Serious CRA’s know that items such as licenses and trainings will expire at different points throughout the study. For this reason it is always important to review the regulatory sections of the ISF. Checking this section is important even if things like the 1572 and delegation of duties have not changed since the last monitoring visit.
This video is from a CRA student’s internship during which AE reporting is discussed. CRA’s are expected to make sure that sites report on AEs. Failing to document an AE as simple as a headache can have serious consequences if the AE turns into an SAE.
Source data verification focuses on making sure that source documents match the EDC. Meanwhile, source data review goes a step further and ensures that the data that is being presented is compliant with the protocol. Both forms of data review may seem different but play important roles in providing sponsors with clean data.
Finding patients of a specific indication for your study is not easy. Finding physicians of a specific indication is simpler since their information is public. Sites should consider focusing on finding physicians and including them in their studies that they already have patients for.
The goal in the research industry is always to get more patients enrolled. To this end, many sites focus their marketing strategies on recruiting patients. While marketing to patients can get patients into your clinic, marketing to physicians who already have patients in their database might be an even more efficient strategy.
One of the major points that is made in this video is that sponsors are beginning to keep track of their site’s progress during startup. This may be due to the fact that there is a large supply of studies in the market which means that sites won’t mind if they lose a study that they don’t want. In response to this some sponsors are making efforts to get acquainted with sites and offer help whenever needed.
This video provides a broad overview of the various visits that monitors will typically conduct. Sites should pay attention to what they should do to be prepared for each visit especially those that decide if a site will be awarded a study. Meanwhile, CRA’s should take notes on what goals should be met at the end of each visit.
Becoming a CRA doesn’t just demand that applicants have a great knowledge of clinical research, it requires that applicants be determined to do whatever it takes to make themselves known. Posting your CV on a job board is a great way to make yourself known. Once you post your CV, you must make sure to update it whenever possible so that potential employers can get a better understanding of your experience.
Sites can post ads on craigslist about their studies without including specific details. Although there may be a nominal cost to posting, doing so can help your site reach a new audience. Some sites have succeeded in recruit physicians by posting on Craigslist.
Recruitment positions are usually entry level which may appear to be simple and of low priority. However recruitment is one of the most important aspect of running a site. This is because recruitment staff must be well informed whenever they communicate with potential patients.
Patient recruitment is something that all sites should be concerned about. Unfortunately there are sites that are willing to cut corners by ignoring privacy and inclusion criteria to obtain patients. While cutting corners may appear tempting, it can quickly turn sites into sites with unhappy recruiters who are more than willing to become whistleblowers.
The Guru goes over some of the most overlooked ways to enter the research industry. Many people who are interested in entering do so with a CRA position in mind. However, coordinator or even recruiter positions may actually be more strategic entries into the industry.
Running several sites is a challenging endeavor for even the most experienced site owners. Because of this, focusing on a single site and building a strong network of PI’s can be more advantageous. Sites that have doctors with different specialties have the potential to be attract more studies thereby increasing their income potential.
A common finding throughout various sites is that screen failures don’t get enough attention. Some sites tend to document less and have missing source documents. One reason for this is that sites don’t always get paid for screen failures, but even this reason is invalid during an FDA audit.
CRA’s are well aware of the many things that sponsors expect from each site. This gives them an advantage during chart reviews but it doesn’t prepare them for all of the challenges of starting a site. A few suggestions are given throughout this video in order to help new CRA’s understand the different goals to meet during different stages of starting a site.
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