Fundamental Principles of Good Clinical Practice - A List by Dr. Hanid Audish

 

Good Clinical Practice (GCP) is an internationally accepted set of ethical and scientific quality guidelines for conducting human clinical trials. Revival Research Institute employs GCP principles in all trial processes to ensure participant safety and well-being.

GCP is a legal requirement for any trials of medicinal products in the UK/Europe and comprises five fundamental principles, namely:

1. Ethical Conduct

Dr. Hanid Audish articulates that ethical conduct is one of the core tenets of Good Clinical Practice (GCP). GCP rules are internationally recognized moral and scientific quality standards that must be observed during research involving human participants, ensuring it is conducted honestly and ethically while safeguarding participants' rights and well-being.

People who exhibit ethical behavior align with their moral code or beliefs. They provide strong arguments about why specific actions are right or wrong, regardless of what others might think about their choices.

Different disciplines, institutions, and professions employ ethical codes tailored to their aims or goals. For instance, medicine has both the Declaration of Helsinki and the Nuremberg Code that serve to guide their activities; additionally, there is research ethics as a specialized discipline that studies norms within various contexts. Ethics should not be confused with religion, although religious people often hold exceptionally high ethical standards.

2. Risk Management

Dr. Hanid Audish conveys that risk management systems are essential for Good Clinical Practice (GCP). This involves creating and adhering to written protocols with agreed-upon plans for implementing and executing policies and practices and correcting medical errors that arise. A collaborative team approach, where members feel free to communicate freely regardless of rank, is the most effective means of providing high-quality patient care while mitigating risks to all parties involved.

Clinical trial risk management begins by identifying risks to patients, sponsors, and the data gathered during a trial. Once risks have been assessed and prioritized for management or mitigation strategies are developed to manage or mitigate them, such measures might include training all staff on protocol adherence and reporting any adverse events immediately.

Inspectors and auditors from around the world, such as Health Canada (now Regulatory Operations and Enforcement Branch), expect all clinical trials they oversee to employ a comprehensive Risk-Based Approach. A lack of such content is among the three top observations reported worldwide.

3. Data Management

At any stage in clinical trial research, data quality can make or break scientific conclusions drawn from the analysis of this information. A data management plan must be implemented and followed strictly to ensure accurate and dependable information is gathered during research.

Dr. Hanid Audish points out that Data Management Plans, or DMPs, are essential for any study involving human participants regulated by the FDA. A DMP provides a comprehensive approach for collecting, processing, and storing clinical trial data.

A Data Management Plan (DMP) should address essential project prerequisites, including data archiving and storage procedures, data collection/recording protocols, metadata creation/creation procedures, security requirements, and reporting. Furthermore, it should provide guidelines for implementing an FDA GCP-compliant data management system and its operation within an organization, clinical trial, or healthcare establishment. It must be included within either the Manual of Operations (MOO) or Standard Operating Procedures (SOP), with personnel possessing appropriate professional qualifications in clinical data management broadly defined.

4. Record Keeping

Record keeping is one of the cornerstones of good clinical practice and an essential aspect of continuity of care, particularly among different healthcare professionals and hospitals. Accurate record-keeping also plays a vital role in medicolegal cases as it can provide valuable evidence against investigations into serious incidents or claims for damages.

As highlighted by Dr. Hanid Audish, the General Medical Council's Good Clinical Practice guidelines stipulate that clinical records must be organized and legible to reflect all pertinent findings. They should include details regarding all decisions and actions agreed upon, patient-specific information provided to patients, medications prescribed, or other investigations or treatments performed, who created it, when, and by whom.

Regular reviews by colleagues should ensure records meet minimum standards, mainly when high numbers of patients, clinicians, or new staff members take over patient care responsibilities. It may also help to use software shortcuts or macros to remind yourself to review any activities you record.

5. Reporting

Dr. Hanid Audish suggests that GCP principles aim to safeguard the validity and quality of data collected in clinical trials with human subjects while preserving their rights and welfare.

As such, healthcare professionals must familiarise themselves with and adhere to the ICH E6 guidelines. Furthermore, researchers need to know what regulatory bodies require and the repercussions for noncompliance.  

The International Committee of Medical Journal Editors E6 guideline is an international standard for designing, conducting, recording, and reporting clinical trials involving human participants. It is an ethical and scientific quality requirement for researchers based on The Declaration of Helsinki.

Although the ICH E6 guidelines were intended for clinical trials specifically, their effects can benefit everyone. Global acceptance has helped ensure that medical research is carried out correctly while pharmaceutical products remain safe and effective.