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GCP Awareness and quality of clinical trials --experience as a CRC

2016-08-31

April 13 this year, I entered Simo for my internship and started my career as a CRC.

I have been engaged in clinical trial related work for 1 year before, and I thought I was an experienced CRC. But I became aware that CRC work was must more professional than I imagined to be, and required a lot of theoretical knowledge and experiences as well as GCP ideas and awareness, which I have never realized before that, so I ended up entering the field as a freshman.

Since the work, I learned a lot of things, and what impressed me the most was the GCP awareness and guarantee of clinical trial quality. I believed that was a basis for clinical trial project, and also a basis for CRC work.

During the first month, in addition to learning specific clinical knowledge from the instruction teacher, we needed to learn theoretical knowledge in various learning platforms of the Company: OA office system, GiKoo learning system, and etc. Such new CRCs as us must be subject to strict clinical instruction and assessment of theoretical knowledge before officially taking the post. At this time, I gradually realized that the learning and work of CRC was systematic, which requires special attention, seriousness and rigorousness. Taking CRC work as a building, and GCP is the basis for this building. However, learning theoretical knowledge is very boring, and the understanding of GCP and the culture of GCP awareness shall continuously be strengthened during the work, which requires an accumulation and experience for a long term and can never be equipped and improved within a short time. GCP awareness shall run throughout my whole career as a CRC. In future work, I shall not only strictly demand on myself with GCP spirit, but also assist researches and research nurses with GCP spirit. I think the quality of clinical trials involves a lot, including not only researchers, research nurses as well as CRC and CRA, but also medical institutions, ethics and various departments cooperating in the examinations, and even the subject himself. Firstly, the researchers, nurses and CRCs participating in clinical trials shall be essentially equipped with GCP awareness before being engaged in clinical trials. We CRCs also play a role in supervision and quality assurance. Coordination is the core word for CRC (Clinical Research Coordinator). As the link of various departments, CRC closely connects various researchers, staff and relevant departments to jointly complete clinical trials throughout the whole course. Taking carrying out clinical drug trials as a program under continuous operation, then the routine work of CRC can be "multi-line operations". CRC enables the tedious detailed work in clinical trials to be completed in parallel. During the communication with the patients, CRC can be more patient than the doctors; have sufficient time to describe the trials when soliciting informed consent and help the patients to weight the advantages and disadvantages from the perspective of the patients; be able to timely identify adverse events and abnormalities in clinical examination value during the trials and timely consult the researchers to find solutions; enable the patients to gain more support and reduce the adverse feeling of subjects as "laboratory rats" when jointly facing adverse events with the patients; coordinate with laboratory department, ECG room and research department to reduce the waiting time of subjects before the subjects seek medical treatment and enable the subjects to feel humane care through green channel; convey the meanings of various parties to coordinate an appropriate solutions when there is a problem in the communication with relevant ancillary department; remind participating trial personnel to complete relevant operation on time during the follow-up of subjects; and remind relevant researcher to timely record and write research medical records after the follow-up of subjects have been completed.

Above is just part of the work content of CRC to assure the quality of clinical trials. It is our common goal to facilitate the researchers to be dedicated to clinical trials and coordinate the researchers to complete clinical trials with high quality and high efficiency. Therefore, it is particularly important to establish GCP awareness during all the aspects of the work. Firstly, we need to truly understand the purpose of clinical trials: to save more patients. Therefore, the safety of the patients and truthfulness of the data is the most important; Secondly, we shall dare to point out and identify the mistakes and have zero tolerance for fraud. For the mistakes of both researchers or research nurses and relevant laboratory departments, we shall timely correct them to ensure the truthfulness and correctness of the data; Thirdly, we shall have a rigorous and earnest attitude. Sometimes we are not unwilling to point out the problems, but we fail to identify them, therefore, earnestness is what each CRC shall be equipped; Fourthly, we need to timely handle the work so as to avoid serious subsequence. Checking a few more times will not cause any burden, but can avoid much trouble.

Now I have just become a full member. I learned a lot and gained a lot during the three-month internship, including not only just experiences and knowledge, but also  friends, friendship and identification of self value. I believe there will be more gains and experiences in my future study and work.

Tigermed: Hangzhou Tigermed Consulting Co., Ltd. (Stock Code: 300347), is a pharmaceutical R & D contract research organization (CRO) focusing on providing professional whole clinical trials. Committed to reduce R&D risks, save R&D costs, and promote products to the market, Tigermed is headquartered in Hangzhou with 33 subsidiaries. It has service outlets in 53 major cities in mainland China and in Hong Kong, Taiwan, Canada, the United States, South Korea, Japan, Australia, Malaysia, Singapore ,India and other places, Its international professional team of more than 2,000 persons, has successfully provided more than 500 clinical trial projects to more than 600 customers worldwide. Tigermed is also known as the "Innovative CRO" due to involving in clinical trials of more than 58 innovative drugs in China. Contact: www.tigermed.net Email: bd@tigermed.net 

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