Managing Informed Consent, Ethics Approval and Documentation

Managing Informed Consent, Ethics Approval and Documentation

Managing the appropriate level of consent is key when dealing with any patient/donor data. Ensuring the correct paperwork is in place (such as ethics approvals) when carrying out projects, studies or clinical trials is often required as part of the laboratories standard operating procedures (SOPs). These are essential elements to ensuring compliance with any regulatory requirements.

 Achiever Medical allows institutions to store documentation in a central repository which can then be accessed via authorised when managing informed consent, ethics approval or auditing.

Consent

Enforces consent as part of standard procedures

Re-consent

Easy re-consent through of various media formats

Data Protection

Permission-based access ensures strict confidentiality

KEY FEATURES

Managing Informed Consent

Achiever has been designed to assist laboratory users in ensuring the appropriate documentation is in place before specific processes can be carried out. In-built business processes prompt users to upload the relevant documentation at key stages with dashboards highlighting any non-compliance.

Detailed information is captured against each document including description, location, version, and when the document was uploaded, with security filters implemented to ensure only those users with the appropriate permissions have access to documents containing sensitive information.

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Audit Management

Every time informed consent information is updated against a patient/donor an audit record is created indicating the change made, the person who carried out the change, the date and time of the change and the informed consent record updated.  This provides users with complete trace-ability of informed consent records.

SEE WHAT OUR CUSTOMERS SAY

“The NUHT biobank team then went through a full HTA audit within three days of go-live and received a glowing HTA assessment.

The quality of the donor, consent, storage and tissue viability data massively increases the value of the tissues to researchers.”