Subjects involved in the study are newborn babies from birth to less than 28 days of age.
Subjects to be involved are not more than 37 weeks from their conception.
The main result that is measured at the end of a study to see if a given treatment worked (e.g., the number of deaths or the difference in survival between the treatment group and the control group). What the primary …
Reasons for the inclusion of subjects in the clinical trial, as described in the protocol.
Clinical Trial Agreement (CTA) is the appropriate term used to describe a document used to agree the contractual terms associated with the specific trial-related tasks and responsibilities. The CTA will be drafted based on the appropriate template for each site/ …
Every trial must be recorded in a publically accessible database before the study starts, or within 30 days from its start. Clinicaltrial.gov is the most common site. A registered user can submit the study on the database, following the instruction …
The Sponsor must notify the appropriate bodies (Ethic Committees and Competent Authority CA) of the end of the study. A Close-Out Visit (COV) is the last monitoring visit performed to each involved center, that determines the closure of the trial …
A Contract Reseach Organization (CRO) is an entity delegated by the sponsor to perform some or all of the activities of a clinical trial on its behalf. The sponsor may decide to delegate part of the work to the CRO …
Selection of laboratories consists in the selection of an independent laboratory for external analysis of Biological samples, imaging, or to analyse the data collected during the study. The sponsor is responsible to scout and select the laboratory.
Data entry is the process of recording patients data or data in a database or sheet of paper. In clinical Studies it could be performed on the Electronic Data Capture (EDC) systems or in the Paper/electronic Case Report Form (CRF/eCRF). …