Governance
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.
