FAQ’s
Frequently Asked Questions
Why these well-paid careers are unknown?
For many reasons.
1) In this industry, the financial stakes are very high, so companies look for experienced staff and don’t announce vacancies to the public.
2) The education system doesn’t produce graduates with practical experience because clinical placement to acquire real hands-on experience is non-existent – the liability insurance against professional errors and omissions is extremely expensive or simply unavailable for inexperienced staff.
3) Employers prefer to get references and target only people who are already in the field with practical experience. For this reason, most positions are never posted. Only with a large network of contacts can someone learn about available positions and this is an important part of our training. Our distance internships provides real hands-on experience for many CRA and CRC tasks, which are not available in other programs.
What is your Job Placement Assistance Program?
Job placement assistance is a crucial factor and is usually missing in other programs. A diploma itself doesn’t solve the problem of getting a job. We get constantly approached by students who got trained elsewhere and cannot find a job because of lack of support, lack of practical experience and lack of contacts.
Our Job Insertion includes preparation of an industry-adapted CV with the use of the specific clinical research abbreviations, terminology and industry slang, initiation on pre-selection questionnaires & job-specific questions with suggestions how to answer them, common interview traps to avoid, coaching and analysis of interviews, initiation and assistance in the creation of a large network of contacts and aggressive distribution of students’ CVs to recruiters & hiring companies, job notifications etc.
Doing some Clinical Research Assistant pro-bono tasks also contributes a lot to a better positioning and generates a large number of contacts in different organizations. Our regular Clinical Research Career Days also provide contacts with professionals from the industry. It is a complex program, thought to provide all the necessary tools to get a job quickly. As we do not require any fee from employers for any placement, this is a major incentive for them to prefer our graduates.
What are the CRA career opportunities & salaries?
Our clinical research program provides the foundation for many positions within the clinical research field. Please follow the Careers tab to find out about some of these opportunities.
Career structures for Clinical Research Associates (CRA) are generally set at 3-4 levels, which may carry different names in different institutions:
How long does it take to complete the course?
The program completion depends on the individual and everybody goes at his or her pace. There are 25 chapters of 40-60 pages each in our main clinical research course, so by completing 2 chapters per week it takes about 3-4 months. However, in real life the expectations to study every day are not realistic. Our experience shows that depending on previous experience, education, level of English and availability, it may take between 3 to 6 months to complete. These are new professions and there is a lot to learn, the course exceeds 1000 pages. The internship goes in parallel to the training from the 2nd module to acquire the longest possible hands-on experience that companies want.
What are the CRA working conditions?
Smart dress code is required. Field-based CRAs (monitors) work mainly alone, travel frequently (3 days per week is normal), some extra hours on occasion and can be also home based if the company doesn’t have a branch in their city. Companies have also in-house (office-based) CRA roles, handling document review and management. Self employment or freelance work is possible and frequent after accumulating 2-3 years of experience and contacts in several companies. Part-time work on contract basis is possible. Women make 60 – 70% of the profession. Career breaks are possible. Working conditions vary between companies. In CROs you may have more hours, but working on weekends or on shifts is uncommon.
What do I need to become a CRA?
You need the following :
1) Sufficient education and qualification to be able to understand a research protocol, preferably in the life sciences or health care fields
2) Functional English, able to communicate effectively
3) Working knowledge of the clinical trial regulations of the country of the trial and of the sponsor
4) Some practical experience in clinical trial tasks
5) Ideally, contacts in several companies to get informed about the hidden (unadvertised) jobs.
We provide an answer to the last two of these requirements with our unlimited internship program and active coaching on how to enter into this field, which continues till hired.
Why should I pay for training? Can't I study myself?
Theoretically, yes. In the Internet era, all the information is accessible if you know what to search for. However, the legal language used in laws and regulations is rather difficult to digest. Besides that, in the university libraries you may find some of the manuals, used for this course. What you can not find is the practical experience and advices. There will be nobody to answer your questions and to test and certify the level of your knowledge. This is what you pay and why schools still exist. If you are a recruiter, will you hire somebody who has no diploma, but says that he studied the manual? Recruiters are HR specialists, not clinical research professionals, they can’t make you an exam to check what you learned.
I don't see lot of jobs. Is there a demand?
Yes, there is even a high shortage of qualified staff, but you won’t see most of the posts for CRA positions. Around 90% of the jobs are never announced because filled-in by references (asking around colleagues, friends, recruiters etc.) There is a very substantial chronic shortage of qualified CRAs and the need will only grow further due to the explosive growth of knowledge in new areas, like brain functions, proteinomics, genetics, epigenetics, stem cell research, nanotechnologies.
Because of this shortage, once you get in the field, the recruiters will start approaching you to offer a higher salary in another company. By having practical experience you will be easy to sell. You only need to get in the field once, and in 6 – 9 months the recruiters will start calling with offers of higher salaries. It is not unusual to see studies where the CRAs have changed several times because the previous left for a better pay. We even provide information on how to transfer the site to the new CRA when you decide to leave.
Why companies ask 2 years CRA experience?
Employers avoid to pay for the training of staff that they cannot keep. Due to the high shortage of qualified staff, CRAs move frequently to other companies. To replace the person who left, they need someone who can start on the go, without any long training (besides on the current protocol). Traditionally 2 years is considered as a guarantee to have acquired experience in all possible tasks and situations. However, CRAs with 2 years of experience know their price and will ask $75-80.000 salary. In several cases the company will have to accept people with 1 year or even 6 months of experience for financial reasons, or simply because they start a big study and know that with the 30% shortage, there is simply no such number of free monitors with experience. Therefore, the 2 years requirement is not always feasible, especially for smaller companies that rely on risk capital only. Hence, small and medium companies are a better source of entry-level jobs.
I am in another country, should I take your course?
Our course is provided online for world-wide accessibility. Although the regulatory agencies are different in every region of the world, the fundamental notions of clinical research are very similar. Most of the world adheres to the principles of Good Clinical Practice (GCP). Most clinical research and pharmaceutical companies are based in North America or Europe. or do business with those that are. A knowledge of GCP and American regulations are centrally important to clinical trials, wherever they are run.
Do I need to relocate to find a job?
Normally it is not necessary but willingness to relocate may give you some additional job opportunities. Lately the companies refrain from covering relocation costs. Most of the companies are American and don’t have offices in every major city. Then the positions are for home-based CRAs (who work from their homes). They travel every week to the investigative sites to verify the trial documentation and how the investigators conduct the study and follow the protocol, then they send their reports from their homes. In-house positions are usually for Clinical Trial Assistants (CTA), which sometimes are called also in-house CRA. They work in the company branch premises and usually don’t travel to do physical monitoring.
What is the difference of this program to others?
Our program entails both international regulatory training, practice in the internship and job placement assistance. It combines on-line regulatory training with plenty of practical advises and tips that other courses don’t give in order to assure successfull interviews and to make the students 100% functional from the 1st day of hiring, unlimited internship in eCRO environment to get ‘hands-on’ experience, 7/7 LIVE support till late evening to allow studying at any time, possibilities for co-op placement for qualified students, industry specific job search training, mentoring and coaching till hire, pre-selection questionnaires and former transferable experience analysis, JD analysis for every job opening, CV adaptation and interview preparation for every position with its subsequent analysis, coaching on professional branding and basic sales techniques, extensive job placement assistance and free mentoring even after hiring. No other provider offers such job wide and goal oriented support.
What is your Mentoring Program?
Every student has access to the 7/7 on-line support from our qualified instructors, who are experienced Clinical Research Porofessionals (CRP). They provide LIVE support till late evening on complicated regulatory questions, JD interpretation, preparation and instructions for the interview, including advanced learning of topics which have not been studied yet by the student, adaptation of the CV for the given job and much more. Questions are answered usually immediately or within an hour, latest in 24 hours.
This support does not end with the termination of the training but continues during your job search and even after hiring, i.e. you can contact your mentor for free consultations on complicated issues even during the first 2 months after you started your first job. (After 2 months the consultations are still provided, but will be charged). This unique service is meant to reduce the new hire stress and preserve your face in your new job.
What is your placement rate?
This is a typical question that candidates ask in order to get reassured, but what is the value of such statements? Universities claim high rates of placement, but their mission is not to help graduates to find a job, and we have no mean to verify their statistics. It is not clear when have they been made, what percentage of the graduates have been interviewed, what kind of jobs they got, in their field, or in some other, like selling insurances? How long it took them to get a job, months or years? We all know that statistics can show everything, and the opposite. Career change is an important step to make a decision based on such unreliable and unverifiable information.
Instead of telling unverifiable fairy tales, we prefer an honest approach – we copy-paste in the Testimonials of our website the real names of these students, who have informed us that they got a job before finishing the course and their comments how they managed to get in the system. In 3 cases even an additional position has been opened to hire our graduate. We are all proud of them and you can find them on LinkedIn if you wish.
In a lot of cases, however, when people get a job, they don’t inform us that they got hired, or never think to change their profile, simply because they don’t look for a job anymore. On LinkedIn, it looks like they don’t have a job and still study because they didn’t change their profile. Sometimes we learn about their jobs only when they call us to ask to continue the course and pass the Final exam. The only way for us to know that is when they have called us to discuss a particular job, and we have prepared them for the specific job interview.
Our last survey shows that with our active placement support, about 60% or more get jobs before the final exam. They usually never finish the program because they will be fully trained by their employer during the first month, and they don’t need a diploma anymore, in 7-8 months the recruiters start calling to offer a better paid job in another company, the shortage of experienced staff is over 30% and with 6 months of experience, they are eligible everywhere. etc).
What are the requirements for the level of English?
There are no formal requirements for the level of proficiency in English but to work successfully as a CRA or CRC, the applicant should have good written and spoken command of English, or, as a start, at least a functional English (capacity to understand emails, write simple messages, queries for data discrepancy clarification and visit reports and communicate by phone). The course gives models, checklists and templates for all the clinical trial tasks and oral English is developed during the course.The course content is made in simplified English, adapted for students, to whom the English is not the mother language. It is possible to have the content also in French, the tests are bilingual but the objective is to prepare for an interview in English, because interviews are in English and it is the only official language of communication for international trials where usually some 35-37 countries participate in the late phases. Support is available in 10 languages.
Who are the typical employers?
Typical employers are Pharmaceutical, Medical device and Cosmetics companies, Contract Research Organizations (CRO) and Site Management Organizations (SMO), who conduct research on behalf of the sponsoring companies, but academic research departments also employ occasionally CRAs in their clinical trials units. In-house CRC positions are available in academia, university hospitals, clinical research centers and medical clinics if they make clinical studies. The regulatory authorities employ only experienced CRA as inspectors.
What are the drawbacks of the CRA job?
The main inconvenience for a field CRA is the frequent traveling (about 3 days almost every week). If you have small kids and nobody to take care of them, you should start as in-house CRA or CRC and move to field CRA when kids grow up enough to can stay at home alone. But there is a substantial advantage that can compensate this nuisance – as a frequent traveler you will accumulate sufficient Air miles, hotel fidelity points, rent-a-car credits and different other perks from your credit cards and hotels where you stay regularly, to pay yourself and your family free vacations a few times per year.
Can I get financial help?
Yes, to give a chance to everybody, the Academy provided a 45% discount and 2-months deferred payment option to help candidates, blocked at home by the lock-downs and young mother with newborn babies, to acquire a new qualification for better paid careers, some practical experience and time to build a network of contact who can tell about the ‘hidden’ jobs that are never posted but filled in by internal promotions and references.
With the release of the sanitary restrictions, this discount will be reduced to compensate for the inflation, which became substantial this year. Unfortunately our program is not subsidized by the government. It leads to well-paid jobs, and governmental programs subsidize only trainings for jobs that nobody wants, paid about the minimal salary. It is also not eligible for the Loans and Bursaries program, which finances only full-time trainings with at least 1 year duration. Our program is not eligible as it is a flexible, self-paced, part-time course, which takes about 3 to 6 months.
Is the CRA/CRC program accredited?
The Clinical Research Professional Certification program CRP 2.0 is accredited by the UK Accreditation organization CPD Group. It provides 125 credits and confers a certificate covering almost all jobs in this field. The International Clinical Research Academy CRA SCHOOL is a recognized provider of Continuing Professional Development by the CPD Group UK.
The Academy is also recognized by Transcelerate as training provider for ICH E6 Good Clinical Practice (GCP) under their Mutual Recognition (MR) program. Most of the training providers offer non-credited courses because in N. America the hiring companies are not interested in accreditations and diplomas. They only seek practical experience, which we provide in our 3 Internship programs.
How is the training organized?
After registering to the program every student received a password to access the training content and on-line tests through the website. Lectures are followed by home work tasks to transform into active vocabulary the new terms and abbreviations, industry terminology and slang and use them during interviews to position yourself as a competent professional. There are also tests to see how questions appear ir real life and internship tasks for practical execution of all major CRA or CRC tasks to acquire experience, that usually takes 1-2 years to acquire. In parallel every homework includes additionally a networking task with the objective to create step by step a network of some 50-100 professional contacts in the target companies during the course and activate them when ready. However experience shows that usually some 15-20 contacts are enough to learn about enough hidden posts and get a job.
Do you have in-class courses?
We make in-class courses only in French when a group of minimum 6 participants is interested in such a course.The objective is to give a better chance to access these professions to francophones who have a difficulty to study in English. For them the presentations are in French, but the main course is in English because the interviews will be in English and on international trials all the study documentation and communication are only in English. The objective of the program is to get a job, and not just another diploma, so we try to provide our students with all the tools to overcome any possible obstacle and get into the field. However in-class courses take much longer because everything has to be studied in 2 languages and are less efficient due to the loss of time in public transport and the limited time for studies.
What is an e-Internship?
It is almost impossible to get a job in clinical research without practical experience in the field – most positions require at least 1-2 years of experience.
Furthermore, the Good Clinical Practice guidances state that individuals working in clinical research must be qualified by education, training, and experience. However, without being hired, how can you get experience?
Very few companies will take on-site interns, for reasons relating to liability, confidentiality, and for the fact that is just “not worth it” for them, takes too much time and money.
To help you resolve this vicious circle, we included 3 remote internships in our program.
The internship modules are designed to provide you some practical and relevant experience in various topics and to address this catch-22 situation.
Their objective is to show that you have a few months of practical experience relating to most clinical research regulatory affairs tasks.
The advantage for you is to familiarize yourself with the subject material to become more comfortable and confident with the required clinical research activities.
The other great real value is to make you eligible for interviews. This is then a tool, which demonstrates previous experience and good familiarity with the key clinical research tasks in a Canadian regulatory environment, which we will be able to confirm at reference verification.
Because of liability concerns, the companies train their new hires on data from old, already closed studies, never with ongoing studies. This is also our approach.
In most chapters there is a section on Internship Tasks, which allow you to add material proof of competence in your CV and be able to discuss these subjects in interviews and while networking.
As with most jobs today, working with data is done remotely. In the Academy, we use 2 old phase II/III studies. As they are not paid anymore, the interns are also not paid but become qualified to apply for jobs. This is a game-changer.
In addition to the Internship Tasks, we provide other, longer e-internship modules, including access to the Datatrak clinical trial management system (CTMS) and monitoring practice with a series of clinical trial documents with errors to identify. Source Documents Verification (SDV) is the core activity of the clinical trial monitor job.
The goal of these e-internships is to add substance to your CV and to get you eligible for interviews. To provide longer experience, the 1st internship starts still in the first module.t
CV adaptation and interview preparation for every job are provided within the Placement Assistance till Hired (PATH) program, an integral part of the CRP 3.0 and all other courses
Subject matter covered in the Monitoring Internship tasks and modules includes:
- Verifying clinical trial source documents
- Creation of Case Report Forms (CRFs)
- Entering data in CRFs and data clarification (query process)
- FDA 1571/Canadian QIU (Qualified Investigator Undertaking)
- Study protocol analysis and creation of protocol summaries
- Ethics board approval applications
- Adverse Events reporting
- Non-Disclosure Agreements
- Informed Consent documentation
- Protocol violations and audit preparation
- Creation of monitoring SOP checklists
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Salaires et pénurie des cadres dans la recherche clinique
Le domaine des essais cliniques des nouveaux médicaments et dispositifs médicaux est très réglementé et bien payé. Il exige beaucoup de personnel pour garantir la protection des droits et de la sécurité des participants et la qualité des données. La pénurie de cadres est très élevée et garantie des promotions presque chaque année.
CRA/CRC Professions, Available Academic Training Courses
Academic Programs in Clinical Research B.Sc. Programs and Certificates: George Washington University, Washington DCCampbell University, Buies Creek, NCDurham Community Technical College, Durham, NC D.E.S.S. Certificate: Drug Development*, McGill University, Montreal,...
Useful links
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Glossary
Adverse Event (AE), (article C.05.001, Health Canada) – Any adverse occurrence in the health of a clinical trial subject, who is administered a drug, that may or may not be caused by the administration of the drug, and includes an adverse drug reaction.
Adverse Event (AE), (ICH/GCP 1.2) – Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product (see the ICH Guidance for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).
Adverse Drug Reaction (ADR), (ICH/GCP 1.1) – In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out. Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function (see the ICH Guidance for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).
Audit, (ICH/GCP 1.6) – A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
Biologic, (Health Canada) – A drug that is prepared using a biological starting material or source material (e.g. derived from a microorganism, virus, animal, human, or plant), and using for example, either conventional manufacturing methods, recombinant DNA technology, and/or other novel approaches. Some examples of biologics include vaccines, blood and its derivatives, certain hormones and enzymes, recombinant DNA products, gene therapies, and transgenics. Biologics make up one large category of drugs; the other major category of drugs is pharmaceuticals, or synthetic drugs, made from chemicals.
Blinding/Masking, (ICH/GCP 1.10) – A procedure in which one or more parties to the trial are kept unaware (blinded) of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) (triple blind) being unaware of the treatment assignment(s).
Clinical Trial, (Art. C.05.001, Health Canada) – An investigation in respect of a drug for use in humans that involves human subjects and that is intended to discover or verify the clinical, pharmacological or pharmacodynamic effects of the drug, identify any adverse events in respect of the drug, study the absorption, distribution, metabolism and excretion of the drug, or ascertain the safety or efficacy of the drug.
Clinical Trial/Study, (ICH/GCP 1.12) – Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational, and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.
Clinical Trial, Multicentre, (ICH/GCP 1.40) – A clinical trial, conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator.
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Case Report Form (CRF), (ICH/GCP 1.11) – A printed, optical, or electronic document designed to record all of the protocol required information on each trial subject to be reported to the sponsor.
Confidentiality, (ICH/GCP 1.16) – Prevention of disclosure of a sponsor’s proprietary information or of a subject’s identity to other than the authorized individuals.
Compliance (in relation to trials), (ICH/GCP 1.15) – Adherence to all trial-related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements.
Comparator (Product), (ICH/GCP 1.14) – An investigational or marketed product (active control), or placebo, used as a reference in a clinical trial.
Contract, (ICH/GCP 1.17) – Written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract.
Contract Research Organization (CRO), (ICH/GCP 1.20) – A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions.
Clinical Trial/Clinical Study Report, (ICH/GCP 1.13) – A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which clinical and statistical description, presentations, and analyses are fully integrated into a single report.
Drug, (Article C.05.001, Health Canada) – A drug for human use that is to be tested in a clinical trial.
Documentation, (ICH/GCP 1.22) – All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and lectrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.
Essential Documents, (ICH/GCP 1.23) – Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced (see 8. Essential Documents for the Conduct of a Clinical Trial).
Good Clinical Practice (GCP), (ICH/GCP 1.24) – Standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
Good Clinical Practices, (Article C.05.001, Health Canada) – Good clinical practices means generally accepted clinical practices that are designed to ensure the protection of the rights, safety and well-being of clinical trail subjects and other persons, and the good clinical practices referred to.
Investigational Product, (ICH/GCP 1.33) – A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.
ICH – International Conference on Harmonization, (www.ich.org) – joint initiative involving both regulators and industry as equal partners in the scientific and technical discussions of the testing procedures which are required to ensure and assess the safety, quality and efficacy of medicines.
Investigator / Institution, (ICH/GCP 1.35) – An expression meaning “the investigator and/or institution, where required by the applicable regulatory requirements”.
Investigator’s Brochure, (ICH/GCP 1.36) – A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects.
Investigator’s Brochure, (Article C.05.001, Health Canada) – Investigator’s brochure means, in respect of a drug, a document containing the preclinical and clinical data on the drug that are described in paragraph C.05.005
Interim Clinical Study Report, (ICH/GCP 1.32) – A report of intermediate results and their evaluation based on analyses performed during the course of a trial.
Institution (medical), (ICH/GCP 1.30) – Any public or private entity or agency or medical or dental facility where clinical trials are conducted.
Inspection, (ICH/GCP 1.29) – The act of conducting an official review of documents by a regulatory authority(ies), on facilities, records, and any other resources, that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and/or contract research organization’s (CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies).
Institutional Review Board (IRB), (ICH, GCP 1.31) – An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
IRB Approval, (ICH/GCP 1.5) – The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints, set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements.
Independent DataSafety Monitoring Committee (DSMC), (ICH/GCP 1.25) – 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.
Informed Consent, (ICH/GCP 1.28) – A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.
Impartial Witness, (ICH/GCP 1.26) – A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.
Legally Acceptable Representative (LAR), (ICH/GCP 1.37) – An individual, or juridical or other body, authorized under applicable law to consent on behalf of a prospective subject, to the subject’s participation in the clinical trial.
Monitoring, (ICH/GCP 1.38) – The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
Opinion (in relation to Independent Ethics Committee), (ICH/GCP 1.42) – The judgment and/or the advice, provided by an Independent Ethics Committee (IEC).
Protocol, (Article C.05.001, Health Canada) – A document that describes the objectives, design, methodology, statistical considerations and organization of a clinical trial.
Protocol, (ICH/GCP 1.44) – A document that describes the objective(s), design, methodology, statistical considerations and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guidance the term protocol refers to protocol and protocol amendments.
Protocol Amendment, (ICH/GCP 1.45) – A written description of a change(s) to or formal clarification of a protocol.
Person responsible for site SOPs – A member of the institutional personnel involved in clinical research is designated by the institution to complete appendix 1, Instructions Specific to the Site. He/she may participate in the SOP revision process or in the SOP annual approval process. They may also participate in the training of institutional clinical research personnel for each standard operating procedure.
Quality Assurance (QA), (ICH/GCP 1.46) – All planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirements.
Quality Control (QC), (ICH/GCP 1.47) – The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.
Research Ethics Board (REB), (Article C.05.001, Health Canada) – A body that is not affiliated to the sponsor, and:
a) the principal mandate of which is to approve the initiation of, and conduct periodic reviews of biomedical research, involving human subjects in order to ensure the protection of their rights, safety and well-being; and
b) that has at least five members, that has a majority of members, who are Canadian citizens or permanent residents under the Immigration and Refugee Protection Act, that is composed of both men and women and that includes at least:
· two members whose primary experience and expertise are in a scientific discipline, who have broad experience in the methods and areas of research to be approved and one of whom is from a medical discipline or, if the clinical trial is in respect of a drug to be used for dental purposes only, is from a medical or dental discipline,
· one member knowledgeable in ethics,
· one member knowledgeable in Canadian laws relevant to the biomedical research to be approved,
· one member, whose primary experience and expertise are in a non-scientific discipline, and
· one member, who is from the community or is a representative of an organization interested in the areas of research to be approved and who is not affiliated with the sponsor or the site, where the clinical trial is to be conducted.
Regulatory Authorities, (ICH/GCP 1.49) – Bodies having the power to regulate. In the ICH GCP guidance the expression Regulatory Authorities includes the authorities that review submitted clinical data and those that conduct inspections (see 1.29). These bodies are sometimes referred to as competent authorities.
Regulatory Requirement, (ICH/GCP 1.4) – Any law and regulation addressing the conduct of clinical trials of investigational products.
Radiopharmaceutical, (Health Canada) – Drugs, which are labelled with a radionuclide in tracer or therapeutic amounts, and which exhibit spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons. They can include drugs either of chemical or biological origin, which are intentionally made radioactive, as well as, kits that are used for the preparation of radiopharmaceutical and radionuclide generators. Radiopharmaceuticals are used as diagnostic or therapeutic agents, and are always prepared and administered by health care professionals; they are never self administered.
Source Data, (ICH/GCP1.51) – All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).
Source Documents, (ICH/GCP 1.52) – Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions, certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial).
Standard Operating Procedures (SOPs), (ICH/GCP 1.55) – Detailed, written instructions to achieve uniformity of the performance of a specific function.
Site standard operating procedure (SOP) – A validated site standard operating procedure is a generic SOP for which appendix 1, Instructions Specific to the Site has been completed. This site standard operating procedure has been ratified by the director of the research center and/or by institution members according to the internal procedures for the validation process. This SOP is in use in the institution.
Specific Site Instructions (QC only) – Specific instructions that outline in a detailed manner the activities related to the institution for a given standard operating procedure
Site / Trial Site, (ICH/GCP 1.59) – The location(s) where trial-related activities are actually conducted.
Sub-investigator, (ICH/GCP 1.56) – Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows).
Subject / Trial Subject, (ICH/GCP 1.57) – An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.
Sponsor, (ICH/GCP 1.53) – An individual, company, institution, or organization, which takes responsibility for the initiation, management, and/or financing of a clinical trial.
Sponsor-Investigator, (ICH/GCP 1.54) – An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and of an investigator.
Trial Flow chart – A table that illustrates and helps visualize a standard operating procedure process. The table is included in the procedure draft to facilitate understanding of the procedure.
Electronic signature, (Statutes of Canada 2000, PIPEDA) – A signature that consists of one or more letters, characters, numbers or other symbols in digital form incorporated in attached to or associated with an electronic document.
Electronic numeric signature, (MSSS, Cadre global des actifs informationnels – sécurité) – Data, appended to an electronic document, allowing the person receiving this document to know the source of the data, to attest its integrity, and to assure the transmitter adherence to the document content. We sometimes use the expression secured electronic signature.
Secure electronic signature, (Statutes of Canada 2000, PIPEDA) – An electronic signature that results from the application of a technology or process prescribed by regulations made under subsection 48 (1).
Vulnerable Subjects, (ICH/GCP 1.61) – Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.
Well-being (of the trial subjects), (ICH/GCP 1.62) – The physical and mental integrity of the subjects participating in a clinical trial.
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