Everything you need to use
Bloqcube with confidence.

Bloqcube is a Clinical Trial Management System (CTMS) that streamlines clinical trial operations from study setup to completion. It provides electronic consent (eConsent), Case Report Form (CRF) management, visit scheduling, document management (eTMF/eISF), and real-time reporting dashboards. The platform is designed for regulatory compliance and supports multi-site, multi-sponsor clinical trials.Watch walkthrough

• Click "Reporting Dashboard" in the navigation menu
• View real-time metrics for your trial/site
• Customize widgets to show relevant data
• Filter by date range, visit type, or other criteria
• Export reports as needed

• Click on "Profile" or "Account Details" in the left navigation menu
• Update your personal information (name, contact details, etc.)
• Click "Save" to apply changes Note: Some fields may be locked and require administrator assistance to modify.

This error appears when you try to access a page you don't have permission to view. Possible reasons:
• Your role doesn't grant access to that feature
• You're not assigned to the specific trial or site you're trying to access
• Your session may have expired - try logging out and back in Contact your site administrator if you believe you should have access.

• Use the Help & Support section for common questions
• Email: support@bloqcube.com
• Include in your request:
• Your username/email
• Trial/site name (if applicable)
• Description of the issue
• Screenshots of any error messages
• Browser and device information

Required fields are marked with a red asterisk (*) next to the field label. You must complete all required fields before submitting the form. The form will not allow submission if any required field is empty.

Eligibility review form decides whether subject can be enrolled for study based on the inclusion and exclusion criteria. Some Criteria marked as Yes or No based on the conditions, derived from the PDL. Some Criteria are allowed to mark Yes or No by PI or coordinator Eligible for study will be derived from previous two forms of inclusion and exclusion criteria. Subject will be eligible if Inclusion Criteria met as Yes and Exclusion Criteria met as No. Else Subject will be moved into non eligible subjects. Other forms can not be filled for subject.

This error appears on a field when:
• The field is supposed to be disabled/locked
• But it still contains a value (likely from before it was disabled) To fix:
• Clear the field's value manually
• The system will then allow submission

Unlike checkboxes, radio buttons typically require a selection. However:
• Click the currently selected radio button again
• This should deselect it (if the form allows)
• If deselection isn't allowed, you may need to select a different option like "None" or "Not Applicable"

• Dropdown: Allows selecting only ONE option from the list. Click the field, select your option, and the dropdown closes.
• Multi-Select Dropdown: Allows selecting MULTIPLE options. Click the field, select as many options as needed, and click outside to close. Selected options appear as chips/tags.

This error appears on a field when:
• The field is supposed to be hidden (based on your other selections)
• But it still contains a value To fix:
• Clear the field's value manually, OR
• Change the controlling field to make this field visible again

• Unsaved data will be lost - The system may show a warning
• Always click "Save" or "Save as Draft" before navigating away

PDL form is the first screening form which will be used for new subject. This form will have index date, date of diagnosis, HBI scores, CDST score information of subject. It will help to decide screening success and eligibility of subject based on fields values. Date range checks in the CRF forms will be based on the dates entered in the PDL formWatch walkthrough

Common reasons and solutions: Required field empty: Fill all fields marked with (*) Validation error: Fix the error shown below the field Hidden field has value: Clear the value or click "Clear Values and Save" Invalid format: Enter data in the correct format (e.g., dates, phone numbers) File upload failed: Re-upload the file Signature missing: Provide your signature

• Click "Forgot Password" on the login page
• Enter your registered email address
• Check your email for a password reset link
• Click the link and create a new password
• Your new password must meet security requirements (minimum 8 characters, including uppercase, lowercase, number, and special character)

CRF forms can have the following statuses:
• Pending - Form is available for data entry but not yet started or incomplete
• Verification_Pending - Form is complete and waiting for PI verification
• External_Verification_Pending - Form is waiting for external verification (e.g., site monitor)
• Completed - Form is fully verified and locked
• On_Hold - Form is temporarily locked pending resolution of an issue
• Withdrawal - Subject has withdrawn; form is locked
• Screening_Failure - Subject did not meet screening criteria
• Enrollment_Failure - Subject was not enrolled

Our CRF system supports over 20 field types: Text Input Fields:
• Text field (single line)
• Multiline text (textarea)
• Number field (with optional units)
• Email field
• Phone number (with country code) Selection Fields:
• Dropdown (single select)
• Multi-select dropdown
• Searchable dropdown
• Radio buttons
• Checkbox (single)
• Checkbox group (multiple) Date/Time Fields:
• Date picker
• Time picker
• Date-time picker
• Year picker Special Fields:
• Signature pad (digital signature)
• File upload (documents, images)
• Slider (numeric scale)
• Color slider (pain scale)
• Audio recording
• Embedded video
• HTML content display

To upload documents:
• Click on the file upload field
• Click Choose File or drag and drop your file
• Wait for the upload to complete
• The file name will appear when successfully uploaded Supported formats typically include:
• PDF documents
• Word documents (.doc, .docx)
• Images (.jpg, .png)
• Other formats as configured File size limits:
• Default maximum: 5MB per file
• Check field description for specific limits To download or view uploaded documents, click the file name or download icon.

If required fields are not completed:
• The form cannot be submitted
• Required fields will be highlighted with error messages
• You can still Save incomplete forms as draft
• The form status will remain "Pending" To complete the form:
• Review all highlighted fields
• Fill in missing required data
• Scroll through all sections to ensure completion
• Click Submit once all required fields are filled Some forms may also have conditional required fields that only appear based on your answers.

A Case Report Form (CRF) is a standardized document used in clinical trials to collect data from study participants at each visit or assessment point. Our electronic CRF system provides:
• Dynamic Forms - Forms are generated from JSON configuration, allowing flexible design
• Multiple Field Types - 20+ field types including text, dropdowns, checkboxes, signatures, and more
• Conditional Logic - Fields can show/hide based on other field values
• Built-in Validation - Automatic data validation to ensure quality
• Role-based Access - Control who can view, edit, and verify forms
• Audit Trail - All changes are tracked for regulatory compliance

You may not be able to edit a form for several reasons:
• Form Status - The form may be in a status that doesn't allow editing (Completed, On_Hold, Withdrawal)
• Subject Status - The subject may be On_Hold, preventing all edits
• Role Permissions - Your role may not have edit access for this form status
• Verification Stage - The form may be pending verification by another role To request edits:
• Contact your PI or data manager
• Raise a query if needed to unlock the form
• Wait for appropriate permissions to be granted If you believe you should have access, verify your role assignment with your site administrator.

Conditional fields are fields that appear, hide, or become required based on the values of other fields. Types of conditional logic:
• Show/Hide - A field appears only when another field has a specific value
• Required If - A field becomes required based on another field's value
• Disabled If - A field becomes disabled (read-only) based on conditions
• Dynamic Options - Dropdown options change based on other selections Example: If you select "Yes" for "Do you have any allergies?", additional fields for "Allergy Details" will appear and become required. This logic ensures you only see relevant fields, making forms easier to complete.

Form verification is a two-step quality assurance process: Step 1: Internal Verification (PI)
• Site coordinator completes the form
• Form status changes to "Verification_Pending"
• Principal Investigator reviews the data
• PI can approve or send back for corrections Step 2: External Verification (Monitor)
• After PI approval, status changes to "External_Verification_Pending"
• Site monitor performs source data verification
• Monitor can raise queries or approve
• Upon approval, form is marked "Completed" The verification workflow ensures data accuracy and regulatory compliance.

To complete a Case Report Form:
• Navigate to the subject's profile
• Select the visit from the visit schedule
• Click on the form you need to complete
• Fill in all required fields (marked with *)
• Review your entries for accuracy
• Click Save to save your progress
• Once complete, click Submit to finalize the form Tips:
• Save frequently to avoid losing data
• Required fields must be completed before submission
• Some fields may auto-populate from previous forms
• Conditional fields appear based on your answers

To add a digital signature:
• Click on the signature field
• A signature pad dialog will appear
• Use your mouse, touchpad, or stylus to draw your signature
• Click Clear if you need to redo
• Click Save to capture the signature Important:
• Signatures are timestamped automatically
• Once saved, signatures cannot be modified without audit trail
• Different roles may have separate signature fields (Participant, Investigator)
• Signature data is securely stored and linked to your identity

Calculated fields automatically compute values based on other field inputs. Common calculated fields:
• Age - Calculated from date of birth
• BMI - Calculated from height and weight
• Clinical Scores - Such as Harvey-Bradshaw Index (HBI) for disease activity
• Duration - Time between two dates How they work:
• Enter the source values (e.g., height and weight)
• The calculated field automatically updates
• Calculated values are typically read-only
• If source values change, calculations update automatically These fields are displayed for reference but cannot be manually edited.

The system applies several types of validation: Required Field Validation:
• Ensures mandatory fields are not left empty
• Conditional required fields based on other answers Format Validation:
• Email - Valid email format (user@domain.com)
• Phone - Valid phone number format with country code
• Date - Valid date in DD/MM/YYYY format
• Number - Numeric values only, with min/max ranges Custom Validation:
• Minimum/Maximum length - Character limits for text
• Pattern matching - Regex patterns for specific formats
• Date ranges - Dates within allowed ranges
• Cross-field validation - Values must match or relate to other fields Clinical Validation:
• Age eligibility criteria checks
• Diagnosis date validation (relative to enrollment)
• BMI calculation and range validation

When you see validation errors:
• Identify the error - Look for red highlighted fields and error messages
• Read the error message - It explains what's wrong
• Correct the value - Enter valid data as described
• Re-save the form - The error should clear Common validation errors:ErrorSolution"This field is required"Enter a value in the field"Invalid email format"Enter email as user@domain.com"Value must be at least X"Enter a higher value"Date must be in the past"Select a past date"Invalid phone number"Enter complete phone with country code

Source Data Verification (SDV) is the process of comparing data entered in the CRF against original source documents to ensure accuracy. The SDV process:
• Site monitor accesses the completed CRF
• Compares CRF data against source documents (medical records, lab reports)
• Verifies data accuracy and completeness
• Raises queries for any discrepancies
• Approves form when data is verified What monitors check:
• Data accuracy against source
• Date and time consistency
• Eligibility criteria compliance
• Protocol adherence
• Signature and consent validity

The Harvey-Bradshaw Index (HBI) is a clinical scoring system used to assess disease activity in Crohn's disease patients. HBI Components:ComponentScore RangeGeneral well-being0-4Abdominal pain0-3Number of liquid stools per dayCountAbdominal mass0-3Complications1 point each Interpretation:
• < 5 - Remission
• 5-7 - Mild disease
• 8-16 - Moderate disease
• > 16 - Severe disease The system automatically calculates the total HBI score when you complete all component fields.

The readOnlyEdit configuration allows advanced control over when users can edit forms that would normally be read-only. Use cases:
• Allow monitors to edit during external verification
• Enable query resolution by specific roles
• Support data correction workflows Configuration options:
• statusAccess - Define which roles can edit at each form status
• queryResolutionAccess - Roles that can edit when queries are open
• allowApplicableStatus - List of statuses where editing is permitted Example: A site monitor can edit a "Completed" form to make corrections during their review, while site coordinators cannot.

Generally, completed forms cannot be edited to maintain data integrity. However, there are exceptions: When edits are possible:
• Open queries require resolution
• Site monitor is performing source data verification
• Data manager has unlocked the form for corrections How to request changes:
• Contact your data manager or monitor
• Explain the reason for the change
• Wait for a query to be raised
• Respond to the query with the correct data
• The change will be tracked in the audit trail All changes to completed forms are logged for regulatory compliance.

Different roles have different access levels to CRFs: Principal Investigator (PI):
• Can edit all site forms
• Can verify forms submitted by coordinators
• Can approve or reject submitted data Site Coordinator:
• Can complete data entry forms
• Cannot perform PI verification
• Can respond to queries Site Monitor:
• Can perform external verification
• Can raise and manage queries
• Can access forms for source data verification Sponsor:
• Can view aggregated data
• Can access reports
• Cannot edit site-level data Access is configured at the form level and may vary by form type and status.

To determine your edit permissions:
• Check the form status - Editable forms show an "Edit" button
• Review your role - Go to your profile to see your assigned role
• Look for disabled fields - Gray fields are read-only for your role
• Check for lock icons - Locked forms cannot be edited If you need access:
• Contact your site administrator
• Request appropriate role assignment
• Wait for queries to be assigned if applicable Remember: Access is designed to ensure data integrity and regulatory compliance.

To respond to a data query:
• Navigate to Queries in your dashboard
• Find the query assigned to you
• Click on the query to view details
• Review the query text and affected field
• Choose your response type:Update Data - Correct the value and explain
• Clarify - Provide explanation without changing data
• Enter your response in the text box
• Click Submit Response Tips:
• Be specific in your response
• Reference source documents if applicable
• Include any supporting information
• Respond within the required timeframe

To view your open queries:
• Go to Dashboard
• Look for the Queries section or widget
• Click View All Queries or the query count Query list shows:
• Subject ID
• Form name
• Field with query
• Query status (Open, Answered, Closed)
• Days open
• Priority Filter options:
• By status (Open, Answered, All)
• By site
• By form type
• By date range You can also see queries on individual subject profiles and within forms.

A data query is a question or clarification request about data entered in a CRF. Queries are used to identify and resolve data issues. Common query types:
• Discrepancy - Data doesn't match source documents
• Clarification - Additional information needed
• Missing Data - Required data not entered
• Range Check - Value outside expected range
• Protocol Deviation - Data indicates deviation from protocol Query workflow:
• Query is raised by monitor or system
• Site staff is notified
• Site staff responds with clarification or correction
• Monitor reviews the response
• Query is closed when resolved

Unresolved queries can have significant impacts:
• Data Lock Delays - Database cannot be locked with open queries
• Compliance Issues - Unresolved queries indicate data quality problems
• Escalation - Overdue queries are escalated to supervisors
• Site Performance - Query metrics affect site evaluations Query aging alerts:
• Queries approaching due date trigger reminders
• Overdue queries are highlighted in dashboards
• Email notifications sent for urgent queries Best practices:
• Check queries daily
• Respond within 3-5 business days
• Escalate if you need help
• Keep source documents accessible