ACRP-CP flashcards

32 cards. Read the term and the definition here. The deck at the top of this page is optional.

Null hypothesis (H0)

The default statistical assumption that no true difference or association exists between groups; a trial is designed to test, and usually reject, this hypothesis.

Statistical power

The probability of correctly rejecting a false null hypothesis, equal to 1 minus beta; confirmatory trials conventionally target 80% to 90% power.

Permuted block randomization

A randomization method using randomly ordered blocks of a fixed size, keeping arms balanced as enrollment proceeds while preventing prediction of the next treatment assignment.

Intention-to-treat analysis

Analysis of all randomized participants in their assigned groups regardless of adherence or withdrawal; preserves the benefits of randomization and limits attrition bias.

Belmont Report principles

The 1979 US framework identifying three ethical principles for human subjects research, respect for persons, beneficence, and justice, which underlie the Common Rule.

Informed consent elements

Disclosures required before enrollment: purpose, procedures, risks, benefits, alternatives, confidentiality, compensation, contacts, and the voluntary right to withdraw without penalty.

Serious adverse event criteria

An adverse event that causes death, is life-threatening, requires or prolongs hospitalization, causes persistent disability, is a congenital anomaly, or is an important medical event.

SUSAR reporting timelines

Under ICH E2A, unexpected suspected serious adverse reactions that are fatal or life-threatening are reported within 7 calendar days; all other SUSARs within 15 calendar days.

Investigational New Drug application

A US application filed with FDA before an investigational drug may be shipped across state lines for human testing; it takes effect 30 days later unless FDA imposes a clinical hold.

Orphan drug designation

US designation for drugs treating diseases affecting fewer than 200,000 people nationwide; it grants seven years of marketing exclusivity plus tax credits and user-fee waivers.

Accelerated approval pathway

An FDA pathway permitting approval based on a surrogate endpoint reasonably likely to predict clinical benefit, requiring confirmatory post-marketing studies; reserved for serious conditions with unmet need.

Maximum recommended starting dose

The first-in-human dose derived from the animal no-observed-adverse-effect level, converted to a human equivalent dose and divided by a default safety factor of 10.

Risk-based monitoring

An ICH E6(R2) approach that allocates monitoring effort according to identified risks to data quality and participant safety, combining centralized data review with targeted on-site visits.

ALCOA-C data attributes

Data quality attributes requiring records to be attributable, legible, contemporaneous, original, accurate, and complete, with corrections traceable so the original entry remains visible.

Protocol deviation versus violation

A deviation is any unintended departure from the approved protocol; a violation is a serious departure that may affect participant safety, rights, or data integrity and needs prompt reporting.

Delegation of authority log

A site record listing every person to whom the investigator delegates trial tasks, with dates of involvement and the signatures of the investigator and each delegate.

Site feasibility assessment

Evaluation of a site's eligible patient pool, competing trials, qualified staff, facilities, equipment, and past performance to judge whether enrollment and protocol requirements can be met.

Drug accountability record

Documentation of investigational product receipt, storage temperature, dispensing to each participant, returns, and final reconciliation or destruction, supporting compliance with protocol and regulations.

Records retention period

Under 21 CFR 312.62, investigators retain trial records for at least two years after a marketing application is approved, or two years after the IND is withdrawn.

Site initiation visit

A pre-enrollment visit confirming that staff are trained, the protocol is understood, facilities and equipment are adequate, and investigational product handling is ready before screening begins.

SDTM standard

CDISC Study Data Tabulation Model: a standard structure for organizing collected trial data into submission domains such as demographics, adverse events, laboratory results, and exposure.

21 CFR Part 11

US regulation establishing criteria for trustworthy electronic records and signatures, requiring validated systems, audit trails, controlled access, and signatures linked to their owners.

Database lock

The documented point at which a clinical database is frozen after queries are resolved and validation is complete, barring further edits except through a formal unlock process.

MedDRA

The Medical Dictionary for Regulatory Activities, a hierarchical terminology used to code adverse events and medical history, organized from System Organ Class down to Lowest Level Term.

Research misconduct

Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research; honest error and differences of scientific opinion are excluded from the definition.

Financial conflict of interest

A financial interest that could directly and significantly affect the design, conduct, or reporting of research, requiring disclosure and institutional management, reduction, or elimination.

Principal investigator accountability

The investigator holds overall responsibility for trial conduct, participant protection, data integrity, and regulatory compliance at the site, including tasks performed by delegated staff.

Root cause analysis

A structured method, such as the five whys or fishbone diagram, that identifies underlying process failures behind a quality problem rather than assigning individual blame.

Teach-back method

A communication technique in which the listener restates information in their own words so the speaker can confirm understanding; common in informed consent discussions.

SBAR framework

A structured handoff framework covering Situation, Background, Assessment, and Recommendation, used to convey urgent or complex information clearly and reduce miscommunication.

Escalation pathway

A predefined route specifying which person receives an issue, through which channel, and within what timeframe, for matters such as safety events or protocol questions.

Back-translation of consent forms

Independent translation of an already translated document back into the source language, compared with the original to verify accuracy, typically for consent forms used with non-English speakers.