- 21 CFR Part 11US FDA regulation
- The FDA regulation that sets the criteria under which electronic records and electronic signatures are considered trustworthy, reliable and equivalent to paper records and handwritten signatures. It covers system validation, secure time-stamped audit trails, access controls and signature controls.
- AccuraTrials is built to support Part 11; compliance is demonstrated by the sponsor for its own validated system. Part 11, clause by clause.
- Adaptive designAdaptive clinical trial
- A clinical trial design that allows prospectively planned changes to the trial, such as to sample size, arms, randomization ratios or eligibility, based on data accumulating in the trial, without undermining its validity or integrity.
- An authorized adaptation reaches the study as a reviewed protocol change, never an unrecorded edit. Adaptations in ARPA-H SURPASS.
- ALCOA+Data-integrity principles
- The data-integrity principles regulators expect clinical data to meet: Attributable, Legible, Contemporaneous, Original and Accurate, extended with Complete, Consistent, Enduring and Available.
- Every AI suggestion, approval and edit is attributed and time-stamped in the same audit trail.
- Audit trail
- A secure, computer-generated, time-stamped record of who created, changed or deleted an electronic record, when, and why, kept so the full history of the data can be reconstructed. Under 21 CFR Part 11 it must not obscure previously recorded information.
- Hash-chained and tamper-evident, with automated evaluations logged alongside human edits.
- CDASHClinical Data Acquisition Standards Harmonization
- The CDISC standard for how data is collected on case report forms, designed so that collected data flows cleanly into SDTM for submission.
- Generated forms are built against a CDASH-aligned field library.
- CDISCClinical Data Interchange Standards Consortium
- The standards body behind the data models used from protocol through regulatory submission, including CDASH, SDTM, ADaM and, since its handover from TransCelerate, USDM.
- CTMSClinical trial management system
- Operational software for planning and tracking a study: sites, enrollment, monitoring visits, milestones and payments. It manages the running of the trial rather than the clinical data itself.
- Integrated over REST rather than replaced.
- Digital Data FlowDDF
- A TransCelerate BioPharma initiative to automate study start-up by turning the protocol into structured, machine-readable data that downstream systems can consume directly. It produced the Unified Study Definitions Model (USDM), now stewarded by CDISC.
- AccuraTrials is a full public supporter of DDF.
- eCRFElectronic case report form
- The screen where study data for a subject is entered at a visit, replacing the paper case report form. eCRFs are built from the protocol's schedule of activities and data requirements.
- Drafted from the protocol model, with each field linked to its source.
- EDCElectronic data capture
- The system sites use to enter clinical trial data into eCRFs, with edit checks, queries, source data verification, electronic signatures and an audit trail. It is the system of record for a study's clinical data.
- AccuraTrials EDC is built to 21 CFR Part 11 and in production on a paid clinical study.
- Edit checkValidation rule
- An automated rule in an EDC that tests clinical trial data as it is entered, such as a value outside its allowed range, a missing required field or two dates in the wrong order. A failing check can block the value, warn the site or open a query.
- Drafted from the protocol, proven on the live evaluator and approved by a person. How automated edit checks work.
- ePRO and eCOAElectronic patient-reported and clinical outcome assessments
- Questionnaires and assessments completed on a device by patients, clinicians or observers, captured directly rather than transcribed from paper.
- ePRO arrives through a patient portal into the same validated forms.
- ICH E6(R3)Good Clinical Practice, revision 3
- The third revision of the ICH guideline for Good Clinical Practice, the international standard for designing, conducting, recording and reporting clinical trials. It emphasizes proportionate, risk-based quality management and data that is fit for purpose.
- Protocol deviations are categorized per ICH E6(R3) and graded minor, major or critical.
- ICH M11Structured clinical protocol
- The ICH guideline for a harmonised, structured clinical protocol (CeSHarP): a common template and technical specification so a protocol can be exchanged as structured data rather than only as a document.
- Clause addresses in the study model follow M11.
- IRT and RTSMInteractive response technology; randomization and trial supply management
- The system that randomizes subjects to treatment arms, manages blinding and tracks investigational product supply at sites.
- Built into the platform, with allocation events in the same audit trail.
- Master protocolPlatform, umbrella and basket trials
- One overarching protocol designed to evaluate several interventions, several diseases or both within a single trial structure, as in platform, umbrella and basket trials. Intervention-specific details usually sit in arm-specific appendices.
- The master protocol and each arm appendix compile into one governed study model.
- MedDRAMedical Dictionary for Regulatory Activities
- The ICH standard medical terminology used to code adverse events, medical history and other medical terms so they can be analyzed and reported consistently.
- Terms resolve to MedDRA codes, or remain a labelled gap for a person to resolve.
- OpenStudyBuilder
- An open-source tool and repository for building study definitions as structured data, released by Novo Nordisk and now built jointly with Bayer and Boehringer Ingelheim.
- AccuraTrials builds on it.
- Phaseless trial designSeamless trial design
- A design that integrates the phases of clinical development in one persistent trial, so an intervention moves from first-in-patient safety evaluation to efficacy, and sometimes confirmatory evaluation, without a new protocol, site network or control group at each phase. ARPA-H’s SURPASS program uses phaseless and seamless as synonyms.
- Phaseless trials and ARPA-H SURPASS.
- Protocol amendment
- A formal, approved change to a clinical trial protocol after it has been finalized, for example to eligibility, visits or procedures. Every amendment has to reach each system that implements the protocol.
- Handled as a reviewed change to the running study and deployed the same day.
- Protocol deviation
- Any change, divergence or departure from the study design or procedures defined in the protocol, such as a visit outside its window or a prohibited medication. Important deviations can affect data reliability or subject safety and must be reported.
- Evaluated when a form is submitted and flagged with the clause and the data that tripped it.
- QueryDiscrepancy note
- A request sent to a site to clarify or correct a data point, raised by an edit check, a data manager or a monitor. The site answers or corrects the value, and the exchange is kept in the audit trail.
- A failing check can open a query on the exact field automatically.
- Real-time clinical trialRTCT
- A trial in which protocol compliance, data quality and safety signals are evaluated as the trial happens, at the point of care, rather than reconstructed weeks or months later during monitoring and data cleaning.
- How AccuraTrials supports real-time trials.
- Schedule of activitiesSoA
- The protocol table that lists which procedures and assessments happen at each visit. It drives the visit schedule and the forms a study needs.
- Parsed from the protocol, including scanned tables.
- SDTMStudy Data Tabulation Model
- The CDISC standard for organizing clinical trial data into domains for submission to regulators such as the FDA and Japan's PMDA.
- Submission datasets fall out of the model by construction.
- Source data verificationSDV
- The monitoring activity of comparing data entered in the EDC against the source documents at the site, such as medical records, to confirm it was transcribed accurately.
- An SDV workflow is built into the EDC.
- USDMUnified Study Definitions Model
- A standard, machine-readable model of a clinical study protocol, covering objectives, endpoints, arms, visits and activities. It was produced by TransCelerate's Digital Data Flow initiative and is now stewarded by CDISC.
- The AccuraTrials study model is USDM-native.
- Visit window
- The allowed range of days around a scheduled study visit, such as Day 28 plus or minus 3 days. A visit outside its window is typically a protocol deviation.
- Windows are computed from the protocol schedule and checked before a visit's form opens.
