CCRP cheat sheet

Core competency domains for the clinical research professional include protocol compliance, subject recruitment and retention, informed consent administration, data management, safety reporting, and regulatory documentation.

ICH GCP E6(R2) defines the investigator as the person responsible for conduct of the trial at a site; the sponsor initiates and manages the trial and holds the investigational product accountability chain.

Essential documents must be filed in the trial master file (sponsor) and investigator site file (site) and retained per applicable regulation - commonly at least 2 years after the last marketing application approval or 2 years after formal discontinuation of development.

Source documents are the original records (hospital charts, lab reports, ECGs, device tracings); source data verification compares these against the case report form entries.

A protocol amendment requires IRB/IEC approval before implementation except when necessary to eliminate an immediate hazard to subjects; such deviations must be reported promptly.

The clinical research professional's education pathway typically includes a health-science degree plus GCP training; certification bodies (e.g., ACRP, SOCRA) require documented GCP training and continuing education hours for recertification.

Adverse event (AE) versus serious adverse event (SAE): SAE criteria are death, life-threatening, hospitalization or prolongation, persistent or significant disability, congenital anomaly, or important medical event requiring intervention.

Site feasibility assessment evaluates patient pool size, competing trials, staff qualifications, equipment availability, and prior enrollment performance before site selection.

The Belmont Report principles are respect for persons (informed consent, protection of vulnerable subjects), beneficence (maximize benefit, minimize harm), and justice (fair subject selection and distribution of burdens/benefits).

The Declaration of Helsinki (WMA) is the foundational ethical statement for human research; it requires independent ethical review, informed consent, and a favorable risk-benefit ratio.

Informed consent elements include purpose, procedures, risks, benefits, alternatives, confidentiality, compensation for injury, voluntary participation, and the right to withdraw without penalty.

Vulnerable populations include children, prisoners, pregnant women, cognitively impaired persons, economically disadvantaged persons, and employees/students under hierarchical influence; additional safeguards are required.

IRB/IEC composition requires at least five members with varied backgrounds, at least one member whose primary concern is non-scientific, at least one independent of the institution, and members of both genders when possible.

The Common Rule (45 CFR 46) governs federally funded human subjects research in the US; subparts B, C, and D address pregnant women/neonates, prisoners, and children respectively.

Minimal risk means the probability and magnitude of harm are not greater than those ordinarily encountered in daily life or during routine physical or psychological examinations.

Waiver of informed consent may be granted only if the research involves no more than minimal risk, the waiver will not adversely affect rights and welfare, the research could not practicably be carried out otherwise, and subjects receive debriefing when appropriate.