The BRCR Global staff is required to have sufficient training and level of preparation and expertise to understand and perform all tasks related to their work in a logical and orderly manner.

The training should cover all aspects related to a study, including the detection and registration of patients, and the finalization, presentation and correction of all data forms.

Each Director has the responsibility, as established in the organizational chart, to communicate the objectives in a clear, timely and effective manner, in order to ensure compliance with the goals assigned to each BRCR Global`s Partners.

All BRCR Global partners must sign confidentiality agreements.

The Department of BRCR GLOBAL QA will be in charge of the administration of its training system, which should cover a variety of training categories to ensure that all members of BRCR Global have the same level of skill and knowledge necessary to carry out their work responsibilities.

The site staff is trained to run online reports on the status of queries, and can view cumulative summaries of data for each of their patients all time.

We provide all the support that our staff requires to develop and enhance the skills required for their daily performance.

• THEORICAL REVIEW
GCP/ ICH GUIDELINES review, PROTOCOL review, internal SOP review

• HANDS-ON SCENARIOS
Enrollment scenarios, regulatory packets completion, source templates creation, IP logs completion, filing, subject visit scenarios.

• WEEKLY TRAINING SESSIONS
Staff meeting including protocol specific training.

• SOP CREATION

New SOP documents, amendments to previous SOPs based on FDA inspections/ Sponsor audits/monitoring visits reports.