Clinical full features

Study management

Create, manage, track, archive a study
User right management by study
Freeze/unfreeze study data

CRF creation and data entry

Paper and Electronic study reports management
Easy clinical data entry
Patients Overview
Create, lock, sign, exchange CRF template
Study documentation

Randomization / IWRS

Configurable randomization
Insert, delete and activate a randomization
Minimization method available
Standardization of randomization configuration
Define rules to trigger the randomization

Unit management

Import Investigational drugs
Allocate Investigational drugs to an investigator
Change the unit allocation
Trigger a randomization from an online study
Unblind a treatment

Validation rules and edit checks

Test on Compulsory Data: Data Not Entered, uniqueness, format
Test on numbers: “Interval” test
Test on date: format, day of the week, comparison, date allowed
Test on Time: wash out, format, duration, comparison,  time allowed
“Time slot” test
“Time allowed between two times and two dates” test
“Comparison between two integers or decimals” test
“Comparison between an integer or a decimal and a constant” test
“Variation” test
“Comparison between two character fields” test
“Comparison with a System variable” test
“Semi-Automatic” test
“Boolean” test
“Attachment” test

Query management

Create, add and manage queries
Customize queries to the investigator
Create automatic, semi-automatic, and manual queries
Create a query using entry comment
Define a result as a deviation from protocol
Send a query form by email, by eCRF, by mail

Data Coding

Coding dictionary management
MEDDRA, WHODRUG (format B & C), VEDDRA, ATCVET, custom dictionaries
Verbatim translation, automatic and manual coding
Association of codes with a verbatim
Management of synonym dictionary 
CRF data modification

Data Export

Table creation wizard
Add a table
Configure variables and occurrences
Define export conditions
Export in all formats for statisticians: SAS, SPSS, ASCII, EXCEL, ORACLE, HTML, XML
Annotated CRF automation including values from library and external tables
Archive a study in ODM format

Query tool

View of the Oracle tables generated
Assign access to the tables and views in Ennov Clinical Online
Import Oracle Tables via ODBC String

Data Import

Create a new import configuration
Formats: xls, xlsx, txt, csv
Import scheduling
File control

Monitoring

Import/Export of a study template
Customization of the forms
Creation of calculated fields
Definition of libraries of authorized values
Configuration of the patient’s visits
Configuration of the tables
Customization by country, region, participant, investigator, patient, visit monitoring, deviation, adverse event
Tables for: general study monitoring, patients’monitoring, on-site documentation, visit monitoring, cumulative contacts, contacts, investigators’expenses
Configuration of the dynamic change of the patient’s status during data entry
Management of investigational drugs and trial materials
Import of Ennov Clinical data into the monitoring module
Import of a list of forms (Regions, Participants, Investigators)
Files attachment
Signature of the visits monitoring
Automatic generation of the monitoring visits report

Design

Quick and easy eCRF design, based on paper version
All field formats available: Text, Number (Integer, Decimal), Date, Time, etc
Computed fields, Interval calculation
Configurable library for authorized values
Define groups of fields
Dynamic activation of fields, defined optional pages
Structure of the study: sections, pages
Conversion Management

Administration

Create and manage users
Automatic notification for user connection credential
User profile and account information management
Investigator userbooks, Import Investigator file
User right management by study