SDV (Source Data Verification)

Why are the Unverified labels greyed out on my CRF?

This usually happens when:

1. The CRF is not Completed. Items can be verified only after the CRF is marked complete.
2. Permissions. Your role may not include SDV verification rights. Contact your study administrator.

If the items are verified but Source Data Verify is disabled, the CRF may have open queries while the study setting Allow SDV when Queries is open is set to No.

Why is the Event view of Source Data Verification empty?

• No subject CRF data has been saved yet for SDV-eligible forms.
• SDV is not configured — review SDV Setup.
• All CRFs in scope have already been verified. Switch filter to show Verified items.

Why is Verify not available for a subject?

Verify appears on the Subject view only when the subject's CRF-level SDV requirements are met — at least one complete event with all its required CRFs verified, or all required CRFs when the study setting Allow SDV a subject when CRF is not Verified is No. Complete CRF-level verification on the Event view first.

What's the difference between CRF-Level and Item-Level SDV?

Mode	Scope	Use Case
CRF-Level	All fields in the CRF must be verified	Standard SDV, high-risk studies
Item-Level	Only specific items (Partial required)	Risk-based monitoring, large CRFs

Item-Level SDV is configured per CRF in the event wizard by setting Source Data Verification to Specific Items. See SDV Setup.

Can I perform SDV on mobile?

Yes, if the study has mobile SDV enabled. Use the CDS Staff Mobile App (iOS/Android). Requires network connectivity — SDV actions sync in real-time.

How do I bulk-verify multiple CRFs?

On the Event view of the Source Data Verification page, select checkboxes for multiple rows and click Verify Selected. Un-Verify Selected clears verification the same way, and both work for subjects on the Subject view.

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Monitoring Visit

Why can't I create a new monitoring visit report?

Check these items:

1. Visit type is active — verify in Monitoring Visit Configuration.
2. CRF name and version are configured for the visit type — without these, report creation is blocked.
3. Visit dependency rules — a prerequisite visit may not be completed (e.g., SIV must be approved before SMV).
4. Role — creating a monitoring visit report requires a role that can manage monitoring visit reports. Available to:Project ManagerSite MonitorStudy AdministratorStudy MonitorSystem Administrator(default roles — your study may differ)

How do I send a report to the sponsor for approval?

The report must go through the full workflow:

1. Draft → Completed (CRA/Monitor marks content complete)
2. Completed → Reviewed (Reviewer assesses quality)
3. Reviewed → Finalized (Reviewer prepares sponsor package — this is the "send to sponsor" step)
4. Finalized → Approved (Sponsor-side approver accepts)

Each transition requires a status note. See Role-Based SOP.

What happens when a report is rejected?

A rejected report returns to Draft status. The rejecting user must provide a note explaining why. The CRA/Monitor then addresses the feedback and restarts the workflow from Draft → Completed.

How do I close a monitoring issue?

1. Open the issue from the Issues list or report sidebar
2. Add Updated Action describing what was done to resolve
3. Set Resolution Date
4. Click Close Issue

Closed issues can be reopened if follow-up is needed.

What's included in a Close-Out Visit?

A close-out visit verifies:

• All subject data entered and verified
• All queries resolved
• All SDV completed
• All IMP accounted for (dispensed, returned, wasted)
• Site file completeness
• Equipment/device accountability

A close-out visit report follows the same status workflow as other visit types; see the Step-by-Step Handoff.

How do remote monitoring visits work?

Remote visits follow the same workflow as on-site visits but are conducted without physical site presence. Configure a dedicated visit type (e.g., "Remote Monitoring Visit") and note "Remote Visit" in the report. Source document review is done via shared screen or portal. See Configure Visit Types and the Step-by-Step Handoff.

Why am I not receiving email notifications for report status changes?

Check the notification configuration:

1. Go to Visit Configuration → Edit for the visit type
2. Verify Email the recipient when the report status updates is enabled
3. Confirm your role is selected as a recipient
4. Check Specific People if ad-hoc emails are used

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General

How do I get access to a module I don't see?

Contact your Study Administrator. Module visibility is controlled by:

• Study configuration (app installation/enablement)
• Role permissions
• Study status (Design vs. Production mode)

Where can I find the audit trail for data changes?

Audit trails are accessible from:

• Study Audit Logs — per-subject history of every subject, event and CRF change
• SDV Events — SDV-specific verification history
• Monitoring Visit Reports — report status change history with notes

The Casebook shows the current data of a subject in one read-only view and exports it to PDF; it does not show the change history.

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Medical Coding

Why are some terms showing "Code Not Found"?

This means the auto-coder and manual search could not find a matching code in the configured dictionary. Common causes:

1. Typo in verbatim term — check the original CRF entry
2. Term not in dictionary — the dictionary may not include this specific term
3. Dictionary version outdated — a newer dictionary version may include the term
4. Regional variant — the term may use a regional name not in the dictionary

Solution: Create an alias mapping the verbatim term to a synonym that exists in the dictionary, or update the dictionary version.

What's the difference between Auto Code and Manual Search?

Method	How It Works	Best For
Auto Code	System matches all unresolved terms against dictionary automatically	High-volume bulk processing, exact matches
Manual Search	Coder searches dictionary by keyword and selects preferred term	Ambiguous terms, context-dependent coding

Auto Code runs first to clear the easy matches. Manual search handles the remaining difficult cases.

How do I handle the same verbatim term needing different codes?

This can happen when the same term has different meanings in different contexts. For example, "Cold" could mean a temperature sensation or a viral illness.

1. Review the Event, CRF, and Item columns to understand the context
2. Assign the context-appropriate code
3. If Code with context is enabled in configuration, the auto-coder considers these fields
4. Document the rationale in a coding note for consistency review

Can I create my own custom dictionary?

Yes. In Medical Coding Setup:

1. Go to the Dictionary section
2. Under Custom Dictionaries, click Add Dictionary
3. Import a CSV with code, preferred name, and synonyms
4. Custom dictionaries are available alongside MedDRA and WHODrug

How do I unlock a term that was coded incorrectly?

Only Lead Coders and Data Managers can unlock terms:

1. Locate the locked term in the coding workspace
2. Click the Action button
3. Select Unlock
4. Provide a reason in the note dialog
5. The term returns to Not Coded for re-coding

All unlock actions are recorded in the audit trail.

Why did Auto Code miss some obvious matches?

Possible reasons:

1. Approval Needed is Yes — terms are coded but awaiting approval before showing as Coded
2. Code with context is enabled — system requires contextual match, not just verbatim match
3. Dictionary connectivity — BioPortal API may be temporarily unavailable
4. Special characters — terms with unusual characters may not match

Check the auto-code results or run auto-code again after resolving dictionary connectivity.

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Pre-Screening & eConsent

Why can't I send a consent invitation?

Check these items:

1. Consent form is Published — forms in Draft status cannot be sent. Go to e-Consent Setup and publish the form.
2. Email is collected — the participant record must have a valid email address.
3. Auto-invite conflicts — if auto-invite is enabled, manual invitations may be restricted.
4. Study status — the study must be in Available status.

Can a participant sign consent remotely?

Yes. eConsent supports remote signing:

1. CRC sends the invitation email to the participant
2. Participant opens the form link on any web browser or mobile device
3. Participant reviews the ICF and signs electronically
4. CRC can guide the participant via phone/video call during the process

The audit trail records that consent was obtained remotely.

How do I handle re-consent after a protocol amendment?

1. Study Admin publishes the new ICF version in e-Consent Setup
2. Archive the old ICF version (do not delete — retained for audit)
3. Identify participants who signed the old version
4. Send a new invitation with the updated form
5. Participant signs the new version
6. Both old (Archived) and new (Consented) records are preserved

See the Re-Consent Workflow for detailed steps.

What happens when a participant withdraws consent?

• Consent Status changes to Withdrawn
• Data already collected is retained per regulatory requirements
• New data collection stops — no new CRFs can be submitted
• The withdrawal date, reason, and user are recorded in the audit trail
• The participant remains in the Screening list for reporting

How many languages can I publish a consent form in?

There is no hard limit. For each ICF version, you can create language variants:

1. Go to e-Consent Setup → Consent Forms
2. Click Add Form for each language
3. Use the same ICF name and version number
4. Select the target language for each variant
5. Publish all language versions

The system can auto-detect a participant's language preference and route them to the correct form.

Why is the enrollment button disabled?

The most common reason is that the participant's Consent Status is not Consented. The enrollment requires:

1. Consent form signed (status = Consented)
2. All required screening data collected
3. Treatment arms configured in the study

If the message says "Screening subject is not consented," complete the consent signing process first.

How do I verify a signature is valid?

eConsent signatures in CDS comply with 21 CFR Part 11 requirements:

• Attributable — linked to the participant's email and screening record
• Legible — printed name captured alongside signature image
• Contemporaneous — timestamp recorded at signing
• Original — signature image stored as original record
• Accurate — form version, date, and signature method documented

All signature data is viewable in the participant's Consent Information section.

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Analytics & Dashboards

What metrics are available on the Study Dashboard?

The Study Dashboard provides real-time widgets for:

• Subjects — total enrolled, status distribution
• Events — completion status across all subjects
• Queries — open, answered, closed counts and by CRF
• SDV — verified vs. not verified
• Enrollment by Site — per-site enrollment progress
• Randomization — randomized subjects count

Each widget is clickable — drill down to the underlying data list.

Can I customize which widgets appear on the dashboard?

Yes. Study Administrators can configure:

1. Open Study Settings → Dashboard
2. Toggle widgets on/off per role
3. Reorder widgets by drag-and-drop
4. Set the default date range

Different roles see different widgets based on their responsibilities.

How do I export dashboard data?

1. Click Export as on any chart section
2. Choose format: CSV (data) or PNG (chart image)
3. For the full dashboard, use Print Dashboard for a print-friendly layout

Is there a cross-study analytics view?

Yes, the Portfolio Dashboard (Home → Analytics) aggregates data across all studies you have access to. It shows:

• Total enrollment across studies
• Enrollment rates
• Query rates and SDV completion rates
• Database lock projections

Why does my dashboard show different numbers than the Subjects list?

The dashboard widget counts may differ from filtered lists due to:

1. Caching — dashboard data refreshes periodically, not in real-time
2. Permission scope — widgets may show study-wide data while your list view is site-scoped
3. Status definitions — widgets may use different status groupings

Click a widget to see the exact list of records it's counting.

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CDS Surveys (PRO/ePRO)

How do participants access surveys?

There are two access methods:

1. Public URL — a shareable link; participants don't need a CDS account
2. Email Invitation — sent via Survey Package; participant clicks the link in the email

Both methods work on web browsers and mobile devices. For app-based access, surveys also appear in the CDS Mobile App.

What's the difference between a Survey Package and a Participant Group?

Component	Purpose
Survey Package	Defines what to send — which surveys, email content, and schedule
Participant Group	Defines who receives it — which subjects, from which site

A Survey Package is assigned to one or more Participant Groups. When the package is sent, all participants in the assigned groups receive the surveys.

How do I set up automated survey delivery?

1. Create the survey in CDS Surveys Setup
2. Create a Participant Group with the target subjects
3. Create a Survey Package including the survey
4. In the package schedule, choose:
   • One-time — specific date and time
   • Recurring — daily, weekly, monthly
   • Event-triggered — on enrollment, randomization, etc.
5. Assign the participant group to the package
6. The system sends surveys automatically per the schedule

Can I use skip logic and branching in surveys?

Yes. In the CRF builder:

1. Open the survey CRF
2. Configure Skip Logic — skip questions based on previous answers
3. Configure Branching — route to different sections based on responses
4. Use Show/Hide Logic — conditionally display items

Test all logic branches in Design mode before publishing to Production.

How do I track survey completion rates?

1. Open the Surveys worklist
2. Filter by date range and status
3. Key metrics:
   • Sent — surveys awaiting response
   • Completed — fully submitted
   • Expired — link expired before completion
4. Click Export as to download data for analysis

Cross-reference with Participant Group membership to calculate per-group completion rates.

Can I resend a survey to a participant who hasn't completed it?

Yes:

1. Find the participant's survey record in the Surveys worklist
2. Check the current status — if Sent or Expired
3. Click Resend in the Action column
4. A new invitation email is sent with a fresh link

For bulk resends, create a new Participant Group with non-responders and trigger the Survey Package again.

Can participants complete surveys on mobile devices?

Yes. Surveys are mobile-responsive and can be completed:

• Via the CDS Mobile App (iOS/Android) — surveys appear in the app
• Via mobile web browser — public URL or email link opens in any browser

The mobile experience is optimized for touch input and smaller screens.

How do I export survey response data?

1. From the Surveys worklist, click Export as
2. Choose CSV or Excel
3. For detailed responses per participant, open the survey CRF via Subjects → Event → CRF
4. Use Data Export for bulk extraction of survey CRF data

Survey response data is stored as CRF data and can be included in standard data exports.