This video documents a full day of live questions submitted by different viewers. Viewers were able to talk to The Clinical Trials Guru and ask questions about how to run a research site and what to do during specific situations. Details regarding an upcoming conference were also revealed to dedicated listeners.
This video includes a lesson from the CRA Academy about the responsibilities of monitoring a site. One of the topics mentioned is what to do when you as a CRA sees AE’s that you think are serious but the site does not. Other important topics include CAPA plans, what to look for in an ISF and what documents to review in every monitoring visit.
Source documents are documents that the site can capture data during patient visits. Most sites will have templates designed to capture as much information as possible. Once these documents are completed, monitors can then review them for accuracy during monitoring visits.
A conversation between the Clinical Trials Guru and other research professionals describes some of the changing trends in the industry. One of these trends is the falling salary for newer CRA’s. Because of this trend, becoming a site owner may be a better option since there is no wage gap for site owners.
This video provides tips for talking to physicians who are not involved in research. Many physicians will not be interested in getting involved in clinical research and may cite various reasons for not wanting to get involved. New sites may encounter hesitant physicians and should be aware of some counter arguments that may help to change the physician’s perspective
Interim monitoring visits are the main topic during this CRA Academy session. CRA students can expect to learn what is required from each site. Some of the majors topics include basic contents of the site’s ISF and SOP’s.
This video provides some guidance for assessing patient compliance with study drug. It is important to know how much medication each patient was supposed to take prior to their next scheduled visit. Patients should also be reminded that taking too much or too little can affect the patient’s safety.
This video provides an overview of the different types of monitoring visits. SSV’s, SIV’s, IMV’s and COV’s are some the major types of visits that are explained. The monitor responsibilities during each visit vary but include training a site, touring a site, and ensuring that essential documents are present in the site’s ISF.
Five of the many misconceptions about research are described in this video. Some of the misconceptions are related to keeping a PI engaged in the startup phase of a research site. Another major idea in this video is that new site owners should be aware of the fact each study is different even when it is for the same indication as another.
This video reviews some of the CRA responsibilities as they are discussed during a CRA academy class. Some of the topics include deviations, sponsor expectations, and patient safety. The students also touch upon the relationship between accountability and safety as they review patient charts.
This video provides a plan for one of most important aspects of starting a new site -keeping the first PI interested in research. New PI’s tend to lose interest in clinical research because they often have minimal involvement and will only be required to complete mionr tasks such as signing CDA’s and other study related documents. It will be a while before they see their first patient and even longer before the first paycheck is issued from their first patient visits.
CRA’s and coordinators don’t typically think about starting a new site. This is especially regrettable for coordinators who are highly knowledgeable about the industry and have a greater chance of running an effective site. CRA’s on the other hand, can produce high quality sites through their knowledge of sponsor expectations.
All CRA’s know that whenever a new amendment for a protocol is approved, each site must re re-consent their subjects. Failure to do so will result in a deviation. As mentioned in this video, CRA’s should ask the site to prepare a CAPA (Corrective Action Preventive Action) for major deviations such as failure to consent a study participant.
Several CRA students talk about their goals after being exposed to a research site. Many of the students in the video plan to either start their own site or pursue other career goals which don’t involve becoming a CRA. The group of students featured in this video also intend to stay in touch, thereby increasing the size of their network.
Savvy sites have developed methods for QA which sponsors greatly appreciate. One simple method is to have a research naive staff member who can perform data entry. After a while the staff member will know what needs to be recorded in a study visit and should be QA the coordinator.
Very few physicians learn how a medication goes from a lab to the pharmacy. These are the same physicians who don’t know how starting a research site can give physicians more control over their schedules and their income. PI’s actually have the can decline studies that they don’t want to participate in and can focus on patient populations that they prefer.
One CRA alumna had to go through 25 interviews and waited eight months before her first CRA position. During her journey she discovered that interviewers can be intimidating because they will often ask series of questions without providing feedback. This former CRA student was not lucky to land a new job, instead she had enough dedication to keep searching.
The Clinical Trials Guru will be releasing a book that will have site owners in mind. People from various other levels of experience will also find value in the book as it is intended to provide a roadmap from study startup to closing. The aim of the book is to make common industry practices more comprehensive.
New site owners who are looking for their first PI must make sure to communicate realistic expectations about clinical research. Potential PI’s should be aware that they may not see any additional income for a long time. Things such as site selections, patient recruitment, data entry and monitoring visits can affect payments.
Quality assurance will always look good on a CRA job application. Coordinators who wish to become CRA’s can easily include QA experience by simply reviewing another coordinator’s work.Site owners should be aware of this and should have system to ensure QA for their sponsors.