Companies cannot market new drugs, medical devices, or biological products, without providing to the U.S. Food and Drug Administration (FDA) proof that the product is safe. Hence, there are types of Clinical trials conducted to show safety, and efficacy of the product.
Regulatory agencies assess the information and data provided by sponsors and investigators, and then decide to approve or reject the marketing application for the product.
The International Council for Harmonization (ICH) E6 standards, has been implemented in the U.S., Europe, Japan, and other countries, to aid in compliance with regulatory requests of many of governmental regulatory agencies.
ICH E6 R1, and its 2016 addendum R2, relates to conducting clinical trials of drugs, medical device and biologics that abide by Good Clinical Practice (GCP) standards.
Many Sponsors and contracted CRO's prefer following ICH GCP guidelines in combination with FDA guidelines to conduct research trials. It is important to note that ICH GCP guidelines are merely a standard in the US and not an enforceable law. Nonetheless, all sponsors require their trials to be conducted in a manner that follows both FDA and ICH GCP standards.
GCP standards are broader than FDA guidelines. ICH, 2016 E6 GCP guidelines, Section 5.0 states that the sponsor should create a system to achieve quality in all phases of the clinical trial. The quality management system should use a risk-based method. This was an essential change for trial monitoring, that extends beyond just routine periodic record auditing. For example, the new ICH E6 integrated addendum (R2), requires sponsors to implement a risk-based process that identifies risks in the study. Sponsors are also required to perform a root case analysis, and also CAPA, Corrective Action and Preventative Action when needed.
Section 4.9.0 of ICH E6 also requires the investigator to sustain adequate and accurate source documents and trial proceedings including all related notes on each of the site’s trial participants. Paper, or electronic source data must follow ALCOA-C. This means it needs to be attributable, legible, contemporaneous, original, accurate, and complete. Any changes to source data should be traceable, it shouldn’t obscure the original entry, and must explained if needed.
ICH E6 Section 5.5.3 further states that the sponsor must confirm that the electronic trial data handling and/or remote electronic trial data systems follow the sponsor’s written requirements for completeness, accuracy, reliability, and are validated. Written requirement should be a written standard operating procedure also know as SOPs.
It is the responsibility of the Sponsor's / CRO's to hire a Clinical Research Professionals who are very experienced in other areas to maintain cost.
Contact us to not only perform monitoring, and auditing of your study trials, but to also validate all your regulatory quality management electronic data.
Written by Elizabeth Bonsu, Founder and President TMEP & DCR
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