WorksheetsCRF and eCRF Practices Worksheet
Total questions: 80
Worksheet time: 40mins
The primary purpose of a CRF is to:
Capture source data exactly as recorded
Serve as a legal document for the investigator
Collect protocol-required data in a structured manner
Replace medical records
Which of the following best defines “CRF completion guidelines”?
Instructions for database programmers
Site-specific SOPs
Sponsor-provided instructions on accurate CRF entry
Regulatory submission requirements
A CRA identifies consistent protocol deviations recorded in source but missing in CRF. This represents a failure in:
Data validation
Source data verification
Data consistency and completeness
Medical coding
Which document primarily governs the design and content of a CRF?
Monitoring Plan
Study Protocol
Investigator Brochure
Statistical Analysis Plan
When should a CRA recommend a CRF amendment?
When a site requests it
When data trends indicate ambiguity or missing protocol-required data
After database lock
Only during audits
In eCRF systems, audit trails must record:
Only final data values
Investigator signatures
Who changed data, when, and why
System administrator access only
Which situation most strongly indicates poor CRF design?
High screen failure rate
Frequent data entry queries across multiple sites
Delayed monitoring visits
Missing delegation logs
For which data is 100% SDV most commonly justified in current trials?
Demographics
Exploratory endpoints
Primary efficacy and critical safety data
Concomitant medications
In an eCRF, edit checks are primarily intended to:
Replace CRA review
Prevent incorrect or inconsistent data entry
Lock the database early
Reduce investigator workload
Which data discrepancy should a CRA escalate immediately?
Minor spelling errors
Missing optional data
Serious adverse event not reported in CRF
Late visit window
Who is ultimately responsible for CRF data accuracy at the site?
CRA
Data manager
A change made directly in eCRF without source documentation is:
Acceptable if signed later
Allowed for non-critical data
A violation of ALCOA+ principles
Sponsor-dependent
Which ALCOA+ principle is most directly supported by eCRF audit trails?
Accurate
Legible
Contemporaneous
Attributable
In risk-based monitoring, CRF review should focus primarily on:
All fields equally
Financial data
Critical data and processes
Historical data only
If a site consistently delays eCRF entry, the CRA should FIRST:
Raise a protocol deviation
Inform the sponsor immediately
Assess root cause and retrain site staff
Lock the site
Which role typically performs medical coding linked to CRF data?
CRA
Investigator
Data management team
Ethics committee
Which scenario best demonstrates correct query resolution?
CRA resolves query on behalf of site
Site deletes incorrect data without explanation
Investigator updates data with justification
Sponsor overrides site response
In eCRF systems, role-based access control ensures:
Faster data entry
Better audit readiness
Users can only perform authorized functions
Reduced monitoring visits
CRF/eCRF data are considered source data when:
Printed and signed
Defined as source in the protocol
Verified by CRA
Uploaded to TMF
During an inspection, incomplete CRFs primarily raise concerns related to:
Investigator workload
Trial timelines
Data integrity and subject safety
Budget management
An Adverse Event (AE) is best defined as:
Any untoward medical occurrence causally related to IP
Any untoward medical occurrence in a subject administered a product, regardless of causality
Any event leading to hospitalization
Any protocol deviation affecting safety
A Serious Adverse Event (SAE) is identified primarily based on:
Severity
Expectedness
Seriousness criteria
Causality
Which of the following is NOT a seriousness criterion?
Death
Life-threatening event
Requires hospitalization
Severe headache
Under NDCT Rules 2019, an SAE must be reported by the investigator to the sponsor within:
12 hours
24 hours
7 calendar days
14 calendar days
As per NDCT, the investigator must report SAE details to CDSCO, Ethics Committee, and Sponsor within:
24 hours
48 hours
7 calendar days
14 calendar days
In India, the responsibility for determining SAE compensation lies with:
Investigator
Sponsor
Ethics Committee
Central Licensing Authority (CDSCO)
Which document is critical for assessing SAE causality?
Monitoring Plan
Informed Consent Form
Investigator Brochure
Site SOP
An event that prolongs existing hospitalization is classified as:
AE
Non-serious AE
SAE
Protocol deviation
A medically important event that does not result in hospitalization may still be an SAE if it:
Is mild
Is unrelated
Requires intervention to prevent serious outcome
Is expected
Who is ultimately responsible for SAE reporting at the site?
CRA
Study coordinator
Investigator
Sponsor
Which AE must always be reported as an SAE?
Grade 3 nausea
Death due to disease progression
Mild rash
Laboratory abnormality without symptoms
Expectedness of an SAE is determined using the:
Protocol
CRF
Investigator Brochure
Monitoring Plan
Under ICH-GCP E6 (R3), safety reporting emphasizes:
Paper-based reporting
Real-time risk management
100% SDV
Site-level decision making
A CRA identifies an SAE recorded in source but not reported. This represents:
Documentation delay
Data entry issue
Serious GCP non-compliance
Minor protocol deviation
Which timeline applies for sponsor reporting of fatal or life-threatening SUSARs to regulators (ICH)?
24 hours
7 calendar days
10 calendar days
15 calendar days
Non-fatal, non–life-threatening SUSARs must be reported within:
7 days
10 days
14 days
30 days
Which of the following is NOT part of SAE initial report requirements?
Subject identifier
Event description
Detailed root cause analysis
Onset date
Follow-up SAE reports are required when
The CRA requests them
New significant information becomes available
Database is locked
EC meeting is scheduled
A pregnancy during a clinical trial is
Always an SAE
Never reportable
An AE of special interest
A protocol deviation
Which role ensures that SAEs are included in Development Safety Update Reports (DSUR)?
CRA
Investigator
Sponsor
Ethics Committee
Severity grading of AEs is usually based on
Investigator judgment only
Regulatory requirement
Predefined grading scale (e.g., CTCAE)
Sponsor discretion
An SAE occurring after study completion but related to IP should be
Ignored
Reported per protocol and regulations
Reported only if fatal
Documented as deviation
Which principle ensures traceability of SAE changes in eCRF?
Completeness
Timeliness
Audit trail
Medical coding
An AE that worsens in intensity should be recorded as
A new AE
Continuation without change
Updated AE with increased severity
SAE automatically
Who is responsible for medical review of SAEs at sponsor level?
CRA
Pharmacovigilance physician
Data manager
Ethics Committee
Which scenario most likely triggers a regulatory inspection finding?
Late query resolution
Missing AE end date
Unreported SAE
Typographical error
An AE judged unrelated to IP still requires reporting if it is
Expected
Serious
Mild
Chronic
Under NDCT, compensation is applicable when SAE is
Expected
Mild
Related to clinical trial
Due to negligence only
Which document guides SAE reporting workflow and timelines?
Monitoring Plan
Safety Management Plan
Delegation Log
Financial Agreement
A CRA’s PRIMARY role in SAE management is to
Assess causality
Enter SAE data
Ensure timely reporting and compliance
Approve compensation
Which AE requires expedited reporting?
Expected AE
Non-serious AE
SUSAR
Resolved AE
An SAE narrative should primarily describe
Financial impact
Regulatory opinion
Clinical course and outcome
Monitoring findings
Which factor does NOT affect SAE causality assessment?
Temporal relationship
Dechallenge/rechallenge
Monitor opinion
Alternative etiology
Under ICH-GCP E6 (R3), safety oversight is best supported by:
Retrospective review
Risk-based approach
Paper documentation
CRA-only review
An AE recorded only in progress notes but not in CRF indicates a lapse in:
Source documentation
Data reconciliation
Data completeness
Protocol adherence
Which committee reviews cumulative safety data at sponsor level?
Ethics Committee
Data Monitoring Committee (DMC)
CRA team
Site management
Which AE outcome must always be followed until resolution or stabilization?
Mild AE
Expected AE
SAE
Screen failure AE
Failure to report an SAE within timelines may result in:
Data query
Monitoring visit
Regulatory action
Database delay only
Which of the following best reflects ALCOA+ in SAE documentation?
Handwritten notes
Delayed entry
Attributable, contemporaneous recording
Monitor verification
During inspection, regulators most commonly verify SAE compliance by reviewing:
Monitoring reports
Safety narratives and reporting timelines
CRA visit frequency
Financial records
The primary ethical principle underlying informed consent is:
Beneficence
Justice
Respect for persons (autonomy)
Non-maleficence
As per ICH-GCP E6 (R3), informed consent must be obtained:
After enrollment
Before any trial-related procedures
Before randomization only
Before first dose only
Under NDCT Rules 2019, who is responsible for obtaining informed consent?
CRA
Study coordinator
Which of the following is NOT a mandatory element of an ICF?
Purpose of the study
Potential risks and benefits
Investigator’s financial disclosures
Voluntary participation and right to withdraw
Informed consent must be documented by:
Verbal agreement only
Subject signature and date
Subject and investigator/designee signatures and dates
CRA confirmation
When must a revised ICF be implemented at the site?
After sponsor approval only
After Ethics Committee approval
After CRA approval
After database lock
Re-consent of trial participants is required when:
The study timeline changes
New safety information becomes available
Monitoring frequency increases
Site staff changes
According to NDCT, audio-visual (AV) recording of consent is mandatory for:
All clinical trials
Phase IV studies only
Vulnerable populations and new chemical entities (as applicable)
Bioavailability studies only
The language of the ICF should be:
English only
Technical and precise
Understandable to the subject
As per sponsor preference
Who should receive a copy of the signed informed consent form?
Sponsor only
CRA only
Trial subject
Ethics Committee only
If a subject is illiterate, informed consent must include:
Thumb impression only
Signature of a legally acceptable representative
An impartial witness signature
CRA signature
Which situation represents invalid informed consent?
Consent obtained before screening
Consent obtained after explaining risks and benefits
Consent obtained after trial-related procedure
Consent documented with signatures and dates
Under ICH-GCP E6 (R3), informed consent is viewed as:
A one-time signature process
An administrative requirement
An ongoing process throughout the trial
A sponsor responsibility
The CRA’s PRIMARY responsibility regarding ICF is to:
Obtain consent
Translate the consent form
Verify proper consent process and documentation
Approve consent versions
Which element must be clearly explained in the ICF regarding compensation?
Sponsor profits
Financial incentives for participation
Compensation for trial-related injury
CRA payments
If a subject withdraws consent, the investigator should:
Destroy all collected data
Stop trial procedures and document withdrawal
Continue safety follow-up without consent
Replace the subject immediately
Who approves the final ICF before use at a site?
Sponsor only
CRA
Ethics Committee
Data Management
Which is a common inspection finding related to ICFs?
Late monitoring visit
Missing subject initials
Use of outdated ICF version
Delayed database lock
Under NDCT, consent must be obtained from a Legally Acceptable Representative (LAR) when:
Subject is elderly
Subject is illiterate
Subject is unable to give informed consent
Subject refuses participation
The principle of voluntariness in informed consent ensures that:
Subjects receive financial benefit
Participation is free from coercion or undue influence
Subjects complete the trial
Sponsor obligations are fulfilled
