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:| Role | Data Entry | Data Submission |
|---|---|---|
| CRC | Yes | Yes |
| Data Entry Specialist | Yes | Limited |
| Sub Investigator | Yes | Yes |
| PI | Yes | Yes |
| Study Team (Data Reviewer) | View only | No |
Data Entry Workflow
Field Types
Questionnaires support various field types:| Type | Description |
|---|---|
| Text | Free text entry |
| Number | Numeric values with optional ranges |
| Date | Date selection with validation |
| Choice | Single or multiple selection from options |
| Boolean | Yes/No responses |
| Attachment | File uploads |
| Calculated | Auto-computed from other fields |
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.