GoodClinica is a Clinical Data Management System (CDMS) for the entry, structuring and validation of data generated in clinical studies. The webbased application is characterized by easy to use user interfaces. Different user-centered views offer a good status overview on the data to be entered and direct access to data entry forms.

The data entry forms (eCRFs) can be created easily and based on individual requirements and can incorporate checks on entered values. Additionally, existing data (e.g. available in Excel-format) can be imported to GoodClinica via an XML-interface. This interface also facilitates the import of existing electronic data deriving from diverse medical examinations (e.g. bioelectrical impedance analysis or laboratory values)

All data entered, changed or deleted in GoodClinica are recorded in an Audit Trail to fulfill regulatory requirements.

Access via tailored views

GoodClinica allows its users to view existing data for a study tailored to their task-oriented requirements, to get a status overview and to enter, re-enter or change data, where necessary. The views are designed to provide high-performance even with large volumes of data:

Study Matrix
The Study Matrix offers a study-based status overview on all events. The status per event is displayed in graphical manner. The user can get information on e.g. the number of expected participants, the entered data records or invalid data records.

Subject Matrix
The Subject Matrix offers a subject-based status overview displaying the current status (open, finished, invalid) per event for each subject. Starting from this view, the user can enter new data for an event or work on invalid records.

Quick Form Entry
The Quick Entry form is an overview on all data entered on one page of a form over all subjects. This view is suitable for the entry of data in a specific form for different subjects

Subject Tree
The Subject Tree is a subject-centered view that lists all forms belonging to a specific subject. This view is suitable for a quick data entry in multiple forms for one subject.

Creating Studies

GoodClinica supports the manual creation of studies and offers flexible control options. Studies consist of different events of any kind. One or more forms can be assigned to an event. Even attachments of any format can be provided for.

Alternatively, studies can be created via the import of XML-files.

GoodClinica supports the following features:

Remote Data Entry
Realized eCRFs via HTML-forms facilitates Remote Data Entry in GoodClinica. Thus, electronic data entry is possible via the web-browser from every desktop- or tablet-PC.

Operating on Multi User mode
GoodClinica operates on multi user mode that supports multiple users working in parallel on the same system. Competing access to the same data record is intercepted and the user is notified through corresponding message.

Manual Data Entry
In addition to the import of existing data, the system facilitates pure electronic data entry, e.g. at admission of new subjects. For that purpose, paper-based CRFs are created electronically in eCRFs. GoodClinica does this automated through a Form-Generator, creating HTML-forms with respective validation features.

Double Data Entry
Double Data Entry can explicitly be set for eCRFs to maximize the data quality on top of the usage of validation features.

Workflows and Annotations
Within the forms, deviations and notes can be added on field level, in order to clarify an issue on entered values. The messages can be assigned to another user. All messages and their answers are displayed in discussion threads and comply with regulatory requirements.

Audit Trail
All data changes and transformations are documented in the system. In the Audit Trail, GoodClinica records which user has performed which activity and when.

Administrative functions

User Management
GoodClinica offers a flexible role and authorization management

Import
The Import interface facilitates the automatic generation of data in GoodClinica (e.g. studies or CRFs)

Export
All data existing in GoodClinica can be exported. The data to be exported can be filtered by subjects or medical events.