Ich Gcp Agreement

5.1.4 Agreements made by the proponent with the investigator or institution and all other parties to the clinical trial should be concluded in writing as part of the protocol or in a separate agreement. The proponent should decide which risks are reduced and/or what risks should be accepted. The approach to reducing risk to an acceptable level should be proportionate to the magnitude of the risk. Risk mitigation measures can be included in the design and implementation of the protocol, monitoring plans, inter-party agreements on the definition of roles and responsibilities, systematic safeguards to ensure compliance with standard operating procedures, and training in processes and procedures. 5.15.1 The proponent should ensure that the protocol or other written agreement stipulates that the auditor or institutions provide direct access to source data/documents for test monitoring, audits, IRB/CIS verification and administrative inspection. The financial aspects of the procedure should be recorded in an agreement between the promoter and the auditor or institution. The proponent and examiner should sign the protocol or an alternative document to validate the agreement. 5.6.2 Before entering into an agreement with an auditor or institution to implement a procedure, the proponent should provide the auditor with the auditor`s minutes and an updated brochure and provide the auditor with sufficient time to review the protocol and the information provided. 5.1.2 The sponsor is responsible for guaranteeing to all parties concerned the direct access agreement (see item 1.21) to all websites, sources/documents and reports relating to monitoring and review by the promoter, as well as inspection by domestic and foreign regulators.

5.6.3 The promoter should obtain the approval of the auditor/institute: 5.10 Notification/submission to the regulator 5.17.1 The promoter should expedite the report to all relevant reviewers/institutions, the IRB/CIS (s) and the regulator of all serious and unexpected adverse effects (ADR). SOPs must cover the installation, installation and use of the system. SOPs must describe system validation and functional testing, data collection and processing, system maintenance, system security measures, change control, data backup, restoration, emergency planning and decommissioning.