Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 53

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.

Taking several of the functional steps included in this definition one can quickly understand how the contents of the Guideline/Standard are structured.

Design – The standard calls for the development of a scientifically sound protocol and investigator’s brochure. The Standard then proceeds to list the content expectations for each document. The Sponsor of a trial need only follow the Standard.

Conduct – The Standard outlines expectations which inform the players how to conduct a trial. For example, obtaining approvals from the IRB as well as the appropriate regulatory authority prior to starting the trial; obtaining informed consent from subjects; maintaining data confidentiality and ensuring product accountability for the IMP. These are just a few examples.

Records and Record Keeping – Ensuring the integrity of data is a must. The ICH E6(R2) includes details about the types of records that are necessary and how to manage those records. Examples are the Case Report Forms, product accountability and the entire Section 8 which outlines the essential document needs for the three phases of the trial.

Reporting – There are a number of reporting requirements that are in place for a clinical trial to be in sync with the requirements of regulatory authorities. Reporting of adverse events, progress reports, final reports, reports of monitoring the trial sites and audit reports come to mind. The Standard references all these types of reporting expectations and others.

This is just a brief listing of the manner in which the Standard, through well‐reasoned and thoughtful development, manages to encompass the full range of functional activities associated with clinical trial conduct.