SIG Services
The Surgical & Interventional Group at the Comprehensive Clinical Trials Unit is able to provide a whole spectrum of services for running high quality clinical trials.
Protocol development
- Protocol writing
- Trial objectives and purpose
- Trial design, including primary and secondary endpoints
- Selection of subjects, including inclusion & exclusion criteria
- Subject Information Sheet and Consent Form
Data management
- Data management plan preparation
- CRF creation
- Database design
- Web based remote data entry system
- Integrated data validation checks
- Data query management
- Report preparation
Safety reporting
- Facilitation of safety reporting
- SAE report management
- Annual safety report preparation
Trial management
- MHRA applications
- Site initiation visits
- Management of monitoring, to include source data verification
- Quality control and quality assurance
- Trial master file management
- Drafting and the management of publication policy
- Writing and implementation of confidentiality agreements
- Submission of NRES documentation
- Identification, selection and initiation of investigators and site staff
- Ensuring compliance with protocol
- Ensuring delivery and adequate storage of investigational product(s)
- Ensuring informed consent of trial subjects
- Compilation of progress and final reports
- Making provision of possible premature termination or suspension of a trial
- Ensuring Appropriate quality assurance and quality control
- Supervision of third-parties e.g. Contract Research Organization (CRO)
- Liaison with medical expertise
- Assisting in the notification/submission to regulatory authority(ies)
- Ensuring consistency across centres in multicentre trials
- Running concurrent sub-protocols
- Archiving
Statistical services
- Sample size calculations
- Stopping rules
- Report preparation
- Statistical analysis
- Contribution to primary papers
Education / training
- Trial manager supervision
- Data manager supervision
- Writing guideline, WPDs and SOPs in line with Good Clinical Practice
Finance
- Full Economic Costing
- Contract management
Trial Secretariat
- Formation of Trial Steering Committee, Independent Data Monitoring Committee & the identification of potential members
- Composing terms of reference
- Generating regular reports and updates
- Arranging meetings, taking minutes & ensuring actions are performed
Other
- Generation of publications and presentations
- Collection of pathology material
- Transportation of precious biological material
- Long-term data collection, including flagging with MRIS
- Large mail-shots hard copy or electronic
Expertise and licences are held for the following applications: SAS and MACRO
- SAS is the industry standard statistical software
- MACRO (InferMed) is the software of choice the SITU uses to set up and manage their databases. The system is FDA-compliant, and conforms to internationally recognized Good Clinical Practice. The databases are tailored to the needs of the individual trials and data is collected on bespoke case record forms. The MACRO software is suited to a wide range of clinical trials, across all phases, and scales from a single site to large international trials with the option of secure online data entry.
