China Resources is not trying to learn the wisdom of others. Training before the start of clinical research and all kinds of training after it are really necessary, but training is more about the interpretation of the research plan by the organizers, CRA or researchers. As a CRC, we must carefully study and understand the research plan, which will be the action guide for our future clinical trials and provide the correct direction for future work. Maybe everyone works in different ways, but they must follow certain principles, namely GCP, which is a research scheme.
Secondly, efficient communication is also a very necessary factor to improve work efficiency.
Communicate with researchers
Researchers are generally first-line and second-line clinicians. Their clinical work is heavy, and sometimes they have to work overtime to complete scientific research, so efficient communication is very necessary. Efficient communication is manifested in reminding researchers to be concise, to the point, to avoid procrastination, regardless of priorities.
Communicate with subjects
There are great differences in illness, living habits, education level, professional background and understanding of the subjects. We must let the subjects know about the research in the most popular language, assist the researchers to make the subjects fully understand the informed consent form and get the support of their families. Full understanding is the first and most critical step in clinical research, because a study usually takes one to two years or even five or even ten years. If the subject hesitates at first, it is likely to fall off later, and obtaining the consent of family members is also very helpful for future compliance and compliance.
In particular, we must respect our subjects. Participants in clinical trials are not greedy for petty gain, but better ensure clinical treatment and make indelible contributions to clinical trials. It is because of their efforts that registered drugs can be listed or delisted; Because of their efforts, they have provided directions for various clinical guidelines and outlines and benefited more patients. Even if we lose the interview, we should respect the opinions of the subjects to the greatest extent.
With CRA &；; Communication of CRC
Nothing is done by one person alone, but by a team. Therefore, it is very important to communicate with CRA in time and answer specific questions in clinical trials. Generally speaking, the research plan may be clearly described, but CRC, researchers will encounter some specific unexpected problems in their specific work, which is inevitable. Therefore, timely communication and settlement is our common goal.
Third, share specific working methods.
Subject follow-up management system
Once the subjects are randomly enrolled in clinical trials, they will be followed up irregularly (depending on the study protocol). How to incorporate the follow-up information with patients into our work mode? I use the excel spreadsheet of office software to calculate the follow-up time of the subjects and reflect it on the work calendar, so as to know which subjects need which follow-up.
Wechat has been paying attention.
Now the network is very developed, even in remote rural areas, you can add WeChat of the subjects or their families to communicate with each other if you have news. My mobile phone is always on. If you have any questions, you can always get answers.
Study the electronization and backup of documents.
In the process of clinical trials, there are a lot of valuable first-hand information. For safety reasons, I scanned the informed consent form and the original medical records, and kept copies of the computer and USB flash drive in case they were lost.
Finally, I want to reiterate my explanation of clinical trials with "Don't forget your active mind, it's always possible". No matter what difficulties I encounter, I must always be true and remember GCP teaching and ethics.