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FAQ

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General

What is the Datacapt platform?

Datacapt is an EDC platform for study management and data collection in the field of clinical research.

Several modules are available to digitize all the processes of a study: eConsent (Consent), eCRF (Case Report Form), ePRO (voluntary questionnaires), eConsult (teleconsultation)

What are the advantages of an EDC platform like Datacapt?

  • Time-saving
  • Optimal data security
  • Better data quality
  • 100% traceability
  • Reduced use of paper and excel spreadsheets
  • 24/7 accessibility of data and studies

Solutions

What is eConsent?

The eConsent is the digital version of your free and informed paper consent.

The module offered by Datacapt allows you to build an interactive consent with text, images, and videos.

Datacapt allows you to send this electronic consent for an electronic signature on a phone, tablet, or computer.

Electronic consent does not replace paper consent 100%. For more information, please contact our team: link

What is ePRO?

ePRO is the digital version of your participant questionnaires.

With the ePRO module, you can build all your questionnaires in record time. Eliminate paper and collect real-life data at any time.

You also have the possibility to create daily logs with the ePRO module.

The ePRO dashboard allows you to monitor the progress of your questionnaires in real-time. Create automatic reminders, collect photos, and much more…

What is the eCRF?

The eCRF is the electronic version of your observation books. This module allows you to create all your studies and forms in a few clicks. Create, collect, control, share and secure all your data on a single platform.

What is eConsult?

The eConsult allows you to contact your subjects in teleconsultation and at any time directly on their phone, tablet, or computer.

This module is linked to the eCRF, eConsent, and ePRO allowing you to collect data on the platform.

Data security and protection

How data protection and privacy are implemented?

Datacapt is a SaaS (cloud) solution hosted on French, German, and Irish servers. All servers are ISO 27001 and HDS certified. Datacapt is GDPR compliant and guarantees the availability and protection of your data.

Datacapt is regularly audited and penetration tested by an external partner company. All data is encrypted and replicated in real-time in several zones.

Where are the data hosted?

The data is hosted on AWS in 3 availability zones. Backups are hosted in Germany or Ireland.

Our HDS servers are managed by COREYE HEALTHCARE (Pictime Group), certified ISO 27001, and HDS (6 layers).

Does Datacapt support two-factor authentication?

Each user can activate two-factor authentication (2FA) if they wish. To do so, they need to download an application such as Google Authenticator, Authy, etc.

Does Datacapt offer SSO?

Datacapt offers SSO using the SAML 2.0 protocol. This means that you can log in with your company’s credentials. The management of passwords is therefore entirely managed via SSO.

Product

When building the eCRF, can we use a previous model or study built in your system?

Yes, you can re-use an eCRF or part of an eCRF in a new study with a few clicks using templates.

The template function allows you to save complete forms, but also sections or sub-sections of your forms. This can be a visit or a sub-visit for example.

This function is particularly useful when you have to create the same visits several times. It saves you time in building your forms.

Does the system support multiple languages?

Yes, the platform is in more than 10 languages regarding the user interface. You can also build all your forms in more than 85 languages.

Does the system support randomization?

Randomization is available on Datacapt. We propose variable randomization by block generated directly by the platform. You can also add one or more stratifications (by the center, by gender, by specific questions…).

Our randomization algorithm is validated and regularly tested during new updates.

Does the system allow for the management of requests by study monitors?

Yes, query management is available on Datacapt. You can add manual queries, each query can have up to 50 responses. Datacapt also allows you to generate automatic queries that can be configured in the eCRF builder.

Queries have 3 statuses: open, resolved, and closed.

An interactive dashboard allows you to follow all the queries in real-time.

Can I upload large images or video files?

In both eCRF and ePRO, users have the possibility to add large files. By default, a limit of 10MB per file is applied, but we can increase this limit according to your needs. Adding images or videos is a type of question available when creating your forms.

It is also possible to view uploaded files in Datacapt.

How to send questionnaires and electronic consent?

Your electronic questionnaires and consents are sent by email or text.

Does the system allow for automatic reporting?

Yes, you have access to automatic real-time dashboards and reports.

Study monitoring: Number of patients included, study and visit progress, signatures, exclusions…

Queries: Number of queries, the status of queries…

Data Review: Data control and review.

In which formats can I export my data?

You can export all your data in Excel (XLSX), PDF, and CSV formats.

For XLSX and CSV formats, you can export in labels (e.g. Female; Male) or in numbers (e.g. 1;2) according to your needs.

Can I set different accesses for different users?

Yes, Datacapt allows great flexibility regarding data access and rights. You can create new roles at any time. Datacapt offers 6 predefined roles: Admin, Project Manager, Auditor, Monitor, Investigator, and Main Investigator.

The Sponsor is not allowed to see the patient's identifying data, how Datacapt make sure of that?

The Datacapt platform allows you to define roles and access authorizations very easily.

Each role has specific access to different functionalities and data.

The person in charge of the platform can prohibit access so that the sponsor cannot access data that identifies patients. To do this, you only need to define a profile with the necessary rights.

Am I limited in the number of users?

No, there is no limit to the number of users in your environment.

Do you have APIs?

Datacapt has an application programming interface (API) that supports authentication and authorization of API calls through the OAuth2 standard.

Validation and compliance

Is Datacapt a validated system?

Yes, Datacapt is a validated and audited system. A quality assurance team is in place and we perform a large number of tests according to defined and specific development and testing procedures.

Is Datacapt, 21 CFR Part 11 compliant?

Yes, the Datacapt platform is FDA 21 CFR Part 11 compliant.

Will my study comply with GCP (Good Clinical Practice) guidelines if I use Datacapt?

Yes, Datacapt ensures compliance with the GCP guidelines by being ICH GCP compliant.

Who owns the data and forms?

You are the owner of your data and the forms created on the Datacapt platform.

The Datacapt teams have no access to your data or your forms.

What IT skills are needed to use Datacapt?

The Datacapt platform does not require any coding or specific skills.

Is it possible to organize a workshop or demonstration of the system?

Yes, you can contact us at any time for a demonstration of our platform. To do so, simply contact us on this page: link

Can you build my study and forms?

Yes, our team can set up and build your study and forms. All you have to do is send us your annotated CRF in Word, Excel, or PDF format.

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