CRNO flashcards

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

ICH E6 GCP

International Council for Harmonisation guideline for good clinical practice; E6(R2) added risk-based quality management, and E6(R3) emphasizes quality by design and proportionate oversight of trial conduct.

21 CFR Part 11

US regulation setting criteria for electronic records and electronic signatures: validated systems, secure access, audit trails, and signatures that capture name, date, time, and meaning.

Form FDA 1572

The investigator's signed statement committing to conduct the study per protocol and GCP, personally supervise the trial, and ensure staff are qualified and informed of their duties.

Common Rule subparts

45 CFR 46 subpart B protects pregnant women, fetuses, and neonates; subpart C protects prisoners; subpart D protects children, each adding specific safeguards and review requirements.

Non-inferiority margin

The pre-specified largest acceptable loss of efficacy versus the active comparator; it must be clinically justified and fixed before unblinding to preserve type I error control.

Intention-to-treat analysis

Analysis of all randomized participants according to assigned treatment regardless of compliance or withdrawal; it preserves randomization's protection against selection bias.

Allocation concealment

Procedures preventing investigators from knowing upcoming treatment assignments before enrollment; it differs from blinding, which conceals assignment after randomization.

Screen failure log

A site record of screened participants who did not enroll, capturing identifiers, consent date, eligibility determination, and the specific reason for failure.

Undue influence in recruitment

Excessive or inappropriate reward, or recruitment by a treating physician, that can override a person's free choice about whether to participate.

Assent

A child's affirmative agreement to participate, required alongside parental permission when the IRB determines the child can understand the research at an appropriate developmental level.

Re-consent

Obtaining a new IRB-approved consent when new information, such as a newly identified risk or a substantive protocol change, could affect willingness to continue.

Legally authorized representative

An individual or judicial body authorized under applicable law to consent on behalf of a prospective participant who lacks capacity to give informed consent.

ALCOA principles

Source data must be attributable, legible, contemporaneous, original, and accurate; complete and consistent are often added to form ALCOA-C.

Protocol deviation

Any departure from the IRB-approved protocol; significant departures that may affect safety or data integrity are often termed violations and require prompt reporting.

Delegation log

A site document listing study staff, delegated tasks, and start and end dates, demonstrating that each task was performed by qualified, authorized personnel.

Investigational product accountability

Records of receipt, dispensing, return, and destruction that reconcile the quantity of product shipped to the site with what was used, returned, or destroyed.

Emergency unblinding

Breaking the treatment code when knowledge is needed to manage a participant's medical emergency; the event and reason must be documented and reported to the sponsor.

Serious adverse event

An adverse event resulting in death, being life-threatening, requiring hospitalization, causing persistent disability, or involving a congenital anomaly, per ICH E2A criteria.

SUSAR

A suspected unexpected serious adverse reaction: an SAE assessed as related to the investigational product and not listed in the investigator brochure or labeling.

Causality assessment

Evaluation of whether an adverse event is related to the investigational product, considering timing, plausibility, dechallenge, rechallenge, and alternative explanations.

Record retention period

Under 21 CFR 312.62, records must be kept at least two years after the marketing application is approved or the investigation is discontinued.

Audit trail

A secure, computer-generated record showing who created, modified, or deleted electronic data, with the date, time, and reason, required under 21 CFR Part 11.

Source data verification

Comparison of case report form entries against original source documents to confirm accuracy and completeness; risk-based monitoring may target only critical data.

Form FDA 483

A form issued at the close of an FDA inspection listing observations of objectionable conditions; the recipient responds in writing with corrective actions.

CAPA plan

A documented corrective and preventive action plan identifying root cause, actions taken, responsible persons, timelines, and verification that the actions were effective.

Belmont Report principles

Respect for persons, beneficence, and justice; these principles underlie informed consent, risk-benefit assessment, and fair selection of research participants.

IND application

A submission to FDA requesting authorization to administer an investigational drug to humans; the sponsor must also report serious and unexpected suspected adverse reactions.

Placebo control justification

Use of placebo must be ethically justified, especially when an effective treatment exists; otherwise an active control or add-on design is generally required.

Stratified randomization

Randomization within pre-specified subgroups such as site or disease severity to balance prognostic factors across treatment arms in the analyzed population.

HIPAA authorization waiver

IRB or privacy board approval allowing use of identifiable health information without participant authorization, subject to criteria on risk, rights, and feasibility.

Exception from informed consent

Under 21 CFR 50.24, emergency research may proceed without consent only if strict criteria are met, including community consultation and public disclosure.

Unanticipated problem

An incident, experience, or outcome that is unexpected, related to the research, and suggests increased risk to participants or others; it must be reported to the IRB.

Risk-based monitoring

A monitoring approach concentrating resources on critical data and processes, combining on-site visits with centralized data review and key risk indicators.