What is a Good clinical practice?

What is a Good clinical practice?

Good clinical practice (GCP) is an international quality standard for trials involving human subjects. It sets ethical and scientific quality standards for designing, conducting, recording, and reporting the trials.

What is the purpose of Good Clinical Practice?

Good clinical practice (GCP) sets guidelines and rules for the safety of clinical trial participants. GCP compliance protects the participants' rights, privacy, and safety. It also ensures that the data collected during the clinical trial is protected and accurate.

Who developed the Good Clinical Practice?

Several unethical human experiments were noted across geographies and nations during World War II. To address these anomalies, the International Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) developed a set of rules and guidelines in 1996 known as Good Clinical Practice.

Three main principles of Good clinical practices

Good clinical practice centers around three main principles: ethical principles, data integrity, and regulatory compliance.

Ethical principles: Good clinical practice emphasizes protecting the clinical trial participant's rights and safety throughout the clinical trial or research. To maintain research ethics, the participant should receive complete information regarding the research, potential risks, and procedures. The participants should sign an "Informed consent form," upon the researcher's request, which means they have understood the study and agreed. Informed consent also gives the participant the right to leave the research trial whenever they want. The researchers should have the participant's rights, safety, and health as a primary consideration.

Data integrity and quality: To ensure credible findings, all clinical trials should adhere to strict compliance standards and procedures. They should also conform to data integrity and quality standards. The regulatory authorities should review the data collected during the clinical trial process to ensure credibility. The data should be accurately recorded and stored with easy access. This data can be used for future reference or further research.

Regulatory compliance: Regulatory compliance plays an important role in clinical trials. Regulatory authorities review the data and grant approvals. If the researchers disapprove, the regulatory authorities can stop the trials if ethical guidelines are not adhered to.

Regulatory Authorities

ICH Guidelines: The Good Clinical Practices guidelines are framed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and are known as ICH E6 (R2). The regulatory guidelines are followed globally by regulatory authorities.

Regulatory Authorities: Adherence to Good clinical practices is needed for the approval of new drugs and therapies. Some such regulatory bodies are the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others.

Key stakeholders in Good clinical practice

There are several key stakeholders involved in conducting the clinical research trials ethically. Some of the key stakeholders involved in the Good clinical practice are:

Investigators: A principal investigator has to conduct the research according to good clinical trials guidelines. The principal investigators get the approvals from sponsors, carry out the investigation, monitor the trial, and ensure the safety of the participants.

Sponsors: A sponsor funds the clinical trial, usually a pharmaceutical company, a biotech firm, or a research organization. The sponsor designs the study, selects the investigators, provides resources, and monitors the trial process. The sponsor also ensures GCP compliance and reports the trials to the regulatory authorities.

Auditors: An auditor or monitor monitors the day-to-day trial activities. They are responsible for verifying data accuracy, ensuring protocol adherence, and identifying and addressing any issues that arise during the trial's conduct.

Regulatory authorities: The regulatory authorities ensure that the clinical trials adhere to the regulations. Authorities like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) ensure that the trials are conducted according to compliance and regulations.

Ethics committee: The ethics committee reviews the research design, the informed consent process and the evaluation of the risks that participants may face.

Clinical research organizations: A clinical research organization is responsible for coordinating various trial activities, data management, and trial adherence to Good clinical practice guidelines. These organizations are independent organizations hired by the sponsors.

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