The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, this Regulations, and the applicable regulatory requirement(s).

The sponsor is responsible for securing agreement from all involved parties to ensure direct access to all trial related sites, source data/ documents, and reports for the purpose of monitoring and auditing by the sponsor, and inspection by the Competent Authority.

Agreements, made by the sponsor with the investigator, the institution and any other parties involved with the clinical trial, should be in writing, as part of the protocol or in a separate agreement.

The sponsor should utilize appropriately qualified individual to design the protocol, produce case report forms (CRFs), plan the analysis, and prepare interim and final clinical trial reports.