Creating eCRF accessible through the internet. more ..
I create your eCRF from paper or electronic documents. Your eCRF is accessible https://www.easy-crf.com/votre_etude
Access by password.
The system meets the requirements of FDA's 21 CFR Part 11.
Create user profiles with specific rights more ..
The basic profiles are: principal investigator, clinical research assistant, investigator, datamanager, visitor. Other profils can be created. Access rights to resources are customizable (monitoring, downloads, user management, invitations, access to statistics inclusion, ...)
Encryption SSL connection (https) by use of a certificate issued by a competent official. more ..
encryption (or encryption) of the connection is made when viewing the website easy-crf.com
It prevents the understanding of what goes over the network to anyone (evil attentive) intercepting the message.
Encryption of patient data. more ..
data are not written in plain text in the database: it is encrypted (= encrypted). Their decryption requires a secret key.
This encryption is transparent to the user participating in a study: software encrypts and decrypts data on the fly patient during CONSULTATIONS or changes eCRF.
Server hosted by AZ Medicube.
A dedicated server is a computer configured web server where an administrator manages all services offered
Unlike the shared servers (sometimes 5000 websites on a server) traffic is guaranteed, the configuration on sécuritée is adjusted to the service.
Server equipped with intrusion detection systems. more ..
servers (such as easy-crf.com) are regularly login attempts by software automatically so surfing the web. These programs try to return to the target servers using dictionaries of passwords. A burglar alarm system blocks these multiple attempts.
Twice daily data backup on another server. more ..
These backups are kept on easy-crf.com's server but also on a backup server in another location.
Keeping an eye on the dashboard. more ..
Key performance indicators and alerts are gathered in a dashboard.
Keep focus on your goal and react quickly to fix issues.
Tracking user logins. more ..
These connection logs are available online for users with this right of consultation (principal investigator, CRA, TEC, ...). They are also available as a .csv file.
Tracking changes of the content of the form fields (audit trail). more ..
Any change in the value of a field is the subject of a registration statement with the user. Track changes in scope is very easy. These entries / modifications are also available as .csv file.
Management queries. more ..
The queries (queries) are issued by users with this right when checking data. Their purpose is to alert the investigator entered the data with a question they were asked to remove ambiguity about the contents of a field or to improve data quality.
These queries are directed by email to the investigator and are also visible on the site easy-crf.com. The answer provided by the investigator is sent to the issuer of the query. The total trade is archivable and registered as a .csv file
Follow graphics inclusions. more ..
With a simple glance, you can see in real time all the inclusions or by investigator. The graph is can be copied within Powerpoint, Word ...
Management of SAEs. more ..
serious adverse events (SAEs) were reported in the eCRF. They are automatically sent by fax and email (in the form of a customizable pdf) serving proficient.
Each declaration of SAEs is then available online (pdf generated automatically from the contents of eCRF).
Send email invitations to participate in the study. more ..
You manage participating in your study through invitations you send by email (thanks to easy-crf.com). You can also open your study to all the world: when registering, you will receive an email alert: you are free to choose whether or not such registration.
This approach increases the rate of participation in a study: simply provide the web address of your study (in a talk for example) so that investigators freely connect to it
Dates coherence tests. more ..
Not to discover during the statistical analysis that some patients are in remission before the date of diagnosis, dates of consistency rules are implemented.
After creating your eCRF, I propose a chart summarizing how the dates seem to organize themselves against each other in time. Your changes and complete the correct topography of the dates. So when writing or editing a date in the eCRF, a search of inconsistency will be systematically destroyed. Any inconsistency is presented to the investigator and then emailed to officials monitoring.
Alerts inconsistency of dates are reported in the journal entries available online and in the document archive entries.
Test validity of numeric fields. more ..
Numeric fields can be integer or decimal, positive or negative or only positive. Seizures that do not satisfy these constraints are subject to an alert message. The data are not saved until the error is not corrected.
Management numeric conversions of different units. more ..
Blood glucose may be so seized in mmol / l or g / l. Conversion to unit of your choice will be made when exporting data to statistical analysis. I will submit PRIOR to a conversion table for validation.
Visualization of the completeness of each page of eCRF. more ..
A global view of the completeness of the pages of eCRF classified by patient or investigator is available to authorized users.
a single click access to page incomplete.
Creating fields mandatory or optional. more ..
This feature tracks the level of completeness of eCRF.
Creating conditional fields. more ..
The answers to certain questions of eCRF make it appear or disappear other.
Possible use of external data tables (codes of diseases, drugs, ...) more ..
This preserves your own coding. It is also possible to create tables supplied by the user input.
Pdf version of the eCRF for filling out online. more ..
For the rare cases where the Internet is not present on the site collection.
Data can be exported in the form of files for SPSS and SAS. The .csv format is also available. more ..
This export is carried out by users entitled thereto. The easy compatibility with CRF SPSS and SAS can export data typing (numerical, dates, strings), missing values and the values of the index (1 = male, 2 = female, ...).
. csv format is universal, it can be read by Excel (which is limited to 255 columns). It does not keep information on data typing.
Exports may be limited to certain pages of eCRF. Authorized users can export data at any time by logging on easy-crf.com
Coded data can be exported and also encoded uncoded. more ..
Example: Fields YES / NO / DK: 0 export in NO, 1 YES in the 999 in DK.
The encoded data can be exported as many columns they have arrangements. Example: Eye color: blue, green, brown, black, DK. If patients with brown eyes, 5 columns:
0, 0, 1, 0, 0.
The field codes are provided by a downloadable pdf.
The initial cost of a study depends on the complexity of eCRF. more ..
It includes the creation of eCRF, the access to the hotline (7/7 24/24)), distance education (principal investigator, datamanager and CRA) and access service for 1 year.
The cost of renewing the service after the first year is set at 15% of initial cost.