Free CCRP Exam Flashcards

Established after the Nazi doctors' trial; its first principle makes voluntary, informed consent an absolute prerequisite for research participation. It has no legal force but is the ethical foundation for later codes and regulations.

The first international ethics guideline written specifically for physician-researchers conducting human experimentation. Introduced the idea of independent ethics-committee review of research and is periodically revised by the WMA.

Respect for Persons (autonomy/informed consent, extra protection for those with diminished autonomy), Beneficence (maximize benefit, minimize harm), and Justice (fair distribution of research burdens and benefits across populations).

The U.S. federal regulation that turns Belmont's principles into enforceable requirements for federally funded human-subjects research: mandatory IRB review and informed consent, plus (Subparts B/C/D) added protections for pregnant women/fetuses/neonates, prisoners, and children.

Nuremberg (1947): first ethics code, consent as an absolute rule, no legal force. Helsinki (1964, WMA): physician-research ethics guideline, introduced ethics-committee review. Belmont (1979): U.S. ethical framework (3 principles), not itself a regulation. Common Rule (45 CFR 46): the U.S. federal regulation with actual legal force that operationalizes Belmont.

At least 5 members with varying backgrounds, including at least 1 member whose primary concerns are scientific, at least 1 whose primary concerns are nonscientific, and at least 1 member unaffiliated with the institution (and not an immediate family member of anyone affiliated).

Used for minimal-risk research or minor changes to already-approved studies that fit specific listed categories (e.g., limited blood draws, certain noninvasive procedures). Conducted by the chair or a designated experienced reviewer, who may approve or request changes -- but only the convened full board can disapprove research.

Required for research that is more than minimal risk. Needs a quorum -- a majority of members present, including at least one nonscientific member -- and approval requires a majority vote of those present at the meeting.

No -- with one narrow exception: the FDA emergency-research exception (21 CFR 50.24), which allows enrollment without prior consent only for specific life-threatening emergency circumstances meeting strict regulatory criteria and community consultation requirements.

(1) purpose/procedures/duration, (2) reasonably foreseeable risks, (3) reasonably expected benefits, (4) alternative procedures/treatments, (5) confidentiality of records, (6) compensation/treatment available if injury occurs (more-than-minimal-risk studies), (7) whom to contact about the research or a research-related injury, and (8) that participation is voluntary with the right to withdraw at any time without penalty.

Added 'when appropriate,' e.g.: unforeseeable risks (including to an embryo/fetus), circumstances under which the investigator may terminate participation without consent, added costs to the subject, consequences of withdrawing, a promise that significant new findings will be shared, and the approximate number of subjects in the study.

Only for research that is no more than minimal risk, where the waiver won't adversely affect subjects' rights/welfare, the research couldn't practicably be done without it, and subjects will be debriefed when appropriate -- a narrower, separate pathway from the 21 CFR 50.24 emergency-research exception.

Assent is an affirmative agreement obtained from the minor (age threshold set by the IRB, based on the child's developmental capacity), obtained IN ADDITION TO the parent's/guardian's permission -- it is a separate process, not a watered-down version of adult consent.

Electronic Records; Electronic Signatures. Sets requirements for when e-records/e-signatures are considered trustworthy and legally equivalent to paper -- audit trails, system validation, and access controls.

Protection of Human Subjects -- governs informed consent requirements (the 8 basic plus optional additional elements). Distinct from Part 56, which governs the IRB itself rather than the consent document.

Financial Disclosure by Clinical Investigators -- requires sponsors to collect information about investigators' financial interests/arrangements (equity, compensation tied to outcome, etc.) so FDA can assess potential bias in study results.

Institutional Review Boards -- establishes IRB composition, function, operating procedures, and recordkeeping requirements (this is where the >=5-member/1-scientific/1-nonscientific/1-unaffiliated rule lives).

Governs Investigational New Drug applications for drug/biologic trials. Once a sponsor submits an IND, FDA has 30 calendar days to review it for safety before the sponsor may begin the clinical study -- unless FDA notifies the sponsor of a clinical hold.

Governs Investigational Device Exemptions. SR device studies require a full IDE application to FDA plus IRB approval; NSR device studies are considered to have an 'approved' IDE once the sponsor obtains IRB approval and follows abbreviated requirements -- no separate FDA IDE submission needed.

Form 1571 is the IND Application cover sheet, filed by the SPONSOR to open/maintain an IND. Form 1572 is the Statement of Investigator, signed by each participating INVESTIGATOR, attesting to qualifications and committing to conduct the study per protocol, ensure IRB oversight, obtain consent, and report adverse events.

AE (Adverse Event): any untoward medical occurrence in a subject, regardless of causality. SAE (Serious AE): an AE resulting in death, is life-threatening, requires/prolongs hospitalization, causes disability, or is a congenital anomaly. SUSAR: a Suspected Unexpected Serious Adverse Reaction -- serious, not described in the current safety information, and reasonably possibly related to the study drug.

Investigators must report serious adverse events to the sponsor immediately, and no later than 24 hours after becoming aware of the event, per ICH GCP.

Must be reported to FDA (and all participating investigators) as soon as possible but no later than 7 calendar days after the sponsor's initial notification, as a preliminary report, followed by a complete follow-up report within 15 calendar days.

Must be reported to FDA in a written IND safety report no later than 15 calendar days after the sponsor determines the information qualifies for reporting.

Investigators must promptly report unanticipated problems involving risks to subjects or others to the IRB, per the institution's written policy -- this IRB-reporting timeline is separate from (and not necessarily identical to) the FDA's 7-/15-day IND safety-report clock.

Sponsors of device studies must report unanticipated adverse device effects (UADEs) to FDA, the reviewing IRB(s), and all participating investigators within 10 working days of first learning of the effect.

An independent group (used especially in large, high-risk, or vulnerable-population trials) that periodically reviews accumulating safety and efficacy data and can recommend continuing, modifying, or stopping a trial early for safety or futility.

Pre-study (site selection/qualification), Initiation (Site Initiation Visit -- staff training, activation), Routine/Interim (ongoing source data verification and compliance checks), and Close-out (final visit reconciling data and IP before study closure).

Comparing data recorded on the CRF/eCRF against the original source documents (charts, lab reports) to confirm accuracy and completeness. It is a core monitoring technique -- but under risk-based monitoring, it is no longer expected to be applied at 100%.

Shifts away from routine 100% on-site SDV toward centralized and statistical monitoring focused on the data and processes most critical to subject safety and trial reliability, guided by a documented quality risk-management/monitoring plan.

An unplanned departure from the IRB-approved protocol or GCP that does NOT significantly affect subjects' rights, safety, or welfare, or the integrity of the study data (e.g., a visit occurring one day outside its window).

A departure from the protocol/GCP that DOES (or could) meaningfully affect subject rights, safety, or welfare, or data integrity -- it typically demands urgent corrective action/reporting and can put the study's IRB approval at risk, unlike a minor deviation.

IRBs must re-review ongoing research at intervals appropriate to the degree of risk -- at least once every 12 months for most greater-than-minimal-risk studies -- to confirm subject protections are still adequate as the study progresses.

The collection of documents that individually and collectively permit evaluation of trial conduct and data quality -- protocol, signed consent forms, IRB approvals, investigator CVs/licenses, and monitoring logs -- maintained and kept current throughout the trial.

The site must maintain complete records of an investigational drug/device's receipt, storage, dispensing/use, and return or destruction, so the sponsor and FDA can confirm product was administered only to enrolled subjects per the protocol.

Storage conditions (e.g., refrigeration logs) are part of IP accountability. Any excursion outside protocol-specified ranges must be documented and reported to the sponsor/monitor for an impact assessment on product integrity and subject safety.

Randomization/blinding integrity is protected through sealed codes or IWRS/IVRS systems. Unblinding is permitted only through protocol-defined emergency procedures and must be documented and reported, since improper unblinding can compromise trial validity.

Personally conduct or supervise the investigation, ensure informed consent is obtained, comply with the protocol and applicable regulations, protect the rights/safety/welfare of subjects, and maintain adequate control over the investigational product.

Select qualified investigators, ensure proper monitoring of the study, maintain IND/IDE compliance, ensure investigational product accountability, and evaluate and report safety information to FDA and to all participating investigators.

Documents which study-related tasks are delegated to which qualified, trained site staff members. Must be signed/dated by the delegating investigator and kept current throughout the trial to demonstrate appropriate oversight.

The revised ICH Good Clinical Practice guideline, adopted in January 2025; SOCRA's exam content reflects it starting January 1, 2026. It shifts GCP's emphasis toward quality by design and proportionate, risk-based oversight rather than uniform maximal checking.

Building quality into the protocol and trial processes from the start -- e.g., simplifying procedures and focusing on the factors critical to reliability -- rather than relying solely on inspection or monitoring to catch problems after the fact.

The intensity of oversight, monitoring, and documentation should scale to the risk and importance of the underlying data or process -- not be applied uniformly at maximum intensity regardless of actual risk.

Sponsors are directed to prospectively identify the data and processes that are critical to subject safety and the reliability of trial results, then prioritize quality-management and monitoring effort on those items.

E6(R3) supports flexible use of qualified electronic systems -- eConsent, ePRO, remote/centralized monitoring -- provided the technology is validated and appropriate for the trial's specific needs and risks.

The final monitoring visit at a site, confirming all data queries are resolved, investigational product is reconciled and returned/destroyed, essential documents are complete, and the site has fulfilled all remaining regulatory and contractual obligations.

Investigators/sponsors must retain essential records for at least 2 years after a marketing application for the drug/device is approved -- or, if no application is filed, for 2 years after the investigation is discontinued and FDA is notified -- whichever applies; sponsor/IRB requirements are often longer.

Completed trial documents (protocol, consent forms, CRFs, monitoring reports, correspondence) must be archived per the sponsor's/institution's retention schedule and remain readily retrievable in case of an audit or FDA inspection.

The sponsor must notify FDA of the end of the investigation, and the investigator must submit a final report to the IRB documenting study closure and outcome per the institution's requirements.

At study end, all investigational product must be fully accounted for -- returned to the sponsor, destroyed on-site with a documented certificate of destruction, or otherwise reconciled -- so accountability records reflect its final disposition.