Medidata + Clinical Trial Context

Edit checks

automated validation used in EDC systems to ensure data accuracy, completeness, consistency

- Range checks - data falls in certain range

- Missing data checks

- Consistency checks - compares related fields to ensure logical alignment

- Logical/cross form checks - validate relationships between variables (ex gender specific) or data sequencing (treatment date after enrollment date)

- Calculation checks - auto calculate/verify derived fields

queries/discrepancy flags

automatic or manual discrepancies noted in data to facilitate data cleaning

Medidata role

- cloud platform for clinical trials

- EDC, RTSM, eCOA, CTMS

Rave EDC

electronic data capture

- function of Medidata

Randomization and trial supply management RTSM

manages patient randomization, drug dosing design, supply chain logistics

- function of Medidata

Electronic clinical outcome assessment eCOA

- software for collecting data about patient's health, symptoms, function

- Patient uploads data themself

- function of Medidata

Clinical trial management system CTMS

software to plan, track, manage operations of clinical trials

- function of Medidata

Clinical trial components

Contract research organization CRO

Sponsor

Site

Patients

Case report form CRF

Contract research organization CRO

external company providing outsourced research, development, clinical trial resources

- clinical trial component

sponsor

designs study protocol, defines data collection guidelines and eCRF, analyzes data

- clinical trial component

site

- maintains physical/electronic study files, ensures trained staff, captures patient data on CRF, responsible for accuracy

- Conducts the study operations

- clinical trial component

patients

provides data

- clinical trial component

Case report form CRF

- structured forms to capture study data

- clinical trial component

Data integrity importance

- collected data is used to determine safety/efficacy of new treatment

- Protects patient safety

- Ensures scientific validity/reproducibility

- Meeting regulatory compliance

- Prevents waste (delays, redoing studies, pulling products)

- Maintaining ethical standards + public trust

Audit trail

- tracks all changes, creations, deletions, interactions with trial data

- Ensures data integrity + regulatory compliance (prevents fabrication)

Food and drug administration FDA

regulates treatment and medicines to protect public health

Good x practice GxP

- collection of quality/regulatory guidelines used in life sciences, medical devices, related industries

- Best practices in various settings (lab, manufacturing, clinical trial)

21 CFR Part 11

- FDA regulation defining criteria under which electronic records are considered trustworthy, reliable, legally equivalent to paper/handwritten records and signatures

Protected health information PHI

individually identifiable health data created/used/disclosed during clinical study

Health insurance portability and accessibility act HIPAA

law to protect sensitive patient health data

General data protection regulation GDPR

EU data privacy and security law