Barts CTU Services
Providing Advice, Expertise and Support
The Barts CTU provides the scientific, technical and computing expertise needed to support clinical trial research from conception through to completion, including an open access consultancy service covering all aspects of trial design, management and analysis.
We offer investigators assistance to build on their ideas or pilot studies and provide support and advice from an expert multi-disciplinary team on the best clinical trial methodology.
Our expertise includes:
- Biospecimen management
- Ethics and regulatory applications
- Establishing collaborative networks of investigators
- Pharmacovigilance and monitoring
- Protocol development and case report form design
- Public and participants involvement (PPI)
- Randomisation procedures
- Research costings and funding applications
- Research governance and quality assurance
- Statistical analysis and reporting
- Strategies for patient recruitment
- Systematic literature review and meta-analysis
- Trial design and conduct
- Web-based data and project management
Web-Based Data Management
The Barts CTU uses web-based systems for clinical data management. Our systems are developed using a standardised form templating tool and code libraries. Within this framework, we have greate flexibility to integrate and deliver additional features to meet our user's requirements. Our systems are thoroughly tested before release to ensure they are fit for purpose.
Systems developed by Barts CTU can offer the following features:
- Online screening and randomisation
- Secure patient data management
- Online clinical data collection and management
- Online tools for managing study centre and staff information
- Realtime reporting, for example current recruitment
- Safety reporting
- Full audit trails
- Automated alerts, either by email or text message
- Online participant entered data
We take data security seriously. All of our web-based systems are access via a secure HTTPS connection and users must proived a provided valid username and strong password. Once a user is signed in they are only allowed to view the participant and clinical information relevant to them.
All patient identifiable data is encrypted. The databases are regularly backed up to ensure data are safeguarded from accidental loss.
Our systems are developed using Java and Oracle technologies.
It is essential for the Barts CTU to be able to gauge public opinion regarding both the information being provided to participants of clinical trials, and also on the principles and priorities that have inspired the proposed studies.
The Queen Mary Trials Advisory Group (QMTAG) can assist the unit by:
- Providing feedback on trial design / research proposals.
- Reading and critiquing the patient documentation e.g. Patient Information Sheet, Consent Forms.
- Evaluating consent procedures.
- Representing the wider patient community by participating in meetings and discussion groups.
- Advising on how specific communities should be approached, and the need for trial-specific consumer groups.
Barts CTU ensures that all issues relating to patient safety adhere to the strict legal requirements in this area by carrying out the following activities:
- advising on how adverse events should be detailed in the protocol
- designing CRFs to capture all the relevant information on adverse events
- providing centres with written procedures on how to record and report adverse events
- monitoring clinical sites to check that safety is being properly reported
- organising a Data Monitoring Committee to regularly assess safety
- alerting principal investigators to important safety issues which may occur during the trial
- managing all aspects of safety reporting to the relevant authorities
The Barts CTU has a wealth of experience co-ordinating the entire specimen life cycle from clinical kit production, clinical site supply, specimen return, processing and sample storage.
Assistance and advice can be given during protocol development stages to ensure that laboratory tests are appropriate for endpoints. The Barts CTU can also co-ordinate with NHS and external laboratories as necessary.
Clinical Kit Supply
Clinical kits can be constructed so that all necessary supplies can be included in one bag. Kits can also be visit specific making specimen collection streamlined, easy and efficient for sites. We have engaged with several suppliers to ensure the best value possible. Costings andadvice can also be provided to aide study setup.
The unit can provide logistics support to enable clinical sites to obtain kits and return specimens as necessary. We have engaged a wide variety of suppliers to allow the timely shipment of samples at the appropriate temperature using compliant packaging. The unit has imported and exported samples to US, EU and Australia/New Zealand with several different logistics partners to ensure best value at every stage.
Samples can be processed in external laboratories or internally as required. The laboratory currently is able to receive BSL-2 samples.
We have a QIA Symphony medium throughput DNA extraction platform as well as two QIA Cubes for lower throughput sample volumes. Additionally, the QIA Agility robot is used for aliquotting and assay setup. We are also able to use the onsite genome centre as well as histopathology core facilities.
The department is also able to scan slides using the Ariolscanner, images can be reviewed remotely and securely.
Sample Storage and Tracking
The department utilises a sample tracking and inventorying system to manage specimen holdings in many controlled environments. Storage facilities include -80°C freezer store as well all as ambient pathology storage. The Barts CTU has implemented the use of 2D coded tubes, racks and labelling allowing for tracking specimens to the aliquot level.
The Barts CTU is licensed by the Human Tissue Authority (link to Barts Health http://www.bartshealth.nhs.uk/research/facilities/human-tissue-resource-centre/) for research and tissue storage. Additionally the specimen team are trained to comply with IATA Dangerous Goods Regulation when sending Class B and Exempt samples by air including the selection of compliant packaging.
The Barts CTU carries out regular monitoring, both at the clinical sites and centrally on the database, to ensure that trials are being conducted according to the protocol and applicable regulatory requirements.
A monitoring plan is created before a trial starts and is tailored to the particular trial and, if necessary, the particular centre. The Barts CTU creates the monitoring plan after carrying out a risk assessment for the trial, which considers risks at all levels - from the rights and safety of patients, to the reliability of the data and results.
Those areas that are at highest risk are monitored with greatest intensity. The process is continually assessed throughout the trial, and monitoring is adjusted accordingly.