Overview

The Manage CRFs (Forms) section is your central hub for managing all Case Report Forms (CRFs) in your clinical study. CRFs are the data entry forms completed for each subject at each event/visit.

The system provides two integrated views to help you manage CRFs efficiently:

• CRFs in Study: Manage CRFs currently active and assigned to your study
• Available CRFs: Library containing all CRFs in the system for reuse or creation

Who should use this guide:

• Study Administrators setting up forms for the study
• Clinical Data Managers structuring and standardizing data collection
• Form Builders designing form interfaces and logic

What you'll learn:

• How to view and manage CRF versions in your study
• How to reuse CRFs from other studies
• How to create new CRFs from Form Builder
• Best practices for naming and managing CRF lifecycle

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📋 CRFs in Study

This view displays all CRFs currently active and assigned to your study. This is where you control form status and edit content.

Area	What it is for	When to use
CRFs Table	View list, status, and versions of CRFs	When you need to review forms in your study
Row Actions	Preview or Edit CRF	When you need to review interface or fix logic issues
Versioning	Manage CRF update versions	When protocol changes or data fields need to be added

CRFs Table

This table provides an overview of all CRFs in your study:

Column	Required	Description	Example
Name	✓	Display name of the CRF	Demographics, Vital Signs
Latest Version	✓	Currently active version identifier	V.1.0, VI_1.0.1
Status	✓	Current status	Available (Ready), Draft, Locked
Created On	✓	Date and time CRF was created	19/01/2026 10:36
Created By	✓	User who created the CRF	James David 1 (root)
Last Updated On	✓	Date and time of last update	12/03/2026 15:14
Description		Description of CRF purpose	Collects demographic information and medical history

Row Actions

Action	Description	When to use
Preview	Opens CRF interface in read-only mode	Review interface, question order, and display logic before assigning to event
Edit	Opens CRF in Form Builder for editing	Add/remove data fields, modify calculation rules, update labels

CRF Versioning

The system supports version control for CRFs:

• When you edit and publish an Available CRF, the system automatically creates a new version
• The Latest Version column displays the most recent version
• ⚠️ Important Note: Previous versions are retained for reference. If subjects were enrolled under an older version, their data will not be affected by the new version

Assigning CRFs to Events

CRFs only become functional when assigned to an Event (e.g., Screening, Baseline, Week 4)

• ⚠️ Mandatory Requirement: CRF must have Available status before it can be assigned to an Event
• How to do it: Navigate to the Manage Events page to assign CRFs to corresponding visits

💡 Pro Tip: Name CRFs to reflect their clinical purpose (e.g., "Vital Signs", "Adverse Events", "ECG Assessment") rather than generic names like "Form 1", "Form 2". This makes the Subject Matrix much easier to navigate.

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🗂️ Available CRFs Library

This view displays the entire CRF library in the system database. This is your resource library to save time by reusing standardized forms.

Area	What it is for	Impact
Available CRFs Table	View all CRFs in the system	Helps find and reuse CRFs from other studies
Add Existing CRF	Add existing CRF to current study	Saves time redesigning from scratch
Create New CRF	Navigate to Form Builder to create new CRF	Design custom forms specific to your study

Available CRFs Table

This table includes an additional Study column compared to the "CRFs in Study" table:

Column	Description
Study	Name of the original study that created or uses this CRF
Actions	Add or Assign button to include CRF in current study

Adding an Existing CRF

Instead of creating from scratch, you can "borrow" CRFs from other studies (e.g., reuse the "Demographics" form from a previous study):

1. Navigate to Available CRFs tab
   • From the left menu, select Available CRFs
2. Search for desired CRF
   • Use the search bar or scroll through the list
   • Check the Status column to ensure CRF is Available
3. Add to Study
   • Click the Add (or Assign) button in the Actions column
   • Confirm the action. The CRF will immediately appear in the CRFs in Study tab
4. Assign to Event
   • Return to the Manage Events page to assign the newly added CRF to appropriate visits

Creating a New CRF

If no suitable CRF exists in the library, you can create one from scratch:

1. Navigate to Form Builder
   • Click the Go to Form Builder button/link
2. Create New CRF
   • Select Create New CRF
   • Name and describe the CRF
3. Design Interface (Drag-and-Drop)
   • Drag components from the toolbar into the form:
     • 📝 Text inputs: Text, numbers
     • 📅 Date/time pickers: Date and time selection
     • 📋 Dropdowns / Radio / Checkbox: Response options
     • 🧮 Calculated fields: Auto-calculated fields (BMI, Age, etc.)
     • ✍️ Signature fields: Electronic signatures
     • 📎 File upload: Images, documents
4. Configure Logic & Validation
   • Set required field rules, display conditions (Skip logic), and error warnings (Range checks)
5. Save and Publish
   • Click Save and change status to Available
6. Return to Manage CRFs
   • The new CRF will appear in the Available CRFs list and is ready to be assigned to your study

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✅ Best Practices

To ensure data collected is accurate, consistent, and easy to maintain, follow these principles:

1. Naming Convention

Do's	Don'ts
✅ Use descriptive names reflecting purpose: Vital Signs, Medical History	❌ Use generic names: Form 1, Test CRF, Untitled
✅ Add prefix if needed: AE - Adverse Events, LAB - Lab Results	❌ Use special characters in ID: CRF#1, Form@2
✅ Use clear, concise names that are easy to understand	❌ Use overly long names that get truncated in displays

2. Versioning

• Always document the reason for updates in the CRF Description when creating a new version (e.g., "V1.2 - Added 'Discharge Date' field per Monitor request")
• Avoid deleting fields that already contain data. Hide them instead of deleting them
• Keep a version history log for audit trail purposes

3. Reusability

• Design CRFs in a modular fashion. For example: Separate "Demographics" form from "Medical History" form so they can be reused across multiple studies
• Create standardized CRF templates for common data collection needs (vital signs, adverse events, concomitant medications)

4. Testing Before Assignment

• Always use the Preview button to test the interface on both Desktop and Mobile before assigning CRF to Event
• Enter dummy data to verify calculation rules and validation work correctly
• Test skip logic and conditional display rules thoroughly

5. Documentation

• Maintain a CRF Completion Guidelines document that explains each field's purpose and acceptable values
• Include field-level instructions in the CRF design where appropriate
• Document any custom validation rules or calculations

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🐛 Troubleshooting

Issue 1: CRF Not Displaying When Assigning to Event

Symptoms:

• When navigating to Manage Events, the CRF list is empty or the newly created CRF is not found

Causes:

• CRF has not been changed to Available status (still in Draft)
• CRF has not been published after editing

Solutions:

1. Return to CRFs in Study or Available CRFs tab
   • Navigate back to the CRF management page
2. Check Status column
   • Verify the CRF shows Available status
3. If status is Draft:
   • Open CRF in Form Builder
   • Click Publish or Set as Available
   • Save changes
4. Return to Manage Events and try assigning again
   • The CRF should now appear in the selection list

Issue 2: Cannot Edit CRF (Edit Button Disabled)

Symptoms:

• Edit button is grayed out (disabled) or shows error when clicked

Causes:

• CRF is in Locked status
• CRF has been assigned to Event and subjects have already entered data (data integrity protection)

Solutions:

If CRF is Locked:

1. Contact Study Administrator to unlock the CRF
2. Provide reason for unlock request
3. Administrator will change status from Locked to Available

If CRF has existing data:

1. System will automatically create a new version when you edit
2. Old subject data will be mapped to the new version
3. ⚠️ Warning: Deleted fields will lose their data
4. Consider using Hide field instead of Delete field
5. Test the new version thoroughly before publishing

Issue 3: Data Lost After CRF Version Update

Symptoms:

• After updating CRF to V2.0, some old subject data fields no longer display

Causes:

• You deleted (Delete) data fields in V2.0 instead of just hiding them (Hide)

Solutions:

Prevention:

• ⚠️ Never delete fields that contain data
• Use Hide field or Disable field features instead
• Document all field changes in version notes

Recovery:

1. Restore the previous version (V1.0) if possible
2. Contact Technical Support to remap data from database
3. For future updates, always test version changes in development environment first

Issue 4: CRF Preview Shows Blank Page

Symptoms:

• Clicking Preview opens a blank page or loading spinner indefinitely

Causes:

• Browser compatibility issues
• CRF contains invalid configuration
• Network connectivity problems

Solutions:

1. Clear browser cache

   • Press Ctrl+Shift+Delete (Windows) or Cmd+Shift+Delete (Mac)
   • Select "Cached images and files"
   • Click "Clear data"
   • Refresh page and try again

2. Try different browser

   • Recommended: Chrome, Firefox, Edge (latest versions)
   • Avoid: Internet Explorer, Safari (older versions)

3. Check CRF configuration

   • Open CRF in Form Builder
   • Verify all fields are properly configured
   • Check for syntax errors in calculation rules
   • Save and try preview again

4. Contact IT Support

   • If issue persists, provide:
     • CRF name and version
     • Browser and version
     • Screenshot of error
     • Timestamp of attempt

Issue 5: Cannot Find CRF in Available Library

Symptoms:

• Searching for a CRF that was created but doesn't appear in Available CRFs list

Causes:

• CRF was created in a different study and permissions restrict visibility
• CRF is in Draft status (not published)
• Search filters are too restrictive

Solutions:

1. Check CRF status

   • Navigate to the study where CRF was created
   • Verify CRF exists and check its status
   • If Draft, publish it first

2. Review search filters

   • Clear all search filters
   • Try searching by exact CRF name
   • Check if status filter is excluding Draft CRFs

3. Verify permissions

   • Ensure you have access to view CRFs from other studies
   • Contact Study Administrator if permissions need adjustment

4. Create CRF directly in current study

   • If you cannot access the CRF from another study
   • Use Go to Form Builder to create a new CRF
   • Copy design from original CRF if needed

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Quick Reference Guide

CRF Status Definitions

Status	Meaning	Can Edit?	Can Assign to Event?
Draft	Under development, not yet published	✅ Yes	❌ No
Available	Published and ready for use	✅ Yes (creates new version)	✅ Yes
Locked	Frozen, no changes allowed	❌ No	✅ Yes (if already assigned)

Common CRF Field Types

Field Type	Use Case	Example
Text Input	Free-text responses	Comments, descriptions
Number Input	Numeric values	Weight, height, lab values
Date Picker	Date selection	Visit date, consent date
Dropdown	Single selection from list	Country, diagnosis
Radio Buttons	Single choice from 2-5 options	Yes/No, Gender
Checkboxes	Multiple selections	Symptoms, medications
Calculated Field	Auto-calculated values	BMI, Age, eGFR
File Upload	Document/image attachment	Lab reports, ECG images
Signature	Electronic signature	Investigator signature

Keyboard Shortcuts (Form Builder)

Action	Windows/Linux	Mac
Save CRF	Ctrl + S	Cmd + S
Undo	Ctrl + Z	Cmd + Z
Redo	Ctrl + Y	Cmd + Y
Delete selected field	Delete	Delete
Duplicate field	Ctrl + D	Cmd + D
Preview CRF	Ctrl + P	Cmd + P

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Learn More

To deepen your understanding of CRF design and operation in the study workflow, explore these related guides:

Study Build & Configuration

• Manage Events — Configure visit schedules and assign CRFs to each event
• Form Builder Guide — Detailed instructions on drag-and-drop, rules, and calculations
• Study Parameter Configuration — Configure Subject ID format and subject parameters

Study Execution

• Data Entry (View V5) — Latest data entry experience for sites
• Queries & Discrepancy Notes — How to handle incorrect or missing CRF data