ICH Abbreviations - and definitions Flashcards
ADR
(Adverse Drug Reaction ) a reaction from a treatment/ intervention where there is evidence of direct causal relationship between the reaction and the drug.
AE
Adverse event - an untoward event/ reaction that occurred during participation in the trial, whether directly related or not.
ALT
Alanine aminotransferase
-assess liver damage
AST
Asparate aminotransferase (enzyme released when liver is damaged)
-assess liver damage
BP
Blood pressure - mm Hg. The top number (systolic) is the pressure of the blood flow when your heart muscle contracts, pumping blood. The bottom number (diastolic) is the pressure measured between heartbeats.
BUN
Blood Urea Nitrogen
-used to measure kidney function
CK
Creatine Kinase - found in heart, brain, skeletal muscle, and other tissue.
-Measures muscle damage.
DCF
Data Clarification Form
GCP
GLP
GMP
- good clinical practices
- good laboratory practices
- good manufacturing practices
hCG
human chorionic gonadotropin - tested in urine for pregnancy or birth defects, uterine/ testicle cancer
ICH
International Conference Harmonization
LAR
Legally Acceptable Representative
MOA
Monoamine Oxidase - detects deficiency, mostly males. mild intellectual disability and behavioral problems beginning in early childhood - Autism/ ADHD
PK
Pharmacokinetics - refers to the movement of drug into, through, and out of the body—the time course of its absorption, bioavailability, distribution, metabolism, and excretion.
*what the body does to the drug
QA /QC
Quality Assurance / Quality Control
SUSAR
Suspected Unexpected Serious Adverse Reaction - untoward and unintended response to a study drug, which is not listed is the applicable product information, and meets one of the following serious criteria: death, life threatening, prolonged hospitalization, persistent disability, congenital anomaly or birth defect
Bias (Statistical & Operational)
The systematic tendency of any factors associated with the design, conduct, analysis and evaluation of the results of a clinical trial to make the ESTIMATE OF A TREATMENT EFFECT DEVIATE FROM ITS TRUE VALUE
- Bias introduced through deviations in conduct is referred to as ‘operational’ bias.
- Flaw in the experiment design or data collection process ‘statistical’. examples are sampling, treatment assignment, etc
Blind Review
The checking and assessment of data during the period of time between trial completion (the last observation on the last subject) and the breaking of the blind, for the purpose of finalizing the planned analysis.
Content Validity
The extent to which a variable (e.g. a rating scale) measures what it is supposed to measure.
Generalization
The extent to which the findings of a clinical trial can be reliably extrapolated from a study to a broader patient population and clinical settings
Double-Dummy
A technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be made identical.
Dropout
A subject in a clinical trial who for any reason fails to continue in the trial until the last visit required of him/her by the study protocol.
Full Analysis Set
The set of subjects that is as close as possible to the ideal implied by the intention-to-treat principle.
(DMC) (Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee)
An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.
Intention-To-Treat Principle
The principle that asserts that the effect of a treatment policy can be best assessed by evaluating on the basis of the intention to treat a subject (i.e. the planned treatment regimen) rather than the actual treatment given
Interim Analysis
Any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to the formal completion of a trial
Meta-Analysis
The formal evaluation of the quantitative (data expressed by a number) evidence from two or more trials bearing on the same question
*statistical combination of the results of multiple studies addressing a similar research question
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
Safety & Tolerability
1) Safety of a medical product concerns the MEDICAL RISK TO THE SUBJECT (assessed by medical tests, vitals, AEs, ECGs, etc
2) Tolerability of the medical product represents the DEGREE TO WHICH OVERT ADVERSE EFFECTS CAN BE TOLERATED BY THE SUBJECTS
Per Protocol Set
The set of data generated by the subset of subjects who complied with the protocol sufficiently to ensure that these data would be likely to exhibit the effects of treatment
Statistical Analysis Plan
a document that contains a more technical and detailed elaboration of the principal features of the analysis described in the protocol, and includes detailed procedures for executing the statistical analysis of the primary and secondary variables and other data.
Treatment Effect
An effect attributed to a treatment in a clinical trial. In most clinical trials the treatment effect of interest is a comparison (or contrast) of two or more treatments.
Treatment Emergent
An event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state.
Adverse Drug Reaction (ADR)
all noxious and unintended responses to a medicinal product related to any dose that has a least a reasonable possibility of being related to the drug
Adverse Event (AE)
any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with treatment
Applicable Regulatory Requirements
any law/regulations addressing conduct of clinical trials and IP
IRB Approval
affirmative decision of the IRB that the trial has been reviewed and may be conducted at the site within the constraints set forth by the IRB, institution, GCP, and regulatory requirements
Audit
systematic and independent exam (usually by sponsor or institution) of trial related activities and documents to determine if trial activities were conducted, data collected/analyzed, and accurately reported according to protocol, SOPs, GCP, and regulatory requirements
Audit Trail
documentation that allows reconstruction of course of events
Blinding/Masking
procedure in which one or more parties to the trial are kept unaware of treatment assignment
Clinical Trial
investigation in human subjects intended to discover/verify the clinical, pharmacological, and pharmacodynamic effects of an IP and identify any AEs to product and ascertain its safety and efficacy
Clinical Trial Report
written description of trial in human subjects in which clinical and statistical description, presentations, and analyses are fully integrated in a single report
Comparator
IP or marketed product (active control) or placebo used as reference in clinical trial
Compliance
adherence to all trial related requirements, GCPs, and regulatory requirements
Confidentiality
prevention of disclosure of a sponsor’s proprietary information or subjects identity
Contract
written, dated, and signed agreement between parties that sets out arrangements on delegation of tasks, obligations, and financial matters
Contract Research Organization
organization or person contracted by sponsor to perform sponsor’s trial related duties and functions
Direct Access
permission to exam, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial
Documentation
all records in any form that describe or record the methods, conduct, and results of a trial
Essential Documents
documents which individually and collectively permit evaluation of the conduct of a study and quality of data produced
*docs in Regulatory Binders
Good Clinical Practice (GCP)
standards for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that data and results are credible and accurate and rights of trials subjects are protected
IDMC/DSMB
independent data monitoring committee established by a sponsor to assess at intervals the progress of a clinical trial, safety data, and efficacy endpoints and to recommend to the sponsor whether to continue, modify, or stop a trial
Impartial Witness
person, independent or trial who can’t be influenced, who attends the informed consent process if the subject or LAR cant read, who confirms ICF process was completed.
*also signs ICF
Informed Consent
process by which subject voluntary confirmed willingness to participate in a trial after having been informed of all aspects of trial relevant to subject’s decision. Documented by means of written, signed, and dated informed consent form
Inspection
act of regulatory authorities of conducing official review of documents, facilities, records, and any other resources related to clinical trial. May be located at site, sponsor/CRO facilities, or any other establishments deemed appropriate by reg. authorities
Institution
entity or agency where clinical trials are conducted
Institutional Review Board (IRB)
independent body consisted or medical, scientific, and non scientific members whose responsibility is to ensure protections or rights, safety, and well being of human subjects by reviewing, approving, and continuing review of protocol and amendments and other methods and material to be used in informed consent process
Interim Clinical Trial Report
report of intermediate results and their evaluation based on analyses performed during a trial
Investigational Product:
pharmaceutical form of active ingredient or placebo being tested or used as reference in clinical trial
-includes product with marketing authorization when used in a different way than approved
-used for an unapproved indication
Investigator
person responsible for conduct of clinical trial at a trial site. In a team at trial site – investigator is responsible leader of team
Investigator Brochure
complication of clinical and nonclinical data on the IP which is relevant to study of IP in human subjects
Legally Acceptable Representative
individual or other body authorized under law to consent on behalf of subject in a clinical trial
Monitoring
act of overseeing the progress of clinical trial and ensuring it is conducted, recorded, and reported in accordance to protocol, SOPs. GCP, and regulatory requirements
Trial Site
location where trial related activities are actually conducted
Unexpected Adverse Drug Reaction
AE which the nature or severity of which is not consistent with the applicable product information (eg IB)
Vulnerable Subjects
individuals whose willingness to volunteer for a trial may be unduly influenced by expectation, benefits, retaliatory response from senior members in a hierarchy
Well-being
physical and mental integrity of the subject in a trial
Monitoring Plan
document that describes the strategy, methods, responsibilities, and requirements for monitoring the trial
-determined by sponsor
Monitoring Report
written report from monitor to sponsor after each site visit and other trial related communication depending on sponsor’s SOPs
Nonclinical trial
biomedical studies not performed on human subjects
Protocol
document that describes objective, design, methodology, statistical considerations, and organization of a trial
Protocol Amendment
written description of a change or a formal clarification of protocol
Quality Assurance
all planned and systematic actions that are established to ensure that the trial is performed and data generated, documented, and reported are compliance with GCP and reg. requirements
Quality Control
operational techniques and activities within QA system to verify requirements for quality of trial related activities have been fulfilled
example- monitoring
Randomization
process of assigning trial subjects to treatment or control groups using chance to reduce bias
Regulatory Authorities
bodies having power to regulate
Define a Serious Adverse Event
untoward medical occurrence at any dose that
- results in death
- lift threatening
- requires inpatient hospitalization or prolongation of existing hospitalization
- results in persistent or significant disability/incapacity
- congenital anomaly/birth defect
Source Data
all info in original records and certified copies of clinical findings, observations, or other activities in a clinical trial necessary for reconstruction and evaluation of the trial – contained in source documents
Source Documents
original documents, data, and records (examples hospital records, clinical and office charts, laboratory notes, CRFs)
Sponsor
individual, company, institution, or organization which takes responsibility for the initiation management, and/or financing a clinical trial
Sponsor-Investigator
individual who both initiates and conducts a clinical trial and under whose immediate direction the IP is administered to, dispensed to, or used by a subject.
Standard Operating Procedures
detailed, written instructions to achieve uniformity of the performance of a specified function
Sub investigator
individual member of clinical trial team designated and supervised by the investigator at a site that performs critical trial related procedures and makes important trial related decisions
Subject
individual who participate in clinical trial
Subject Identification Code
unique identifier assigned by the investigator to each trial subject to protect subjects ID
Regulation vs Guidelines
regulation: issued by regulatory authorities (example FDA)
- Only applicable in country’s jurisdiction
Guidelines: global standards developed by International Council for Harmonization (ICH), example GCP
- Helps enhance efficiency and cost effectiveness of research
ICH E2A
Clinical Safety Data Management
ICH E8
General Considerations
ICH E9
Statistical Principles
ICH E6
GCP
ICH E11
pediatric drug development
TSH
Thyroid Stimulating Hormone
test used to assess the function of the thyroid gland
LDH
Lactate Dehydrogenase
check for damage to the tissue of the heart, liver, kidney, muscles, brain, blood cells, and lungs
BUN
Blood Urea Nitrogen – kidney function test
Hct
Hematocrit - blood test measuring the percentage of the volume of whole blood that is made up of red blood cells
Therapeutic Efficacy
capacity for beneficial change
Phase 1
tolerability of dose ranges
safety
PK and PD
Phase 2
explore therapeutic efficacy
Phase 3
confirm therapeutic benefit
Phase 4
after drug approval
beyond prior demonstration of safety, efficacy, and dose definition
