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FAQ

FAQs

Frequently Asked Questions

CRFweb FAQs

GENERAL

Is CRFweb proven in the marketplace?

CRfweb’s first study went live in 2015, we have repeat clients across Europe and India.

What type of organisations is CRFweb suitable for?

CRFweb is used by organisations , including CROs, performing clinical trials in the pharmaceutical, medical device and food industries. We also work with a number of Universities.

Can we demo the system?

Of course, we offer demonstrations by skype/webex and they typically take around 45 minutes.

SECURITY, COMPLIANCE, AUDITING

Do we capture an audit trail? 

Yes for both Design and Data entry, also ODM gives us both snapshot and transactional data.

Is CRFweb built to GCP standards?

Yes

Is CRFweb GDPR compliant?

Yes. Subject data is anonymised through use of subject ID numbers. Critically, we are also able to match server locations to local markets to meet local compliance requirements.

Are we able to audit your system?

We are always willing to help should you require your own audit of CRFweb and have comprehensive policy documents we can provide.

How do we validate the eCRF before going live with the study?

Ultimately it is the client’s responsibility to confirm that the study meets requirements but we do everything we can to assist the process. You can review the eCRF as a PDF, an annotated PDF to show edit checks and formulas,  and we also offer a separate validation report where the system checks for errors and allows you to input sample data to check results.

Has CRFweb been independently audited for compliance purposes?

Yes. For further details visit our security and compliance page on our website. The full audit is available on request.

IS CRFweb FDA compliant?

Yes. CRFweb is FDA compliant. It is a purpose built application designed to meet security and compliance guidelines and has been independent audited. For further details see HERE.

Note: The FDA does not issue certificates. Compliance is a self certification process and the best way to demonstrate this is via an independent audit.

FEATURES & TECHNICAL

Can data in graphs be drilled down?  

The Graphs for Logs can be drilled down to subjects and the number of entries for that log.

Can questions be filtered to have a report output.

Yes the Search Report facility allows users to filter data to get the output in excel and graphs.

Can a Sponsor have a read only access.

Yes. The system allows for multiple roles to be set up and to have flexible access rights and responsibilities within those roles. Read only access for sponsors is one of many.

What Notifications does the application support?

Notifications (email alerts) can be sent:
when saving sections and Logs, eg AE notification
when a subject is enrolled and any document is attached.
when queries are raised.
when a visit is Submitted for review, submitted for sign off and sign off.

Can queries be raised?

Yes queries can be raised and assigned to the users in the hierarchy. Notifications can be sent to users for queries assigned.

What software is used for the application, both user interface and backend?

The User Interface uses .net and the backend is  an SQL database.

Do you offer randomization?

Currently, this is a manual process but an integral randomization module is in development and will be available shortly.

What reporting is available?

We offer a comprehensive suite of standard reports and bespoke reports can be created at clients’ requests. We offer XML ODM Transactional and Snapshot outputs. Alternatively, data can be translated to a SAS Export file or simply outputted directly to an excel spreadsheet. For further information see the Managing and Reporting section on the system Overview section of the website.

Can I upload files and logs to a study?

Yes. Logs are integral to the EDC functionality and we also offer eTMF functionality to upload relevant documents to the study. Follow the links for further details.

Do you have an app?

Yes. The CRFweb app is available on IOS and Android and is the ideal way to access ePRO and eDiary functionality.

Can subjects complete an eDiary with reminders?

Yes. We offer an eDiary module. As with everything on CRFweb it is integrated, not standalone, patients can complete eDiary entries on their mobile device and be sent reminders. For further details see the eDiary

Can we do double data entry?

Yes. We have a double data entry facility, that compares 2 entries for the same subject and allows the data manager to review whilst maintaining the audit trail.

Do you offer medical dictionary coding?

Yes. The system offers MedDRA coding, the leading dictionary coding system. For further details, please see the MedDRA

What customer support do you offer?

The system has comprehensive help files. Our customer support lines are open during standard European working hours. Any queries will get a response, from a human being within 24 hours, usually much quicker. We pride ourselves on the level and attentiveness of our customer service, as numerous of our customers have testified to.

What languages can we run studies in?

Default language is English. Studies can be translated into the language/dialect of your choice.

Can we input and access the data from multiple sites?

Yes. The system facilitates studies across multiple sites.

Can we capture data from subjects directly?

Yes. We have an integrated ePRO (electronic patient reported outcome) facility.  Subject data can be collected securely online or offline via tablet/pc as required.