Study Information | Clinicaldatas

Overview

The Study Information page is your command center for configuring and maintaining clinical trial information. Whether you're setting up a new study or updating an existing one, this guide will walk you through every section with practical, step-by-step instructions.

Who should use this guide:

Study Administrators configuring new studies
Clinical Research Coordinators updating study details
Principal Investigators reviewing study configurations
Data Managers ensuring compliance with protocol amendments

What you'll learn:

How to update study metadata and protocol information
How to configure subject ID generation rules
How to set up facility and contact information
How to customize email notifications for your team
Best practices to avoid common configuration errors

Study Description

The Study Description section contains the core identity of your clinical trial. This information appears in reports, exports, and is used for regulatory compliance.

Area	What it is for	When to update
Core Metadata	Define study identifiers, titles, and key personnel	At study creation; when protocol amendments occur
Study Type & Enrollment	Classify design and set timeline targets	During initial setup; when enrollment targets change
Document Requirements	Configure required study documents	When IRB/ethics requirements change

Core Metadata

What you'll configure:

Field	Required	Character Limit	Example	Tips
Study Name	✓	100 chars	CARDIO-RELIEF 2025	Use internal naming convention; avoid special characters
Brief Title	✓	200 chars	CardioRelief vs Placebo in Moderate Heart Failure (Phase III)	Write for public/patient audience; avoid jargon
Brief Summary	✓	1000 chars	This study evaluates the efficacy and safety of once-daily oral CardioRelief (CRF-101) compared to placebo...	Include: condition, intervention, population, primary outcome
Unique Protocol ID	✓	50 chars	CDS-2025-CR-001	Follow sponsor's numbering system; cannot be changed after first subject enrollment
Secondary IDs		200 chars	NCT01234567, EUDRACT-2024-001234-56	Separate multiple IDs with commas; useful for registry cross-referencing
Principal Investigator	✓	100 chars	Dr. Alexandra Chen, MD, PhD	Include full credentials; this appears on regulatory documents
Investigational Product		100 chars	CardioRelief (CRF-101)	Use generic name if possible; include code name in parentheses
Official Title		500 chars	A Phase III, Double-Blind, Randomized, Multi-Center, Placebo-Controlled Study of CardioRelief...	Full protocol title; matches IRB submission exactly
Sponsor	✓	200 chars	Demo Pharma Inc.	Legal entity name; appears on informed consent forms
Collaborators		500 chars	National Heart Institute, Harvard Medical School	Separate with commas; funding partners, research institutions

Step-by-step: Updating Study Metadata

Navigate to Study Description
- From Home, click on your study name (e.g., "CARDIO-RELIEF 2025")
- The Study Setup page opens automatically to the Study Description tab
- If not, click "Study Description" in the left sidebar
Update Basic Information
```
Study Name: CARDIO-RELIEF 2025
Brief Title: CardioRelief vs Placebo in Moderate Heart Failure (Phase III)
```
- Click inside any text field to edit
- Changes are highlighted in yellow until saved
- Use Tab key to move between fields quickly
Write an Effective Brief Summary

✅ Good example: "This study evaluates the efficacy and safety of once-daily oral CardioRelief (CRF-101) compared to placebo in adults with NYHA Class II-III heart failure over 52 weeks."

❌ Avoid: "We are testing a new heart drug." (too vague) "This double-blind, randomized, placebo-controlled trial with stratification by baseline LVEF..." (too technical for brief summary)
Set Protocol ID Carefully
- ⚠️ Warning: Unique Protocol ID cannot be changed after the first subject is enrolled
- Format suggestion: [SPONSOR]-[YEAR]-[STUDY-CODE]-[VERSION]
- Example: DEMO-2025-CR-001 or PHARMA-2024-ONC-015
Save Your Work
- Click Save changes to stay on this page
- Click Save & Overview to return to study dashboard
- ⚠️ Unsaved changes are lost if you navigate away

Study Type & Enrollment

Study Type Selection:

Protocol Type:
● Interventional  ○ Observational

Expected total enrollment*: [240]
Study Start Date*: [15/01/2025] [Now]
Study Completion Date*: [30/06/2027] [Now]
Protocol Verification/IRB Approval Date: [10/12/2024] [Now]

Which type should you choose?

Type	Choose this if...	Examples
Interventional	Participants receive specific interventions (drug, device, procedure) per protocol	Drug trials, device studies, behavioral interventions
Observational	Participants receive care as per usual practice; researchers observe outcomes	Registry studies, cohort studies, chart reviews

Enrollment Configuration:

Expected Total Enrollment:

Enter the target number of subjects you plan to enroll
This number is used for:
- Randomization list generation
- Supply forecasting (drug, kits, etc.)
- Timeline planning
💡 Tip: Add 10-15% buffer for screen failures
- If you need 200 randomized subjects, enter 220-230 for expected enrollment

Key Dates:

Date Field	Purpose	Can it change?
Study Start Date	First subject first visit (FSFV) or site activation date	Yes, but document in study log
Study Completion Date	Last subject last visit (LSLV) target	Yes, update as needed
IRB Approval Date	Date of ethics committee approval	No, this is historical; add new approval as amendment

Using the Date Picker:

Click the calendar icon 📅 next to any date field
Navigate months using ◄ ► arrows
Click on the desired date
Or click [Now] to instantly set today's date
Format is always: DD/MM/YYYY

⚠️ Validation Rules:

Study Start Date must be before Study Completion Date
IRB Approval Date must be before Study Start Date
Dates cannot be in the past for future studies (system will warn you)

Document Requirements

Configure which documents subjects must provide:

Attached Files*: ○ Required  ● Optional  ○ Not used

Document Label: [File đính kèm]
Document type: ○ Required  ○ Optional  ● Not used

When to use each option:

Setting	Use when...	Example
Required	Document MUST be uploaded before subject can proceed	Signed Informed Consent, Eligibility Checklist
Optional	Document MAY be uploaded if applicable	Additional medical records, Patient diaries
Not used	This document type is not needed for your study	Genetic testing consent for non-genetic study

Step-by-step: Configuring Document Requirements

Select usage level
- Choose: Required / Optional / Not used
- This applies to ALL sites unless overridden at site level
Label your document
```
Document Label: [Informed Consent Form]
```
- Use clear, descriptive names
- Avoid abbreviations that sites may not understand
- Consider multilingual studies: use English as base
Set document type (if applicable)
- Some systems allow categorizing documents (e.g., Consent, Lab Report, Imaging)
- Select appropriate type for better organization

Default Facility Information

This section sets the default facility details that apply across your entire study. Individual sites can override these defaults if needed.

Area	What it is for	Important for
Facility Details	Name, address, and location information	Regulatory submissions, site identification
Facility Contact	Primary contact person for the facility	Subject inquiries, monitoring coordination

Facility Details

Fields to complete:

Field	Required	Example	Format Tips
Facility Name	✓	HORUS Medical Center	Use official legal name
Facility City	✓	Ho Chi Minh City	Full city name, no abbreviations
Facility State/Province	✓	Ho Chi Minh	Required for US studies; use full name
Facility ZIP	✓	700000	Use local postal code format
Facility Country	✓	Vietnam	Select from dropdown; affects regulatory pathway

💡 Pro Tips:

Multi-site studies: Set generic defaults here, then customize per site

Default: Facility Name = "Participating Site"
Site A: Override to "HORUS Medical Center"
Site B: Override to "National Heart Institute"

Country selection matters:
- Determines regulatory requirements (FDA, EMA, local IRB)
- Affects date formats, measurement units
- Cannot be easily changed after enrollment starts

Facility Contact

This is the primary contact for subjects with questions about the study.

Field	Required	Example	Validation
Facility Contact Name	✓	Dr. Nguyen Van Tuan	Full name with title
Facility Contact Degree	✓	MD, PhD	Professional credentials
Facility Contact Phone	✓	+84 28 1234 5678	Include country code; format: +[country] [area] [number]
Facility Contact Email	✓	vo.tuan@horus.com.vn	Must be valid email format; checked by system

Best Practices for Contact Information:

✅ DO:

Use a study-specific email (e.g., cardio-relief@horus.com.vn) not a personal email
Provide a direct phone line that is monitored during business hours
Include backup contact in Detailed Description if primary is unavailable
Update immediately if contact person changes

❌ DON'T:

Use personal email addresses (Gmail, Yahoo, etc.)
List phone numbers that go to voicemail only
Leave contact info outdated when staff changes

Example of Complete Facility Contact:

Facility Contact Name: Dr. Nguyen Van Tuan
Facility Contact Degree: MD, PhD, FACC
Facility Contact Phone: +84 28 3822 9999
Facility Contact Email: cardio.study@horus.com.vn

Study Parameter Configuration

This section controls how subjects are identified and what demographic data you collect. These settings affect every subject in your study.

Area	What it is for	Impact
Subject ID Format	Rules for generating unique subject identifiers	Appears on CRFs, reports, drug labels
Subject Parameters	Which demographic fields to collect	Determines data entry forms and validation

Subject ID Format

How will subject IDs be generated?

You have three options:

How to Generate Subject ID*:
○ Manual Entry
○ Auto-generated and Editable
● Auto-generated and Non-editable

Option 1: Manual Entry

What it means: Site staff types in each subject ID
When to use:
- Small studies (< 50 subjects)
- Studies with pre-assigned IDs from sponsor
- When you need custom ID formats per site
Pros: Maximum flexibility
Cons: Risk of typos, duplicates, inconsistencies
Example: Site staff enters "CR-001", "CR-002", etc. manually

Option 2: Auto-generated and Editable

What it means: System creates ID automatically, but staff can modify it
When to use:
- Most studies (recommended default)
- When you want consistency but need override capability
- Multi-site studies with site-specific requirements
Pros: Prevents duplicates; allows corrections
Cons: Staff might accidentally change valid IDs
Example: System generates "CR-001", staff can change to "CR-001A" if needed

Option 3: Auto-generated and Non-editable

What it means: System creates ID; staff cannot change it
When to use:
- Large multi-site studies (> 100 subjects)
- Studies requiring strict audit trail
- When randomization depends on sequential IDs
Pros: Guaranteed uniqueness; no human error
Cons: No flexibility for special cases
Example: System generates "CR-001", "CR-002" - locked permanently

Configuring Auto-Generated IDs

If you choose auto-generation, configure these settings:

Prefix: [CR]
Separator: [-]
Digits: ○ 3  ● 4  ○ 5  ○ 6
Preview Subject ID: CR-XXXX
Study Subject ID Label: [Participant]

Prefix:

Purpose: Identifies the study at a glance
Length: 2-4 characters recommended
Format: Letters only (no numbers or special chars)
Examples:
- CR = CARDIO-RELIEF
- ONC = ONCOLOGY trial
- DIAB = DIABETES study
💡 Tip: Use study acronym or therapeutic area code

Separator:

Purpose: Visually separates prefix from number
Options:
- - (hyphen) - Most common, recommended
- _ (underscore)
- . (period)
- (space)
Example: CR-001 vs CR_001 vs CR.001

Digits (Length):

Purpose: Determines how many subjects you can enroll
Choose based on expected enrollment:

Digits	Max Subjects	Use for...
3	999	Small pilot studies, Phase I
4	9,999	Most Phase II/III studies ✓
5	99,999	Large outcomes trials, registries
6	999,999	Multi-year programs, platform studies

Example: If you expect 240 subjects, choose 4 digits
- IDs will be: CR-0001, CR-0002, ... CR-0240, ... CR-9999

Preview Subject ID:

What you see: Live preview of the ID format
Example: With Prefix="CR", Separator="-", Digits=4
- Preview shows: CR-0001
Use this to verify your configuration before saving

Study Subject ID Label:

Purpose: What you call subjects in the UI
Options:
- Participant - Patient-friendly, commonly used
- Subject - Traditional clinical trial term
- Patient - Clinical/medical context
- Volunteer - Healthy volunteer studies
This label appears:
- In navigation menus
- On CRF headers
- In reports and exports
- In email notifications

Complete Example Configuration:

How to Generate Subject ID*: ● Auto-generated and Non-editable
Prefix: [CR]
Separator: [-]
Digits: ● 4
Preview Subject ID: CR-0001
Study Subject ID Label: [Participant]

Result: First subject = CR-0001, Second = CR-0002, etc.

Subject Parameters

Configure which demographic fields are collected for each subject:

Collect Date of Enrollment for Study?
○ Required  ○ Optional  ● Not used

Collect Personal Data
○ Required  ● Optional  ○ Not used

Sex:
○ Required  ● Optional  ○ Not used

Date of Birth:
○ Year only
○ Month and year
● Day, month and year

Field-by-Field Guide:

Parameter	When to set as Required	When Optional	When Not Used
Date of Enrollment	All interventional studies	Observational studies	Retrospective chart reviews
Sex	Drug trials, device studies	Studies where sex is not relevant	Anonymous surveys
Date of Birth	Age is eligibility criterion	Demographic collection only	Studies with age ranges only

Date of Birth Precision:

Choose the level of detail you need:

○ Year only          → "1985" (age calculated as of Dec 31)
○ Month and year     → "March 1985" (better precision)
● Day, month and year → "15 March 1985" (exact age calculation)

Recommendations:

Use "Day, month and year" for:
- Studies with age-based eligibility (e.g., "18-65 years")
- Pediatric studies (exact age matters)
- Long-term follow-up studies
Use "Month and year" for:
- Studies where exact age is less critical
- Privacy-sensitive populations
Use "Year only" for:
- Anonymous registries
- Studies with very broad age ranges

Event Parameter Configuration

Events are study visits or timepoints (Screening, Baseline, Week 4, etc.). This section configures what data is collected at every event by default.

Area	What it is for	Affects
Event-Level Parameters	Start/end times, location, randomization settings	All study events/visits

Event-Level Parameters

Configuration Options:

Collect Start Date*: ● Required  ○ Optional
                     ○ Not used
                     [Start Date/Time]

Collect End Date*:   ● Required  ○ Optional
                     ○ Not used
                     [End Date/Time]

Collect Location*:   ● Required  ○ Optional
                     ○ Not used
                     [Custom label]

Start Date/Time:

Setting	Use when...	Example
Required	Every event must have a start time	Drug administration visits, procedures
Optional	Some events may not have specific times	Phone follow-ups, unscheduled contacts
Not used	Timing is not relevant	Retrospective data collection

💡 Best Practice:

Set as Required for all protocol-scheduled visits
Set as Optional for Unscheduled/Early Termination events

End Date/Time:

Setting	Use when...	Considerations
Required	Events have defined end times	Infusions, surgeries, hospital stays
Optional	Events may or may not have end times	Clinic visits (variable duration)
Not used	Events are instantaneous	Lab draws, questionnaires

Example Configuration by Event Type:

SCREENING VISIT:
Start Date/Time: Required
End Date/Time: Optional (screening may take multiple days)
Location: Required

BASELINE VISIT:
Start Date/Time: Required
End Date/Time: Required (randomization occurs at specific time)
Location: Required

WEEK 4 FOLLOW-UP:
Start Date/Time: Required
End Date/Time: Not used (quick visit)
Location: Required

UNSCHEDULED VISIT:
Start Date/Time: Optional (may be phone call)
End Date/Time: Not used
Location: Optional

Location Field:

Custom label: Change "Location" to something specific
- Examples: "Clinic Room", "Infusion Suite", "Imaging Center"
Required: If subjects must be seen at specific locations
Optional: If location varies or is not important
Not used: For remote/telemedicine visits

Email Settings

Automated email notifications keep your study team informed. Configure who gets notified when new subjects enroll and customize the email content.

Area	What it is for	Frequency
New Subject Enrollment Email	Select recipients for enrollment alerts	Sent automatically on enrollment
Email Template	Customize email content and variables	Applied to all enrollment emails

New Subject Enrollment Email

Who should be notified?

Select all roles that need to know when a new subject enrolls:

Send email notification to following recipients:

☐ Study Administrator        ☐ Site Monitor
☐ Study Monitor             ☐ Investigator
☐ Study Sponsor             ☐ Clinical Research Coordinator
☐ Study Coder               ☐ Facility Contact
☐ Study Evaluator           ☐ Other Recipients

Role-by-Role Guide:

Role	Notify them if...	Why
Study Administrator	Always ✓	Oversees entire study; needs enrollment metrics
Study Monitor	Monitoring required	Schedules site visits based on enrollment
Study Sponsor	Sponsor requires updates	Contractual obligation; budget tracking
Investigator	PI wants real-time updates	Responsible for subject safety
Clinical Research Coordinator	CRC manages enrollment	Coordinates subject visits and data entry
Site Monitor	Multi-site study	Tracks enrollment at specific sites
Study Coder	Medical coding required	Prepares to code adverse events, medications
Study Evaluator	Independent assessment	Blinded or unblinded outcome assessment
Facility Contact	Subjects may have questions	Front-line contact for study inquiries
Other Recipients	Custom stakeholders	Data Safety Monitoring Board (DSMB), etc.

💡 Recommended Minimum:

✅ Study Administrator
✅ Investigator (or Sub-Investigator)
✅ Clinical Research Coordinator

For Multi-Site Studies:

✅ Study Administrator (central)
✅ Site Monitor (per site)
✅ Investigator (per site)

Email Subject Line

Craft a clear, informative subject line:

Email Subject: [New Subject Enrolled: ${subjectID} at ${siteName}]

Subject Line Best Practices:

✅ DO:

Include subject ID for quick reference
Mention site name for multi-site studies
Keep it under 60 characters (mobile-friendly)
Use action-oriented language

Examples:

✅ "New Enrollment: CR-0042 at HORUS Medical Center"
✅ "Subject CR-0156 Enrolled - CARDIO-RELIEF 2025"
✅ " New Subject: CR-0089 (Site 001)"

❌ "Notification" (too vague)
❌ "A new subject has been enrolled in the study CARDIO-RELIEF 2025
    at HORUS Medical Center on 15/01/2025 at 10:30 AM by Dr. Nguyen"
    (too long)

Email Template

Customize the email body using the rich text editor:

✉️ Email Content Editor

[Toolbar: Paragraph, Font size, Bold, Italic, Bullet points, etc.]

Email Content
[Rich text area - write your message here]

Press ⌘\ for help    0 words
<> View all Variables

Using Variables:

Click View all Variables to insert dynamic content that changes for each enrollment:

Variable	Replaced with	Example
`${studyName}`	Study name	CARDIO-RELIEF 2025
`${subjectID}`	Subject identifier	CR-0042
`${siteName}`	Site/facility name	HORUS Medical Center
`${enrollmentDate}`	Date of enrollment	15/01/2025
`${enrollmentTime}`	Time of enrollment	14:30
`${investigatorName}`	Principal Investigator	Dr. Alexandra Chen
`${coordinatorName}`	Study Coordinator	Ms. Sarah Johnson

Professional Email Template Example:

Dear Study Team,

A new subject has been enrolled in ${studyName}:

📋 Enrollment Details:
Subject ID: ${subjectID}
Site: ${siteName}
Enrollment Date: ${enrollmentDate} at ${enrollmentTime}
Principal Investigator: ${investigatorName}

✅ Next Steps:
1. Complete baseline assessments within 7 days
2. Dispense study medication per protocol
3. Schedule Week 4 follow-up visit
4. Enter all data within 48 hours

📞 Questions?
Contact the study coordinator at coordinator@study.com

Thank you for your continued participation.

Best regards,
Clinical Data Management Team
${studyName}

Email Formatting Tips:

✅ DO:

Use clear headings and bullet points
Include action items with deadlines
Provide contact information
Keep it concise (under 300 words)
Use professional tone

❌ DON'T:

Use all caps (looks like shouting)
Include confidential information (PHI)
Use informal language or emojis (unless appropriate for your study)
Make emails too long (busy clinicians won't read them)

Testing Your Email Template:

Before going live:

Enroll a test subject in development environment
Check email delivery to all selected recipients
Verify variables are populating correctly
Review formatting on mobile and desktop
Confirm links (if any) are working

Saving Changes

Two Save Options:

Button	What it does	When to use
Save changes	Saves and stays on current page	Making multiple edits to same section
Save & Overview	Saves and returns to study dashboard	Finished with current section

Important Notes:

⚠️ Auto-save is NOT enabled

You MUST click Save button or changes will be lost
System will warn you if you try to navigate away with unsaved changes
However, browser crashes can still cause data loss

✅ Best Practice:

Click Save changes every 5-10 minutes while working
Use Save & Overview when moving to a different section
For major updates, export study config first as backup

Confirmation Messages:

After saving, you'll see:

✅ Study updated successfully

❌ Error: [Specific error message]

If you see an error:

Read the error message carefully
Check for required fields (marked with *)
Verify date formats (DD/MM/YYYY)
Ensure no duplicate IDs
Contact Study Administrator if error persists

Best Practices

Follow these guidelines to ensure smooth study setup and updates:

Before Making Changes

Step	Action	Why it matters
1. Review Protocol	Check protocol version and amendment history	Ensures changes align with approved protocol
2. Check Permissions	Confirm you have Study Administrator rights	Prevents unauthorized changes
3. Notify Team	Inform investigators, coordinators of planned changes	Avoids confusion during data collection
4. Backup Config	Export current study configuration	Allows rollback if needed
5. Test in Dev	Make changes in development environment first	Catches errors before affecting live data

While Making Changes

Do's	Don'ts
✅ Update one section at a time	❌ Change multiple sections simultaneously
✅ Save after each section	❌ Wait until end to save everything
✅ Use consistent naming conventions	❌ Mix naming styles (e.g., "Subject" vs "Participant")
✅ Document reason for changes	❌ Make changes without logging rationale
✅ Verify dates and numbers	❌ Rush through data entry

After Making Changes

Step	Action
1. Verify	Review all updated fields for accuracy
2. Test	Enroll a test subject to verify configuration
3. Train	Update study team on new settings if needed
4. Document	Log changes in study master file
5. Monitor	Watch for issues in first 24-48 hours

Regulatory Compliance

ICH-GCP Considerations:

5.5.1: The investigator should not implement any deviation from the protocol without prior review and documented approval from the sponsor and IRB
5.5.3: The investigator should maintain adequate and accurate case report forms and other study-related documents

21 CFR Part 11 (Electronic Records):

Changes to study configuration must be auditable
System must maintain audit trail of who changed what and when
Changes affecting data integrity require justification

When Changes Require IRB Approval:

Change Type	IRB Approval Needed?	Timeline
Primary outcome measure	✅ Yes	Before implementation
Sample size increase	✅ Yes	Before enrollment continues
Study dates extension	✅ Yes	Before original end date
Contact information update	❌ No (notify only)	Within 5 business days
Typo correction	❌ No	Document in study log

Troubleshooting

Common issues and how to resolve them:

Issue 1: Cannot Save Changes

Symptoms:

Save button is grayed out (disabled)
Error message: "Please fill in all required fields"
Red borders around certain fields

Causes:

Missing required fields (marked with *)
Invalid data format
Validation errors

Solutions:

Check for required fields:

Look for fields marked with red asterisk (*)
Common missing fields:
- Study Name
- Brief Title
- Brief Summary
- Unique Protocol ID
- Principal Investigator
- Expected total enrollment
- Study Start Date

Verify data formats:

Dates: Must be DD/MM/YYYY
Example: 15/01/2025 ✅
         01/15/2025 ❌ (US format not accepted)
         15-01-2025 ❌ (use slashes, not hyphens)

Numbers: Must be positive integers
Example: 240 ✅
         -5 ❌
         240.5 ❌
         two hundred forty ❌

Email: Must be valid format
Example: user@domain.com ✅
         user@domain ❌
         @domain.com ❌

Clear browser cache:

Sometimes browser cache causes issues:
- Press Ctrl+Shift+Delete (Windows) or Cmd+Shift+Delete (Mac)
- Select "Cached images and files"
- Click "Clear data"
- Refresh page and try again

Issue 2: Subject ID Not Generating Correctly

Symptoms:

Subject IDs don't follow configured format
Duplicate IDs appear
System skips numbers

Causes:

Prefix too long or contains invalid characters
Insufficient digit length
Separator conflict

Solutions:

Check prefix configuration:

✅ Valid: CR, ONC, DIAB, ABC
❌ Invalid: CARDIO-RELIEF (too long), CR1 (contains number),
            CR_2025 (special characters)

Fix: Use 2-4 letters only

Verify digit length:

If you expect 240 subjects but chose 3 digits:
Max = 999 subjects ✅

If you expect 15,000 subjects and chose 4 digits:
Max = 9,999 subjects ❌

Fix: Choose 5 digits for 10,000+ subjects

Check for separator issues:

If prefix is "CR-2025" and separator is "-":
Result: CR-2025-0001 (confusing, two separators)

Fix: Either:
- Change prefix to "CR25" (no hyphen)
- Change separator to "_" (underscore)

Issue 3: Email Notifications Not Sending

Symptoms:

Users don't receive enrollment emails
Email shows as sent in logs but not received
Only some users receive emails

Causes:

No recipients selected
Invalid email addresses
Email server configuration issue
Spam filters

Solutions:

Verify recipients are selected:

Go to: New Subject Enrollment Email section
Check: At least one role is checked ☑
Recommended: Study Administrator + Investigator + CRC

Check user email addresses:

Navigate to: User Management > [User Name] > Profile
Verify: Email field is populated and valid
Example: john.doe@hospital.com ✅
         @hospital.com ❌
         john.doe ❌

Test email delivery:

Step 1: Enroll a test subject
Step 2: Check if email is sent (check system logs)
Step 3: Ask recipients to check spam/junk folder
Step 4: Whitelist system email domain if needed

Contact IT if issue persists:

Provide:
- Study name and ID
- Timestamp of test enrollment
- List of expected recipients
- Screenshot of configuration

Issue 4: Date Validation Errors

Symptoms:

Error: "Study Start Date must be before Study Completion Date"
Error: "IRB Approval Date cannot be in the future"
Date picker shows wrong month/year

Causes:

Dates entered in wrong order
System timezone issues
Browser locale settings

Solutions:

Verify date sequence:

Correct order:
IRB Approval Date ≤ Study Start Date ≤ Study Completion Date

Example:
IRB Approval: 10/12/2024 ✅
Study Start: 15/01/2025 ✅
Study Completion: 30/06/2027 ✅

Use date picker instead of manual entry:

Instead of typing: 15/01/2025
Click: 📅 calendar icon
Select: January 2025
Click: 15
System enters: 15/01/2025 (correct format guaranteed)

Check browser timezone:

Press F12 to open Developer Console
Type: new Date().toString()
Verify: Timezone matches your location
If wrong: Adjust browser or system timezone settings

Issue 5: Permission Denied

Symptoms:

Error: "You do not have permission to modify this study"
Save button disabled
Fields are read-only

Causes:

Insufficient user role
Study is locked or completed
Site-level restrictions

Solutions:

Check your role:

Navigate to: Profile > My Roles
Required roles for Study Setup:
- Study Administrator ✅
- Study Director ✅
- System Administrator ✅

Insufficient roles:
- Data Entry Only ❌
- Monitor (read-only) ❌

Verify study status:

Study Status:
- Draft ✅ (can edit)
- Active ✅ (limited editing)
- Completed ❌ (cannot edit)
- Locked ❌ (cannot edit)

If study is Completed/Locked:
Contact Study Administrator to unlock or create amendment

Request access:

Email Study Administrator with:
- Your username and full name
- Study name and ID
- Reason for access needed
- Duration of access (temporary or permanent)

Example:
"Please grant me Study Administrator access to
CARDIO-RELIEF 2025 (CDS-2025-CR-001) to update
facility contact information. This is needed for
IRB renewal. Thank you."

Quick Reference Guide

Keyboard Shortcuts

Action	Windows/Linux	Mac
Save changes	Ctrl + S	Cmd + S
Navigate to next field	Tab	Tab
Navigate to previous field	Shift + Tab	Shift + Tab
Open date picker	Alt + ↓	Option + ↓
Help in email editor	Ctrl + \	Cmd + \

Field Validation Rules

Field Type	Rules	Examples
Text (Study Name)	1-100 characters, letters/numbers/spaces	"CARDIO-RELIEF 2025" ✅
Email	Valid format with @ and domain	`user@hospital.com` ✅
Phone	International format preferred	`+84 28 1234 5678` ✅
Date	DD/MM/YYYY format	`15/01/2025` ✅
Number (Enrollment)	Positive integer, no decimals	`240` ✅
Protocol ID	Alphanumeric + hyphen/underscore	`CDS-2025-CR-001` ✅

Status Indicators

Symbol	Meaning
`*`	Required field (must fill)
`●`	Radio button selected
`○`	Radio button not selected
`☑`	Checkbox selected
`☐`	Checkbox not selected
`📅`	Date picker available
`[Now]`	Button to set current date
`🔒`	Field is locked (cannot edit)

Character Limits

Field	Max Length
Study Name	100
Brief Title	200
Brief Summary	1000
Official Title	500
Detailed Description	5000
Protocol ID	50
Investigator Name	100
Sponsor	200

Learn More

To deepen your understanding of study management, explore these related guides:

Study Build & Configuration

Manage CRFs (Forms) — Design and configure Case Report Forms
Manage Events — Set up study visits and timelines
Study Group Classes — Configure treatment arms for randomization
Manage Rules — Create edit checks and calculated fields

Study Execution

Subjects — Enroll and manage study participants
Data Entry — Enter and verify clinical data
Queries — Resolve data discrepancies

Administration

User Management — Add, edit, and remove study users
Audit Login — Review system access logs
Randomization Setup — Configure randomization workflows

Overview​

Study Description​

Core Metadata​

Study Type & Enrollment​

Document Requirements​

Default Facility Information​

Facility Details​

Facility Contact​

Study Parameter Configuration​

Subject ID Format​

Configuring Auto-Generated IDs​

Subject Parameters​

Event Parameter Configuration​

Event-Level Parameters​

Email Settings​

New Subject Enrollment Email​

Email Subject Line​

Email Template​

Saving Changes​

Best Practices​

Before Making Changes​

While Making Changes​

After Making Changes​

Regulatory Compliance​

Troubleshooting​

Issue 1: Cannot Save Changes​

Issue 2: Subject ID Not Generating Correctly​

Issue 3: Email Notifications Not Sending​

Issue 4: Date Validation Errors​

Issue 5: Permission Denied​

Quick Reference Guide​

Keyboard Shortcuts​

Field Validation Rules​

Status Indicators​

Character Limits​

Learn More​

Study Build & Configuration​

Study Execution​

Administration​

Overview

Study Description

Core Metadata

Study Type & Enrollment

Document Requirements

Default Facility Information

Facility Details

Facility Contact

Study Parameter Configuration

Subject ID Format

Configuring Auto-Generated IDs

Subject Parameters

Event Parameter Configuration

Event-Level Parameters

Email Settings

New Subject Enrollment Email

Email Subject Line

Email Template

Saving Changes

Best Practices

Before Making Changes

While Making Changes

After Making Changes

Regulatory Compliance

Troubleshooting

Issue 1: Cannot Save Changes

Issue 2: Subject ID Not Generating Correctly

Issue 3: Email Notifications Not Sending

Issue 4: Date Validation Errors

Issue 5: Permission Denied

Quick Reference Guide

Keyboard Shortcuts

Field Validation Rules

Status Indicators

Character Limits

Learn More

Study Build & Configuration

Study Execution

Administration