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CCRP CERTIFIED CLINICAL RESEARCH
PROFESSIONAL CERTIFICATION EXAM
KEY CONCEPT/MUST KNOW STUDY
GUIDE (HIGH YEILD)
Investigator's Brochure A compilation of the clinical and nonclinical data on the investigational products which is relevant to the study of the investigational products in human subjects. (ICH GCP E6 1.36) Legally Acceptable Representative An individual or juridicial or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subjects participation in the clinical trial. (ICH GCP E6 1.37) Monitoring Report A written report from the monitor or sponsor after each site visit and/or other trial-related communication according to the sponsor's SOPs. (ICH GCP E6 1.39)
Multicentre Trial A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator. (ICH GCP E6 1.40) Nonclinical Study Biomedical studies not performed on human subjects. (ICH GCP E6 1.41) Protocol Amendment A written description of changes to or formal clarification of a protocol. (ICH GCP E6 1.45) Quality Assurance (QA)
Form 1572 Statement of investigator for IND Form 1571 Cover sheet for an IND application Private Information
- information about behavior which occurs in a context in which an individual can reasonably expect that no observation or recording is taking place
- information which has been provided for a specified purpose by an individual and which the individual can reasonably expect will not be made public (e.g. medical record) IRB membership requirements according to 45 CFR 46
- minimum of 5 members
- IRB must be qualified through experience, expertise, diversity
- diversity with respect to race, gender, cultural background
- cannot consist of members of one profession
- at least one member must have a primary concern in a scientific area and one in a non-scientific area
- at least one member not affiliated with the institution Circumstances/conditions required for informed consent
- subject has had sufficient opportunity to consider whether to participate
- the possibility of coercion or undue influence is minimized Institution Any public or private entity or agency (including Federal, State or other agencies). The word facility as used in section 520(g) of the Act is deemed to by synonymous with the term institution for purposes of this part.(21 CFR, sec. 50.3) Institutional Review Board (IRB)
Legally Authorized Representative An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedures involved. (21 CFR, sec. 50.3) Family Member Any one of the following legally competent persons: spouse; parents; children (including adopted children); brothers, sisters and spouses of brothers and sisters; and any individual related by blood or affinity whose close association with the subject is equivalent of a family relationship. (21 CFR, sec. 50.3) Assent A child's affirmative agreement to participate in a clinical investigation. Mere failure to object may not, absent affirmative agreement, be construed as assent. (21 CFR, sec. 50.3) Children
Persons who have not attained the legal age for consent to treatment or procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the clinical investigation will be conducted. (21 CFR, sec. 50.3) Parent A child's biological or adoptive parent. (21 CFR, sec. 50.3) Ward A child who is placed in legal custody of the State or other agency, institution, or entity, consistent with applicable Federal, State or Local law. (21 CFR, sec. 50.3) Permission The agreement of the parent(s) or guardian to the participation of their child or ward in a clinical investigation. Permission must be obtained in compliance with part 50 subpart B and must include all the elements of the informed consent. (21 CFR, sec. 50.3)
A person that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the FDA. (21 CFR, sec. 312.3) IND An investigational new drug application. Is synonymous with "Notice of Claimed Investigational Exemption for a New Drug". ( CFR, sec. 312.3) Independent Ethics Committee (IEC) A review panel the is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation and is adequately constituted to provide assurance of that protection. An IRB is one type of IEC. (21 CFR, sec. 312.3) Custom Device
A device that 1) necessarily deviates from devices generally available 2) is not generally available to Physicians/dentists 3) not generally available in finished form for purchase or dispensing 4) is not offered for commercial distribution through labeling/advertising 5) is intended for use by an individual patient named in the order of the physician or dentist and is made to be in a specific form for that patient. (21 CFR, sec. 812.3) Implant A device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more. (21 CFR, sec. 812.3) Investigational Device A device, including a transitional device that is the object of investigation. (21 CFR, sec. 812.3) Monitor
Termination A discontinuance, b a sponsor or by withdrawal of IRB or FDA approval, of an investigation before completion. (21 CFR, sec. 812.3) Translational Device A device that FDA considered to be a new drug or and antibiotic drug before May 28, 1976. (21 CFR, sec. 812.3) Unanticipated Adverse Device Event Any serious adverse effect on the health or safety or any life- threatening problem or death caused by, or associated with, a device, if that effect or problem, or death was not previously identified in nature, severity or degree of incidence in the investigational plan or application. (21 CFR, sec. 812.3) Department of Agency Head The head of any federal department or agency and any other officer or employee of any department or agency to whom authority has been delegated. (45 CFR, sec. 46.102)
Legally Authorized Representative (LAR) An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedures involved in the research. (45 CFR, sec. 46.102) Viable As it pertains to the neonate, means being able after delivery to survive. Human Subject A living individual about whom an investigator conducting research obtains 1)Data through intervention or interaction with the individual 2) Identifiable private information. (45 CFR, sec. 46.102) Certification
Audit A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsors SOPs, GCP and the applicable regulatory requirements. (ICH GCP E6 1.6) Audit Certificate A declaration of the confirmation by the auditor that an audit has taken place. (ICH GCP E6 1.7) Audit Report A written evaluation by the sponsor's auditor of the results of the audit. (ICH GCP E6 1.8) Audit Trail Documentation that allow reconstruction of the course of events. (ICH GCP E6 1.9)
Blinding/Masking A procedure in which one or more parties to the trial are kept unaware of the treatment assignment. (ICH GCP E6 1.10) Case Report Form (CRF) A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject. (ICH GCP E6 1.11) Clinical Trial/Study Report A written description of a trial/study of any therapeutic, prophylactic or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analysis are fully integrated into a single report. (ICH GCP E6 1.13) Comparator (Product)
Coordinating Committee A committee that a sponsor may organize to coordinate the conduct of a multicentre trial. (ICH GCP E6 1.18) Coordinating Investigator An investigator assigned the responsibility for the coordination of investogators at different centres participating in a multicentre trial. (ICH GCP E6 1.19) Contract Research Organization (CRO) A person or an organization (commercial academic or otherwise) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. (ICH GCP E6 1.20) Direct Access Permission to examine, analyze, verify, and reproduce any records and reports that are important to the evaluation of a clinical trial. (ICH GCP E6 1.21)
Documentation All records, in any form, that describe or record the methods, conduct and or results of a trial, the factors affecting the trial and the actions taken. (ICH GCP E6 1.22) Biometrics A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) Closed System An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) Digital Signature
