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CPEDC practice questions

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Question 1Regulatory Framework and Clinical Trial Standards

Under the ICH E6 Good Clinical Practice guideline, who is responsible for obtaining the informed consent of a trial participant?

  1. The clinical research associate
  2. The institutional review board chair
  3. The investigator or a qualified designee Correct answer.
  4. The sponsor's designated monitor

Explanation

ICH E6 assigns the duty of obtaining informed consent to the investigator or a person designated by the investigator who is qualified and appropriately trained. The sponsor, monitors, and IRB do not obtain participant consent.

Question 2Regulatory Framework and Clinical Trial Standards

Which document describes the objective, design, methodology, and statistical considerations of a clinical trial?

  1. The standard operating procedure
  2. The investigator's brochure
  3. The case report form
  4. The clinical trial protocol Correct answer.

Explanation

The protocol is the document that states the rationale, objectives, design, methodology, statistical considerations, and organization of a trial. The investigator's brochure summarizes the investigational product, and the CRF captures subject data.

Question 3Regulatory Framework and Clinical Trial Standards

A serious adverse event is one that, at any dose, results in which of the following outcomes?

  1. Death, life-threatening condition, hospitalization, or persistent disability Correct answer.
  2. A headache reported by the subject
  3. A mild rash that resolves without treatment
  4. A laboratory value outside the reference range

Explanation

Serious adverse events are defined by outcomes such as death, a life-threatening condition, inpatient hospitalization or prolongation of hospitalization, persistent or significant disability, congenital anomaly, or an important medical event. Severity and seriousness are distinct concepts.

Question 4Regulatory Framework and Clinical Trial Standards

Which body is primarily responsible for reviewing and approving a clinical trial before it begins at a site, to protect the rights and welfare of subjects?

  1. The contract research organization
  2. The institutional review board or ethics committee Correct answer.
  3. The data safety monitoring board
  4. The sponsor's medical monitor

Explanation

The IRB or ethics committee is the independent body that reviews trial documents and protects the rights, safety, and well-being of subjects. DSMBs monitor data during the trial, and sponsors oversee the study but are not the ethics approval authority.

Question 5Regulatory Framework and Clinical Trial Standards

According to ICH E6, which party holds ultimate responsibility for the quality and integrity of the trial data?

  1. The statistician
  2. The sponsor Correct answer.
  3. The site coordinator
  4. The IRB

Explanation

The sponsor is responsible for implementing and maintaining a quality management system and for the overall quality and integrity of trial data. Sites generate data, but the sponsor bears ultimate oversight responsibility.

Question 6Regulatory Framework and Clinical Trial Standards

Which of the following is a required element of the informed consent discussion?

  1. The names of all other enrolled subjects
  2. The statistical analysis plan
  3. The sponsor's internal budget for the trial
  4. The anticipated expenses and compensation for trial participation Correct answer.

Explanation

Informed consent must disclose anticipated expenses and any compensation for participation, along with risks, benefits, alternatives, and voluntariness. Internal budgets, other subjects' identities, and statistical plans are not required disclosures.

Question 7Regulatory Framework and Clinical Trial Standards

What is the primary purpose of the investigator's brochure?

  1. To list the site's standard operating procedures
  2. To document informed consent signatures
  3. To provide the investigator with preclinical and clinical information about the investigational product Correct answer.
  4. To record each subject's visit schedule

Explanation

The investigator's brochure compiles preclinical and clinical data on the investigational product so the investigator can understand its risks and administer it appropriately. It is distinct from consent forms, CRFs, and site procedures.

Question 8Regulatory Framework and Clinical Trial Standards

Which regulation establishes the requirements for informed consent and IRB review for human subjects research conducted or supported by U.S. federal agencies?

  1. 21 CFR Part 11
  2. 21 CFR Part 312
  3. ICH E8
  4. The Common Rule (45 CFR 46) Correct answer.

Explanation

The Common Rule, codified at 45 CFR 46, sets baseline protections for human subjects research, including informed consent and IRB review. 21 CFR Part 11 addresses electronic records, and Part 312 covers investigational new drug applications.

Question 9Regulatory Framework and Clinical Trial Standards

During a monitoring visit, a monitor finds that a subject signed the consent form after a study procedure was performed. What is the most appropriate classification of this finding?

  1. An expected adverse event
  2. A routine source data verification discrepancy
  3. A protocol deviation involving consent obtained before procedures, which must be documented and reported Correct answer.
  4. A minor administrative deviation requiring no action

Explanation

Consent must be obtained before any study-specific procedure; performing procedures first violates the protocol and consent requirements and must be documented and reported per applicable rules. It is not a minor administrative matter.

Question 10Regulatory Framework and Clinical Trial Standards

A sponsor wants to add a new secondary endpoint to an ongoing trial. What is the correct regulatory approach?

  1. Record the change only in the monitoring report
  2. Amend the protocol, obtain required approvals, and document the change before implementation Correct answer.
  3. Ask the site coordinator to note it in the source documents
  4. Implement the change immediately and inform the IRB at study close

Explanation

Protocol changes generally require a formal amendment with IRB and, where applicable, regulatory approval before implementation, except where needed to eliminate immediate hazard. Documentation must precede implementation.

Question 11Regulatory Framework and Clinical Trial Standards

A subject experiences a hospitalization during a trial. Within what timeframe must the investigator generally report the serious adverse event to the sponsor?

  1. Within 90 days
  2. Within 24 hours of awareness, per most protocols and ICH E6 expectations Correct answer.
  3. Within 30 calendar days
  4. Only in the final study report

Explanation

ICH E6 and most protocols require the investigator to report serious adverse events to the sponsor immediately, commonly operationalized as within 24 hours of first awareness. Delayed reporting can compromise subject safety and regulatory compliance.

Question 12Regulatory Framework and Clinical Trial Standards

An IRB approves a study with a consent form that omits the statement that participation is voluntary. What should happen before enrollment begins?

  1. The consent form must be revised and re-reviewed before any subject is enrolled Correct answer.
  2. Enrollment may proceed because the omission is minor
  3. The sponsor may waive the requirement
  4. Subjects may be enrolled if they are told verbally

Explanation

Informed consent must state that participation is voluntary and that refusal will not affect care. A deficient consent form must be corrected and re-approved before enrollment; verbal additions do not substitute for an approved written form.

Question 13Regulatory Framework and Clinical Trial Standards

Which role is responsible for verifying that source data match the case report form during a monitoring visit?

  1. The data manager
  2. The principal investigator
  3. The IRB coordinator
  4. The clinical research associate acting as monitor Correct answer.

Explanation

Source data verification is a core monitoring activity performed by the sponsor's monitor, often a clinical research associate. The investigator generates source data, and data management handles database processes.

Question 14Regulatory Framework and Clinical Trial Standards

A trial enrolls a vulnerable population of prisoners. Which additional safeguard is generally required?

  1. Elimination of the data safety monitoring board
  2. Additional IRB scrutiny to ensure risks are minimized and selection is equitable Correct answer.
  3. Waiver of informed consent
  4. Exemption from adverse event reporting

Explanation

Research involving prisoners and other vulnerable populations requires additional protections, including heightened IRB review to ensure risks are minimized and subject selection is equitable. Consent and safety reporting requirements still apply.

Question 15Regulatory Framework and Clinical Trial Standards

Which document must the sponsor provide to the investigator before the investigator agrees to conduct a trial, outlining the financial arrangements and obligations?

  1. The statistical analysis plan
  2. The clinical trial agreement or contract Correct answer.
  3. The clinical study report
  4. The case report form

Explanation

The clinical trial agreement or contract defines the financial arrangements and obligations between sponsor and site before the trial begins. The clinical study report is produced after the trial, and CRFs and analysis plans serve other purposes.

Question 16Regulatory Framework and Clinical Trial Standards

A monitor discovers that a site has been enrolling subjects without documenting eligibility criteria in source records. What is the most appropriate first action?

  1. Immediately terminate the investigator without review
  2. Delete the affected records
  3. Ignore the issue if the CRF is complete
  4. Document the finding, assess its impact on subject safety and data integrity, and report per the monitoring plan Correct answer.

Explanation

The monitor should document the finding, evaluate its impact on safety and data integrity, and escalate according to the monitoring plan and applicable regulations. Termination and deletion are not appropriate first responses.

Question 17Regulatory Framework and Clinical Trial Standards

Under ICH E6, which of the following must be included in the investigator's report to the IRB at least annually?

  1. A summary of the trial's progress and any safety issues Correct answer.
  2. The sponsor's financial statements
  3. Individual subject consent forms
  4. The full statistical analysis plan

Explanation

The investigator must submit periodic progress reports to the IRB at least annually, summarizing trial progress and safety information. Financial statements, analysis plans, and consent forms are not part of this report.

Question 18Regulatory Framework and Clinical Trial Standards

A sponsor plans to use an electronic data capture system for a regulated trial. Which regulation governs the use of electronic records and signatures in this context?

  1. 21 CFR Part 50
  2. 21 CFR Part 11 Correct answer.
  3. 45 CFR 46
  4. ICH E2A

Explanation

21 CFR Part 11 sets criteria for electronic records and electronic signatures to be considered trustworthy and reliable. Part 50 covers informed consent, E2A covers safety reporting, and 45 CFR 46 is the Common Rule.

Question 19Regulatory Framework and Clinical Trial Standards

An investigator wants to deviate from the protocol to eliminate an immediate hazard to a subject. What is the correct course of action?

  1. Ask the sponsor to amend the protocol first
  2. Act immediately, then report the deviation and the reason to the IRB and sponsor as soon as possible Correct answer.
  3. Record the deviation only in the final report
  4. Wait for IRB approval before acting

Explanation

ICH E6 permits deviation from the protocol without prior approval when necessary to eliminate an immediate hazard to a subject, provided the deviation and reason are reported promptly. Waiting could harm the subject.

Question 20Regulatory Framework and Clinical Trial Standards

Which statement best describes the relationship between the sponsor and the investigator under ICH E6?

  1. The sponsor has no role in investigator qualification
  2. The investigator supervises the sponsor's monitoring activities
  3. The investigator is responsible for approving the investigator's brochure
  4. The sponsor selects qualified investigators and ensures they are informed of the protocol and product information Correct answer.

Explanation

The sponsor is responsible for selecting qualified investigators and providing them with the protocol and investigator's brochure so they can conduct the trial properly. Investigators do not approve the brochure or supervise the sponsor.

Question 21Regulatory Framework and Clinical Trial Standards

A site's IRB approval expires while the trial is ongoing. What must the investigator do to continue enrolling subjects?

  1. Notify the sponsor only
  2. Continue enrollment because the protocol is unchanged
  3. Rely on the sponsor's approval
  4. Obtain continuing review or re-approval from the IRB before further enrollment Correct answer.

Explanation

IRB approval is time-limited and must be renewed through continuing review before enrollment can continue. Sponsor approval does not replace IRB approval.

Question 22Regulatory Framework and Clinical Trial Standards

An investigator receives a new safety signal about the investigational product that may affect subject safety. What should the investigator do with the informed consent document?

  1. Consider revising the consent form and re-consenting affected subjects after IRB approval Correct answer.
  2. Inform only new subjects verbally
  3. Leave it unchanged until study close
  4. Discard previously signed consent forms

Explanation

When new information may affect subjects' willingness to participate, the consent form should be revised and, after IRB approval, currently enrolled subjects should be re-consented. Silence or verbal-only updates are inadequate.

Question 23Regulatory Framework and Clinical Trial Standards

A sponsor's monitor identifies systematic fraud in source documentation at a site. Which sequence best reflects appropriate regulatory handling?

  1. Document and investigate the finding, notify the sponsor and IRB, and take corrective action including possible regulatory notification Correct answer.
  2. Quietly correct the records and continue
  3. Terminate the subject without notifying anyone
  4. Ignore the finding because the CRF data appear plausible

Explanation

Suspected fraud must be documented, investigated, and escalated to the sponsor and IRB, with corrective actions and, where required, regulatory notification. Concealment or silent correction violates integrity and reporting obligations.

Question 24Regulatory Framework and Clinical Trial Standards

Which situation would most likely qualify for a waiver of informed consent under the Common Rule?

  1. A minimal-risk study where the rights and welfare of subjects are protected and the waiver is impracticable Correct answer.
  2. Any study involving children
  3. A trial requiring an invasive surgical procedure
  4. A Phase III trial of a new chemotherapy agent

Explanation

The Common Rule permits waiver of consent for minimal-risk research when subjects' rights and welfare are protected, the waiver is impracticable, and appropriate information is provided afterward. Greater-than-minimal-risk trials generally cannot be waived.

Question 25Regulatory Framework and Clinical Trial Standards

A sponsor wants to use a surrogate endpoint not previously accepted for the indication. What regulatory consideration is most relevant?

  1. The sponsor should consult the regulatory authority on the acceptability of the endpoint before relying on it Correct answer.
  2. Only the IRB determines endpoint acceptability
  3. Surrogate endpoints require no regulatory discussion
  4. Endpoints are chosen by the site coordinator

Explanation

Use of a novel or unaccepted surrogate endpoint generally requires early consultation with the regulatory authority to confirm acceptability for the intended indication. The IRB reviews ethics, not endpoint validity.

Question 26Regulatory Framework and Clinical Trial Standards

Under the Common Rule, which body is responsible for reviewing and approving human subjects research at an institution before enrollment begins?

  1. The institutional biosafety committee
  2. The institutional review board Correct answer.
  3. The office of research integrity
  4. The data safety monitoring board

Explanation

The Common Rule requires that research involving human subjects be reviewed and approved by an IRB before it may proceed. The IRB evaluates risks, consent procedures, and subject protections. Other committees serve different oversight functions and cannot substitute for IRB approval.

Question 27Regulatory Framework and Clinical Trial Standards

A sponsor is conducting a trial under an investigational new drug application. Which document must the sponsor submit to the regulatory authority before initiating the clinical investigation?

  1. The investigational new drug application Correct answer.
  2. The certificate of analysis
  3. The marketing authorization
  4. The clinical study report

Explanation

A sponsor must have an investigational new drug application in effect before shipping investigational product for use in humans in the United States. The application contains preclinical data, the protocol, and manufacturing information for regulatory review. Clinical study reports are generated after the trial, and marketing authorization comes much later.

Question 28Regulatory Framework and Clinical Trial Standards

An investigator plans to make a protocol change that affects subject safety and alters the risk-benefit ratio. Which action is required before the change is implemented, absent an immediate hazard?

  1. Submit the change directly to the regulatory authority
  2. Obtain IRB approval of the amended protocol Correct answer.
  3. Notify the sponsor after implementing the change
  4. Document the change only in the final study report

Explanation

Protocol amendments that affect subject safety or alter the risk-benefit assessment require IRB review and approval before implementation. The exception is when a deviation is needed to eliminate an immediate hazard to a subject. Retroactive documentation alone does not satisfy the approval requirement.

Question 29Regulatory Framework and Clinical Trial Standards

A sponsor proposes to use a placebo control in a condition for which an effective proven treatment exists. Which regulatory and ethical consideration is most relevant to this design choice?

  1. Whether the placebo group will be large enough for statistical power
  2. Whether use of placebo is justified when withholding proven treatment could cause harm Correct answer.
  3. Whether the placebo will be supplied free of charge to subjects
  4. Whether placebo-controlled data can be published in a peer-reviewed journal

Explanation

Ethical and regulatory frameworks require that placebo use be justified, particularly when an established effective treatment exists and withholding it could cause serious harm. The design must minimize risk and may require an add-on design or rescue provisions. Statistical, logistical, and publication factors are secondary to this protection.

Question 30Regulatory Framework and Clinical Trial Standards

A trial is conducted at a site in one country and the sponsor seeks to submit the resulting data to a regulatory authority in another country. Which principle most directly governs whether the foreign clinical data will be accepted?

  1. The data must have been generated exclusively by local investigators
  2. The data must be published before submission
  3. The site must hold accreditation from the receiving country's regulator
  4. The study must comply with applicable good clinical practice standards and the authority must be able to validate the data Correct answer.

Explanation

Regulatory authorities generally accept foreign clinical data when the studies were conducted in accordance with good clinical practice and the authority can validate the data through on-site inspection or other means. Local investigator nationality and prior publication are not determinants of acceptability. Accreditation by the receiving regulator is not a general prerequisite.

Question 31EDC System Requirements and Architecture

In a clinical trial EDC system, what is the primary purpose of a discrepancy (query) management module?

  1. To generate randomization codes for enrolled subjects
  2. To archive the final database for regulatory submission
  3. To calculate drug accountability at each site visit
  4. To track and resolve data issues raised by automated checks or manual review Correct answer.

Explanation

Query management exists to capture, route, and resolve data discrepancies detected by edit checks or raised by reviewers. Randomization, archiving, and drug accountability are separate functions.

Question 32EDC System Requirements and Architecture

Which data standard is most commonly used to define the structure and content of datasets submitted to regulatory authorities for clinical studies?

  1. CDISC SDTM Correct answer.
  2. DICOM
  3. HL7 FHIR
  4. ISO 14155

Explanation

CDISC SDTM (Study Data Tabulation Model) is the standard framework for organizing tabulation datasets for regulatory submission. FHIR and DICOM target healthcare interoperability and imaging respectively, and ISO 14155 is a good clinical practice standard.

Question 33EDC System Requirements and Architecture

A trial team needs an audit trail that records who changed a data value, when, and what the prior value was. Which system capability is being described?

  1. Audit trail functionality Correct answer.
  2. Electronic source documentation
  3. Role-based access control
  4. Electronic signature workflow

Explanation

An audit trail captures the who, what, when, and prior value for data changes, supporting data integrity. Access control governs permissions, signatures authenticate approvals, and source documentation is the origin record.

Question 34EDC System Requirements and Architecture

Which characteristic best distinguishes an ePRO device from a site-entered EDC form?

  1. It is completed directly by the subject at home or in clinic Correct answer.
  2. It cannot be integrated with the EDC database
  3. It requires no validation checks
  4. It is always entered by the investigator

Explanation

Electronic patient-reported outcomes are captured directly by the subject, whereas site-entered EDC forms are completed by site staff. ePRO data still undergo validation and are often integrated into the EDC system.

Question 35EDC System Requirements and Architecture

What is the function of an edit check in an EDC system?

  1. To encrypt data at rest in the database
  2. To automatically flag data that fail predefined validation rules Correct answer.
  3. To generate the randomization schedule
  4. To assign users to study roles

Explanation

Edit checks are programmed validation rules that flag inconsistent or out-of-range values for review. Encryption, randomization, and role assignment are separate system functions.

Question 36EDC System Requirements and Architecture

Which access model ensures that users can only perform actions appropriate to their job function within the EDC system?

  1. Two-factor authentication
  2. Data encryption
  3. Single sign-on
  4. Role-based access control Correct answer.

Explanation

Role-based access control assigns permissions according to a user's role, limiting actions to those required for the job. Single sign-on and two-factor authentication are authentication mechanisms, and encryption protects data confidentiality.

Question 37EDC System Requirements and Architecture

What does database lock signify in a clinical trial EDC system?

  1. The system is taken offline for maintenance
  2. The database is permanently deleted
  3. The data are considered final and further edits require formal unblinding or unlock procedures Correct answer.
  4. All subjects have completed the trial

Explanation

Database lock indicates the data are finalized for analysis and submission, and any subsequent changes require documented unlock procedures. It does not mean deletion, downtime, or that all subjects finished.

Question 38EDC System Requirements and Architecture

Which document typically defines the data fields, edit checks, and visit schedule for an EDC study build?

  1. The investigator brochure
  2. The informed consent form
  3. The data management plan Correct answer.
  4. The clinical study report

Explanation

The data management plan describes data handling, including field definitions, edit checks, and data flow. The clinical study report presents results, the consent form documents subject agreement, and the investigator brochure summarizes the investigational product.

Question 39EDC System Requirements and Architecture

A sponsor wants subjects to complete a daily symptom diary on a handheld device, with data flowing into the EDC database. Which system component is most directly responsible for this integration?

  1. The statistical analysis plan
  2. The ePRO-to-EDC interface Correct answer.
  3. The site monitoring plan
  4. The randomization module

Explanation

An ePRO-to-EDC interface transfers subject-entered data into the EDC database. The analysis plan and monitoring plan are documents, and randomization is an unrelated function.

Question 40EDC System Requirements and Architecture

During user acceptance testing of a new EDC build, which activity best confirms the system meets study requirements?

  1. Reviewing the vendor's marketing brochure
  2. Confirming the server is powered on
  3. Counting the number of users created
  4. Executing scripted test cases covering data entry, edit checks, and workflows Correct answer.

Explanation

User acceptance testing relies on executing scripted test cases that exercise data entry, validation, and workflow behavior against requirements. Brochures, power status, and user counts do not verify functional requirements.

Question 41EDC System Requirements and Architecture

A data manager wants a query to be raised automatically whenever a subject's systolic blood pressure exceeds 180 mmHg. Which configuration is most appropriate?

  1. An electronic signature requirement on the form
  2. An automated edit check with a range rule Correct answer.
  3. A manual query template applied at monitoring visits
  4. A role-based access restriction on the field

Explanation

Automated edit checks with range rules raise queries immediately when values fall outside defined limits. Manual templates, access restrictions, and signature requirements do not automatically detect out-of-range values.

Question 42EDC System Requirements and Architecture

Which design approach best supports compliance with 21 CFR Part 11 for electronic records in an EDC system?

  1. Storing data only on local site computers
  2. Allowing shared login accounts for site staff
  3. Using unique user accounts with audit trails and controlled electronic signatures Correct answer.
  4. Permitting deletion of records without a trace

Explanation

Part 11 requires unique user identification, secure audit trails, and controlled electronic signatures. Shared accounts, local-only storage, and untraced deletion undermine these controls.

Question 43EDC System Requirements and Architecture

A study team needs to prevent a site coordinator from viewing data entered by other sites. Which system feature should be configured?

  1. A global data export function
  2. Site-level data segregation with role-based permissions Correct answer.
  3. A password complexity policy
  4. A time-zone setting

Explanation

Site-level segregation combined with role permissions restricts users to their own site's data. Export functions, password policies, and time-zone settings do not limit cross-site visibility.

Question 44EDC System Requirements and Architecture

Which practice best supports data integrity when source data are entered into EDC from paper records?

  1. Allowing sites to overwrite values without an audit trail
  2. Performing source data verification and documenting discrepancies Correct answer.
  3. Entering data without verifying against the source
  4. Deleting original paper records after entry

Explanation

Source data verification compares EDC entries against source records and documents discrepancies, supporting accuracy. Unverified entry, untraced overwrites, and destruction of source records undermine integrity.

Question 45EDC System Requirements and Architecture

What is the main advantage of using standardized CDISC controlled terminology in an EDC build?

  1. It guarantees zero data entry errors
  2. It improves consistency and enables reliable pooling and submission Correct answer.
  3. It eliminates the need for user training
  4. It reduces the need for any edit checks

Explanation

Controlled terminology standardizes how values are coded, improving consistency and enabling reliable data pooling and regulatory submission. It does not remove the need for edit checks, training, or error prevention.

Question 46EDC System Requirements and Architecture

A sponsor requires that all data changes be attributable to a specific individual. Which combination of controls best satisfies this requirement?

  1. A single administrator account for all staff
  2. Unique user credentials plus an automated audit trail Correct answer.
  3. Anonymous data entry with periodic review
  4. Shared accounts plus a paper logbook

Explanation

Attribution requires unique credentials tied to each individual and an automated audit trail recording each change. Shared, single, or anonymous accounts cannot attribute changes to a person.

Question 47EDC System Requirements and Architecture

Which factor most directly influences the choice between a fully electronic eSource model and a paper-to-EDC model for a new trial?

  1. The color scheme of the EDC interface
  2. The sponsor's corporate logo
  3. Site infrastructure and willingness to adopt direct electronic capture Correct answer.
  4. The number of tables in the clinical study report

Explanation

Adopting direct eSource depends heavily on site infrastructure, connectivity, and willingness to change workflows. Interface colors, report tables, and logos are irrelevant to this decision.

Question 48EDC System Requirements and Architecture

During a system migration to a new EDC vendor, what is the most critical data integrity consideration?

  1. Reducing the number of users in the new system
  2. Ensuring the new interface uses the same fonts
  3. Shortening the study timeline
  4. Verifying complete and accurate transfer of data, metadata, and audit trails Correct answer.

Explanation

Migration must preserve data, associated metadata, and audit trails completely and accurately to maintain integrity and traceability. Fonts, user counts, and timelines are secondary to data fidelity.

Question 49EDC System Requirements and Architecture

Which statement best describes the role of metadata in an EDC system?

  1. It refers only to the graphical layout of forms
  2. It describes the structure, meaning, and constraints of the data Correct answer.
  3. It is identical to the raw subject data values
  4. It is used solely for billing purposes

Explanation

Metadata describe data structure, definitions, and constraints, enabling interpretation and validation. It is not merely layout, raw values, or billing information.

Question 50EDC System Requirements and Architecture

A sponsor wants real-time visibility into enrollment and query status across sites. Which EDC capability primarily supports this?

  1. A randomization schedule
  2. A data encryption standard
  3. A reporting and dashboards module Correct answer.
  4. A signature workflow

Explanation

Reporting and dashboard modules aggregate enrollment and query metrics for real-time oversight. Signatures, randomization, and encryption serve different purposes.