Case Report Form.
Current Data Plan Template (Excel): DataPlanTemplateV1-1
5.CRF Design Guide v1.0: this document provides guidelines how to design a Case Report Form with some useful hints and tips and it also gives guidance on how to manage Case Report Forms.
6. Data Entry Manual: this manual provides guidelines how to create new subjects and enter data in OpenClinica. It is useful for Data Entry Person.