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ePRO study materials
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ePRO practice questions

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Question 1ePRO (electronic patient-reported outcomes)

In an ePRO system, what does the term 'eDiary' most specifically refer to?

  1. The audit trail that logs site staff edits to patient data
  2. An electronic interface where patients record time-stamped symptom entries at scheduled intervals Correct answer.
  3. A paper diary that is later transcribed into the clinical database
  4. The statistical analysis plan section covering patient-reported endpoints

Explanation

An eDiary is the electronic replacement for a paper patient diary, capturing entries directly from the patient with timestamps and usually schedule-driven prompts. It is patient-facing and distinct from back-end audit trails or analysis documentation.

Question 2ePRO (electronic patient-reported outcomes)

A sponsor wants patients to complete a symptom questionnaire at home each evening. Which ePRO modality is designed primarily for that scheduled, patient-initiated use case?

  1. Interactive voice response by telephone
  2. Electronic clinic tablet used only during site visits
  3. Handheld or smartphone eDiary application Correct answer.
  4. Clinician-completed case report form

Explanation

A handheld or smartphone eDiary application is built for patients to self-complete instruments at scheduled times outside the clinic. Clinic tablets and clinician-completed forms capture data at visits or by staff, not patient-initiated home entries.

Question 3ePRO (electronic patient-reported outcomes)

What is the primary purpose of a timestamp in an ePRO entry?

  1. To encrypt the patient's responses during transmission
  2. To prove the entry was made within the protocol-defined window and support data integrity Correct answer.
  3. To identify which site staff member reviewed the entry
  4. To calculate the total questionnaire score automatically

Explanation

Timestamps record when the patient actually completed the entry, allowing the sponsor to verify compliance with protocol windows and to support the credibility of the data. Encryption, staff review, and scoring are handled by other system functions.

Question 4ePRO (electronic patient-reported outcomes)

Which regulatory concept requires that ePRO records be attributable, legible, contemporaneous, original, and accurate?

  1. 21 CFR Part 11 electronic signature rules
  2. ALCOA principles for data integrity Correct answer.
  3. Good Clinical Practice inspection readiness
  4. ICH E6 statistical reporting standards

Explanation

ALCOA (attributable, legible, contemporaneous, original, accurate) is the widely used data-integrity framework that ePRO records must satisfy. Part 11 addresses electronic records and signatures specifically, while GCP and ICH E6 set broader trial conduct expectations.

Question 5ePRO (electronic patient-reported outcomes)

A patient misses the scheduled evening eDiary window and the system blocks entry until the next day. What is the main reason ePRO systems often enforce such windows?

  1. To reduce the storage burden on the device
  2. To comply with local tax reporting requirements
  3. To prevent recall bias by limiting how late a report can be made Correct answer.
  4. To ensure the site nurse can co-sign each entry

Explanation

Enforcing completion windows limits the delay between the experience and the report, reducing recall bias and preserving the meaning of the scheduled assessment. Storage, co-signature, and tax rules are not the rationale for time windows.

Question 6ePRO (electronic patient-reported outcomes)

Which party is responsible for training patients on how to use the ePRO device before first use?

  1. The site staff, following the study training plan Correct answer.
  2. The sponsor's statistical programmer
  3. The institutional review board
  4. The device manufacturer's support desk only

Explanation

Site staff typically train patients on device use according to the study-specific training plan and document that training. The sponsor designs the system and materials, but hands-on patient training is delegated to the site.

Question 7ePRO (electronic patient-reported outcomes)

An ePRO system displays a questionnaire to a patient in the wrong language because the site selected the incorrect locale. Which type of issue does this represent?

  1. A configuration or localization error Correct answer.
  2. A data analysis error
  3. A randomization error
  4. A serious adverse event

Explanation

Presenting the wrong language stems from incorrect locale configuration or localization setup in the ePRO system. It is a system configuration issue rather than an analysis, randomization, or safety event.

Question 8ePRO (electronic patient-reported outcomes)

What does the term 'patient-reported outcome' specifically require about the source of the information?

  1. The report must be collected only during scheduled clinic visits
  2. The report must be confirmed by a clinician before entry
  3. The report must be recorded on paper and then scanned
  4. The report must come directly from the patient without interpretation by others Correct answer.

Explanation

A PRO is by definition reported directly by the patient, without a clinician or anyone else interpreting the responses. Clinician confirmation, visit-only collection, and paper scanning would change the nature of the data source.

Question 9ePRO (electronic patient-reported outcomes)

A patient enters an eDiary response at 22:15, but the protocol window closes at 22:00. The system accepts the entry and flags it as late. Which statement best describes how this entry should be handled?

  1. Exclude the patient from the study immediately
  2. Move the timestamp back to 22:00 so the entry appears compliant
  3. Keep the entry with its late flag and evaluate it per the pre-specified analysis rules Correct answer.
  4. Delete the entry because it falls outside the window

Explanation

Late entries are generally retained with their actual timestamp and late flag so that pre-specified rules can determine how they are used in analysis. Altering timestamps or deleting data would compromise integrity, and a single late entry does not justify patient removal.

Question 10ePRO (electronic patient-reported outcomes)

During a monitoring visit, a coordinator notices that a patient's eDiary shows entries made while the patient was hospitalized and unable to use the device. What is the most appropriate first action?

  1. Ignore the entries because ePRO data are not monitored
  2. Raise a query and investigate the discrepancy through the site's data review process Correct answer.
  3. Overwrite the entries with corrected values
  4. Ask the sponsor to delete the patient's record

Explanation

Suspicious entries should be investigated through the query and data-review process so the cause can be documented and resolved transparently. Overwriting, ignoring, or deleting records would hide a potential integrity problem rather than resolve it.

Question 11ePRO (electronic patient-reported outcomes)

A sponsor is choosing between a provisioned device and a bring-your-own-device (BYOD) model for ePRO collection. Which consideration most directly favors the provisioned device approach?

  1. Automatic translation of questionnaires
  2. Lower upfront hardware cost
  3. Greater control over device configuration and validated software versions Correct answer.
  4. Elimination of the need for patient training

Explanation

Provisioned devices give the sponsor control over hardware, operating system, and validated software versions, which supports consistency and regulatory defensibility. BYOD usually reduces cost but introduces variability in devices and platforms.

Question 12ePRO (electronic patient-reported outcomes)

An ePRO system sends automated reminders to patients who have not completed a scheduled assessment. What is the primary benefit of such reminders?

  1. They guarantee complete data for every patient
  2. They allow site staff to complete the questionnaire on the patient's behalf
  3. They improve compliance with scheduled entries and reduce missing data Correct answer.
  4. They replace the need for an audit trail

Explanation

Reminders support timely completion and help reduce missing data, which strengthens the analyzable dataset. They cannot guarantee complete data, do not substitute for audit trails, and must not lead to staff completing patient reports.

Question 13ePRO (electronic patient-reported outcomes)

Which scenario best illustrates a risk that ePRO systems are designed to mitigate compared with paper diaries?

  1. Patients completing several days of diary entries in one sitting just before a visit Correct answer.
  2. Sites storing completed diaries in a locked cabinet
  3. Patients asking questions about an item's meaning
  4. Patients reading the questionnaire instructions carefully

Explanation

Paper diaries allow back-filling, where patients complete multiple days at once before a visit, producing fabricated timing. ePRO systems with timestamps and windows make this difficult and detectable, which is a core integrity benefit.

Question 14ePRO (electronic patient-reported outcomes)

A study team must ensure that an ePRO instrument's electronic implementation matches the validated paper version in content and order. What activity most directly supports this?

  1. Cognitive debriefing and equivalence testing of the electronic version Correct answer.
  2. Randomization schedule generation
  3. Site budget negotiation
  4. Usability testing with the sponsor's staff only

Explanation

Cognitive debriefing and equivalence testing confirm that the electronic version preserves the meaning, content, and order of the validated instrument. Usability testing with staff alone, randomization, and budgeting do not address instrument equivalence.

Question 15ePRO (electronic patient-reported outcomes)

Which element of an ePRO audit trail is most important for demonstrating that a data change was legitimate?

  1. The device's battery level at the time of the change
  2. The identity of the user, the date and time, and the reason for the change Correct answer.
  3. The number of questionnaires in the system
  4. The color scheme of the user interface

Explanation

An audit trail must capture who made the change, when, and why, so reviewers can reconstruct and justify modifications. Interface appearance, battery level, and questionnaire counts do not establish the legitimacy of a change.

Question 16ePRO (electronic patient-reported outcomes)

A patient reports that the ePRO app crashes each time a specific questionnaire opens. What is the most appropriate immediate step to protect data collection?

  1. Log the issue with the help desk, provide a documented workaround if available, and track resolution Correct answer.
  2. Instruct the patient to enter responses on paper without any documentation
  3. Ask the patient to skip the questionnaire permanently
  4. Discontinue the patient from the study

Explanation

Technical issues should be reported through the support process, with documented workarounds and tracked resolution to preserve data quality. Undocumented paper substitution or permanent skipping would create unmanaged deviations.

Question 17ePRO (electronic patient-reported outcomes)

Which statement best describes the role of the electronic signature in an ePRO workflow where site staff review patient data?

  1. It replaces the need for any audit trail
  2. It encrypts the patient's responses on the device
  3. It automatically corrects errors in the patient's entries
  4. It provides a legally binding attestation of the reviewer's action and identity Correct answer.

Explanation

An electronic signature under applicable regulations serves as a legally binding attestation linking the signed record to a specific authenticated individual. It does not replace audit trails, encrypt data, or correct errors.

Question 18ePRO (electronic patient-reported outcomes)

A trial collects ePRO symptom data daily and clinic assessments at scheduled visits. A reviewer wants to compare the two data streams for the same patient. What is the most reliable linking approach?

  1. Matching patients by the order in which records were entered
  2. Using a unique patient identifier assigned at enrollment across both sources Correct answer.
  3. Matching on the patient's reported symptom severity
  4. Matching on the device serial number only

Explanation

A unique patient identifier assigned at enrollment provides an unambiguous link between ePRO and clinic records. Entry order, symptom values, and device serial numbers are not reliable or unique patient links.

Question 19ePRO (electronic patient-reported outcomes)

Which practice best supports compliance with privacy requirements when ePRO data are transmitted from a patient device?

  1. Sharing patient login credentials among household members
  2. Emailing questionnaire responses to the site coordinator
  3. Encrypting data in transit and at rest and limiting access by role Correct answer.
  4. Storing all data unencrypted on the device for convenience

Explanation

Encryption in transit and at rest, combined with role-based access controls, are core safeguards for protecting patient data. Unencrypted storage, shared credentials, and unsecured email all increase the risk of unauthorized disclosure.

Question 20ePRO (electronic patient-reported outcomes)

A protocol specifies that a questionnaire must be completed within 24 hours of a symptom onset. The ePRO system instead allows entry up to 72 hours later. What is the most significant consequence?

  1. The sponsor must change the protocol to 72 hours
  2. The data are automatically invalid and must be deleted
  3. The system configuration deviates from the protocol, potentially affecting data interpretability Correct answer.
  4. The patient must repeat the entire study

Explanation

A mismatch between the configured window and the protocol is a deviation that can affect whether data reflect the intended timeframe and how they are interpreted. The appropriate response is to correct the configuration and assess impact, not to delete data or force protocol changes.

Question 21ePRO (electronic patient-reported outcomes)

Which measure best evaluates whether patients can independently use an ePRO device as intended?

  1. Counting the number of questionnaires configured in the system
  2. Reviewing the system's server uptime statistics
  3. Conducting usability testing that includes representative patients performing realistic tasks Correct answer.
  4. Reviewing the sponsor's marketing materials

Explanation

Usability testing with representative patients performing realistic tasks reveals whether the interface is understandable and usable without assistance. Server uptime, questionnaire counts, and marketing materials do not assess patient usability.

Question 22ePRO (electronic patient-reported outcomes)

An ePRO dataset shows that a patient's responses were all entered within a single two-minute period for a week of daily diaries. Which interpretation is most appropriate for the reviewer?

  1. This proves the patient is highly compliant
  2. This pattern suggests possible back-filling and warrants a query and review Correct answer.
  3. This is expected because ePRO systems batch entries automatically
  4. This indicates the device clock is always wrong

Explanation

Multiple daily entries compressed into a very short period suggest the patient may have back-filled responses rather than reporting in real time, which warrants investigation. ePRO systems do not automatically batch patient entries, and the pattern does not by itself prove compliance or clock failure.

Question 23ePRO (electronic patient-reported outcomes)

A sponsor plans to migrate ePRO data from a legacy vendor to a new platform mid-study. Which control is most critical to preserve regulatory defensibility?

  1. Maintaining a validated, documented migration with reconciliation and preserved audit trails Correct answer.
  2. Allowing sites to re-enter historical data from memory
  3. Deleting the legacy audit trail to avoid confusion
  4. Changing the questionnaire wording during migration to improve clarity

Explanation

A validated migration with documented reconciliation and preserved audit trails maintains traceability and defensibility of the record. Altering instruments, discarding audit trails, or reconstructing data from memory would undermine integrity.

Question 24ePRO (electronic patient-reported outcomes)

In a blinded trial, ePRO symptom data could reveal treatment assignment to site staff. Which approach best protects the blind while preserving data quality?

  1. Preventing patients from reporting symptoms altogether
  2. Restricting access to potentially unblinding ePRO detail to designated unblinded personnel Correct answer.
  3. Showing all ePRO data to every site staff member in real time
  4. Disabling timestamps so patterns cannot be seen

Explanation

Limiting access to potentially unblinding detail to designated unblinded personnel protects the blind while keeping the data intact for analysis. Suppressing patient reporting, broad real-time access, or disabling timestamps would harm data quality or integrity.

Question 25ePRO (electronic patient-reported outcomes)

A regulatory inspector asks how the sponsor knows that ePRO entries attributed to a patient were actually made by that patient. Which combination of controls provides the strongest evidence?

  1. Unique authenticated patient credentials plus device-level and server-side audit logs with timestamps Correct answer.
  2. Relying on the site coordinator's memory of patient training
  3. Paper diaries collected at visits without signatures
  4. A single shared login for the household plus verbal confirmation

Explanation

Unique authenticated credentials tie entries to an individual, and device and server audit logs with timestamps document when and how entries occurred. Shared logins, unsigned paper, and staff recollection do not provide reliable attribution evidence.

Question 26ePRO (electronic patient-reported outcomes)

In an ePRO system, what does the term 'compliance' most precisely refer to when reported in a study dashboard?

  1. The count of audit-trail records generated per patient per month
  2. The share of questionnaires that were translated and linguistically validated
  3. The percentage of sites that have completed all source document verification activities
  4. The proportion of scheduled assessments for which a valid patient entry exists within the protocol-defined window Correct answer.

Explanation

ePRO compliance measures whether patients actually submitted required data within the protocol-specified timing windows, not whether sites or vendors completed administrative tasks. It is usually expressed as a percentage of expected entries that were received and valid.

Question 27ePRO (electronic patient-reported outcomes)

A protocol requires a pain diary each evening. Which ePRO configuration element most directly defines when an entry is considered on time?

  1. The reminder message text
  2. The site training log
  3. The device provisioning list
  4. The completion window rule Correct answer.

Explanation

Completion window rules in the ePRO build specify the open and close times for each scheduled assessment and therefore determine whether a submission counts as on time. Reminder text, provisioning lists, and training logs support the process but do not define timeliness.

Question 28ePRO (electronic patient-reported outcomes)

Why is a patient's local time zone typically captured in an ePRO system?

  1. To decide which device model the patient receives
  2. To align assessment windows with the patient's actual day and clock time Correct answer.
  3. To select the language of the reminder message
  4. To determine the currency used for site payments

Explanation

Diary windows are anchored to the patient's real-world day, so the system must know local time to open and close assessments correctly and to timestamp entries accurately. Time zone data has no bearing on payments, language selection, or device assignment.

Question 29ePRO (electronic patient-reported outcomes)

What is the primary purpose of a help desk with defined service levels in an operational ePRO deployment?

  1. To adjudicate clinical endpoints reported by patients
  2. To approve protocol amendments before implementation
  3. To perform statistical analysis of diary data
  4. To provide documented, timely support to patients and sites when technical issues arise Correct answer.

Explanation

An ePRO help desk exists to resolve access, device, and usability problems quickly so that data collection continues and patients are not lost to follow-up. Endpoint adjudication, protocol approval, and statistical analysis belong to other functions.

Question 30ePRO (electronic patient-reported outcomes)

Which data element is essential for linking an ePRO entry to the correct subject in a multi-site trial?

  1. The patient's home address
  2. A unique subject identifier assigned by the system Correct answer.
  3. The site investigator's name
  4. The brand of the patient's mobile device

Explanation

A unique subject identifier ensures each entry is attributed to exactly one participant and supports traceability across sites and systems. Addresses, investigator names, and device brands do not reliably or uniquely identify a subject record.

Question 31ePRO (electronic patient-reported outcomes)

A sponsor wants to confirm that an ePRO questionnaire's electronic version preserves the validated content of the original instrument. Which activity addresses this directly?

  1. A review of the vendor's financial stability
  2. A usability test with five healthy volunteers
  3. A comparison of the electronic rendering against the validated source instrument Correct answer.
  4. A cognitive debriefing interview about the device

Explanation

Demonstrating content equivalence requires a documented comparison of the electronic version against the validated instrument, often called a screen-by-screen or content-equivalence review. Usability and cognitive testing address different questions about use and comprehension.

Question 32ePRO (electronic patient-reported outcomes)

What is the main reason ePRO systems often require a patient to confirm identity at login?

  1. To reduce the risk that entries are attributed to the wrong person Correct answer.
  2. To shorten the questionnaire length
  3. To satisfy advertising consent requirements
  4. To increase the number of audit-trail records

Explanation

Authentication at login supports attribution, so the sponsor can reasonably assert that the person submitting data is the enrolled patient. It is not intended to inflate audit records, address advertising, or alter instrument length.

Question 33ePRO (electronic patient-reported outcomes)

Which output is a typical product of an ePRO system's data export to the study database?

  1. A site monitoring plan
  2. A narrative clinical study report
  3. A structured dataset with timestamps and submission metadata Correct answer.
  4. A statistical analysis plan

Explanation

ePRO systems export structured data, including response values, timestamps, and metadata needed for traceability and analysis. Narrative reports, monitoring plans, and analysis plans are authored documents produced by study teams.

Question 34ePRO (electronic patient-reported outcomes)

A patient misses three consecutive evening diary entries because the provisioned device was left at a relative's home. Which immediate action best preserves data quality while respecting the patient?

  1. Document the missed entries and re-train the patient on device handling and reminders Correct answer.
  2. Exclude the patient from the per-protocol analysis without documentation
  3. Backfill the missing entries from the patient's recollection at the next visit
  4. Change the protocol window so the entries become on time

Explanation

Missed entries should be documented as missing and addressed by re-training and reminder configuration rather than reconstructed later, which would introduce recall bias. Retrospective backfilling and silent protocol changes both compromise data integrity.

Question 35ePRO (electronic patient-reported outcomes)

An ePRO system is configured to allow entry only between 18:00 and 23:59 for an evening diary. A patient attempts entry at 00:20 the next day. What is the most appropriate system behavior?

  1. Automatically shift the timestamp to 23:59
  2. Delete the previous day's entry to avoid duplication
  3. Reject or flag the entry as outside the window according to the configured rule Correct answer.
  4. Accept the entry and label it as on time

Explanation

The configured window defines what counts as on time, so a late entry should either be blocked or captured and clearly flagged as out of window. Altering timestamps or deleting prior data would falsify the record.

Question 36ePRO (electronic patient-reported outcomes)

A patient reports that the ePRO app shows a blank screen after a software update pushed overnight. Which combination of actions is most appropriate?

  1. Instruct the patient to reinstall the app without notifying the vendor
  2. Wait until the next scheduled monitoring visit to investigate
  3. Log the issue with the help desk, provide a documented workaround, and assess impact on other users Correct answer.
  4. Manually enter the patient's responses into the database from a phone conversation

Explanation

Technical incidents should be logged, triaged, and resolved through controlled processes, with impact assessment across the user population. Unlogged fixes, delayed investigation, and proxy data entry all undermine traceability and patient safety.

Question 37ePRO (electronic patient-reported outcomes)

A study uses a bring-your-own-device model. Which control most directly addresses the risk that a patient's personal phone is shared with family members?

  1. Increasing the reminder frequency to twice daily
  2. Requiring a device passcode or biometric lock tied to the patient's account Correct answer.
  3. Providing a paper backup diary
  4. Shortening the questionnaire to reduce burden

Explanation

Account-level authentication on the personal device reduces the chance that someone other than the enrolled patient submits entries. Reminders, shortened instruments, and paper backups address burden or continuity but not attribution.

Question 38ePRO (electronic patient-reported outcomes)

A site coordinator wants to correct a patient's entered value because the patient telephoned to say it was wrong. Which approach is most consistent with good ePRO practice?

  1. Leave the error uncorrected to preserve the original data
  2. Ask the patient to submit a new entry and document the clarification Correct answer.
  3. Delete the original entry and re-enter the corrected value
  4. Edit the original record directly in the database

Explanation

Patient-reported data should remain patient-reported; corrections are best handled by having the patient provide the updated response with documentation of the clarification. Direct edits by site staff and deletions obscure provenance.

Question 39ePRO (electronic patient-reported outcomes)

Which design feature best supports a patient with low digital literacy in completing a daily ePRO diary?

  1. A large-font interface with simple navigation and practice sessions at enrollment Correct answer.
  2. A daily password reset requirement
  3. A requirement to type free-text explanations for every response
  4. A hidden menu for changing assessment schedules

Explanation

Simple navigation, readable text, and hands-on practice reduce errors and support independent completion for patients with limited digital experience. Free-text requirements, hidden menus, and frequent password resets add burden and risk.

Question 40ePRO (electronic patient-reported outcomes)

A sponsor wants to reduce recall bias in a weekly symptom questionnaire. Which design choice best supports this goal?

  1. Combine several weeks into a single long form
  2. Allow completion at any time during the week with no anchoring
  3. Anchor the recall period explicitly and prompt completion at consistent times Correct answer.
  4. Permit retrospective completion for up to one month

Explanation

Explicit recall-period anchoring and consistent prompting help ensure patients report the intended interval rather than reconstructing from memory. Open timing, long retrospective allowances, and combined forms all increase recall error.

Question 41ePRO (electronic patient-reported outcomes)

An auditor asks how the sponsor verifies that the ePRO system's clock is reliable across regions. Which evidence is most relevant?

  1. A list of patients enrolled in each time zone
  2. A vendor statement that servers are hosted in a specific country
  3. Documentation of time synchronization controls and timestamp audit records Correct answer.
  4. The number of reminders sent per patient

Explanation

Reliable timestamps depend on documented time-synchronization controls and auditable records showing how times are generated and stored. Hosting location, enrollment lists, and reminder counts do not demonstrate clock reliability.

Question 42ePRO (electronic patient-reported outcomes)

A protocol defines a 48-hour window after a procedure for a symptom assessment. The ePRO build opens the assessment at the procedure time and closes it 72 hours later. What is the most significant consequence?

  1. The instrument's translation will be invalidated
  2. The audit trail will stop recording changes
  3. Patients will receive too few reminders
  4. Entries made between 48 and 72 hours will be misclassified as on time Correct answer.

Explanation

A window that is longer than the protocol specifies allows late entries to be treated as compliant, which misclassifies data and can bias analyses. Reminder counts, audit-trail function, and translation validity are not directly affected by window length.

Question 43ePRO (electronic patient-reported outcomes)

A reviewer notices that a patient's ePRO entries are consistently submitted at exactly the same minute each day, including weekends and holidays. What is the most reasonable first interpretation?

  1. The system clock must be broken
  2. The patient is highly adherent and no review is needed
  3. The questionnaire is too short
  4. The pattern may indicate automated or proxy submission and warrants investigation Correct answer.

Explanation

Suspiciously uniform timing can suggest automation, shared devices, or proxy entry, so it should prompt review rather than automatic acceptance. A broken clock would affect all users, and instrument length is unrelated to timing patterns.

Question 44ePRO (electronic patient-reported outcomes)

Which approach best protects patient confidentiality when ePRO data are viewed on a site laptop?

  1. Emailing patient-level data to personal accounts
  2. Storing exported files on the desktop for convenience
  3. Sharing a single site login among all coordinators
  4. Role-based access with session timeouts and encrypted storage Correct answer.

Explanation

Role-based access, automatic session timeouts, and encryption limit exposure of patient data on local machines. Shared logins, desktop storage, and personal email all increase the risk of unauthorized access.

Question 45ePRO (electronic patient-reported outcomes)

A sponsor is drafting a validation plan for an ePRO system used in a registrational trial. Which element is most essential to include?

  1. A list of marketing materials for the device
  2. Documented requirements, risk assessment, and test evidence with traceability Correct answer.
  3. A summary of competitor products
  4. The names of patients enrolled at each site

Explanation

Computerized system validation depends on documented requirements, risk-based assessment, and test evidence traceable to those requirements. Marketing materials, patient names, and competitor summaries are not validation evidence.

Question 46ePRO (electronic patient-reported outcomes)

A trial team wants to detect whether a specific site's patients are systematically entering diary data later than patients at other sites. Which analysis approach is most suitable?

  1. Compare the distribution of submission times relative to the window across sites Correct answer.
  2. Review the vendor's software release notes
  3. Compare the number of site staff trained
  4. Count the total number of questionnaires in the database

Explanation

Comparing the distribution of submission timing relative to the window by site reveals systematic differences in timeliness. Total counts, release notes, and training numbers do not show when entries were submitted.

Question 47ePRO (electronic patient-reported outcomes)

During a blinded trial, a sponsor wants to keep treatment assignment hidden from site staff while still allowing them to follow up on missed ePRO entries. Which approach best achieves both goals?

  1. Give site staff full access to all patient responses
  2. Send response-level data to site staff by daily email
  3. Restrict response-level access and provide only completion status to site staff Correct answer.
  4. Disable all reminders to patients

Explanation

Limiting site staff to completion status lets them address missing data without seeing responses that could unblind treatment. Full access and daily response emails would risk unblinding, while disabling reminders harms compliance.

Question 48ePRO (electronic patient-reported outcomes)

An ePRO vendor plans a mid-study migration to a new platform. Which control is most critical to preserve the interpretability of the combined dataset?

  1. Changing the questionnaire wording to fit the new platform
  2. Maintaining a documented mapping of variables, coding, and timestamps between old and new systems Correct answer.
  3. Shortening the completion window after migration
  4. Increasing the number of reminders after migration

Explanation

A documented mapping preserves the meaning and traceability of variables and timestamps across systems so the combined dataset remains analyzable. Changing wording or windows introduces confounding, and reminders do not address data comparability.

Question 49ePRO (electronic patient-reported outcomes)

A regulatory inspector asks how the sponsor can demonstrate that ePRO entries attributed to a patient were made by that patient. Which combination of evidence is most persuasive?

  1. A statement from the site coordinator that patients seemed reliable
  2. A signed paper diary kept at home
  3. The total number of entries submitted by the site
  4. Unique account credentials, device binding or authentication records, and audit-trail timestamps Correct answer.

Explanation

Attribution is supported by evidence that only the enrolled patient could have submitted the data, such as unique credentials, device binding, and auditable timestamps. Coordinator impressions and entry volumes do not establish who submitted the data.

Question 50ePRO (electronic patient-reported outcomes)

A protocol requires patients to complete a symptom questionnaire before each clinic visit. The ePRO system instead opens the questionnaire only after the visit is recorded. What is the most appropriate classification of this finding?

  1. A cosmetic configuration preference with no impact
  2. An acceptable adaptation because patients prefer completing forms later
  3. A protocol deviation in system configuration requiring correction and impact assessment Correct answer.
  4. A statistical analysis issue to be resolved at database lock

Explanation

A build that contradicts the protocol's timing requirement is a configuration deviation that must be corrected and assessed for impact on already collected data. It is not cosmetic, patient preference does not override the protocol, and it cannot be deferred to analysis.