Monitoring constitutes a key element of quality assurance, helping to ensure transparency and reliability of data obtained in clinical trials. In accordance with Good Clinical Practice principles described by ICH-GCP, constant monitoring is recommended before, during and after clinical performance evaluation.
A clinical trial should be conducted based on the previously drafted trial protocol, and any data obtained must be thoroughly documented. Moreover, trial data must be analysed and reported according to the trial design. What is particularly important is for the ethical aspects of the trial to be in line with the applicable legal provisions. Trial monitoring covers the scope of planned, systematic activities that are to ensure transparency in conducting clinical trials, data reliability and protection of the subjects’ rights.
The Pure Clinical team is composed of experts in various fields. We provide monitoring support for a wide range of diagnostic trials. We have the skills and structures necessary to cooperate with trial sites in a seamless and effective manner.
What is monitoring?
Performance evaluation monitoring is a set of systematic activities that are to provide trial progress oversight and ensure that it is conducted, recorded and reported in accordance with the plan and procedures established.
What is point of enrolment?
Point of enrolment is the moment when, after being recruited, the subject signs and dates an informed consent form or otherwise starts their participation in the trial.
What is informed consent?
Informed consent is a process by which a subject voluntarily confirms their willingness to participate in a particular performance evaluation, after having been duly informed of all aspects of the trial that are relevant to the decision to participate.
What is the Declaration of Helsinki?
The Declaration of Helsinki is a document of the World Medical Association which was first drafted in 1964. It defines principles for medical research involving human subjects.
What is GCP?
GCP stands for Good Clinical Practice. It is an international set of rules determining the principles for designing, performing and recording results of clinical research on human subjects. Good Clinical Practice was compiled by the International Conference on Harmonization of Good Clinical Practice (ICH-GCP).