Protocol Development: The sponsor is responsible for developing the trial protocol, including the design, methodology, and objectives.

Regulatory Compliance: Ensuring that the trial complies with all regulatory requirements and obtaining necessary approvals, including obtaining informed consent from patients.

Consent: Ensuring each sample has patient consent, where required, prior to despatch to the biobank.

Funding and Resources: Providing financial support and resources necessary for the trial.

Oversight and Monitoring: Overseeing the trial's progress, including monitoring data collection and ensuring adherence to the protocol.

Sample Collection and Storage: Our main purpose is to provide long-term storage of biological samples, but we can also help support aggregation and processing if required.

Data Management: We will ensure the integrity and confidentiality of the data associated with the samples in our custody.

Quality Control: We will apply defined quality control measures to maintain the reliability of the samples and data.

Compliance with Ethical Standards: All projects are subject to Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations) and Research Ethics Committee Approval. This includes adherence to the institution’s consent from participants for the use of their samples. A review would be part of any material transfer agreement.

We are here to support trials, not run them.
While we are open to discussing the governance framework, our general approach is set out below.

Institution

Oxford BioVault