A / B / C / D / E / F / G / H / I / J / K / L / M / N / O / P / Q / R / S / T / U / V / W / X / Y / Z

The following list of terms is not exhaustive. If you wish to make changes or additions, please inform us by This e-mail address is being protected from spambots. You need JavaScript enabled to view it. .

A:

 

B:

  • Blinding: procedure whereby one or more participants in the trial are unaware of the treatment administered. A single blind trial means that only the subjects are unaware, whereas a double line trial means that the subjects, the investigators, the monitors and, in some cases, the data analysts are unaware of the treatment administered

 

C:

  • CA: Competent Authority
  • CLA: Clinical Trial Authorisation
  • CRA: Clinical Research Associate
  • CEC: Critical Events Committee
  • CIAC: Central Independent Adjudication Committee
  • CNIL: Commission Nationale Informatique et Libertés
  • Co-Investigator: member of the team in charge of performing the clinical trial, appointed and supervised by the principal investigator whose role entails conducting the fundamental procedures related to the trial or making important decisions in this respect
  • Confidentiality: protection of the identity of the persons taking part in a trial, to their personal or medical data. If the checking procedure requires for this data to be inspected, only one duly authorised person may have access to this data. Any information enabling a person to be identified must be kept confidential. Authorisation to use data for verification must be obtained from the person before the start of the trial ensuring complete confidentiality. When he/she reports an adverse event or any other information to the sponsor and/or authorities concerned, the investigator must ensure that personal privacy is not infringed
  • CRF: Case Report Form: document, regardless of the carrier, designed to gather in writing, all the information required under the protocol relating to each person willing to take place in the biomedical research
  • CRO: Contract Research Organization: service provider
  • Clinical trial/study or biomedical research relating to a drug: in compliance with the first paragraph of article R; 1121-1 of the public health code, biomedical research relating to a drug is understood as any clinical trial (conducted on humans) of one or more drugs aimed at determining or confirming their clinical, pharmacological effects and the other pharmacodynamic effects or at highlighting any adverse effect, or at studying their absorption, distribution, metabolism and excretion, for the purpose of determining their level of safety or efficacy
  • CTAF: Clinical Trial Authorisation Form
  • CRU: Clinical Research Unit
  • CIPRU: Clinical Research, Innovation and Pharmacology Unit

 

D:

  • DMI: Department of Medical Information
  • DICR: Delegation to the Inter-regional Clinical Research
  • DSMB: Data Safety and Monitoring Board
  • DVP: Deep Vein Thrombosis

 

E:

  • EC: Ethics Committee: There are 40 ECs in France who meet approximately once a month to examine the dossiers submitted to them 2 to 3 weeks beforehand
  • EC: Executive Committee

 

F:

  • Follow-up period: period subsequent to the run in period of a clinical trial
  • FPI : First Patient In

 

G:

  • GCP: Good Clinical Practice

 

H:

  • HIT: Heparin-Induced Thrombocytopenia

 

I:

  • Informed consent: process whereby a subject confirms his/her full consent to take part in a specific trial after having been informed of all the aspects of the trial likely to influence his/her decision. Informed consent is recorded on a written form which is signed and dated. According to the Huriet law, a free, informed and express consent (required for the trial to come and it alone) must be obtained prior to conducting medical research
  • Inclusion criteria: characteristics listed in the technical protocol which must present the participants in order to be able to enter into the run in period of the clinical trial, i.e. to be included
  • IVMD: In Vitro Medical Devices
  • IND: Investigational New Drug
  • INR: International Normalized Ratio
  • Investigator: person responsible for the execution of the clinical trial at the places of the trial. If the trial is performed by one team, the investigator plays the part of team leader and can also be called Principal Investigator
  • IRB: Institutional Review Board

 

J:

 

K:

 

L:

  • LITT: Local Invitation to Tender
  • LMWH: Low-Weight Molecular Heparin
  • LPO: Last Patient Out

 

M:

  • MA: Marketing Authorisation
  • MD: Medical device
  • MGISC: Missions of General Interest and Support to Contracting

 

N:

  • Non-inclusion (or exclusion) criteria: characteristics listed in the technical protocol opposing the inclusion of a participant in the run in period of the clinical trial
  • NDA: New Drug Application

 

O:

 

P:

  • PE: Pulmonary Embolism
  • Participant: any human being (patient or healthy volunteer) taking part in a clinical trial
  • Patient: participant in a clinical trial suffering from a disease or who presents a condition constituting an indication of the product tested
  • Phase I: trial of the first administration of a new drug on humans. Evaluation of tolerance of the product (determination of posology and optimum methods of administration). Trials conducted on healthy volunteers. Usually studies on small numbers
  • Phase II: trial of the development of a new drug. Assessment of the pharmacological efficacy of the drug in patients directly or indirectly suffering from the disease to be treated. Trials conducted on medium-sized groups
  • Phase III: trial of the development of a new drug. Assessment of its efficacy and tolerance at long term. Trials conducted on large groups
  • Phase IV: trial after the marketing authorisation (MA). Trial of efficacy and tolerance of drug under the usual prescription conditions, detection of side effects, if any. Trials often conducted on thousands of patients
  • PLA: Product License Application
  • Placebo: substance with the same aspect as the drug to which it is compared but not containing any active substance
  • PHRC: Programme Hospitalier de Recherche Clinique
  • PTS: post-thrombotic syndrome

 

Q:

  • QA : Quality Assurance

 

R:

  • RDCRI: Regional Delegation for Clinical Research and Innovation
  • Run in period: this is the active phase of a clinical trial (the run in period is the period during which the participant takes the product tested or the comparison product)
  • Randomisation: process whereby the subjects participating in a trial are randomly assigned to different treatment groups

 

S:

  • SAR: Substantial Amendment Request
  • SUO: Serious Undesirable Occurrence
  • SOP: Standard Operating Procedures
  • Sponsor: person, company, institution or organisation in charge of the implementation, management or funding of a clinical trial
  • SPC: Summary of Product Characteristics
  • SAE: Serious Adverse Event
  • SIGAPS: Système d'Interrogation, de Gestion et d'Analyses des Publications Scientifiques (System of interrogation, management and analysis of scientific publications): The SIGAPS project, funded by the DHOS (Directorate of Hospitalisation and Care Management), is a project dedicated to the identification, assessment and valuation of scientific publications of an institution conducting medical research activities. It allows for part of the TRRIM budget to be allocated to eligible institutions
  • SIGREC: Système d'Information et de Gestion de la Recherche et des Essais Cliniques (Information and Management System for Clinical Research and Trials): The SIGREC project, commissioned and funded by the DHOS and the CeNGEPS is a project dedicated to identifying and monitoring clinical trials conducted in an institution
  • SIV: Study Initiation Visit
  • SMCC: Study Management and Coordination Committee
  • SmPC: Summary of Product Characteristics
  • STIC: Support for Innovative and Costly Techniques
  • SVT: Superficial Vein Thrombosis

 

T:

  • TEE: ThromboEmbolic Event
  • TRRIM: Teaching, Research, Reference, Innovation Missions

 

U:

  • UFH: UnFractionated Heparin

 

V:

  • VTED: Venous thromboembolism Disease

 

W:

 

X:

 

Y:

 

Z:

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Le Groupe d'Investigation et de Recherche Clinique sur la Thrombose (GIRC Thrombose) est un réseau français de professionnels de la santé. Cette association regroupe plus de cinquante médecins appartenant à des Centres Hospitaliers Universitaires (CHU), à des Centres d'Investigation Clinique (CIC) de l'INSERM / DGOS, à des Centres Hospitaliers (CH) ou à des cabinets libéraux de Médecine Vasculaire. Tous interviennent dans la prévention et le traitement des maladies Thromboemboliques (MVTE) qui s'exprime sous deux formes, la phlébite ou thrombose veineuse profonde et l' embolie pulmonaire.
Recherche clinique thrombose, maladie thrombo embolique, maladie thromboembolique, maladie thromboembolique veineuse, maladies thromboemboliques, phlébite informations, phlébites, thromboses veineuses profondes, embolies pulmonaires.