Data management is the process of collection, cleaning, and management of subjects data in compliance with regulatory standards. The primary objective of the data management processes is to provide high-quality data by keeping the number of errors and missing data …
The data management plan describes the processes and the specific procedures to be applied to ensure consistent and effective data management for the study trial.
The Data Safety Monitoring Board (DSMB) is an independent committee that reviews clinical trial progress and safety, and advises whether to continue, modify, or terminate a trial. If required by the protocol, the members of DSMB must be decided before …
At the end of the trial, the database of the study must be locked, so that it is no longer possible to edit data. There are two Type of Data base lock that can be performed according the needed revison …
The electronic Case Report Form (eCRF) is a software, web app or electronic folder that allow to collect data of the clinical trial according to the protocol requirements after that an Informed consent is signed by the Patient. The electronic …
Independent reviewing body that considers and approves/disapproves biomedical research involving human subjects. Ethics Committee approval is required for each clinical study protocol and Principal Investigator prior to study initiation.
The Ethic Commettee (EC) of each site must be notified of the first patient enrolled in its own site. This is usually done by the site but the Sponsor is responsible for checking that this communication has been made or …
The stipulation of an insurance policy must take place before the study can officially start. The Insurance policy is typically requested for an Interventional study to cover the intervention that is not recognised as standard practice. The process for a …
Before the study starts and during the study, one or multiple Investigators Meetings (IMs) may be scheduled to update all the study team on the study progress, results, updates, or address major issues. A presentation on the topics of the …
The monitoring plan is the document that details the monitoring policies and procedures, and the proposed frequency of on-site monitoring visits across the trial sites, for a particular trial. Is drawn up by the sponsor or its delegates