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Samenvatting Lecture 3 - Clinical Trials and Clinical Development AM_1180 (AM_1180)
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Lecture 3Abbreviations and acronyms
ACRP = Association of Clinical Research Professionals
ADR = Adverse Drug Reaction (side effect)
AE = Adverse Event (could be any medical occurrence, related or unrelated to drug)
AMP = Auxiliary Medicinal Product (product not under investigation but part of the protocol,
rescue medication for example)
ANDA = Abbreviated New Drug Application
BID = Twice in a Day
BSA = Body Surface Area
CA = Competent Authority (is called regulatory authorities in EU)
CAPA = Corrective and Preventive Actions
CDP = Clinical Development Plan (document describing the clinical studies that must be
performed during development, plan contains clinical trial decision points)
CFR = Code of Federal Regulations (implementation of US law into the books)
CHD = Coronary Heart Disease
CI = Confidence Interval (Contra-indication is not used that much)
CIOMS = Council for International Organisations of Medical Sciences (report unexpected
serious side effects)
CNS = Central Nervous System
CRA = Clinical Research Associate
CTA = Clinical Trial Assistant/Administrator
CTA = Clinical Trial Agreement (contract between sponsor and clinical site)
CTR = Clinical Trial Regulations
CYA = Cover Your Ass management (they never come for you, all eyes closed, eliminating
all chances at being pointed at for delivering low quality)
DCT = Decentralized Clinical Trial
E6 = Efficacy guideline number 6 (up until 19), all deal with the clinical research
E9 = ICH-E9, Methodology of statistical principles of clinical trials
EDC = Electronic Data Collector
EMEA = Europe, Middle East, Africa
EudraCT = EU database for clinical trial (is replaced by CTIS)
GCP = Good Clinical Practice
GDPR = General Data Protection Regulation
GLP = Good Laboratory Practices
ICF = Informed Consent Form
ICH = International Council for Harmonisation / (International Conference of Harmonisation is
old name)
IEC = Independent Ethics Committee (Global)
IMP = Investigational Medicinal Product
IND = Investigational New Drug Application
IP = Investigational Product
IRB = Institutional Review Board (USA)
ISF = Investigational Site File
IVRS = Interactive Voice Response System
MAA = Marketing Authorisation Application (Global term)
NAD = No Abnormalities Detected
NCE = New Chemical Entity
, NDA = New Drug Application (FDA term) / Non Disclosure Agreement
PI = Principal Investigator
PIF = Patient Information Form
PIS = Patient Information Sheet
PK/PD = Pharmacokinetics/Dynamics
PMS = Post Marketing Surveillance
PRN = Taken when Needed
QALY = Quality Adjusted Life Year
QOL = Quality Of Life
QTL = Quality Tolerance Limit
RCT = Randomized, double-blind controlled trial
SAE = Serious Adverse Event
SDV = Source Data Verification (the process by which collected data are compared to the
original source of information, is the data correctly entered and not missed?)
SUSARs = Suspected Unexpected Serious Adverse Reactions
UADR = Unexpected Adverse Drug Reaction
WMA = World Medical Association
Lifecycle of a Drug: in silico→in vitro→in vivo→ in humano is made up term by Eric.
To sell drugs on the market, you must obtain a marketing authorization application
(MAA).
For MAA/NDA (Non Disclosure Agreement), the products must fulfill the following criteria:
● Safe→ establish a safety profile of the product in Preclinical Phase, which is
predictive for human use. To ascertain safety, you do that in Phase 1.
● Efficacious→ whether or not something works, is disease indication
dependant.
○ Example: Thalidomide has efficacy in rheumatoid artritis and oncology. But is
on the market under a different name and different indication. Other example:
Viagra.
● Clean and reproducible manufacturing.
Drug development process is:
● Complex: many laws and regulations, many disciplines/departments involved,
technical.
● Expensive
● Full of risks
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