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SECTION A: SDV vs SDR

Total questions: 100

Worksheet time: 50mins

Name
Class
Date
1.

SDV primarily involves:

a)

Reviewing protocol deviations

b)

Comparing CRF data against source documents

c)

Reviewing audit reports

d)

Database locking

2.

SDR focuses on:

a)

100% verification of data

b)

Validation of EDC systems

c)

Evaluation of data quality and critical processes

d)

Statistical analysis

3.

Under risk-based monitoring, SDR replaces:

a)

All monitoring activities

b)

On-site visits

c)

SDV entirely

d)

Traditional 100% SDV

4.

Which data is typically prioritized for SDV?

a)

Administrative logs

b)

Financial records

c)

Primary efficacy endpoints

d)

Training attendance

5.

SDR is best described as:

a)

Data transcription review

b)

Statistical data cleaning

c)

Holistic review of site processes and data trends

d)

Source document archiving

6.

A key advantage of SDR is:

a)

Increased site workload

b)

Reduced CRA responsibility

c)

Improved efficiency and focus on critical data

d)

Elimination of monitoring plans

7.

Which document defines the SDV/SDR strategy?

a)

CRF Completion Guidelines

b)

Monitoring Plan

c)

Investigator Brochure

d)

Protocol Synopsis

8.

In SDR, missing data trends are identified by:

a)

Line-by-line comparison

b)

Statistical and clinical review

c)

Ethics Committee

d)

Pharmacy staff

9.

SDV is least useful for:

a)

Informed consent verification

b)

Serious adverse event confirmation

c)

Identifying systemic site issues

d)

Endpoint validation

10.

Which approach is emphasized in ICH E6 (R3)?

a)

100% SDV

b)

No on-site monitoring

c)

Risk-based monitoring including SDR

d)

Remote monitoring only

11.

SDR reviews include:

a)

Drug accountability logs only

b)

Data trends, protocol compliance, safety reporting

c)

Investigator CVs

d)

Vendor contracts

12.

An example of critical data for SDR is:

a)

Study budget

b)

Subject initials

c)

Eligibility criteria

d)

Site address

13.

SDV requires:

a)

Access to source documents

b)

Statistical software

c)

Safety database access

d)

TMF ownership

14.

SDR can be performed:

a)

Only on-site

b)

Only by QA

c)

On-site and remotely

d)

Only after database lock

15.

Which is NOT a goal of SDR?

a)

Ensuring subject safety

b)

Identifying systemic errors

c)

Verifying every data point

d)

Assessing data reliability

16.

SDV intensity is usually determined by:

a)

CRA preference

b)

Sponsor SOPs only

c)

Risk assessment

d)

Investigator decision

17.

Which scenario supports reduced SDV?

a)

First-in-human study

b)

High-risk IMP

c)

Well-controlled low-risk study

d)

High SAE rate

18.

SDR findings usually lead to:

a)

Immediate database lock

b)

Root cause analysis

c)

Subject withdrawal

d)

Protocol amendment

19.

SDR focuses more on:

a)

Individual errors

b)

Systemic issues

c)

Typographical mistakes

d)

Formatting errors

20.

Which activity is common to both SDV and SDR?

a)

Statistical programming

b)

Data quality assessment

c)

TMF reconciliation

d)

Site initiation

21.

SDR supports which principle?

a)

Quality by inspection

b)

Quality by design

c)

Total quality management

d)

Post-marketing surveillance

22.

Which data is usually excluded from SDV?

a)

SAEs

b)

Primary endpoint

c)

Non-critical exploratory data

d)

Eligibility criteria

23.

SDR findings are documented in:

a)

Audit reports

b)

Monitoring visit reports

c)

CSR only

d)

Protocol deviation logs

24.

Which role primarily performs SDV/SDR?

a)

Investigator

b)

CRA

c)

Statistician

d)

Ethics Committee

25.

SDR supports early detection of:

a)

Data entry delays

b)

Systemic non-compliance

c)

Budget overruns

d)

Vendor issues

26.

SDV is considered:

a)

Process-focused

b)

Trend-focused

c)

Data-point focused

d)

Outcome-focused

27.

Which is a limitation of SDV?

a)

Identifies systemic risks

b)

Resource intensive

c)

Improves efficiency

d)

Enhances oversight

28.

SDR typically reviews:

a)

Random samples

b)

Entire database line-by-line

c)

Only pharmacy data

d)

Only lab data

29.

Risk-based monitoring aims to:

a)

Eliminate monitoring

b)

Focus on what matters most

c)

Increase SDV

d)

Reduce documentation

30.

Which factor increases SDV need?

a)

Experienced site

b)

Low enrollment

c)

Complex protocol

d)

Automated data capture

31.

SDR complements SDV by:

a)

Replacing audits

b)

Identifying trends SDV may miss

c)

Eliminating queries

d)

Locking data early

32.

Which is reviewed during SDR but not SDV?

a)

Consent signatures

b)

Protocol compliance trends

c)

Source notes

d)

Lab reports

33.

SDV errors usually result in:

a)

CAPA only

b)

Data queries

c)

Site closure

d)

Ethics reporting

34.

SDR supports regulatory expectations by:

a)

Increasing documentation

b)

Enhancing data integrity and subject protection

c)

Eliminating SDV

d)

Reducing CRA oversight

35.

The primary responsibility for IP accountability lies with:

a)

CRA

b)

Sponsor

c)

Investigator/site

d)

Ethics Committee

36.

IP accountability records must document:

a)

Only dispensing

b)

Receipt, storage, dispensing, return/destruction

c)

Budget usage

d)

Randomization only

37.

Temperature excursions should be:

a)

Ignored if brief

b)

Documented and assessed for impact

c)

Reported only at close-out

d)

Corrected without documentation

38.

IP should be stored:

a)

Anywhere convenient

b)

With site supplies

c)

As per protocol and pharmacy manual

d)

In investigator office

39.

The CRA’s role in IP management includes:

a)

Dispensing IP

b)

Accountability verification

c)

Manufacturing IP

d)

Labeling IP

40.

IP labels must include:

a)

Subject name

b)

Study identification and storage conditions

c)

Investigator signature

d)

Price

41.

Reconciliation of IP is performed:

a)

Only at study end

b)

During monitoring visits

c)

Only by sponsor

d)

Only during audits

42.

Blinded studies require:

a)

Open-label dispensing

b)

Controlled access to randomization codes

43.

IP destruction requires

a)

Verbal confirmation

b)

Sponsor authorization

c)

CRA approval

d)

EC approval only

44.

Which document guides IP handling?

a)

Monitoring Plan

b)

Pharmacy Manual

c)

CSR

d)

TMF Index

45.

Drug accountability discrepancies indicate

a)

Minor issue only

b)

Potential compliance risk

c)

Data management issue

d)

Statistical error

46.

IP expiry management is responsibility of

a)

Sponsor only

b)

CRA only

c)

Site with CRA oversight

d)

Ethics Committee

47.

Returned IP should be

a)

Re-dispensed

b)

Destroyed immediately without record

c)

Accounted and stored securely

d)

Given to subjects

48.

IP accountability logs should be

a)

Optional

b)

Retrospectively completed

c)

Accurate and contemporaneous

d)

Maintained by CRA

49.

CRA verifies IP by

a)

Interviewing subjects only

b)

Physical count vs records

c)

Reviewing EDC

d)

Checking CSR

50.

Temperature monitoring devices should be

a)

Optional

b)

Calibrated and documented

c)

Used only during shipment

d)

Ignored

51.

IP shipment receipt should be documented by

a)

Sponsor

b)

Courier

c)

Site staff

d)

CRA

52.

Emergency unblinding should be

a)

Avoided even for safety

b)

Documented and justified

c)

Done by CRA

d)

Done without notification

53.

IP storage access should be

a)

Unrestricted

b)

Limited to authorized personnel

c)

Open to monitors

d)

Shared with lab samples

54.

IP mis-dispensing is classified as

a)

Data query

b)

Protocol deviation

c)

SAE

d)

Audit finding only

55.

CRA identifies repeated IP errors; next step?

a)

Ignore

b)

Document and escalate

c)

Close site

d)

Amend protocol

56.

IP compliance assessment is done by

a)

Pill counts / returns

b)

Lab reports

c)

AE logs

d)

Financial records

57.

IP accountability must reconcile with

a)

Subject diary only

b)

EDC enrollment

c)

Sponsor inventory

d)

All applicable records

58.

Which is critical for blinded IP?

a)

Transparent labeling

b)

Identical appearance

c)

Investigator knowledge

d)

Subject awareness

59.

IP handling deviations must be

a)

Ignored if no impact

b)

Documented and assessed

c)

Deleted

d)

Reported as SAE

60.

CRA review of IP supports

a)

Subject safety

b)

Data integrity

c)

Compliance

d)

All of the above

61.

IP destruction certificates are filed in

a)

Site TMF

b)

Investigator CV

c)

CRF

d)

CSR only

62.

Accountability logs should be

a)

Editable anytime

b)

Signed and dated

c)

Maintained by sponsor

d)

Destroyed post-study

63.

IP recall requires

a)

Immediate subject withdrawal

b)

Controlled communication and documentation

c)

CRA discretion only

d)

No action

64.

CRA ensures IP management complies with:

a)

Site preference

b)

Protocol and regulations

c)

Sponsor budget

d)

Subject request

65.

IP accountability discrepancies may lead to:

a)

CAPA

b)

Audit findings

c)

Regulatory action

d)

All of the above

66.

IP storage conditions are verified by:

a)

Monitoring visits

b)

Statistical review

c)

Ethics committee

d)

CSR writing

67.

IP management documentation retention follows:

a)

Site discretion

b)

Regulatory requirements

c)

CRA preference

d)

Subject consent

68.

Final IP reconciliation is confirmed during:

a)

SIV

b)

IMV

c)

Close-out visit

d)

Database lock

69.

An AE is defined as:

a)

Any unfavorable medical occurrence

b)

Only drug-related events

c)

Only serious events

d)

Protocol deviations

70.

An SAE includes:

a)

Mild headache

b)

Hospitalization

c)

Lab abnormality without symptoms

d)

Protocol deviation

71.

AE causality is assessed by:

a)

CRA

b)

Sponsor

c)

Investigator

d)

Ethics Committee

72.

SAE reporting timelines are:

a)

Flexible

b)

Defined by regulations

c)

Determined by CRA

d)

Optional

73.

All AEs must be:

a)

Reported to EC immediately

b)

Recorded in CRF

c)

Reported to regulator

d)

Ignored if mild

74.

SAE initial report should be:

a)

Complete before submission

b)

Submitted promptly even if incomplete

c)

Submitted after database lock

d)

Submitted by CRA

75.

Unexpected SAEs are:

a)

Expected reactions

b)

Not in IB or label

c)

Always non-related

d)

Protocol deviations

76.

The CRA verifies SAE reporting by:

a)

Medical judgment

b)

Source vs safety database review

c)

Causality assessment

d)

EC approval

77.

AE severity is graded by:

a)

CRA

b)

Sponsor

c)

Investigator

d)

Monitor

78.

Follow-up SAE information should be:

a)

Optional

b)

Submitted as available

c)

Ignored

d)

Submitted annually only

79.

Which AE must be reported as SAE?

a)

Mild nausea

b)

Death

c)

Headache

d)

Injection site pain

80.

Pregnancy in a trial subject is:

a)

AE only

b)

SAE only

c)

Special situation requiring reporting

d)

Protocol deviation only

81.

SAE reconciliation ensures:

a)

Data entry speed

b)

Consistency across records

c)

Budget accuracy

d)

EC approval

82.

AE onset date should reflect:

a)

CRA visit date

b)

First awareness by investigator

c)

Data entry date

d)

Monitoring date

83.

AE outcome includes:

a)

Only recovered

b)

Only fatal

c)

Recovered, ongoing, fatal, unknown

d)

Not required

84.

CRA identifies delayed SAE reporting; action?

a)

Ignore

b)

Document and escalate

c)

Close site

d)

Amend protocol

85.

AE reporting period is defined in:

a)

Protocol

b)

Monitoring Plan

c)

CSR

d)

TMF Index

86.

Safety narratives are required for:

a)

All AEs

b)

SAEs

c)

Minor deviations

d)

All lab abnormalities

87.

Relationship of AE to IP is:

a)

CRA decision

b)

Sponsor decision

c)

Investigator decision

d)

EC decision

88.

SAE reports must be:

a)

Signed by CRA

b)

Medically reviewed

c)

Submitted post-lock

d)

Optional

89.

AE underreporting impacts:

a)

Subject safety

b)

Data integrity

c)

Regulatory compliance

d)

All of the above

90.

Safety data review is part of:

a)

SDV only

b)

SDR and SDV

c)

Database lock

d)

CSR only

91.

AE coding is done using:

a)

WHO-DD only

b)

MedDRA

c)

ICD-10

d)

Free text

92.

CRA reviews AE logs against:

a)

Lab data only

b)

Source notes and CRF

c)

Budget

d)

Monitoring plan

93.

SAE follow-up ends when:

a)

Subject withdraws

b)

Event is resolved or stabilized

c)

Database lock

d)

CRA visit

94.

Which is NOT an SAE criterion?

a)

Death

b)

Hospitalization

c)

Mild transient fever

d)

Life-threatening event

95.

AE documentation should be:

a)

Retrospective

b)

Contemporaneous

c)

Optional

d)

CRA-completed

96.

Safety oversight responsibility ultimately lies with:

a)

CRA

b)

Sponsor and Investigator

c)

Ethics Committee only

d)

Data Manager

97.

Effective AE/SAE management ensures:

a)

Regulatory compliance

b)

Subject protection

c)

Data credibility

d)

All of the above

98.

Reduce SDV should be justified by :

a)

CRA workload

b)

cost constraints

c)

Risk assessment documentation

d)

Site request

99.

Which finding is most critical?

a)

Missing signature

b)

Minor calculation error

c)

Unaccountable IP units

d)

Late entry

100.

Medically important event are :

a)

Always non serious

b)

Considered serious even without hospitalization

c)

Protocol Deviations

d)

Data Errors

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