Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 95

In the previous section, we defined the various main players involved in the clinical research conduct. The players are the Sponsor, Investigator, Trial Subject, IRB/IEC, and the Regulatory Authority. Figure 7.1 depicts the lines of communication between and among each of the main players.

Figure 7.1 Players interaction.

We recall that the initiation of a clinical trial comes from the Sponsor, and the Regulatory Authority is a public authority or government agency that is essentially the gate‐keeper between the Sponsor and the public who will eventually use the product.

Before a trial may be initiated, the Sponsor must communicate its intention to the governing regulatory authority or authorities who will provide feedback as to whether or not the trial may be conducted. The Sponsor reports the progress and the final outcome of the trial to the authority(ies) who review, ask questions, or request additional information as needed form the Sponsor. The Sponsor also engages the Investigator and provides them with the investigational product for the trial and all information they need to execute the trial at the trial site.

Prior to the Investigator initiating the clinical trial, the Investigator must obtain an approval from a duly constituted IRB/IEC to conduct the trial. The Investigator will communicate the progress and outcome of the trial to the IRB/IEC as well as the Sponsor. The Investigator, of course, will recruit the Trial Subject, who is asked to volunteer for the trial and to commit to following the trial procedures. The Trial Subject has the right to contact the IRB/IEC at any time if they have questions or concerns regarding the conduct of the clinical trial.

Lastly, the Regulatory Authority oversees all the players who have GCP responsibilities. We note that the Investigator and IRB/IEC do not typically communicate directly with the Regulatory Authority for routine trial conduct, but may certainly do so if the need arises.