Working As A Clinical Research Associate

By Author: Rajesh Kumar
Total Articles: 17
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If you want to work as CRA (Clinical Research Associate) or monitor of clinical trials in laboratories and companies related to the pharmaceutical or clinical research industry, you should at least know the following.

What is a CRA?
What is clinical research and it phases?
What is Good Clinical Practice (GCP)?
What is the International Conference on Harmonization (ICH)?
What are Case Report Forms or CRFs?

1. CRA OR CLINICAL TRIALS MONITOR

"Clinical Research Associate" or Clinical Trial Monitor is a profession defined by the GCP "Good Clinical Practice". The main function of a CRA is to instruct clinical processes. You can work directly with the company sponsoring or funding a clinical study or work independently for a CRO "Clinical Research Organization" or organization that does clinical research. Clinical Research Monitor is responsible for ensuring compliance with the Clinical Research Protocols for tests and clinical activities, conducting research site visits, review the CRFs ...
... or data collection forms for each clinical investigation and maintains constant communication with other researchers of clinical analysis. You are required to possess a degree in health sciences and a deep knowledge of both the standards of Good Clinical Practices and the local legislation. In the U.S. these rules are codified in Title 21 Code of Federal Regulations in the European Union and these rules are part of EudraLex (collection of rules and state regulations relating to medicinal products within the European Union).


2. CLINICAL RESEARCH OR CLINICAL PHASES

Clinical Research or "Clinical Trials" measures whether a drug is safe and effective for humans in the treatment of the disease in question. Clinical trials are divided according to their objectives and the available prior information in four phases (Phase I, Phase II, Phase III and Phase IV).


Phases of Clinical Trials :

Phase I - Provides preliminary information on the effects and safety of a new drug, a small number of healthy subjects, in some cases, patients.
Phase II - Studies in this phase are carried out on a sample of patients diagnosed with the disease. It provides preliminary information on efficacy that can extend the safety data obtained in Phase I.
Phase III - Clinical trials in this phase involve a much larger sample of patients to evaluate the efficacy and safety prior to approval by health authorities.
Phase IV - This phase, following the approval of the drug, used to complete the safety and efficacy data.

3. GOOD CLINICAL PRACTICE (GCP)

Good Clinical Practice is an international quality standard developed by the International Conference on Harmonization "ICH" hereinafter ICH "CIARM", an international body that defines these standards, which become responsible for the rules governing those clinical investigations that affect or involve human subjects. These rules ensure the protection of human rights as a subject in clinical processes and the safety and efficacy of newly developed compounds. Standards of Good Clinical Practice include how the research process should be conducted, defining roles and responsibilities of sponsors, investigators and monitors of clinical trials. In the pharmaceutical industry, the monitors are generally called CRAs (Clinical Research Associates). Every research organization must follow the GCP during their clinical trials services, medical writing, clinical data management or any other medical research services.


4. INTERNATIONAL CONFERENCE ON HARMONIZATION (ICH)

The International Conference on Harmonization is a project jointly leading legal authorities in Europe, Japan and the United States and experts from the pharmaceutical industry in these areas to discuss the technical and scientific aspects of product registration. The aim of the ICH is to reduce or highlight the need to duplicate the testing carried out during the investigation and development of new medicines by recommending ways to achieve greater harmonization in the interpretation and application of standards and technical requirements for the registration of new products. Harmonization would lead to economize on the use of human, animal and material and to eliminate unnecessary delays in the development and availability of new medicines while maintaining safeguards on quality, safety and efficacy and legal obligations to protect public health. The guidelines of the ICH have been adopted as laws in many countries, not the United States where the Food and Drug Administration only used as advice.


5. CASE REPORT FORMS "CRF" or NOTEBOOK COLLECTION OF DATA “CRD”

The case report data (CRD) is a form designed to record the variables collected during a clinical trials. International regulations require that the CRD is included in the documentation submitted for approval by the institutional ethics committees and health authorities. This document, always customized for each specific clinical research project and should allow recording of all data requested in the protocol and reflect the original clinical documentation (medical history, lab reports and additional examinations) individually for each patient to facilitate replication of the data generated, the statistical analysis, preparation and correction of the final report of a clinical trial and should be the scientific support of a new drug or medical device.


Basic principles to be considered in the making of a CRD are: the type of information to be recorded, how to complete the data and general rules for the graphic design of the document.