JavaScript is disabled. Please enable to continue!
Eurofins >> Cosmetics >> FAQ & Glossary

Glossary & FAQ

Always on the safe side

Index:

Glossary and Accronyms

Concept

Descriptions

AAS

Atomic Absorption Spectrometry.

Allergy

The body’s response to a foreign substance perceived as dangerous, called allergen.

ATEX

Atmospheres EXplosibles.

Clinical study

Any investigation carried out on human subjects to discover or to confirm the effects of one or several cosmetic products, to identify any adverse reaction in order to evaluate their safety and efficacy.

Constraints

 A set of rules imposed by the nature of the study, which by signing the informed consent form the subjects are obliged to comply with; failure to comply may result in exclusion from the study.

Compensation

Amount offered as compensation to the subjects for the constraints that they have been submitted throughout the study; this amount is not the equivalent of a salary but is an occasional gain; the research center pays the income tax, so that the subjects receive a net financial compensation.

Consent for inclusion into the database

Form by which a subject voluntarily confirms his (unconstrained) written permission to be a part of the database, after he/she accepts to provide his personal data (data that will be operated according to the legal regulations in force).

Database

The manner of storing certain information, data regarding the subjects who wish to participate in clinical tests; this is made up of individual records of the subjects. All of the subjects who appeared to the physiologic and medical examination and who prior signed the consent for the inclusion into the database.

Daily log

The document that the subjects will take home and in which they will note the discomfort sensations, the medication throughout the study, their comments regarding the tested product, the dates and frequency of utilization of the product, etc.

EP

European Pharmacopeia.

Ethics Committee

An independent organism, constituted of members from medical, scientific and non-medical fields, whose responsibility is to ensure the protection of rights, safety and comfort of the subjects involved in a study; it works by evaluating, approving and verifying continuously the study’s protocol and its amendments as well as the methods and materials that should be used in order to obtain and record the expressed informed consent knowingly.

Experimental area

A skin area chosen and delimited by the technical staff of the investigating center, where a testing product is going to be applied.

FCST

Final Clinical Safety Test.

Finantial Department

The department that handles the financial management of the company.

GC

Gas Chromatography.

GC-MS

Gas Chromatography - Mass Spectrometry.

GLP

Good Laboratory Practices.

GMP

Good Manufacturing Practices.

HPLC

High Performance Liquid Chromatography.

HRIPT

Human Repeat Insult Patch Test.

ICP-MS

Inductively Coupled Plasma - Mass Spectrometry.

INCI

International Nomenclature of Cosmetic Ingredients.

Investigating Centre

The institute responsible for organizing and conducting a study.

Informed consent

Form by which a subject voluntarily confirms his (unconstrained) written permission to participate in a certain study, after receiving the relevant information regarding all aspects of the study (important and sufficient) in order to decide his inclusion into that study.

Inclusion criteria

Set of requirements necessary for the selection of subjects, required by the study protocol.

Investigator

Medic (dermatologist and/or ophthalmologist, and/or dentist, and/or gynecologist) who is responsible for conducting the clinical study and for the synthesis of recorded data in a report. *

* definition is specific to the investigating center, according to the procedures.

Identification ticket

A document handed to the subjects in the first day of each study, which contains the following information: study’s number, batch and the subject’s reference within the study. Subjects are identified at the reception desk with the help of this document, valid only during the study period.

LAL

Limulous Amoebocyte Lysate.

LC-MS

Liquid Chromatography - Mass Spectrometry.

Medical examination

Medical evaluation summary of the subject by which the doctor performs a brief history of the personal/familial physiological and pathological antecedents, as well as the frequency of using cosmetics, thus assessing the adequacy of the health of the subject to the inclusion criteria in different types of studies.

NDELA

N-nitrosodiethanolamine.

OECD

Organisation for Economic Co-operation and Development.

Open test

Test for checking the skin’s compatibility after open applications, in controlled and very close to normal conditions of use.

PAH

Polycyclic Aromatic Hydrocarbons.

Passed for payment ticket

Document issued by the responsible technician from the Technical Department proving that the subject has participated in all the study, respected the constraint and can receive the allowance; therefore the allowance can be cashed only on the basis of this ticket.

Pause

The rest period, the period of unavailability to participate in other studies; its duration will be communicated by the recruitment department.

Panel

Group of subjects selected according to the inclusion and non-inclusion criteria corresponding to test study, as they are described in the study protocol.

Personal data

Confidential information regarding the subject’s identity: name, surname, contact data, medical data, psychological data, etc.

Psycological examination Psychological evaluation summary of the subject which aims to establish the degree of risk for inclusion in the database, the ability to understand the information and to comply with the instructions provided in writing or verbally by the investigating center staff; this is performed by a psychologist.

Protocol study

This document describes the principle objectives, methodology, conditions for the realization of the study, the instruments, the analysis of the statistics of the results, together with any amendments; the study of protocols is validated by an internal or independent Committee of Ethics, in order to ensure the protection of the rights of subjects.

Randomization

The process of distribution of the study subjects in groups for treatment or control by using a hazard element which will reduce the possibility of influencing the study’s results by a systematic error.

 Recruitment Inclusion of the subjects in the database in order to select them for different types of studies.

Sample

The quantity of product being tested; the samples are being weighed before and after use and they will be used only for the ongoing study.

SPF

Sun Protection Factor.

Sponsor

A person, a company, an institution or organization which assumes the responsibility of starting the management and/or the financing of a clinical study.

Study calendar

The individual schedule of the subjects’ visit to our center, provided at the beginning of the study.

Study reference

A unique code assigned to a study. It consists on the year and the chronological number.

Study withdrawal

Study interruption by a subject; the study withdrawal must be announced to the investigating center; if the withdrawal occurs due to objective reasons, independently from the subject’s will, the subject will receive a financial compensation proportional with the study participation; if the withdrawal occurs due to subjective reasons, the subject implicitly renounces to the financial compensation.

Subject identification code

The modality of encoding the subjects’ identity in order to protect their personal data.

Technical Department

The department that handles the technical execution of the studies.

Use

Verifying the acceptability and/or the assessment of the cosmetic qualities and/or efficacy of a cosmetic product after repeated applications in very close to normal conditions of use.

USP

United States Pharmacopeia.

Page Top

FAQ

How can I enlist into the study database?

In order to enlist into the database you need to go to the Recruitment Department of the investigating center.

How do I know when I can be called to participate to studies?

The Recruitment Department will make the selection from the database according to the imposed criteria and will contact the able subjects, in order to obtain a personal verbal agreement to participate in the next study.

I have lost the calendar; what should I do?

You can contact the recruitment department in order to obtain another calendar.

I have lost the ticket with the batch and reference; what should I do?

You can contact the recruitment department in order to obtain another ticket, based on your ID card.

What should I do if I can not get to a scheduled visit during the study?

You must call the technical department to announce in due time and to receive information regarding this issue.

What are the foreseeable risks of the participation in a study?

During the study mild and reversible discomfort sensations may appear such as stinging, itching, warmth sensation, slight redness.

The testing of cosmetic products may reveal an allergy already acquired to a cosmetic ingredient, in this case the reaction is usually limite.

The compensation that I receive is included in the annual statement of income?

Yes, the compensation that you receive must be included into the annual statement of income.

The compensation that I receive affects in any way the receiving of support/social grant?

It is possible, depending of the type of support that you receive and also in the case that it is exceeded the threshold required by the law of the income per family member. For further information feel free to contact us.

Which are the tested products?

The tested products can be:

  • Cosmetic products:
    1. care products (for body, face, hands, feet, hair etc.), for example : moisturizing cream, sun protection cream;
    2. hygiene products (for body, face, hands, feet, hair etc.), for example: shampoo, shower gel, deodorant;
    3. for make-up and cleansing (for body, face, hands, feet, hair etc.), for example: nail polish, lipstick, makeup, cleansing milk; in the form of cream, milk, stick, lotion, powder.
  • Several medical devices (for example: patches, etc.).
  • Nutritional supplements.
  • Biocides.
  • Textile (for example: aloe vera nylon tights, etc.).
  • Ingredients for the cosmetic industry.

What are the conditions that must be performed in order to become a subject?

In order to participate in the studies performed by our center you must fulfill the following criteria:

  • your age should be between 18 and 70 years old;
  • you should have a family doctor and medical insurance;
  • you should live near the institute or to have means of transportation that will allow you to respect the schedule imposed by the studies in which you may participate;
  • you must accept a psychological and medical check (lasting maximum an half of hour), performed by a psychologist and a doctor consisting in: psychological examination and a brief clinical exam, mainly based on the mental and physical state of health and on cosmetic habits;
  • you must not be registered with diseases nor be under any medical treatments (unauthorized by the investigating doctor; which can influence the results of the study);
  • you must not consume drugs or alcohol;
  • you must give your written consent for inclusion into our database.

If you are co-ensured, you must present us a proof of this fact, respectively a certificate from the family doctor.

If you are house hold (without income), you must have health insurance paid. 

If you are retired because of illness, early retired, unemployed or you are a beneficiary of social insurance, please contact us for further information at our center. There may be conflicts between the subject state and the one of social assisted.

What are the conditions that must be performed in order to be included in a study?

  • you must be registered into our subjects’ database; this will allow the investigating center to regularly contact you;
  • you must not be sick or under any medical treatment other than the one authorized by the investigator;
  • you must not be pregnant and you must engage yourself that you will prevent this fact from happening during the study (if applicable);
  • you must not be in the lactation period (if applicable);
  • you must correspond to the specific criteria imposed by the study (example: sensitive eyes, oily skin, dandruff, etc);
  • you must not be in the exclusion period;
  • you must be available on all of the study duration as well as in the next period, in case that it is necessary to perform additional studies;
  • you must not participate in the same time to another study in another experimentation center;
  • you must read, understand, and if you agree, sign the “Informed Consent Form”.

What are your guarantees?

  • the studies are performed in accordance with the in force regulations by a competent, qualified and experimented personnel, which guarantees your safeness;
  • confidentiality of your personal data provided to the institute, according to the law no. 677/2001;
  • clear and accurate information, verbal and in written, regarding the ongoing study in which you participate and also the possibility to ask the institute’s staff about additional information;
  • the study is performed with products provided by companies that benefits from civil liability insurance and which undertakes that the provided products are of good quality and for which the institute has sufficient safety data to eliminate all the risks of local intolerance;
  • freedom to accept or to refuse the study that we propose or to withdraw your participation in the study that you have been included without being compelled to motivate your decision.

What are the constraints imposed to you during a study?

  • to respect the using instructions and the constraints of the study, described verbally and in writing at the beginning of the study within the “Informed Consent Form”;
  • to inform the institute of all the deviations from this consent and especially to describe the concomitant medication taken during the study;
  • to comply with the dates and hours provided for coming to the institute and to announce the personnel from the Technical Department in case of absence from a valid reason;
  • to respond correctly to the questionnaire (if applicable);
  • to return the samples at the indicated date (in case of home using);
  • to warn as soon as possible the institute if during the study you notice any adverse reaction or have discomfort sensations;
  • to respect the exclusion period during which you cannot participate in any other study and whose duration is indicated in the “Informed Consent Form”.
  • for safety reasons, during the visit to the institute you should not be accompanied by children who can not be left unattended (especially in the laboratories);
  • for hygienic and safety reasons, pets are prohibited in the institute.

What should I do if I am requested to participate in studies?

  • to inform the institute whether you are interested or not of the proposed study;
  • to come at the established date and hour to the institute (if you are retained please announce us as soon as possible);
  • to follow the study’s specific instructions.

Am I allowed to remove the patch from my back?

It is strictly forbidden to remove the patch by any other person except for the technical personnel from the investigating center; violation of this rule can lead to exclusion from the study (exceptionally, if it is requested, the patch can be partially removed, according to the precise indications of the technical personnel). In case of accidental removal, contact as soon as possible the investigating center and respect exactly the instructions provided by the Technical department.

What is the maximum compensation that I can receive?

There is no minimum or maximum compensation, the amount varies depending of the type and duration of the study.

I forgot at home the testing product or daily log; what should I do?

Inform the technical department and establish with one assent the modality of returning the objects, according to the study requirements.

What happens if, from reasons independent to my will, I cannot participate to the ongoing study?

In case of hospitalization, disease or accident, you must inform the investigator and then to bring the supporting documents (certificate, ticket for hospital discharge, etc.) and beginning with the final date of the study you will receive a part of the allowance provided.

What documents do I receive when I am included in a study?

      • Informed Consent Form;
      • calendar with visiting dates until the end of the study (if applicable);
      • identification ticket with batch and reference (if applicable);
      • daily log;
      • the using instructions of products at home (if applicable).

Page Top

Locations
Need help?