Table 2 Training topics and modules
From: Good Statistical Practice—development of tailored Good Clinical Practice training for statisticians
Areas of direct relevance to statisticians |
□ Requirement for a statistical analysis plan (SAP) and recommendations around timing of sign-off (Module 5) |
□ Documentation of protocol non-compliances and exclusions from per-protocol populations (Module 5) |
□ Processes and documentation to be in place for formal interim analyses (Module 4) |
□ Recommendations for blinding and interim data access, e.g. for data monitoring committee reports (Module 5) |
□ Security of datasets and analysis files (Module 5) |
□ Recommendations for statistical programming practices, including controls over hard-coding (Module 5) |
□ Version control of statistical reporting and output (Module 5) |
□ Requirement for an audit trail to link output used in a report or publication back to programming output (Module 5) |
□ Validation of statistical programming and quality control checks of the statistical analysis process (Module 5) |
□ Computer system validation (Module 5) |
□ Specification, production and control of the randomisation schedule/code (Module 3) |
Areas usually requiring statistical input/involvement |
□ Statistical input into trial design and protocol development, including sample size validation (Module 3) |
□ Maintenance of blinding and procedures for unblinding for analysis (Module 3) |
□ Development and review of case report forms (CRFs) (Module 4) |
□ Review of database specification and data validation plan (Module 4) |
□ Central/statistical monitoring (Module 4) |
□ SAE reconciliation (Module 4) |
□ Use and validation of non-CRF data (e.g. central laboratory data) (Module 4) |
□ Coding free text fields (Module 4) |
□ Data lock and processes for obtaining the data for analysis (Module 4) |
General GCP principles which extend to statistical processes |
□ Quality systems, written procedures, etc. (Module 2) |
□ Training documentation (Module 2) |
□ Trial master files and archiving (Module 2) |
Core GCP material |
□ Introduction to GCP (Module 1) |
□ UK regulations, frameworks and guidance and ICH GCP (Module 1) |
□ Principles of GCP (Module 1) |
□ Roles and responsibilities (Module 1) |
□ Informed consent (Module 1) |
□ Safety reporting definitions (Module 1) |
□ Serious breaches (Module 1) |