WHAT IS THE REGULATORY STARTUP PROCESS IN A CLINICAL RESEARCH STUDY?
In this blog post, I am going to briefly go over a typical study start up process that goes on at your neighborhood clinical research facility. I’m going to particularly emphasize the 1572 form, the IRB approval process and the informed consent form.
The way this works for most of the research sites out there, is that they use what is known as a central IRB. If you are under the jurisdiction of a local IRB, like many hospitals and academic institutions and certain nonprofit organizations are, then part of this blog post won’t really apply to you. The majority of private industry research clinics out there are able and willing to utilize central IRBs. The central IRB is appointed by the Sponsor of the trial.
In order for a research site to obtain IRB approval for a particular study, the IRB’s have forms for the investigative sites to fill out. They all have different forms, but they’re all essentially the same. They want to know who the PI is, how many studies they have going on, how many support staff do they have, etc. They want to make sure the PI or the study coordinators are not overworked. Basically, they want to ensure that the study staff can handle the study. It is also important to keep in mind that IRB’s are always looking at things from the perspective of patient safety.
At the end of the day, an IRB wants to make sure that the PI has enough oversight over the conduct of the study, and can reasonably look after the safety and well being of his or her study participants. They also ensure that they have delegated the right people to work on their study such as coordinators, sub investigators and also that these coordinators and sub investigators are adequately trained in GCP and other such related courses. IRB’s also ask whether or not any regulatory agencies such as the FDA or another IRB have audited the site in the past. Another thing they look for is how many subjects from all the clinical trials that the PI has responsibility over are actively enrolled at that particular moment in time. A typical IRB approval form for research site is anywhere from 12 to 17 pages or so.
After the IRB approval form is submitted to the IRB, they will also need the 1572 form. This form is arguably the most important form in clinical research at least from a regulatory perspective. On it you have the investigator’s name, the address, the name of the clinic, the name of the IRB, all the Sub Investigators, the protocol title, who the sponsor is, basically everything is on there. Any other facilities where the study might be conducted, like if you are going to be doing MRIs or using a local lab, you’ll include those facility names and addresses. The lab company which processes the labs, even if it’s a central lab from the sponsor or CRO, needs to go on the 1572. So, that’s what the 1572 is and you don’t need to change it once submitted unless a facility changes addresses or you add a facility, or you add a Sub Investigator, or a Sub Investigator leaves; that’s when you update a 1572. Typically doing a routine study, you may go through 3 or 4 different 1572 updates.
The last regulatory start up item for the purpose of this blog post is the Informed Consent Form. I’ve done lots of videos just on this topic alone. The Informed Consent is, not just a form, it is a process that is crucial for informing the study participant patients of the risks, their rights, the benefits, everything that is known about the drug and the potential side effects. The Informed Consent is considered a process, because as the Sponsor learns more about the study, they update the Informed Consent to reflect this..
For the purpose of getting your site started up for a new study the following are important points to keep in mind. If you are working with a central IRB, they will send you an Informed Consent template. If you have a choice, always use a central IRB, don’t use a local IRB. When you submit your initial IRB submission form for your site they usually prepopulate your Informed Consent form, but you’ll have to go in there and make sure everything such as site address, PI name, and research clinic name have been entered correctly. Also, make sure your 24 hour emergency line is active and being answered. We’ve had monitors actually call the 24 hour line at random times of the night, just to make sure that it was a working number and that someone was answering. If a patient has an emergency and for some reason they don’t call 911, or they do call 911 but they still want to talk with someone from the clinic, they have to have a 24 hour emergency number on there from which thy can communicate with the study staff.
