Clinical Trial Monitoring is mainly performed to ensure that the rights, safety and well being of the clinical trial subjects are protected and that the data that comes out of a clinical trial is credible and accurate.
Clinical trial monitoring is conducted by a sponsor representative, usually a clinical research associate (CRA) by actually visiting a clinical trial site in person at frequent intervals where the sponsors study is being conducted.
The responsibility of the monitor is to ensure that the trial is being conducted in accordance with ICH GCP guidelines, Schedule Y, study protocol and any other guidelines/regulations as applicable. The process of monitoring involves verifying the informed consent process by reviewing the associated documents and source notes, along with the conduct of other procedures associated with the study protocol. Clinical trial monitoring also includes reviewing the essential documents available in the investigator site files to ensure that all essential documents as specified in ICH GCP are available and the file is up to date, and conducting source data verification which is to cross check the data filled by the site staff in the case report forms (CRFs) against source documents such as patients hospital file, previous prescriptions, patient diary etc. The data in the case report forms is sent to the sponsor for analysis, thus to conduct source data verification is a very important duty of a clinical research associate.
Quality Assurance (QA) in clinical research is a department which performs compliance check of processes involved in clinical research from the time a clinical trial is assigned to the time the final clinical study report is written. These compliance checks are done through audits which can be investigator site audits or in house company audits to ensure that the studies are carried out as per organizational SOPs, GCP, protocol, and applicable regulatory requirements. Quality Assurance department then reports the observations and findings (if any) which are rectified by the responsible personnel. Though rectifying the identified problem is not the responsibility of the Quality Assurance department itself, however they must follow up with the concerned person to ensure that all identified findings or observations are rectified within agreed upon time lines.
Apart from these activities the Clinical Research Quality Assurance department also handles external inspection or audits by the regulatory authorities and sponsor(s). It prepares reviews and manages the Standard Operating Procedures of the organization and conducts routine trainings as required. This is a department which is responsible for the overall quality of the organization and is independent of other departments and functions within a clinical research organization. The QA team directly reports to the company head. Quality assurance roles are challenging and demand a lot of knowledge about applicable guidelines and regulations. Personnel working in Clinical Quality Assurance need to have good communication and persuasion skills and more then anything else, they need to have an eye for detail to pick up errors that may have been over looked by many.
To know more about online course in Clinical Quality Assurance please click here
A number of Clinical Research Institutes in India offer training in clinical research. Some of them have been operating for a number of years, some of them quite recent and some are very new. Not only does the age of these institutes vary, but also the mode of training they offer varies from one institute to another. Some institutes are purely only training providers whereas some of them are contract research organizations that have developed industry oriented training programs. These training institutes normally offer full time, part time, correspondence or online courses and every student as per his/her requirements or understanding decides to take up one or the other course. The question however is: Are you making the right choice? Do you thoroughly understand what kind of clinical research course best suits your requirements? How much time are you going to invest? and last but not the least, how much money are you going to invest in getting trained?… Continue reading
Many fresher’s who want to make a career in clinical research are often confused about which clinical research domain they should choose for themselves. They frequently come across terms like medical writing, pharmacovigilance, regulatory affairs, business development, quality assurance, etc but being new to this industry they are not able to make out what lies ahead of them and what is exactly meant by these terms and what job profiles they comprise of. In this post, let us talk about Medical Writing and we hope that this will give you aspiring clinical research professionals some idea about what medical writing is all about!
If you look up in Wikipedia, you will get the following definition of medical writing:
“Medical writing is the activity of producing scientific documentation by a specialized writer. The medical writer typically is not one of the scientists or doctors who performed the research”.
A medical writer does not necessarily have to be a medical person by qualification however some degree of familiarity with medical terms is preferable. A medical writer does not work in isolation, rather works in a team environment. Now, who is team that we are talking about? Doctors, people who conducted the research, statisticians, regulatory professionals and other subject matter experts work hand in hand with medical writers to produce documents that are of highest quality and meet all the applicable regulatory requirements… Continue reading
Following the tremendous success of clinical research courses and the appreciation received from the industry, looking at the demand for trained professionals in the drug development and healthcare industry, James Lind Institute is pleased to announce the launch of new courses to cater to the needs of both these sectors. JLI announces the launch of the following innovative training programs all of which will be delivered via e-learning in the state-of-the-art virtual campus with cutting edge technology:
— Professional Diploma in Medical Journalism
— Advanced Post-Graduate Diploma in Scientific Writing & Medical Journalism
— Advanced Post-Graduate Diploma in Healthcare & Hospital Management
— Certificate in Healthcare Risk Management
— Certificate in Pharmaceutical Event Management
— Advanced Certificate in Medical Law & Bioethics
More information about these and how they can help you advance your careers will be posted on this blog on a regular basis.
Clinical Research Industry at the moment is looking for people who are trained in clinical research before they are hired. This brings value for the hiring company as a trained individual takes lesser time to get on the job and to start being productive. The company does not need to invest time and energy in training the person from scratch which saves them a lot of valuable resources. Obtaining clinical research training from a reputed institute like JLI prior to applying for jobs certainly improves a candidates chances of getting the job as the candidates are able to demonstrate a better understanding of key concepts and thus perform better. Not only that, JLI also equips students with good communication and presentation skills that makes them highly attractive compared to other candidates that the employer may have interviewed. If you are looking to get yourself trained in clinical research and want to make a lifelong lucrative career in the drug development industry, joining an academic course from JLI will certainly take you a long way in your career.
A ‘clinical research coordinator’ (CRC) also sometimes referred to as ‘site research coordinator’ (SRC) or ‘study coordinator (SC)’ or simply ‘research coordinator’ is one of the most important person at a clinical research site and plays a very vital role in the conduct of a clinical trial. A good CRC with good understanding of the clinical trial processes, guidelines and regulations is a huge advantage to any clinical trial site. A CRC is the person who is regularly in touch with clinical trial subjects and conducts most of the study related procedures and documentation as delegated to him/her by the principal investigator… Continue reading
A lot of freshers who want to make a career in clinical research especially those who already know that they want to start their career as a clinical research associate often wonder which clinical research course would suit them best. Many take up full time courses, some take up online learning and a few take up distance learning. Distance learning is a concept of the past as it has many disadvantages and almost no major education provider in developed nations offer distance education any more. For them distance learning is now synonymous with online learning. Full time programs are not for all as they tend to be more time consuming, more expensive and a fresh batch may not be starting anytime soon. If you are looking forward to become a clinical research associate …. Continue reading
James Lind Institute offers a number of online courses in clinical research which are industry oriented and have been developed by experienced professionals from the clinical research industry. Online courses in clinical research offered by James Lind Institute are highly interactive in which every student is in constant touch with his/her mentor, faculty and fellow students. James Lind Institute’s virtual campus takes online learning to the next level by bringing all benefits of full time learning to a student via the internet. Now you need not quit your current job nor do you need to give up your formal education for pursuing a career in clinical research. James Lind Institutes online courses are your solution to advance your career in research!!!
James Lind Institute is pleased to announce the start of its Full Time Batch for Post Graduate Diploma In Clinical Research at Hyderabad in association with Global Hospitals from Mar 01, 2011. James Lind Institute and Global Hospitals have joined hands in order to help students to get an opportunity of working on clinical trials by providing six month internships along with class room training.