Data Collection Overview
Data Entry
Enter data into questionnaires and forms.
Questionnaires
Structure and behavior of data collection forms.
Workflows
Task sequences for operational processes.
Submission
Submit and finalize collected data.
Data Collection Methods
Questionnaires (CRFs)
Structured forms for capturing participant data:- Demographics
- Medical history
- Assessment results
- Adverse events
- Outcome measures
Workflows
Task sequences for operational processes:- Site onboarding
- Regulatory document collection
- Training completion
Pathways
Scheduled sequences of questionnaires:- Visit-based data collection
- Time-point assessments
- Longitudinal tracking
Data Entry Roles
Different roles have different data entry capabilities:Data Entry Workflow
1
Access Form
Navigate to the participant and select the questionnaire to complete.
2
Enter Data
Fill in fields according to source documents and clinical observations.
3
Save
Save progress at any time. Data is preserved for later completion.
4
Complete
Mark the form as complete when all required fields are filled.
5
Submit
Submit for study team review (status changes to Completed Site).
Field Types
Questionnaires support various field types:Data Validation
Validation occurs during entry:- Required field enforcement
- Range checks (min/max values)
- Format validation
- Conditional logic
Data Quality
After submission, data quality processes include:- Study team review
- Query generation for discrepancies
- Verification and sign-off
Best Practices
Timely Entry
Timely Entry
Enter data as close to collection time as possible for accuracy.
Source Verification
Source Verification
Verify data against source documents before entry.
Complete Save
Complete Save
Use the save feature frequently to prevent data loss.
Follow Instructions
Follow Instructions
Review form instructions and guidelines before entering data.
