Commonly used abbreviations in Pharmaceutical Industry
Commonly used abbreviations in Pharmaceutical Industry
Pharmaceutical industry abbreviations
ACRO
Academic Research Organization
CDMoP
Clinical Data Monitoring Plan
CRA
Contract Research Associate
CRO
Contract Research Organization
CSR
Clinical Study Report
CTTI
Clinical Trials Transformation Initiative
DM
Data Manager
DMon
Data Monitoring – All raw and source data review activities by a sponsor that guarantee the protection of trial subject safety and privacy as well as provide assurance that the clinical data meet quality requirements and are fit for purpose. This includes direct (on site) review and verification but also distributed or centralized intra- and inter-site data checks in order to identify trends, signals etc. These activities are usually documented in one or more manuals or plans (such as the CDMoP, DMP, SAP, etc.)
DMP
Data Management Plan
DSci
Data Science –Analytical role enabling the creation of data products that tackle all aspects of a problem, from initial data collection and data conditioning to drawing conclusions across programs
EMA/GCP/INS
European Medicines Agency Good Clinical Practice Inspectors Group
FDA
Food and Drug Administration
GCP
Good Clinical Practices
GxP
Abbreviation for the basket of regulatory guidance for clinical, laboratory, and manufacturing practices
GPvP
Good Pharmacovigilance Practice
ITT
Intent to Treat
IVRS/IWRS
Interactive Voice/ Web Response System
QA
Quality Assurance
QC
Quality Checks Risk-Based Approach
rSDV
Reduced Source Document Verification
SDR
Source Document Review – Process of holistic review of documentation for patient data as indicated by the protocol, e.g. real subject, documents maintained, investigational product.
SDV
Source Document Verification – Process of point-to-point verification of site data entry values between source and database
SAP
Statistical Analysis Plan
STS
(drug safety ) Signal Tracking System
Compassionate use
In certain situations, the Food and Drug Administration (FDA) allows companies to provide their experimental drugs to people outside of clinical trials. This is referred to as compassionate use. Basically, compassionate use to the treatment of a seriously ill patient using an unapproved drug (investigational drug) when no other treatments are available.
Development international birth date (dibd)
The date of first authorization for the conduct of an interventional clinical trial in any country.
International birth date (idb)
The date of the first marketing authorization for any product containing the active substance granted to any company in any country in the world.
Investigational drug
The term investigational drug indicates only the experimental product under study or development. This term is more specific than investigational medicinal product, which includes comparators and placebos.
Medicinal product
Medicinal product is a product containing a substance or a combination of substances produced and intended for the treatment or prevention of diseases in humans or in animals, for diagnostic purposes, improvement or modification of physiological functions or for achieving other medically justified objectives.
Non-interventional trials
Non-interventional trials are not within the scope of the regulations, that is, those where the medicinal product is prescribed in the usual manner in accordance with the terms of the marketing authorization. In these cases the assignment of a patient to a particular therapeutic strategy is not decided in advance by a trial protocol, but falls within current practice, and the prescription of the medicine is clearly separated from the decision to include the patient in the study. Also, no additional diagnostic or monitoring procedure related to the therapeutic strategy is applied to the patients and epidemiological methods that are to be used for the analysis of data.
Ongoing clinical trial
Trial where enrolment has begun, whether a hold is in place or analysis is complete, but for which a final clinical study report is not available.
Solicited reports
Solicited reports are those derived from organized data collection systems, which include clinical trials, registries, post-approval named patient use programs, other patient support and disease management programs, surveys of patients or healthcare providers, or information gathering on efficacy or patient compliance.
Spontaneous report or spontaneous notification
An unsolicited communication to a company, regulatory authority, or other organization that describes an adr in a patient given one or more medicinal products and which does not derive from a study or any organized data collection scheme.