Free CCRC Exam Flashcards

The protocol is the master document defining the trial's rationale, objectives, design, methodology, statistical plan, and organization. Site staff who deviate from it without prior IRB/sponsor approval create a protocol deviation or violation.

A compilation of the clinical and nonclinical data on the investigational product. Its reference safety information is what the sponsor uses to judge whether a reaction is 'expected' (nature and severity consistent with it) or 'unexpected', which drives expedited reporting timelines.

The primary endpoint is the single pre-specified outcome that answers the study's main question and determines the sample-size/power calculation. Secondary endpoints add supportive evidence but do not drive that calculation.

Screen fail rate is the percentage of prescreened candidates who don't meet eligibility criteria and never enroll. Sites use it to size the recruitment funnel large enough to hit the enrollment target within the study timeline.

An AE is any untoward medical occurrence in a participant, regardless of severity. It becomes an SAE if it results in death, is life-threatening, requires/prolongs hospitalization, causes persistent or significant disability, or is a congenital anomaly/birth defect; an important medical event that may jeopardize the participant or need intervention to prevent one of those outcomes is generally treated as serious too. Seriousness is about outcome criteria, not intensity.

A SUSAR is a Suspected Unexpected Serious Adverse Reaction: serious, with a reasonable possibility that the investigational product caused it, and unexpected, meaning its nature or severity isn't consistent with the IB's reference safety information (a more severe or more specific form of a listed reaction counts as unexpected). The sponsor reports it to regulators no later than 7 calendar days after first knowledge if fatal/life-threatening (complete report within 8 more days), and within 15 calendar days otherwise.

Informed consent must be obtained and documented BEFORE any study procedure, including screening tests that aren't part of the subject's standard-of-care. Consent obtained after the fact is a GCP violation, not just a deviation.

Purpose of the research, expected duration, procedures, foreseeable risks/discomforts, expected benefits, alternative treatments, confidentiality provisions, and a statement that participation is voluntary with the right to withdraw at any time without penalty.

When new information may affect a participant's willingness to continue (e.g., a new safety signal or added procedure), participants are told in a timely manner and that is documented. The new information is assessed to decide whether re-consent is needed (it may matter only to new participants); if it is, re-consent uses revised consent materials that the IRB/IEC approved in advance, and it is obtained before any new procedure those materials cover.

The consent discussion is conducted orally in the presence of an impartial witness, who signs and dates the consent form attesting that the information was accurately explained and the subject appeared to understand and voluntarily agree.

Assent is the child's own age-appropriate agreement to participate; consent is the legal permission given by a parent or legally acceptable representative (LAR). Both are needed: the representative's consent, and the minor's assent as appropriate (ICH E6(R3) 2.8.12).

Respect for persons (autonomy and protection of those with diminished autonomy), beneficence (maximize benefit, minimize harm), and justice (fair distribution of research burdens and benefits) — the 1979 U.S. foundation for human-subjects protection.

A World Medical Association statement of ethical principles for medical research involving human subjects, first adopted in 1964 and periodically revised. ICH GCP explicitly grounds its ethical principles in this declaration.

Report suspected fraud or misconduct promptly through the site's/sponsor's escalation channel; concealing or failing to report it is itself an ethical and GCP violation, separate from whatever the original misconduct was.

Phase I: safety in a small group (often healthy volunteers). Phase II: dose-finding and preliminary efficacy. Phase III: large confirmatory efficacy/safety trial supporting approval. Phase IV: post-marketing surveillance after the product is approved.

An IND (Investigational New Drug application) is the FDA pathway that permits human trials of a drug or biologic. An IDE (Investigational Device Exemption) is the separate FDA pathway for investigational medical devices — same underlying safeguard, different product category.

An independent body of medical, scientific, and non-scientific members that reviews and must approve the protocol, informed consent form, and amendments before a trial starts, safeguarding participants' rights, safety, and wellbeing throughout the study.

No — amendments require prior IRB/IEC approval before implementation. The exceptions: changes needed to eliminate an immediate hazard to participants, which may be implemented at once (the sponsor is informed promptly and the IRB/IEC gets a prompt report), and, where regulations allow, purely logistical or administrative changes.

An audit is a systematic, independent examination of trial conduct and data performed by the sponsor, a service provider such as a CRO, or the institution. An inspection is a regulatory authority's official, legally-empowered review of the same — audits are quality assurance; inspections carry enforcement authority.

Transparency requirements (e.g., ClinicalTrials.gov in the U.S.) require registration before or shortly after enrollment begins, so regulators, IRBs, and the public can track ongoing research and later verify that results were reported.

It's the record of each site staff member and the specific trial tasks the investigator has delegated to them. Under ICH E6(R3) the record is proportionate to the significance of the task, and activities done as part of clinical practice may not need it; a trial-specific task done by someone with no recorded delegation is a finding, even if the person was qualified.

A corrective action fixes a problem that has already occurred (e.g., retraining after a documentation error); a preventive action addresses a potential problem before it happens (e.g., adding a double-check step). A CAPA plan typically includes both.

Source data verification (SDV) — that CRF entries match source documents — plus protocol/GCP compliance, IP accountability, and regulatory document currency. Findings are followed up and tracked to resolution before the next visit.

A pre-study visit qualifies and selects a site BEFORE it's chosen for the trial. The SIV happens after selection, before enrollment opens, and trains staff on the protocol, procedures, and systems — different visits, different purposes and timing.

No — the PI may delegate specific tasks to qualified, trained staff via the delegation log, but ultimate responsibility for protocol compliance, subject safety, and data integrity at the site remains non-delegable.

Whether it realistically has the patient population, qualified staff, equipment, and time to successfully conduct the study as designed — done before agreeing to participate, to avoid under-enrollment or non-compliance later.

The sponsor funds the trial, supplies the investigational product, and holds ultimate accountability. A CRO (Contract Research Organization) may be delegated specific sponsor duties like monitoring, but the sponsor remains accountable. The regulatory authority reviews/approves the trial and can inspect or halt it.

The monitor reconciles investigational product accountability, resolves outstanding data queries, confirms essential documents are complete, and verifies proper record archiving before the site's role in the trial formally ends.

A deviation is an unplanned, unapproved departure from the protocol discovered after the fact and then reported. An amendment is a planned protocol change that receives IRB/IEC approval BEFORE it takes effect — reactive versus proactive.

Notify the sponsor and IRB/IEC promptly with full documentation; serious violations (unlike minor deviations) can trigger a formal CAPA, additional monitoring, or in severe cases suspension of the site's participation.

Monitors, auditors and inspectors check competence for delegated tasks through records. ICH E6(R3) asks for trial-related training on whatever the delegated activities need beyond the person's usual training and experience, so training that isn't documented can't be shown to have happened.

The investigator must make sure they are qualified and adequately informed about the protocol, the investigational product and their tasks, and record the delegation in proportion to the task (activities done as part of clinical practice may not need it) — sequence matters: training and delegation come before task performance, not after.

Every unit of IP from receipt through dispensing, return, or destruction — quantities in, quantities out, to whom, and when — so the sponsor can reconcile exactly what happened to every dose supplied to the site.

Quarantine the affected product immediately (stop using or dispensing it), document the exact time/duration/temperature range of the excursion, then notify the sponsor and await their stability determination before resuming use or destroying it.

At minimum: protocol/study identifier and storage conditions, and (for blinded studies) a randomization code rather than the actual treatment name — labeling must never inadvertently reveal a subject's treatment assignment in a blinded trial.

Shipment requires verified chain-of-custody and, for temperature-sensitive product, continuous monitoring devices with the shipment. Storage requires the site to maintain and log the specified conditions (e.g., temperature range) continuously once product arrives on site.

Per-subject visit and procedure costs, overhead/administrative fees, and a payment schedule typically tied to milestones like enrollment, visit completion, or data lock — captured in the site's contract with the sponsor/CRO.

Improper collection, processing, or storage can degrade a sample before it's analyzed, invalidating the result — coordinators must follow the lab manual exactly so specimen integrity supports valid, usable data.

Pill counts, subject diaries, and sometimes drug-level assays or device data logs — used to confirm the participant is actually following the protocol-required dosing or procedure schedule between visits.

Document the missed visits, assess whether the gap affects subject safety or data validity, follow the protocol's discontinuation/deviation procedure, and report to the sponsor/IRB if required by that protocol's non-compliance management plan.

Coordinating and overseeing third parties the trial depends on — central labs, IRT/IWRS providers, imaging cores, specialty couriers — confirming their services meet contract terms and protocol specifications, since their errors become the site's problem.

Any data generated by equipment outside its calibration/maintenance schedule is considered unreliable — the readings can't be trusted as accurate, which can invalidate the endpoints or safety assessments that depended on them.

Data lock is the point when the trial database is finalized and no further changes are permitted. Coordinators track enrollment, recruitment/retention, and query-resolution timelines because unresolved items delay lock and the overall trial schedule.

Data reported to the sponsor must be consistent with the source records, or the discrepancy explained (ICH E6(R3) 2.12.6). Usually the source is the original record and the eCRF entry is corrected to match; but where data are captured directly into the eCRF, that entry is the source.

A flag raised (usually by a monitor or data manager) when a CRF entry is inconsistent, missing, or conflicts with source data. The coordinator must investigate against the source and resolve — correct, clarify, or confirm — before the item can be closed.

The Interactive Web/Voice Response System (IWRS/IRT) manages randomization assignment and real-time investigational product inventory at the site, ensuring the right product/dose is dispensed and stock levels trigger resupply automatically.

E6(R3) calls them essential records: the documents and data that support managing the trial and collectively allow evaluation of how it was run and whether its results are reliable (e.g., signed protocol, IRB approvals, signed consent forms, delegation record). The sponsor keeps them in the trial master file (TMF) and the site in the investigator site file (ISF), paper or electronic.

Both matter: under ICH E6(R3) 2.12.12 the site keeps essential records for the required period under applicable regulations or until the sponsor informs it they are no longer needed, whichever is longest. The sponsor's contract can require longer than the regulatory minimum, and destruction waits for the sponsor's written notice.

Source Data Verification (SDV) compares a specific CRF entry against the source document to confirm they match. Source Data Review (SDR) is the broader review of the source record itself for completeness and quality, independent of any CRF entry.

Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available — the nine traits in ACRP's CCRC content outline for judging whether study documentation and data can be trusted. ICH E6(R3) 2.12.2 names the first six (ALCOA plus complete).