Country where the organisation or individual, who is providing the finance or resources for the clinical trial, has the registered office .
The date upon which the clinical trial commenced. Coincides with the date of the opening of the first clinical centre participating in the study.
Data cleaning consists primarily in implementing error prevention strategies before they occur (see data quality control procedures later in the document). However, error-prevention strategies can reduce but not eliminate common errors and many data errors will be detected incidentally during …
The design quality plan is the guide document which identifies the procedures, comprising the design phase, and describes the systems for control the design output. It describes the methods for monitoring and verification, and provides samples of the documentation to …
If the study is randomized, a randomization list must be prepared. The decision on how to stratify it is a responsibility of the statistician experts. The randomization list provides the possibility to randomly associate the treatment of an RCT according …
Preliminary, interim or final reports are reports written before the end of the study , with the data available up to that point or at the end of the study once the data are cleaned, verified, monitored and approved. Are …
The risk management analysis consists in the creation of a system for managing risks during the study, to identify, mitigate, verify, and trace products and study risks.
The sample size is the number of evaluable subjects required for achieving desired statistical significance for a given hypothesis. The number report the number of how many patients are needed in the study.
The Site Initiation Visit (SIV) is a meeting arranged and conducted by Sponsor team or its delegate to train the study personnel on the study procedures and Good Clinical Practice and regulatory requirements. The SIV is the last step before …