Good Clinical Practice (GCP) is an ethical and scientific international quality standard provided by the International Conference on Harmonisation (ICH) for designing, conducting, performing, monitoring, auditing, recording, analysing and reporting of clinical trials, or studies that involve the participation of human subjects. Governments have transposed GCP into regulations for clinical trials. Compliance to this standard provides assurance to the public that clinical trial data and reported results are credible and accurate. It also demonstrates that the rights, safety, integrity, confidentiality and well being of trial subjects are protected, consistent with the principles enshrined in the Declaration of Helsinki.
GCP can add to the quality of work and help to establish the most efficient and effective way to adhere to its guidelines. As healthcare practitioners, physicians, scientists, and researchers, everyone wants safe and effective treatments for patients. Adherence to GCP is the best way to ensure this in a clinical trial. It is also in the best interests of the patient.
Conducting clinical research in accordance with the principles of GCP helps to ensure that participants in clinical research are not exposed to undue risk, and that data generated in the research is legitimate and correct. Thus, GCP serves not only the interest of clinicians and those involved in the research process, but also protects the rights, safety, and wellbeing of subjects at the same time as ensuring that investigations are scientifically sound and advance public health goals.
Paradigm Shift from the West to East
Historically, clinical trials were primarily conducted in the United States. More recently there has been a shift from the west to the east for conducting clinical trials. This is due, in part, to the cost factor, particularly in developing countries such as India, China and South East Asian countries.
India has exploited the potential for clinical research by attracting various international and domestic pharmaceutical companies. India offers unique opportunities for conducting clinical trials and research. It has a huge population, large numbers of patients, well equipped hospitals, trained doctors, government initiatives and low costs, when compared to developed countries. Many factors contribute to lower costs, including clinical researchers, nurses, doctors, infrastructure facilities and fees paid to the volunteers recruited for clinical trials.
India’s government has taken the initiative and implemented regulations in data protection and data exclusivity, and has exempted clinical trials from import duty. It has improved the availability of infrastructure for conducting clinical research, including enabling connectivity with remote locations. It is now possible to conduct meetings/training through strong networking facilities provided by the information technology sector.
Clinical trials and research is now a major business in India. Top multinational pharmaceutical companies like Pfizer, Glaxo Smith Kline, Aventis, Novartis, Novo Nordisk, Astra Zenica, Eli Lilly are conducting clinical trials in India in addition to local Indian companies like Dr. Reddys, Nicholas Piramal, Cipla and Lupin.
The GCP Guidelines
GCP guidelines establish two fundamental principles: protection of human rights for subjects in clinical trials, and authenticity of biomedical data generated. The guidelines include standards on how clinical trials should be conducted. They also define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. In the pharmaceutical industry, monitors are often called Clinical Research Associates.
These guidelines have been devised with consideration of the World Health Organisation (WHO), ICH, U.S. Food and Drug Administration (USFDA), and European GCP guidelines, as well as the ethical guidelines for biomedical research on human subjects issued by the Indian council of medical research. They should be followed for carrying out all biomedical research in India at all stages of drug development, whether prior or subsequent to product registration in India.
The Indian GCP Guidelines provide a framework to deliver clinical research of uniform quality throughout the country and to generate data for the registration of new drugs before their use in the Indian population. An expert committee set up by the Central Drugs Standard Control Organisation (CDSCO), in consultation with clinical experts, has formulated the Indian GCP guideline. The Drug Technical Advisory Board (DTAB), the highest technical body under the D&C Act, has endorsed adoption of this GCP guideline to streamline clinical studies in India.
Indian GCP guidelines will be immensely useful to research institutions, investigators, institutional ethics committees and regulators in providing direction. In addition, it will help companies who may want to locate their clinical programme in this country.
GCP Training Is Key
The Research Governance Framework sets out the responsibilities of employers: “Employers of staff undertaking health and social care research have responsibility for developing and promoting a high quality research culture in their organisation and for ensuring that their staff are supported in, and held to account for, the professional conduct of research. This involves careful attention to training, career planning and development, and the use of clear codes of practice and systems for monitoring compliance, dealing with non-compliance or misconduct, and learning from errors and complaints. These responsibilities apply to both private and public sector employers.”
The principles of GCP state that: Each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task(s) as per the Guidelines for GCP. GCP training forms one component of the systems for ensuring high quality research. It’s a key requirement for anyone carrying out, or involved, in clinical research and clinical trials to ensure they are best prepared to carry out their duties.
GCP training provides the research community with insight into the rules and regulations that are applicable to clinical trials, highlights the roles and responsibilities of a principle investigator, the complexities of informed consent, personal information, storage of materials, etc. It serves as a basic education platform on the standards of practice for conducting research.
The training should be appropriate and proportionate to the type of research undertaken, and should cover the responsibilities of researchers as they are set out in relevant legislation and standards. There is no set requirement for the frequency of such training. Researchers are expected to maintain awareness of current standards through reference to published guidance and relevant policies. Training should be updated when legislation has changed, new policies or practice have been implemented, different research activities are to be undertaken, or a significant period of time has elapsed since research activities have been conducted.
The training is therefore relevant to:
- Investigators from hospitals, pharmaceutical companies, and research institutes.
- Clinical trials support staff (e.g. staff working in contract research organisations).
- Research nurses.
- R&D staff involved in approving and monitoring clinical trials.
- Members of ethics committees.
- Graduates looking to develop a career in clinical research.
Goals of SGS’s GCP Training
- To protect the rights, safety and welfare of humans participating in research.
- To assure the quality, reliability and integrity of data collected.
- To provide standards and guidelines for the conduct of clinical research.
- Good Clinical Practice = Ethics + Quality Data.
Major Topics of Training include:
- Certified in Good Clinical Practices and Investigator.
- Certified in Good Clinical Practices and In Monitoring.
- Certificate course for Clinical Research Associate.
- Certificate course in Pharma Co Vigilance.
- Certificate course in Electronic Submission Standards.
- Certificate course in Statistics Related to Clinical Data Analysis.
Find out more about Clinical Research Services.