Safety Monitoring

The importance of safety monitoring in clinical trials

It is necessary to ensure the cent percent safety of the participant during the clinical trials. Few medications and procedures can be tiresome and risky. The National Statement on Ethical Conduct in Human Research 2007 has remarked that all the sponsors, Human Research Ethics Committees (HRECs), institutions and researchers /investigators are responsible for monitoring all the details of the clinical trials. The following recognition is designed mainly to signify the accountability of every person involved during the trial in relation to the adverse events, unexpected, unfortunate severe reactions, and serious adverse events. The following is an excellent step in context to risk assessment and safety monitoring. Several guidelines are made in accordance with the adverse events occurring at the trials of the investigation medical devices (IMDs) and investigation medical products (IMPs) for which the institutions carrying out trials are responsible along with the approval and review of Human Research Ethics Committees (HRECs). The following guidelines are even applicable to all the clinical trials which use therapeutic goods. The pharmaceutical sponsors are directed to work collaboratively and dedicatedly along with the stakeholders to have a systematic approach towards safety monitoring. There is an evolution in the field in consonance with the increasing requirement for risk evaluations, safety monitoring, and risk management plans. The clinical industry has shifted from the passive form of safety monitoring to the active form of safety monitoring. It will enhance the innovative approach which applies qualitative methods of recording data from various sources. The statistical methods based on the famous Bayesian framework are the essential tools to maintain rigor and objectivity for the safety monitoring processes.

The clinical trials give the basis for the official regulatory approvals for effective and safe medicines. As time is passing by, the costs in conducting the respective clinical trials are also being increased. The regulators and pharmaceutical companies are striving hard to make the trails more proactive in terms of safety evaluations. The clinical trials are the experiments conducted on humans which must be executed by keeping the well being and safety of the participant. The early safety monitoring even leads to the cost reduction for the development and ensures the better safety of the patient in every aspect.


There are few standards which are set up in accordance with the safety. The standards include the following:

  • International Ethical Guidelines for Biomedical Research Involving Human Subjects by the Council of International Organizations of Medical Sciences (CIOMS).
  • International Conference on Harmonization Good Clinical Practice (ICH-GCP).
  • Ethical Principles in the Declaration of Helsinki.


GCP is considered to be the standard for the monitoring, conduct, design, performance, auditing, reporting of trials, and analysis. It provides the security of the accuracy reported results and protection of the participant’s rights.


Numerous Practices in Safety Monitoring


The sponsors (usually the various pharmaceutical companies), who supplies the medical supplies for the development of the trial protocol. The protocol is the initiation document which tells the subject about the further processes of the clinical trial. The protocol is also responsible for letting the participant know about the various safety monitoring at the time of the clinical trial and at the serious adverse events. The Informed Consent Form (ICF) describes briefly about the risks, procedures, and benefits of the trial on the participants of the clinical trial. The respective sponsor also designs several Case Report Forms (CRFs) as one of the data collection tools.



Subjects are considered to as the participants who agree to participate in the respective clinical trials by signing the ICF. The ICF provides the necessary safety information so that the subject can land to a firm decision regarding participation in the trial. The following consent much is provided without any coercion with a clear understanding of the trial. As the consent is given by the subject, he/she permits the investigators to fetch the body measurements and health information as per the official protocol. The subjects can withdraw the consent at any time whenever they feel like without giving any particular reason for the stoppage of the clinical trial.



Investigators are the qualified individuals who have gone through rigorous training to serve the medical care to the enrolled subjects in a safer form. The investigators are responsible for all the events happening before, during and after the clinical trial. They are responsible for educating and letting the subjects know about the further happenings and other effects of the respective clinical trials. During the trial, the investigators are supposed to work within the boundaries of their protocol in delivering the needed care. One of the central works of the investigators is to evaluate, manage and observe the effects of the treatment and reporting of the adverse effects.


Regulatory authorities

According to the US laws, the pharmaceutical sponsors are required to submit an Investigational New Drug (IND) application to the FDA before the initiation of any processes. Then FDA comes up with the conclusion over IND confirming the respective subjects will not be posed to any health risks during the specific clinical trial with the following medications. IN 2010, the FDA even issued guidance to the investigators as well as sponsors regarding the safety reporting requirements for biological products and human drugs. The main focus of the guidance was to ensure the proper safety in the conduction of the clinical trials with a proper review, submission of the relevant information and timely reviews of information.


The evaluation of safety is a vital component at every stage of the lifecycle of drug development. Before the usage of any drug or medication, the following has to go through the pre-clinical trials to get approved for the main grounds. The pharmaceutical companies or sponsors have to characterize the safety profile of their respective products in order to gain marketing authorization with regulatory approval. The most recommended approach is the Bayesian approach in the context of safety monitoring due to the flexibility in the analytical framework.

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