Many notable events have taken place in history to get clinical research to where it is today. As such, clinical trials by organizations like Veristat are conducted to ensure they provide public assurance; uphold the safety, rights, and wellbeing of participants as well as generate reliable data. Not considering whether a clinical trial is a small pharmacological study or a large, multi-center study, the relevant Good Clinical Practice (GCP) standard must be followed by all the stakeholders. The stakeholders here include sponsoring companies, the ethics committee, the investigators, and the clinical research organizations. To ensure you uphold the set standards, you should ensure the following factors are taken into account.
Obtain informed consent from patients
You must maintain subject confidentiality and obtain their informed consent in any study. As such, responsible investigators need to choose participants depending on the eligibility requirements of a study protocol. That’s why you must consider the safety of the patients during the virtual clinical trials.
Work with qualified personnel
Another important factor to remember is ensuring that you employ qualified teams with sufficient experience in clinical research. Doing so ensures clinical trials are carried out following the Good Clinical Practice guidelines. Also, all stakeholders should be educated on the significance of conformity with the GCP guiding principle in clinical trials. And note that compliance with GCP is crucial for expansion in scientific knowledge, guarantee public welfare, confidentiality, and safety.
Ensure data accuracy
The research investigator should account for the investigational product data, and maintain accurate records. Plus investigators should also update Institutional Review Board, and get informed consent from the participants. Additionally, the teams reviewing your clinical research need to approve the research protocols and consent forms before initiating the study. Even then, ensure that the investigators diligently follow GCP to safely and effectively conduct trials in a well-designed manner. This will help generate accurate data for advancing medical knowledge. Note that the responsibility of investigators in guaranteeing good quality clinical research is only possible if you have a Good Clinical Practice.
Establish an oversight role
An oversight function in trials includes choosing qualified study investigators, reporting safety information, and generating accurate data at all times. Overseeing the entire progress of your clinical trial requires that you ensure the procedures for conducting, recording as well as reporting conform to the protocol, SOP (standard operating procedures), GCP, and any other applicable regulatory requirements.
Have Auditing systems in place
It’s important that you implement auditing functions at the end of the trial. That’s because this allows for systemic and independent assessment of trial-related documents and activities. This also ensures that your clinical trials are carried out with sound scientific proof, observance of ethical principles, and well-detailed protocols. As such, carrying out clinical trials involves factoring in the benefits of appreciating the risks involved. At the same, it helps guarantee the safety, well-being, and rights of trial participants.
Conforming to the set GCP guidelines when conducting clinical trials is important as they help protect trial participants. With a well-designed strategy, you’ll be able to generate accurate data. Plus GCP foundation ensures that you can share meaningful data with participants in the future.