wayground logo

Free Printable Worksheets

Font size

S
M
L
XL
Worksheets

ASSESMENT 28.01.2026

Total questions: 92

Worksheet time: 46mins

Name
Class
Date
1.

The primary purpose of source notes in a clinical trial is to:

a)

Help sponsors with marketing

b)

Record data before entering into CRF/EDC

c)

Replace the CRF

d)

Reduce monitoring visits

2.

Source documents are best defined as:

a)

Any trial-related email

b)

Original records where trial data is first recorded

c)

Copies of CRFs

d)

Sponsor-provided templates only

3.

Which of the following is considered a source document?

a)

Monitor visit report

b)

Signed ICF

c)

Query log

d)

Investigator brochure

4.

ALCOA+ in source documentation stands for all EXCEPT:

a)

Attributable

b)

Legible

c)

Consistent

d)

Original

5.

“Attributable” means:

a)

Data is signed by sponsor

b)

It is clear who recorded the data

c)

Data is stored electronically

d)

Data is reviewed by PI

6.

The best time to document a clinical assessment in source notes is:

a)

At end of day

b)

During monitoring visit

c)

Immediately after the assessment

d)

Before entering in CRF

7.

Late entries in source notes should be:

a)

Avoided and never documented

b)

Written without date

c)

Clearly marked as late entry with current date and reason

d)

Backdated to visit date

8.

Backdating source notes is:

a)

Acceptable if PI approves

b)

Allowed for missed vitals

c)

Considered data falsification

d)

Permitted in emergencies

9.

Which correction method is GCP-compliant?

a)

Erasing incorrect data

b)

Using correction fluid

c)

Single line through error, initial, date, reason (if needed)

d)

Overwriting data

10.

Electronic source data must have:

a)

Password sharing

b)

Audit trail

c)

Editable logs

d)

Sponsor access at all times

11.

Who is ultimately responsible for source documentation at the site?

a)

Sponsor

b)

CRC

c)

PI

d)

Monitor

12.

A source note template provided by sponsor:

a)

Is mandatory to use

b)

Replaces medical records

c)

Supports but does not replace routine medical documentation

d)

Can be modified without approval

13.

If a patient forgets to report a symptom during visit but calls next day, CRC should:

a)

Ignore

b)

Document in source as late entry with date/time of call

c)

Backdate to visit date

d)

Wait for monitor advice

14.

Source notes must allow reconstruction of:

a)

Sponsor profits

b)

Entire clinical trial conduct at site

c)

Monitoring schedule

d)

CRO contracts

15.

Which is NOT typically documented in source notes?

a)

Adverse events

b)

Concomitant medications

c)

Monitor travel details

d)

Study procedures performed

16.

When documenting AEs, CRC must include:

a)

Only severity

b)

Only outcome

c)

Onset date, severity, action taken, outcome

d)

Sponsor’s opinion

17.

Concomitant medication documentation must include:

a)

Brand name only

b)

Indication, dose, route, start/stop dates

c)

Pharmacy address

d)

Cost of drug

18.

Source documentation should be written using:

a)

Pencil

b)

Blue/black permanent ink

c)

Red ink

d)

Highlighter

19.

Illegible source notes may lead to:

a)

Faster approvals

b)

Minor issue only

c)

Major audit finding

d)

No impact

20.

Who can make entries in source notes?

a)

Only PI

b)

Only CRC

c)

Delegated and trained study staff

d)

Monitor

21.

Delegation of authority log is important because it:

a)

Tracks salary

b)

Identifies who is authorized to document data

c)

Is required only by sponsor

d)

Replaces training log

22.

Temperature logs for IP storage are:

a)

Regulatory only

b)

Financial records

c)

Source documents

d)

Optional

23.

A blank source note section for a visit should be:

a)

Left empty

b)

Crossed out with N/A

c)

Torn out

24.

Retrospective reconstruction of source data from memory is:

a)

Good practice

b)

Acceptable if PI signs

c)

Unacceptable

d)

Required for audits

25.

Which is an example of original source?

a)

Photocopy of lab report

b)

Transcribed vitals sheet

c)

First lab report from lab

d)

CRF printout

26.

Certified copies must be:

a)

Signed by monitor

b)

Verified as exact copy of original

c)

Kept only by sponsor

d)

Color photocopies

27.

Investigator oversight of source notes should include:

a)

Signing blank pages

b)

Periodic review and sign-off

c)

Letting CRC handle all

d)

Reviewing only at close-out

28.

Source notes for screening failures should be:

a)

Destroyed

b)

Maintained as per protocol

c)

Sent to sponsor

d)

Optional

29.

If lab normal ranges change during study:

a)

No action needed

b)

Document new ranges with effective date

c)

Use old ranges

d)

Inform sponsor only

30.

Which supports data credibility most?

a)

Verbal confirmation

b)

Memory-based notes

c)

Contemporaneous documentation

d)

Sponsor emails

31.

Missing source data detected by monitor should be addressed by:

a)

Ignoring

b)

Creating backdated entry

c)

Writing late entry with explanation

d)

Asking sponsor to remove data

32.

If BP machine was malfunctioning during visit:

a)

Do not record BP

b)

Estimate value

c)

Document issue and repeat measurement with working device

d)

Copy previous visit value

33.

Source notes should document protocol deviations:

a)

Only major ones

b)

Only if monitor asks

c)

All deviations with explanation

d)

None

34.

The most common reason for source documentation findings in audits is:

a)

Too much detail

b)

Illegible handwriting

c)

Missing or inconsistent data

d)

Excess signatures

35.

For electronic medical records used as source:

a)

Print everything

b)

Ensure access and audit trail availability

c)

Allow editing anytime

d)

Share passwords

36.

Source notes must reflect informed consent process including:

a)

Only signature

b)

Date/time of consent and version used

c)

Sponsor approval

d)

Monitor presence

37.

If patient vomits dose at site:

a)

Ignore

b)

Document in source with time and action taken

c)

Only update CRF

d)

Inform sponsor only

38.

Which is NOT part of good source note practice?

a)

Chronological order

b)

Clear visit identification

c)

Copying previous visit text without verification

d)

Investigator review

39.

Source notes should allow an independent person to:

a)

Predict results

b)

Reconstruct trial conduct

c)

Identify sponsor strategy

d)

Approve protocol

40.

Visit windows missed should be:

a)

Ignored

b)

Adjusted in CRF only

c)

Documented with reason in source

d)

Hidden from monitor

41.

Telephone follow-up assessments should be:

a)

Not documented

b)

Entered only in CRF

c)

Documented in source with date/time

d)

Recorded by sponsor

42.

Use of abbreviations in source notes should be:

a)

Unrestricted

b)

Site-standard and understandable

c)

Sponsor-defined only

d)

Avoided completely

43.

When PI reviews source notes, it demonstrates:

a)

Data entry

b)

Oversight and responsibility

c)

Sponsor monitoring

d)

Budget approval

44.

If subject refuses a procedure:

a)

Leave blank

b)

Mark “not done” without reason

c)

Document refusal and reason if given

d)

Remove subject

45.

Source notes must match CRF data because:

a)

Sponsor demands

b)

They are verified during SDV

c)

CRC prefers

d)

Saves time

46.

A missing signature on source notes may indicate:

a)

Efficient documentation

b)

Lack of attribution

c)

Monitor oversight

d)

Sponsor issue

47.

Which is an example of contemporaneous documentation?

a)

Writing visit details 3 days later

b)

Entering vitals during patient visit

c)

Filling after monitor reminder

d)

Copying from memory

48.

Source data verification compares:

a)

Protocol vs IB

b)

Source vs CRF/EDC

c)

Budget vs contract

d)

SOP vs GCP

49.

If multiple staff document in source, each must:

a)

Use same handwriting

b)

Initial/date their entries

c)

Inform sponsor

d)

Avoid signatures

50.

Good source documentation ultimately protects:

a)

Sponsor revenue

b)

CRC workload

c)

Subject safety and data integrity

d)

Monitor schedule

51.

The primary responsibility for IP accountability at site lies with:

a)

Sponsor

b)

Monitor

c)

Principal Investigator

d)

Pharmacist only

52.

The IP accountability log should record:

a)

Only dispensing dates

b)

Receipt, dispensing, return, and balance

c)

Subject medical history

d)

Monitor visit dates

53.

When IP is received at site, the CRC should FIRST:

a)

Dispense to subjects

b)

Inform sponsor finance team

c)

Verify quantity, batch number, and condition

d)

Store in general pharmacy

54.

If IP shipment arrives with damaged outer packaging, CRC should:

a)

Accept and store

b)

Dispense immediately

c)

Quarantine and inform sponsor

d)

Discard

55.

Temperature excursions for IP must be:

a)

Ignored if short

b)

Documented and reported to sponsor

c)

Corrected by adjusting log

d)

Hidden from monitor

56.

Access to IP storage should be limited to:

a)

All study staff

b)

Only PI

c)

Authorized and delegated personnel

d)

Monitor

57.

IP storage temperature should be recorded:

a)

Weekly

b)

Only during monitoring visits

c)

Daily (or per protocol/SOP)

d)

Only when excursion occurs

58.

If subject loses IP tablets at home, CRC should:

a)

Ignore

b)

Dispense more without note

c)

Document loss and inform sponsor/PI

d)

Adjust accountability log quietly

59.

The IP label must contain all EXCEPT:

a)

Protocol number

b)

Subject name

c)

Storage conditions

d)

Expiry/retest date (if applicable)

60.

Blinded IP should be handled in a way that:

a)

Allows CRC to know treatment

b)

Prevents accidental unblinding

c)

Lets subject choose treatment

d)

Avoids documentation

61.

Unblinded staff must:

a)

Participate in efficacy assessments

b)

Be separated from blinded assessments

c)

Discuss allocation with subjects

d)

Report directly to sponsor only

62.

IP dispensing must follow:

a)

Subject preference

b)

Monitor instructions

c)

Protocol and prescription by investigator

d)

Sponsor email only

63.

If subject takes wrong dose accidentally, CRC must:

a)

Replace tablets silently

b)

Document as protocol deviation and inform PI

c)

Remove subject immediately

d)

Adjust log only

64.

IP accountability reconciliation should occur:

a)

Only at study end

b)

During each monitoring visit and close-out

c)

Only when sponsor asks

d)

Never at site

65.

IP expiry date check is important because it ensures:

a)

Sponsor compliance

b)

Drug stability and subject safety

c)

Faster enrollment

d)

Easier storage

66.

Expired IP should be:

a)

Dispensed if close to expiry

b)

Destroyed immediately without documentation

c)

Quarantined and sponsor notified

d)

Mixed with new stock

67.

The drug accountability log should always show:

a)

Zero discrepancies

b)

Running balance of IP

c)

Sponsor signature

d)

Subject diagnosis

68.

A discrepancy in IP count means:

a)

Monitor error

b)

CRC must adjust numbers

c)

Investigation and documentation required

d)

Sponsor is responsible

69.

IP returned by subject should be:

a)

Discarded immediately

b)

Counted, documented, and stored separately

c)

Given to another subject

70.

Subject compliance is often assessed by:

a)

Verbal confirmation only

b)

Pill count and diary review

c)

Sponsor report

d)

Lab tests only

71.

If subject forgets to bring IP for return visit:

a)

Skip documentation

b)

Estimate compliance

c)

Document and request return at next visit

d)

Replace full quantity

72.

IP should be stored:

a)

In open shelf

b)

With routine hospital medicines

c)

In secure, access-controlled area

d)

In investigator office drawer

73.

Refrigerated IP must be stored with:

a)

Food

b)

Vaccines

c)

Temperature monitoring device

d)

Water bottles

74.

If temperature log shows freezer at -5°C instead of required -20°C:

a)

Ignore if brief

b)

Immediately inform sponsor and quarantine IP

c)

Adjust log

d)

Move IP without record

75.

Who can prescribe IP to subject?

a)

CRC

b)

Sponsor

c)

Investigator/Sub-investigator per delegation

d)

Pharmacist only

76.

Subject-specific dispensing logs are useful for:

a)

Billing

b)

Monitoring staff attendance

c)

Tracking individual IP assignment

d)

Sponsor inventory only

77.

In double-blind trials, emergency unblinding should occur:

a)

For curiosity

b)

Only when medically necessary

c)

At subject request

d)

At monitor visit

78.

Documentation of emergency unblinding must include:

a)

Sponsor budget

b)

Reason, date, and personnel involved

c)

Monitor signature

d)

New protocol version

79.

IP destruction at site must be:

a)

Done by CRC alone

b)

Documented and authorized per sponsor instructions

c)

Immediate after last visit

d)

Optional

80.

If sponsor requests IP return instead of destruction:

a)

Refuse

b)

Ship without documentation

c)

Follow sponsor procedure with records

d)

Destroy anyway

81.

IP shipment documentation should be filed in:

a)

Subject file

b)

Pharmacy only

c)

Investigator Site File (ISF)

d)

Sponsor TMF only

82.

If kit numbers are pre-assigned via IWRS, CRC must:

a)

Choose any kit

b)

Follow IWRS allocation strictly

c)

Use smallest expiry

d)

Ask subject preference

83.

IWRS helps with:

a)

Budget tracking

b)

Randomization and IP assignment

c)

Temperature monitoring

d)

AE reporting

84.

If CRC dispenses wrong kit number:

a)

Ignore if same drug

b)

Document medication error and inform PI/sponsor

c)

Adjust accountability log only

d)

Replace kit quietly

85.

IP storage area should have:

a)

Open access

b)

Backup power (if temperature controlled)

c)

Sponsor branding

d)

Windows open

86.

Accountability logs must be:

a)

Completed by monitor

b)

Completed in pencil

c)

Contemporaneous and accurate

d)

Rewritten if messy

87.

A subject should NEVER:

a)

Return unused IP

b)

Share IP with another person

c)

Bring diary

d)

Report side effects

88.

If IP is stolen from site:

a)

Replace stock quietly

b)

Document incident and notify sponsor immediately

c)

Hide loss

d)

Wait for monitoring visit

89.

The purpose of IP reconciliation is to:

a)

Match sponsor inventory

b)

Ensure all IP is accounted for

c)

Reduce storage space

d)

Speed enrollment

90.

If subject overdoses IP accidentally:

a)

Ignore if mild

b)

Document and inform PI immediately

c)

Remove subject from study

d)

Adjust logs only

91.

Drug accountability errors are considered:

a)

Minor paperwork issue

b)

Serious GCP compliance issue

c)

Sponsor responsibility

d)

Financial issue only

92.

IP labels should not be altered because:

a)

Sponsor prints them

b)

It may affect blinding and compliance

c)

CRC is not allowed to write

d)

They look official

Similar Resources on Wayground

1-10 vocab_AVCN2

96 questions

1-10 vocab_AVCN2

quiz

Worksheet

•

Professional Development