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Study objectives define the research goals of your clinical study. Configure objectives to document what the study aims to achieve and how success will be measured.

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What are Study Objectives?

Objectives describe the specific goals of the research study:
  • Primary Objectives: The main questions the study is designed to answer
  • Secondary Objectives: Additional questions of interest
  • Exploratory Objectives: Hypothesis-generating analyses
Each objective is typically linked to specific endpoints that measure the outcome.

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Creating Objectives

1

Navigate to Objectives

Open Study Design > Objectives.
2

Add Objective

Click “Add Objective” to create a new objective.
3

Enter Details

Configure the objective:
  • Objective type (primary, secondary, exploratory)
  • Description of what the study aims to achieve
  • Associated endpoints
4

Save

Save the objective configuration.

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Objective Configuration

FieldDescription
TypePrimary, secondary, or exploratory
DescriptionClear statement of the research goal
EndpointsMeasurable outcomes that address the objective

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Endpoints

Endpoints are the specific measurements used to evaluate objectives:

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Primary Endpoints

The main outcome measures that determine study success. Examples:
  • Reduction in disease severity score
  • Time to event
  • Response rate

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Secondary Endpoints

Additional outcomes that provide supporting information:
  • Quality of life measures
  • Safety parameters
  • Biomarker changes

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Linking Objectives to Data Collection

Objectives and endpoints inform your data collection strategy:
  1. Identify Required Data: Determine what data points are needed to measure each endpoint
  2. Design Questionnaires: Create CRFs that capture the required information
  3. Schedule Collection: Plan when data should be collected in the participant pathway
Ensure each endpoint has a corresponding data collection point in your study design. Missing data makes endpoints impossible to evaluate.

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Best Practices

Write objectives that are Specific, Measurable, Achievable, Relevant, and Time-bound.
Define endpoints precisely, including measurement methods, timing, and analysis populations.
Focus on one or two primary objectives. Too many primary objectives can compromise statistical power.
Ensure objectives in Carelane match your study protocol exactly for regulatory consistency.

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Displaying Objectives

Objectives can be displayed in:
  • Study Overview: Summary of objectives for study team reference
  • Public Info Hub: Share objectives with potential participants
  • Exports: Include objectives in study documentation exports

Study Arms

Configure treatment arms for the study.

Questionnaire Templates

Design data collection forms.