Compliance with guidelines of Good Clinical Practice (GCP) as the minimum standard is identified as key characteristics for conducting clinical research. Clinical research is conducted in a manner to provide public assurance; safeguard rights, safety and wellbeing of involved participants and generate reliable data. The accessibility and accuracy of preserved records should be easily retrievable for analysis, verification, reporting and interpretation.
Good Clinical Practice guidelines
Good clinical practice guidance produced by the International Council for Harmonisation (ICH) of technical requirements is applicable for registration of pharmaceuticals, medicines and healthcare products. Internationally scientific, ethical and quality standards of Good Clinical Practice (GCP) is essential for designing, conducting, performing, monitoring, auditing, recording, analysing and reporting clinical trials. It serves to protect integral rights and confidentiality of trial subjects along with ensuring the credibility and accuracy of reported data and results. The oversight function in clinical trials includes selection of study investigators, safety information reporting and providing accurate information at all times. Regulatory Agency for human use advocates proportionate approach towards application of GCP in conducting clinical trials, seeking informed consent from participants and appropriate training of the involved staff.
Sponsor and investigator of a clinical study should be familiar with respective duties, guidelines and regulations set out under GCP. The sponsor oversees the role of investigator, incorporates monitoring and balances between minimum bias, maximum patient safety and trial validity. The sponsor also provides important information about the product to allow the investigator to recognize adverse events and protect the subjects during the study. Responsible investigators select participants based on eligibility requirements of the study protocol and ensure the welfare of the study subjects at the clinical site. The duties of an investigator include protocol-specified evaluations, collection and reporting of safety data or information to the sponsor. Investigator accounts all investigational product data, maintains accurate records, updates Institutional Review Board and procures informed consent from all study participants. The board and committee reviewing a clinical study need to approve the clinical research protocol and consent form before the study is initiated at that institution.
Importance in clinical trials
Clinical trials are conducted with sound scientific evidence, compliance to ethical principles and clear detailed protocols. Conducting clinical research involves considering the benefits of recognising risk factors along with ensuring rights, safety and well-being of trial participants. Obtaining informed consent and maintaining confidentiality of subjects in a study is of paramount importance. Overseeing the clinical trial progress requires ensuring the process of conducting, recording and reporting in accordance with the standard operating procedures, protocol, GCP and applicable regulatory requirements. Auditing at the end of the trial allows independent and systematic examination of trial-related activities and documents. Employing appropriately qualified personnel with adequate experience in a clinical research can ensure clinical trials are conducted as per GCP guidelines.
All the stakeholders are made aware of the importance of compliance with Good Clinical Practice guidelines in clinical trials. GCP guidelines ensure clinical data generated are verifiable, accurate and reproducible during a trial. Compliance with GCP is necessary for advancement in scientific knowledge and assurance of public well-being, safety and confidentiality. Following GCP guidelines while conducting research is a law made to protect trial participants. Investigators need to diligently follow GCP for effectively and safely conducting trials in a properly-designed manner to produce accurate data and medical knowledge. The obligation of investigators to assure quality of clinical trials is possible through GCP that ensures sharing of meaningful information with patients in the future. International standard of GCP also allows conducting trials in multiple centres and countries.
Online Course at JLI
James Lind Institute (JLI) provides an online program in GCP Training & Certification Program to enhance career in clinical research.
For more information please visit: www.jli.edu.in