CCRP Exam Terms
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Adverse Drug Reaction (ADR): Pre-approval
All noxious and unintended responses to a medicinal product related to any dose. [causal relationship between med. product and adverse event cannot be ruled out]
Adverse Drug Reaction (ADR): Marketed Product
Response to drug which is noxious and unintended and which occurs at doses normally used for prophylaxis, diagnosis or therapy or for modification of physical function.
Adverse Event (AE)
Untoward medical occurrence in a patient or clinical trial subject administered a pharmaceutical product which does NOT necessarily have a causal relationship with this treatment. IE sign symptom just temporally associated with the use of an IP
Contract Research Organization (CRO)
Person/ organization contracted by Sponsor to perform Sponsor's duties
All records that describe or record the methods, conduct, and/or results of a trial, factors affecting trial and actions taken
International Conference on Harmonisation
Documents that permit the evaluation of the conduct of a study and quality of the data produced
Independent Data-Monitoring Committee (IDMC)
May be established by the Sponsor to assess the progress of clinical trial, safety data, efficacy endpoints, recommend to sponsor to continue, modify or stop trial
Independent Ethics Committee (IEC)
Independent body constituted of medical and non-med. members that ensures the protection of the rights, safety and well being of human subjects involved in a trial and to provide public assurance of that protection by reviewing/approving the trial protocol, suitability of investigators, facilities, and methods/materials used to obtain informed consent.
Pharmaceutical form of active ingredient or placebo tested or used as ref. in clinical trail. This includes a product with marketing authorization when used/assembled in a way diff. from the approved form, when used for an unapproved indication, or used to gain further info about an approved use.
Responsible for the conduct of a clinical trial at the trial site. If done by a team, they are the responsible leader of the team.
Describes the objectives, design, methodology, stat considerations, and organization of the trial. Usually also gives background and rationale for the trial, but these can be in other referenced documents. Refers to the amendments as well.
Quality Assurance (QA)
planned/systematic actions established to ensure the trial is performed and the data generated in compliance w/ GCP and reg. requirements
Quality Control (QC)
Operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial related activities have been fulfilled.
Personnel that review submitted clinical data and those that conduct inspections. AKA "competent authorities"
Serious (AE) or (ADR)
- Any medical occurrence that at any dose
- -results in death
- -is life-threatening
- -requires inpatient hospitalization or prolonged hospital stay
- -results in persistent or sig. disability/incapacity
- -is a congenital anomaly/birth defect
Information in original records and certified copies of original records of clinical findings in a clinical trial necessary for the reconstruction and evaluation of the trial. Found in source documents.
Original doc. data and records (eg. lab notes, memoranda, subject diaries, pharmacy dispensing records, photographic negatives etc.)
Standard Operating Procedure (SOP)
Detailed written instructions to achieve uniformity of the performance of a specific function
Adverse reaction the nature/severity of which is not consistent with the applicable product information.
- members of group with hierarchical structure (medical, pharmacy, dental, nursing)
- subordinates of the hosp./lab personnel
- employees of pharm. industry
- members of armed forces, people in detention
- others: pts with incurable diseases, people in nursing homes, unemployed/ impoverished people, pts in emergency situations, ethnic minority groups, homeless, nomads, refugees, minors and those incapable of giving consent
Parallel Group Design
most common confirmatory trial, randomized to one of two or more treatment arms. IP at one or more dose vs. control/active comparator
Randomized to a sequence of two or more treatments, subject acts as own control. Concern: carryover, disease should be stable and chronic before start
Two or more treatments evaluated simultaneously through combinations of treatments (ex. A +B, A alone, B alone, no A or B) used to examine interaction of A and B, or to establish dose + response characteristics of use of A + B
Act by reg. authorities of conducting a review of documents, facilities, records, and other resources deemed related to clinical trial that may be located at site, at Sponsor or other appropriate establishments
Systematic and independent examination of trial related activities and documents to determine whether the evaluated trail related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, GCP, SOPs, and applicable reg. requirements.
Written evaluation by sponsor's auditor of the results of the audit
Declaration of confirmation by the auditor that an audit has taken place
Documentation that allows reconstruction of the course of events
not performed on human subjects
Retain blind when administering supplies, when two treatments can't be made identical. Supplies are made for treatment A (active and placebo) and treatment B (active and placebo). Subjects take two sets of treatment; either A (active) and B (placebo), or A (placebo) and B (active).
Response to two or more treatments differ by amount clinically unimportant
Full Analysis Set
Set of subjects close as possible to the ideal implied by the intention-to-treat principle
Global Assessment Variable
Objective variables + the Investigator's overall impression
Subjects in treatment group should be followed up/assessed as members of that group regardless of compliance to course of treatment. Idea that effect of treatment is best assessed by evaluation on basis of intention to treat subject rather than actual treatment given.
When difference between IP and control is dependent on another factor (i.e. site). Can be qualitative and quantitative
Quantitative evidence from two or more studies about the same question
Response to IP is not clinically inferior to comparator (placebo or active control)
In a hierarchical medical dictionary, the lowest level of dictionary term to which the investigator description is coded. ex. "joint pain"
In a hierarchical medical dictionary, the level of grouping of included terms typically used in reporting frequency of occurrence. ex. "arthralgia"
Per Protocol Set (Valid Cases, Efficacy Sample, Evaluable Subjects Sample)
set of data generated by subjects who followed protocol sufficiently to ensure these data would likely exhibit effects of treatment. Compliance covers such things as exposure to treatment, availability of measurements and absence of protocol violations.
Showing a response to an IP is superior to a comparator
Indirect measure of effect where direct measurement is not feasible
Event that emerges during treatment having been absent pre-treatment, or worsens relative to pre-treatment state
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