The Informed Consent Form is one of the first documents that must be accurately completed by patients. Any errors during the ICF completion are usually reportable to the IRB and are also deviations. Sites must make every effort to ensure that appropriate SOP’s are being followed and compliant with GCP guidelines.
Having experience in clinical research is often a requirement for most jobs in clinical research. In order to meet this criteria many job seekers are advised to become involved at local research sites and help with things such as recruitment, which is often an area in which most sites focus on. Physicians can also enter the clinical research field by becoming a Sub-I at a local site in order to gain research experience and eventually become a PI.
Opening a site can be extremely challenging for anyone who is entering the research industry with a limited amount of knowledge. Fortunately there are services such as those offered by the CRA and Site Owner Academy, which are highly effective at teaching major clinical research concepts. A further challenging goal is to take the ideas presented in the academy and adapt them in such a way that allows your new site to be distinct from other sites in the industry.
Most people don’t realize that there are many paths to follow within the clinical research industry besides CRA or CRC. In fact, the guest in this video was able to become a business development director. This guest was able to do reach his position by first focusing on recruitment and serves as an example for anyone without clinical skills who is adamant about entering research.
Some academic institutions have made an effort to use central IRB’s and have also worked on projects with private institutions. Private research has less limitations but lacks some of the prestige that academic institutions typically possesses. During the course of this video, several efforts that the private research sector has developed in order to increase the positive relationships between patients and research sites are discussed.
Generally speaking, adverse events are medical occurrences that happen after a patient signs an ICF. An AE may range from falling or developing an illness but must be recorded by the site. If the event is an SAE then the patient has most likely experienced a hospitalization or death. After all data is collected, the PI must make a determination regarding the cause and severity of an AE and SAE.
Clinical research has yet to uncover many of the mysteries revolving the digestive system and health. Two experts discuss some of the limitations that surround the treatment of different digestive conditions. One of the major points that is brought up is the lack of data surrounding diet during clinical trials which in turn may greatly affect study results.
Sponsors will spend a large amount of their trial budgets on recruiting and keeping sites during each clinical trial. For this reason sponsors are often exploring new ways to conduct their trials without having to find many new sites. Sites are encouraged to maintain a good relationship with sponsors by meeting their needs which are typically related to making clinical data available as quickly as possible.
Having a PhD allows holders to easily gain employment in biotech companies, research sites, research vendors, or regulatory agencies. Meanwhile physicians who are hospitalists may also have no trouble finding a site to work for but may not be able to offer the site potential patients for screening. Sites who do work with hospitalists will have to continue to find patients from their own databases or other recruitment efforts.
Clinical research offers a variety of employment opportunities as evident by the guest in this video. Although this guest currently works for Bioclinica, he has worked in many other agencies including an IRB. By making use of his various employment experiences, he is able to see the needs of both sites and sponsors in order to provide solutions for both.
An experienced PI talks about her experience as both a doctor and as an entrepreneur in clinical research. During her conversation, she is able to explain how most physicians think during their early years of medical practice and how that has changed as insurance companies requirements are taken into consideration. It is her opinion that not all doctors should enter research, but those who do should make every effort to maintain oversight in order to maintain a high quality site.
Getting into the research industry can be as simple as interning at a clinical research site. The major consideration for taking this approach is that the site that is providing the interning experience will have to invest time and effort to train you, which might not sound appealing to most sites. Therefore, it is important for anyone who is trying to get an internship to show what kind of value they can provide to the organization that will provide the experience.
The recent Drug Information Association (DIA) meeting revealed many of the possible changes to the clinical research industry. After reflecting on the conference, technology and site consolidation appear to be major elements that are having a profound impact on the research field. Perhaps one of the best things that sites can do to face the changing environment is to network and find ways to improve the quality of their own site.
This video features a guest who is an example of how a positive attitude can go a long way. Fore example, having positive relationships with monitors can lead to long term professional relationships such as mentoring opportunities. A positive attitude also helped this CRA during an economic recession in which she had no choice but to go into sales however, she was able to see an opportunity to learn about the art of marketing and selling.
After attending the 2019 DIA Conference several major ideas appear to be common among research professionals. Consolidation of many services seems to be one of the major developments which has been enabled by various technological advancements which in turn make use of information that sponsors collect. Most research professionals who attended the DIA meeting were able learn about such trends and network with sites, CRA’s, CRO’s, vendors, and even sponsors.
The 2019 Drug Information Association (DIA) conference was as informative as ever. This video discusses the importance of attending conferences like these in order to network. Another topic covered in this video is the creation of a CRC academy which will prepare research coordinators for new sites and can update coordinators stay up to date on changes in the research industry.
Clinical adjudication or end point adjudication has emerged as a data quality verification for clinical trials. While Clinical adjudication does not guarantee and is not required by the FDA, sponsors that go through the process of adjudication can be confident that the FDA may look favorably upon their clinical trial. Clinical adjudication can also help validate data and confirm whether or not specific drug related evens are or are not related to the study drug under investigation.
Every site must have an adequate supply of lab kits for each upcoming patient visits. This task is more difficult than it might appear which means that sites tend to either have too many or too little lab supplies when they need them. As a representative from a supply management solution company suggests, almost 40% of shipments sent to sites expire before they can be used.
This video's guest suggest that a proper mentor can help relieve some of the stress that many CRA's experience. It is also important for CRA's to be able to communicate about their workload with the company they work for. By combining these two strategies, many CRA's can avoid burnout which is a serious problem.
Many industry thought leaders predict that the clinical research industry will inevitably gravitate towards preferred sites. Meanwhile, smaller sites are advised to enter the industry as soon as possible and focus on improving their performance. This has led many PI’s such as the one featured in this video to manage the business side of their research site.