> ## Documentation Index
> Fetch the complete documentation index at: https://docs.carelane.io/llms.txt
> Use this file to discover all available pages before exploring further.

# Glossary

> Definitions of key terms used in Carelane

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

## 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.

## 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.

## 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.

## 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.

## F

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

## G

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

## I

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

## 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.

## 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").

## Q

**Query**
A question or request for clarification raised on submitted data.

**Questionnaire**
A data collection form in Carelane (equivalent to CRF).

## 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.

## 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.

## T

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

## V

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

## W

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

## Status Codes

### Participant Status

| Status         | Description                      |
| -------------- | -------------------------------- |
| **Candidate**  | Potential participant            |
| **Screening**  | Undergoing eligibility screening |
| **Eligible**   | Meets eligibility criteria       |
| **Ineligible** | Does not meet criteria           |
| **On Study**   | Actively participating           |
| **Follow-up**  | In follow-up period              |
| **Off Study**  | Completed participation          |
| **Withdrawn**  | Withdrew from study              |

### Record Status

| Status                    | Description                 |
| ------------------------- | --------------------------- |
| **In Progress**           | Data entry ongoing          |
| **Completed (Site)**      | Submitted by site           |
| **Queries in Progress**   | Has open queries            |
| **Verified (Study Team)** | Reviewed and verified       |
| **Signed (Site)**         | Signed by authorized signer |

### Site Status

| Status            | Description                     |
| ----------------- | ------------------------------- |
| **Pending**       | Awaiting approval               |
| **Active**        | Approved, setting up            |
| **Enrolling**     | Actively enrolling participants |
| **None Enrolled** | Active but no participants      |
| **Deactivated**   | No longer participating         |