This new version of ShareCRF presents very important improvements which will help our clients during the data validation process of the collected data and the generation of the annotated CRF.
Annotated CRF automatic generation
With a simple click, ShareCRF generates automatically a PDF file including the complete information associated with the forms, automatic rules, set of answers,…etc. This annotated CRF is very helpful during the task of data analysis as it shows the relationship between the exported data and their presentation to the user.
This functionality will only be available for studies with subscription associated Advanced or higher.
We have developed a very important change and improvement in the old module Status control, that from the version 2.8 will be renamed to Approval statuses. The main purpose of this renovated module is to allow complete customisation of the approval status and their behaviour, allowing ShareCRF to adapt even better to the requirements of each trial and organisation.
Some of the more important changes are explained below:
- Name, icon associated and colour of the status customisable, to adapt each status to the needs of the study: Signature, Verification, Data Manager Control, Final approval, or any other one you could need.
- Up to 5 approval statuses.
- There are not restrictions in the statuses between them. It is allow to use multiple status independently, allowing parallel actions of data verification by monitors, data managers and researchers.
- Declaration associated with the digital signature associated with the configurable state. When requesting the signature to the user when setting a status, the statement associated to the status will be displayed in the pop-up window where the user must enter their password, as it behaves as a digital signature.
- Capability of configuring the status to be eliminated automatically when any field changes.
- Split permission associated with activate a status and deactivate a status. In previous versions, there was only 1 permission which allowed you to perform both actions.
NOTE: Current studies will keep behaving practically the same way as they did, since the configuration of the statuses has be adjusted automatically to be similar as they were. The only changes that can happen are:
- It is no longer necessary for the Completion status to be active in order to set the Verified status (SDV), now all the statuses are independent among them.
- The Data Source Verification (SDV) status is renamed to Verified. There is always the possibility to change the name of the status in this new module of Approval statuses.