Inappropriate & Insufficient training at Entry level hammers your growth in Clinical Research
Clinical Research means that research you are doing is very important and responsible. Let me clarify here that in Clinical Research you work on only human subjects, those may be healthy volunteers or patients. As you are not dealing with any kind of animal experimentation,so human life becomes all the more important while doing the research. You should be careful about drugs safety profile and efficacy profile.
The training of Clinical Research Coordinator and Clinical Research Monitor plays very critical role while measuring the clinical outcomes. They should be very well trained on study protocol and should have clear understanding of Adverse events, Serious Adverse Events or adverse drug reaction. It is the clinical research coordinator who will come to know first about adverse reaction and Clinical Research Monitor will know whether PI/CRC has reported the adverse event to authorities or not. So CRC and CRA must be clearly aware of possible side effects of the drug.
CRF is also an important document and CRC completes the form at the site. CRC must know, how to fill the CRF and if any mistake has happened in the CRF, then how to rectify such mistakes. CRC must know that he has to use Ball point pen, avoid using white fluids or correction fluids and dates should be in DD/YY/MM format etc. So it is very important to have thorough training of CRF.
Informed consent form is another important document and CRC must be trained on it. CRC must under -stand what is informed consent form, how & when it filled and who should fill it. A copy of ICF-Informed consent form must be handed over to patients for his records.
Log books must be clearly maintained and managed by CRC or designated person. The content written in log books must be readable and it must comply with the protocol. All the log books must be filled with care. Any wrong entry in CRF/log books may give false impressions, so each document must be properly checked and wrong entries must be document by CRC.
Moreover, it is important to have training on GCP guidelines and regulatory guidelines so that CRC, PI, and CRA are aware of important precautions they have to take while taking up clinical trials.
We believe that post graduates or doctorate students must have thorough training of GCP before applying for CRC positions so that they are confidant of the task they are doing.