Glossary

This glossary defines key terms used throughout Carelane and clinical research.

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A

Action A task within a workflow, such as completing a questionnaire or uploading a document. Amendment A formal change to a study’s configuration after it has been activated. Arm A treatment group within a study (e.g., treatment arm, placebo arm). Audit Trail A chronological record of all changes and actions in the system. Authorized Signer A role that permits signing CRFs and other study documents electronically.

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C

CRC (Clinical Research Coordinator) A site role responsible for coordinating study activities and data collection. CRF (Case Report Form) A data collection form used to capture participant information. In Carelane, CRFs are implemented as questionnaires. CI (Chief/Coordinating Investigator) The lead investigator responsible for overall study conduct.

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D

D-CI (Deputy Coordinating Investigator) A role supporting the CI with oversight responsibilities. Data Reviewer A study team role that reviews and verifies submitted data.

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E

EDC (Electronic Data Capture) A computerized system for collecting clinical trial data. Export The process of extracting data from Carelane in a downloadable format.

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F

FHIR (Fast Healthcare Interoperability Resources) An international standard for healthcare data exchange. Carelane uses FHIR R5.

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G

GCP (Good Clinical Practice) International ethical and scientific quality standards for clinical research.

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I

ICH (International Council for Harmonisation) The organization that develops GCP and other pharmaceutical guidelines.

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O

Organization The top-level workspace in Carelane containing studies, templates, and members. Onboarding The process of setting up a site to participate in a study.

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P

Participant A research subject enrolled in a study. Pathway A schedule of activities that defines the participant journey through a study. PHI (Protected Health Information) Individually identifiable health information protected by privacy regulations. PI (Primary/Principal Investigator) The lead investigator at a study site responsible for site conduct. PIN A code used for site self-registration or external access. Pseudonym A study-specific identifier for a participant (e.g., “001-001”).

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Q

Query A question or request for clarification raised on submitted data. Questionnaire A data collection form in Carelane (equivalent to CRF).

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R

Record Status The workflow state of a questionnaire response (e.g., In Progress, Completed, Verified). ResearchSubject The FHIR resource representing a study participant. Role A set of permissions assigned to a user at organization, study, or site level.

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S

SAE (Serious Adverse Event) An adverse event that results in death, hospitalization, or other serious outcomes. Service Provider An external organization providing centralized services (e.g., central laboratory). Site A research location where participants are enrolled and data is collected. SoA (Schedule of Activities) The protocol-defined schedule of visits and assessments. Implemented as pathways in Carelane. Study A clinical research study configured in Carelane.

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T

Template A reusable design for questionnaires, workflows, or pathways.

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V

Verification The process of confirming data accuracy by the study team.

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W

Workflow A sequence of tasks for operational processes like site onboarding.

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Status Codes

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Participant Status

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Record Status

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Site Status