The monitoring process is designed to ensure that the clinical trial is conducted in compliance with the human health and rights, study protocol, principles of Good Clinical Practice (GCP), and with the applicable regulatory requirement(s) . Compliance with GCP provides public …
It is the step in which it is decided which sites will participate in the trial. Sites are invited based on previous experience, expertise on the pathology/investigational product and volume of potential patients. Site feasibility for conducting the trial is …
Data generated from and collected during the study are statistically analysed as detailed in the statistical analysis plan and then presented as tables, figures and listings.
The Statistical Analysis Plan (SAP) describes the planned analysis of clinical trials. The SAP is intended to be a comprehensive document that contains a detailed and technical description of the principal features of the analysis outlined in the protocol. It …
At the end of a clinical trial, a Study Report must be produced, regardless of the success of the trial. The report should provide a clear explanation on the study design and all the relevant information about its conduction so …
Before the study starts everyone involved in the conduct of clinical research must have updated and adequate CVs and training to ensure they are well experienced in clinical trials and are aware of their responsibilities. It is required evidence of …
A Trial Master File (TMF) is the collection of essential documents that is used by Sponsor, CROs, and Investigators/Institutions for the management of the trial and by data monitors, auditors and inspectors to review and verify whether the Sponsor and …
Healthy subjects who voluntarily decide to take part in a clinical study.
Subjects to be included in the study are unborn infants, still in the womb.
A shortened title or description of the clinical trial established by the sponsor at the time of drafting the study protocol.