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HRIP practice questions

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Question 1Healthcare Data Governance and Stewardship

Under a typical healthcare data governance framework, which group holds ultimate accountability for approving enterprise-wide data policies and resolving cross-departmental data disputes?

  1. The clinical informatics help desk team
  2. The front-line registration staff
  3. The data governance steering committee or council Correct answer.
  4. The external claims clearinghouse vendor

Explanation

A governance steering committee or council is the decision-making body that approves enterprise data policy and arbitrates disputes spanning business and clinical units. Operational teams and vendors execute and support policy but do not hold accountability for enterprise-wide decisions.

Question 2Healthcare Data Governance and Stewardship

A hospital designates a senior clinician in each service line to own the definition, quality, and appropriate use of a specific clinical data domain such as laboratory results. Which role is this?

  1. Release of information clerk
  2. Data steward Correct answer.
  3. Network administrator
  4. Chief information security officer

Explanation

A data steward is accountable for a defined data domain, including its definitions, quality, and proper use. This domain-level ownership distinguishes stewardship from security, infrastructure, or disclosure roles.

Question 3Healthcare Data Governance and Stewardship

An analyst discovers that two departments report different counts of active patients because each uses a different definition of 'active.' Which governance artifact most directly resolves this inconsistency?

  1. A software license inventory
  2. A disaster recovery test report
  3. An approved enterprise data dictionary with a certified metric definition Correct answer.
  4. A firewall rule set restricting database access

Explanation

A governed data dictionary with certified metric definitions establishes one authoritative meaning for a term across the enterprise. Standardizing the definition eliminates the divergence at its source rather than masking it downstream.

Question 4Healthcare Data Governance and Stewardship

Which statement best describes the principle of data stewardship as distinct from data ownership in a healthcare organization?

  1. Stewardship and ownership are identical concepts with no practical distinction
  2. Stewardship is the operational accountability for data quality and use on behalf of the organization, while ownership rests with the enterprise Correct answer.
  3. Stewardship applies only to paper records and ownership only to electronic records
  4. Stewardship means legal title to the data resides with the steward personally

Explanation

Stewardship is delegated operational accountability for the care and use of data, whereas ultimate ownership and authority reside with the enterprise. The steward acts on the organization's behalf rather than holding personal title.

Question 5Healthcare Data Governance and Stewardship

A governance policy requires that any new analytic report drawing on protected health information be reviewed before release. Which control type does this represent?

  1. A preventive governance control applied at the point of approval Correct answer.
  2. A detective control that logs access after the fact
  3. A compensating control that substitutes for encryption
  4. A corrective control that restores data after loss

Explanation

Requiring pre-release review stops inappropriate use before it occurs, which is the definition of a preventive control. Detective and corrective controls operate after an event rather than blocking it in advance.

Question 6Healthcare Data Governance and Stewardship

Which document formally assigns decision rights, escalation paths, and accountability for data across clinical and administrative units?

  1. The vendor's software release notes
  2. The data governance charter Correct answer.
  3. The employee handbook's dress code section
  4. The network topology diagram

Explanation

A data governance charter establishes the authority, roles, decision rights, and escalation mechanisms for data-related decisions. It is the foundational document that legitimizes governance bodies and their scope.

Question 7Healthcare Data Governance and Stewardship

A steward is asked to classify a new dataset containing patient diagnoses and dates of service. Which classification outcome most appropriately governs its handling?

  1. Classify it as sensitive health information subject to the organization's highest handling requirements Correct answer.
  2. Classify it as de-identified because it omits patient names
  3. Classify it as unrestricted because it contains no financial account numbers
  4. Classify it as public because diagnoses are common knowledge

Explanation

Diagnoses linked to dates of service are identifiable health information and warrant the organization's most protective handling tier. The absence of names or financial data does not render such data public or de-identified.

Question 8Healthcare Data Governance and Stewardship

Which practice best supports data quality stewardship at the point of entry in a clinical system?

  1. Allowing free-text entry for every demographic field to maximize flexibility
  2. Relying on patients to detect errors in their records years later
  3. Deferring all error correction to an annual audit
  4. Implementing field-level validation rules and controlled vocabularies at data capture Correct answer.

Explanation

Validation rules and controlled vocabularies prevent invalid or inconsistent values from entering the system, which is the most efficient point to protect quality. Correcting errors later is costlier and less reliable than prevention at capture.

Question 9Healthcare Data Governance and Stewardship

In a healthcare data governance model, what is the primary purpose of a data domain council?

  1. To coordinate stewardship decisions and standards for a related set of data subject areas Correct answer.
  2. To manage the physical network cabling of the data center
  3. To negotiate software licensing discounts with vendors
  4. To process patient billing claims directly

Explanation

A domain council brings together stewards and stakeholders to set and align standards for a cluster of related data subject areas. It coordinates decisions rather than performing infrastructure, procurement, or transactional work.

Question 10Healthcare Data Governance and Stewardship

A steward finds that the same patient identifier is used inconsistently across two systems, causing merged records. Which governance action addresses the root cause?

  1. Archive all records and start a new numbering scheme each year
  2. Establish and enforce an enterprise master patient index standard with defined matching rules Correct answer.
  3. Instruct staff to stop recording patient identifiers
  4. Delete one of the systems to eliminate the conflict

Explanation

An enterprise master patient index with governed matching rules creates a single authoritative identity across systems. Enforcing that standard resolves the inconsistency at its source rather than removing data or systems.

Question 11Healthcare Data Governance and Stewardship

Which activity is a core responsibility of a data steward rather than of the information security team?

  1. Configuring intrusion detection sensors on the network
  2. Managing encryption key rotation schedules
  3. Conducting penetration testing of applications
  4. Defining business rules that determine when a data element is considered complete and accurate Correct answer.

Explanation

Stewards own the business rules governing data content, completeness, and accuracy within their domain. Security teams own technical safeguards such as intrusion detection, key management, and penetration testing.

Question 12Healthcare Data Governance and Stewardship

An organization wants to ensure that data governance decisions are transparent and consistently applied. Which mechanism best supports this goal?

  1. Verbal decisions communicated only within a single department
  2. Undocumented exceptions granted at the discretion of individual analysts
  3. A policy that governance decisions remain confidential to leadership
  4. Documented decision logs and published data policies accessible to stakeholders Correct answer.

Explanation

Documented decision logs and published policies make governance reproducible and auditable across the organization. Transparency reduces inconsistent application and supports accountability.

Question 13Healthcare Data Governance and Stewardship

A data steward is prioritizing remediation of quality defects. Which approach best aligns remediation effort with organizational risk?

  1. Address only defects reported by the largest department
  2. Fix defects strictly in the order they were discovered
  3. Remediate randomly to distribute effort evenly
  4. Rank defects by their potential impact on patient safety and regulatory obligations Correct answer.

Explanation

Risk-based prioritization directs limited stewardship resources toward defects with the greatest safety and compliance consequences. Order of discovery or departmental size does not reflect actual risk.

Question 14Healthcare Data Governance and Stewardship

Which statement correctly characterizes the relationship between data governance and data management?

  1. Management sets policy while governance executes operational tasks
  2. Governance sets the decision rights and policies; management executes the day-to-day activities that comply with them Correct answer.
  3. Governance and management are the same function performed by the same team
  4. Governance applies only to unstructured data and management only to structured data

Explanation

Governance defines who decides and what rules apply, while data management carries out the operational work under those rules. This separation of decision authority from execution is fundamental to the discipline.

Question 15Healthcare Data Governance and Stewardship

A steward must decide whether a proposed data-sharing agreement with a research partner meets organizational standards. Which governance input is most essential to that decision?

  1. The color scheme of the partner's website
  2. The approved data use and disclosure policy governing permitted purposes and safeguards Correct answer.
  3. The partner's marketing plan for the coming year
  4. The physical location of the partner's office furniture

Explanation

Data-sharing decisions are evaluated against the approved policy that defines permitted purposes, required safeguards, and disclosure conditions. Only that policy provides the criteria needed for a defensible determination.

Question 16Healthcare Data Governance and Stewardship

What is the primary function of a data governance maturity assessment?

  1. To evaluate current capabilities against a defined model and identify prioritized improvement areas Correct answer.
  2. To replace the need for data policies
  3. To calculate the organization's annual tax liability
  4. To certify individual employees as data stewards

Explanation

A maturity assessment benchmarks current governance capabilities against a reference model and highlights gaps for prioritized improvement. It informs planning rather than certifying individuals or replacing policy.

Question 17Healthcare Data Governance and Stewardship

A steward notices that a clinical registry accepts entries with missing laterality for surgical procedures. Which governance response is most appropriate?

  1. Define a mandatory data element rule requiring laterality and enforce it through system validation Correct answer.
  2. Allow clinicians to supply laterality only when they remember
  3. Remove laterality from the registry schema entirely
  4. Accept the missing values because laterality is rarely important

Explanation

Laterality is safety-critical, so stewardship should mandate the element and enforce it through validation at entry. Accepting or removing the field would perpetuate a patient-safety risk.

Question 18Healthcare Data Governance and Stewardship

Which artifact defines the permissible values, format, and meaning of a single data element for consistent enterprise use?

  1. A data element specification within the data dictionary Correct answer.
  2. A service level agreement for network uptime
  3. A project risk register
  4. A capacity planning spreadsheet

Explanation

A data element specification documents permissible values, format, and semantics so the element is used consistently. Other artifacts address project risk, capacity, or service performance rather than data content.

Question 19Healthcare Data Governance and Stewardship

An organization is forming its first data governance program. Which sequencing of activities is most sound?

  1. Purchase a data catalog before defining any roles or policies
  2. Establish the charter and roles, then define policies and standards, then operationalize stewardship workflows Correct answer.
  3. Begin enforcing penalties before roles and policies exist
  4. Deploy reporting tools first, then decide later whether governance is needed

Explanation

Sound programs first legitimize authority through a charter and roles, then codify policies and standards, and only then operationalize workflows. Tools and enforcement without foundational authority tend to fail.

Question 20Healthcare Data Governance and Stewardship

Which metric best indicates the effectiveness of stewardship over a clinical data domain?

  1. The number of meetings held by the governance council
  2. The rate of resolved data quality issues against defined thresholds over time Correct answer.
  3. The count of software applications deployed
  4. The total budget allocated to the IT department

Explanation

Effectiveness is measured by whether data quality issues are resolved and thresholds met over time. Activity counts and budget figures describe inputs rather than stewardship outcomes.

Question 21Healthcare Data Governance and Stewardship

A steward is asked to approve access to a sensitive dataset for a quality improvement project. Which consideration is most central to a defensible decision?

  1. Whether the request was submitted on a Friday
  2. Whether the requested use matches an approved purpose and the access is limited to the minimum necessary Correct answer.
  3. Whether the requester is a personal friend of the steward
  4. Whether the dataset is stored on the newest hardware

Explanation

Access decisions rest on whether the purpose is approved and whether access is limited to the minimum necessary for that purpose. Personal relationships, hardware, or timing are irrelevant to the determination.

Question 22Healthcare Data Governance and Stewardship

Which practice best demonstrates stewardship accountability when a data quality defect is traced to an upstream source system?

  1. Documenting the root cause and coordinating with the source system owner on a corrective action plan Correct answer.
  2. Ignoring the defect because it originated outside the steward's domain
  3. Blaming the source system team and closing the issue
  4. Manually correcting each downstream record indefinitely

Explanation

Accountable stewardship traces defects to their source and coordinates a durable corrective action with the owning system. Blame, avoidance, or endless manual correction fails to prevent recurrence.

Question 23Healthcare Data Governance and Stewardship

What role does a data governance council typically play regarding enterprise data standards?

  1. It delegates standard-setting entirely to external auditors
  2. It writes all standards single-handedly without input from stewards
  3. It has no involvement in standards and focuses only on budgeting
  4. It ratifies standards proposed by domain stewards and resolves conflicts between them Correct answer.

Explanation

Councils ratify standards developed by domain experts and arbitrate conflicts across domains. They provide cross-enterprise authority while relying on stewards for subject-matter expertise.

Question 24Healthcare Data Governance and Stewardship

Which statement best reflects the principle of minimum necessary in data governance for clinical analytics?

  1. Analysts should receive data only after the project concludes
  2. Analysts should receive data without any documented purpose
  3. Analysts should receive only the data elements required for the approved analytic purpose Correct answer.
  4. Analysts should receive all available data to avoid future requests

Explanation

Minimum necessary limits data access to what is required for the approved purpose, reducing exposure and supporting privacy obligations. Broad or undocumented access increases risk without justification.

Question 25Healthcare Data Governance and Stewardship

A steward is designing a process to handle conflicting data definitions submitted by two clinical departments. Which approach best embodies governance principles?

  1. Escalate to the software vendor to choose the definition
  2. Adopt whichever department submitted its definition first
  3. Let each department keep its own definition indefinitely
  4. Convene stakeholders to reconcile the definitions against enterprise standards and document the approved resolution Correct answer.

Explanation

Conflicts are resolved through structured reconciliation against enterprise standards, with the outcome documented for consistency. First-come, unilateral retention, or vendor selection bypasses governance authority.

Question 26Healthcare Data Governance and Stewardship

A hospital's governance committee wants to ensure that all staff who create or modify patient records understand their accountability for data accuracy and completeness. Which role is primarily responsible for this day-to-day data quality stewardship at the departmental level?

  1. Chief Information Security Officer
  2. Privacy officer
  3. Data steward Correct answer.
  4. Data architect

Explanation

Data stewards are business or clinical staff accountable for the quality, integrity, and appropriate use of data within their domain; they translate governance policy into operational practice at the point of data creation. The CISO, data architect, and privacy officer have enterprise-wide technical or compliance mandates, not departmental data quality accountability.

Question 27Healthcare Data Governance and Stewardship

A health system is implementing a new enterprise data governance policy. Which action best demonstrates the principle of data stewardship at the executive level?

  1. Requiring all staff to sign an annual data confidentiality agreement
  2. Establishing a data governance council with decision rights and accountability for data assets Correct answer.
  3. Delegating all data-related decisions to the IT department
  4. Outsourcing data quality monitoring to a third-party vendor

Explanation

Executive stewardship means accepting accountability for data as a strategic asset and creating formal structures-such as a governance council-that assign decision rights and oversight. Delegating to IT, outsourcing monitoring, or focusing only on confidentiality agreements does not establish executive ownership of data quality and use.

Question 28Healthcare Data Governance and Stewardship

A data steward discovers that the 'discharge disposition' field is populated with free-text entries in one EHR module but uses a controlled vocabulary in another. Which governance action should the steward take first to resolve the inconsistency?

  1. Immediately modify the free-text module to enforce the controlled vocabulary
  2. Escalate the issue to the data governance council for a decision on the enterprise standard Correct answer.
  3. Ask clinicians to manually standardize their entries after the fact
  4. Document the inconsistency and continue using both formats until the next system upgrade

Explanation

When data definitions or formats conflict across systems, the steward's first step is to escalate to the governance body that owns enterprise data standards, so a consistent decision is made with proper authority. Unilateral technical changes, indefinite tolerance, or manual cleanup do not establish a durable standard.

Question 29Healthcare Data Governance and Stewardship

A steward is reviewing a proposed data-sharing agreement with a public health agency. The agreement permits the agency to use identifiable patient data for a purpose not described in the original consent. Which governance principle should guide the steward's response?

  1. Data minimization, ensuring only necessary data elements are shared
  2. Data accuracy, ensuring the data is free of errors before sharing
  3. Data retention, ensuring data is deleted after a fixed period
  4. Purpose limitation, ensuring data use is restricted to the purpose for which it was collected or consented Correct answer.

Explanation

Purpose limitation requires that data be used only for the purpose specified at collection or agreed by the data subject; sharing identifiable data for a new purpose without consent violates this principle. Minimization, retention, and accuracy are important but do not directly address the unauthorized new use.

Question 30Healthcare Data Governance and Stewardship

A health plan's data governance council is evaluating a proposal to create a new analytics data mart containing claims and clinical data. The council must decide whether to approve the mart. Which criterion is most directly aligned with the council's stewardship mandate?

  1. The mart has a named business owner and documented data quality controls for its critical data elements Correct answer.
  2. The mart uses the latest cloud infrastructure technology
  3. The mart includes all available data fields to maximize future flexibility
  4. The mart can be built within the current fiscal quarter

Explanation

A governance council's stewardship mandate is to ensure data assets have clear accountability and appropriate quality controls; a named owner and documented controls for critical data elements directly satisfy that. Technology choice, speed, and maximal data inclusion are not governance criteria and may increase risk.

Question 31Clinical Data Management and Standards

Under CDISC SDTM, which observation class is used to represent findings that are collected at planned visits and have a defined structure of topic, qualifier, and result variables?

  1. Events
  2. Special Purpose
  3. Findings Correct answer.
  4. Interventions

Explanation

The Findings class covers observations that are measured or assessed, such as laboratory tests and vital signs, and always includes a topic variable, qualifiers, and a result variable. Interventions describe treatments or procedures, while Events describe occurrences without a planned result.

Question 32Clinical Data Management and Standards

In a CDISC SDTM submission, which variable carries the unique identifier assigned by the sponsor to a subject across the entire study?

  1. SPDEVID
  2. SUBJID
  3. USUBJID Correct answer.
  4. SITEID

Explanation

USUBJID is the unique subject identifier that must be unique across the whole submission and is typically built from study, site, and subject components. SUBJID is only unique within a site and is not globally unique.

Question 33Clinical Data Management and Standards

Which controlled terminology codelist in SDTM provides the standard values for the variable AEOUT in the adverse events domain?

  1. NY
  2. OUT
  3. AEOUT
  4. OUTCOME Correct answer.

Explanation

AEOUT uses the Outcome codelist, which contains values such as RECOVERED, RECOVERING, NOT RECOVERED, FATAL, and UNKNOWN. The codelist name differs from the variable name, so matching variable names to codelists requires the define metadata rather than assumption.

Question 34Clinical Data Management and Standards

A sponsor maps a collected lab result of "<0.5" for a numeric laboratory test. Which SDTM variables should carry the operator and the numeric portion respectively?

  1. LBSTRESN and LBSTRESU
  2. LBSTRESC and LBSTRESN Correct answer.
  3. LBSTRESN and LBSTNRLO
  4. LBSTNRLO and LBSTNRHI

Explanation

The character result LBSTRESC holds the result as collected or standardized, including the operator, while LBSTRESN holds the numeric portion when one exists. Units belong in LBSTRESU and reference ranges in LBSTNRLO and LBSTNRHI.

Question 35Clinical Data Management and Standards

In CDISC ADaM, what is the defining characteristic of a Basic Data Structure (BDS) dataset?

  1. One record per subject per parameter per analysis time point Correct answer.
  2. One record per visit regardless of parameter
  3. One record per adverse event reported
  4. One record per subject with only demographic variables

Explanation

A BDS dataset is structured as one record per subject per parameter per analysis time point, with PARAMCD and AVAL carrying the parameter and analysis value. This structure supports repeated measures such as lab analyses or efficacy endpoints.

Question 36Clinical Data Management and Standards

Which ADaM variable holds the analysis value for a parameter in a BDS dataset?

  1. BASE
  2. A VAL
  3. AVAL Correct answer.
  4. CHG

Explanation

AVAL is the analysis value, the numeric result analyzed for a given parameter and time point. BASE holds the baseline value and CHG holds the change from baseline.

Question 37Clinical Data Management and Standards

In ADaM, which variable is used to flag the records that belong to the primary analysis population for an endpoint?

  1. ITTFL
  2. ANL01FL Correct answer.
  3. SAFFL
  4. EFFFL

Explanation

ANL01FL is a record-level analysis flag identifying records included in a specific analysis. Population flags such as SAFFL or ITTFL are subject-level indicators, not record-level selection flags.

Question 38Clinical Data Management and Standards

In a define.xml file, which element describes a variable's metadata such as its name, label, data type, and role?

  1. ItemDef Correct answer.
  2. ItemGroupDef
  3. CodeList
  4. MetaDataVersion

Explanation

ItemDef defines an individual variable's metadata, including OID, name, label, data type, length, and role. ItemGroupDef groups ItemDefs into a dataset, and CodeList defines permitted values.

Question 39Clinical Data Management and Standards

Which CDISC standard is specifically designed to support the exchange of tabular data collected during a clinical trial from the site to the sponsor?

  1. SDTM
  2. SEND
  3. CDASH Correct answer.
  4. ADaM

Explanation

CDASH provides standard CRF content and naming for data collection at the site. SDTM structures submission data, ADaM supports analysis, and SEND applies to nonclinical studies.

Question 40Clinical Data Management and Standards

A trial collects a date of birth and an informed consent date. Under CDASH, which convention supports later derivation of age?

  1. Collect only age in years
  2. Collect age as a free-text field
  3. Collect birth year only
  4. Collect the birth date and consent date as complete dates Correct answer.

Explanation

CDASH recommends collecting complete dates for birth and consent so that age at consent can be derived precisely. Collecting only a year or a free-text age loses precision and traceability.

Question 41Clinical Data Management and Standards

In SDTM, which domain is the parent domain for the Findings About structure that captures additional measurements about an event or intervention?

  1. RELREC
  2. CO
  3. SUPPQUAL
  4. FA Correct answer.

Explanation

The Findings About (FA) domain stores findings about a parent record, linked through RELREC or the FAOBJ variable. SUPPQUAL stores non-standard qualifiers as name-value pairs, and RELREC defines relationships.

Question 42Clinical Data Management and Standards

Which SDTM variable links a supplemental qualifier record back to its parent record in SUPPQUAL?

  1. RDOMAIN and USUBJID
  2. IDVAR and IDVARVAL Correct answer.
  3. QLABEL and QORIG
  4. QNAM and QVAL

Explanation

IDVAR names the parent variable and IDVARVAL holds its value, allowing the supplemental qualifier to be joined to the parent record. RDOMAIN identifies the parent domain but not the specific record.

Question 43Clinical Data Management and Standards

According to ICH E6 Good Clinical Practice, which principle applies to the recording and correction of source data?

  1. Corrections may be made only by the sponsor's data manager
  2. Corrections may overwrite the original entry without a trace
  3. Corrections require no documentation if the change is minor
  4. Corrections must be traceable, with the reason and the person and date recorded Correct answer.

Explanation

GCP requires that any change to source data be traceable, with the original value retained and the reason, date, and person making the change documented. Overwriting without an audit trail destroys data integrity.

Question 44Clinical Data Management and Standards

In 21 CFR Part 11, which control is required for electronic signatures to be considered trustworthy and reliable?

  1. Signatures must be handwritten and scanned
  2. Each signature must be unique to one individual and not reused Correct answer.
  3. Signatures may be shared among study team members
  4. Signatures must be applied by the sponsor only

Explanation

Part 11 requires that electronic signatures be unique to an individual and not reassigned or reused. The system must also verify identity and link the signature to the record.

Question 45Clinical Data Management and Standards

An audit trail in an electronic data capture system records a change to a value from 120 to 102. Which elements must the audit trail capture to support data integrity?

  1. Only the new value
  2. Only the user and the new value
  3. The old value, new value, user, date and time, and reason for change Correct answer.
  4. The new value and the monitor's approval

Explanation

A compliant audit trail preserves the previous value, the new value, who made the change, when it occurred, and why. This allows reconstruction of the data history during inspection.

Question 46Clinical Data Management and Standards

In a clinical data management plan, which document defines how discrepancies are raised, tracked, and resolved between the site and the sponsor?

  1. Data Validation Plan Correct answer.
  2. Investigator's Brochure
  3. Informed Consent Form
  4. Statistical Analysis Plan

Explanation

The data validation plan describes edit checks, discrepancy generation, query workflow, and resolution expectations. The statistical analysis plan covers analysis methods rather than data cleaning procedures.

Question 47Clinical Data Management and Standards

A sponsor uses MedDRA to code adverse events. Which level of the MedDRA hierarchy is most commonly used for summary safety tables?

  1. System Organ Class Correct answer.
  2. High Level Group Term
  3. Lowest Level Term
  4. Preferred Term

Explanation

System Organ Class groups events by body system and is widely used for summary tables, while Preferred Term provides the specific event term. Both levels are typically presented together.

Question 48Clinical Data Management and Standards

Which WHO Drug Dictionary level provides the standard generic name used for coding concomitant medications in SDTM?

  1. Preferred Name Correct answer.
  2. Anatomical Therapeutic Chemical code
  3. Herbal name
  4. Trade Name

Explanation

The Preferred Name is the generic name used to code a medication, while the Trade Name captures the brand. The ATC code classifies the drug but is not the generic name itself.

Question 49Clinical Data Management and Standards

In SDTM, which variable in the Demographics domain stores the subject's age at a reference time point?

  1. BRTHDTC
  2. AGE Correct answer.
  3. AGEGR1
  4. AGEU

Explanation

AGE stores the age value and AGEU stores its unit, such as YEARS. BRTHDTC holds the birth date and AGEGR1 is an analysis grouping variable.

Question 50Clinical Data Management and Standards

A study team needs to submit nonclinical data for a toxicology study to the FDA. Which standard applies?

  1. SEND Correct answer.
  2. CDASH
  3. SDTM
  4. ADaM

Explanation

SEND is the Standard for Exchange of Nonclinical Data and applies to animal studies submitted to the FDA. SDTM and ADaM apply to human clinical data.