Ich Gcp Agreement

5.15.1 The Sponsor should ensure that the minutes or other written agreement specify that the entity`s auditor(s) grant direct access to source data/documents for study monitoring, audits, IRB/IEC inspection and administrative inspections. 5.6.2 Before entering into an agreement with an examiner or institution to carry out an audit, the sponsor should make available to the auditor(s)/institution the minutes and an updated audit brochure and allow sufficient time for the auditor/institution to verify the minutes and information provided. 5.1.2 The Sponsor shall be responsible for obtaining the agreement of all parties concerned in order to ensure direct access (see paragraph 1.21) to all study sites, sources/documents and reports for the purposes of monitoring and auditing the sponsor, as well as inspection by supervisory authorities, both local and foreign. 5.6.3 The sponsor should obtain the agreement of the reviewer/institution: 5.1.4 Agreements concluded by the sponsor with the reviewer/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 sponsor must decide which risks it reduces and/or which risks to accept. The approach to reducing the risk to an acceptable level should be proportionate to the significance of the risk. Risk reduction activities can be integrated into the design and implementation of protocols, monitoring plans, agreements between parties defining roles and responsibilities, systematic security measures to ensure compliance with standard work instructions, and training in processes and procedures. The sponsor and the auditor/institution should sign the minutes or an alternative document to confirm this agreement. The financial aspects of the study should be recorded in an agreement between the sponsor and the auditor/institution.

5.8.2 The sponsor`s policies and procedures should address the costs associated with treating participants in the event of an injury, in accordance with applicable regulatory requirements. If it is found that non-compliance is likely to seriously affect the protection of subjects or the reliability of the results of the study, the sponsor must conduct an analysis of the causes and take appropriate corrective and preventive measures. 5.4.1 The proponent should use qualified individuals (e.g. B biostaters, pharmacologists and physicians) to the planning of analyses, analysis and the preparation of interim and final reports on clinical trials. 5.5 Study management, data processing and record retention The proponent should regularly review risk control measures to determine whether the quality management activities implemented remain effective and relevant in the light of new knowledge and experience. 5.5.11 Essential documents specific to a sponsorship should be kept in an ICH region for at least 2 years after the last marketing authorisation, and until no application for authorisation has been pending or considered in an ICH region or at least two years have elapsed since the formal discontinuation of the investigational clinical development of the investigational medicinal product. However, these documents must be retained for a longer period of time if this is necessary for applicable regulatory requirements or at the request of the proponent.

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