CSA— Computer Software Assurance
ProcessFDA-promoted, risk-based successor to CSV. Focuses validation effort on patient safety and data integrity rather than exhaustive documentation. The validation route shows CSA-style evidence.
Glossary
64 terms across 6 categories. Every acronym and concept used across the platform — ALCOA+, Part 11, autonomy classes, GAMP 5, CDISC, RAG, and more.
CSR— Clinical Study Report
ProcessThe ICH E3 final report of a clinical trial: design, conduct, results, discussion. Authored by medical writing; backed by the SAP, ADaM datasets, and TLFs.
CSV— Computer System Validation
ProcessTraditional GxP system validation: requirements, design, OQ/PQ testing, traceability. Largely being superseded by CSA for GxP software.
GAMP 5— Good Automated Manufacturing Practice, version 5
ProcessISPE risk-based framework for validating computerized systems in regulated industries. GAMP 5 (2nd ed.) embraces critical thinking and CSA over checklist-driven CSV.
IIT— Investigator-Initiated Trial
ProcessA study sponsored by the investigator rather than a pharmaceutical company. Often phase 1 or 2 academic studies; same GCP and Part 11 rules apply.
Phase 1— Phase 1 clinical trial
ProcessFirst-in-human studies focused on safety, dose, and pharmacokinetics. Small cohorts, often healthy volunteers (except in oncology).
Phase 2— Phase 2 clinical trial
ProcessEstablishes preliminary efficacy and refines dose in the target patient population. Typically a few hundred subjects.
Phase 3— Phase 3 clinical trial
ProcessPivotal efficacy and safety trial supporting marketing authorization. Hundreds to thousands of subjects, often global and multi-site.
Phase 4— Phase 4 clinical trial
ProcessPost-marketing studies conducted after approval to monitor long-term safety, real-world effectiveness, or new indications.
RBQM— Risk-Based Quality Management
ProcessICH E6(R2/R3) framework that focuses monitoring and oversight on the highest-risk processes and data. Drives the risk register surfaced on the risks route.
SAP— Statistical Analysis Plan
ProcessPre-specified document describing every analysis to be performed in a study. Locked before database lock so analyses cannot be cherry-picked.
SDV— Source Data Verification
ProcessComparing EDC entries against source documents at the site. RBQM has shifted this from 100% SDV to risk-targeted SDV.
SOP— Standard Operating Procedure
ProcessControlled document describing how a regulated activity must be performed. Every agent on this platform maps to one or more SOPs that govern its scope.
TLF— Tables, Listings, and Figures
ProcessThe statistical outputs produced from ADaM datasets according to the SAP. The raw material from which medical writing assembles the CSR.