In particular, “for reasons,” audits carried out by the promoter in connection with a claim or quality defect (for example, quality. B, packaging, labelling, etc.) can be of great importance when patient safety or well-being may be compromised or even threatened by the problem/defect. As far as contracts are concerned, regardless of the contractual constellation planned or in progress (contract: sponsor – CRO; CRO – subcontractors; From a GCP and GMP perspective, it is concluded that contracts between the parties must allow the clinical trial sponsor, CROs (s) and subcontractors (ICH GCP (R2), 5.2.1 and 5.2.2 Addendum and GMP Vol 4, Chapter 7). Essential documents are also used for a number of other important objectives. The timely presentation of essential documents to control centres/institutions and sponsor sites can greatly contribute to the proper management of a process by the auditor, promoter and monitor. These documents are generally verified by the promoter`s independent audit function and verified by the regulator as part of the procedure to confirm the validity of the test behavior and the integrity of the data collected. The proponent is ultimately responsible for validating clinical experimental procedures, assisted by electronic systems, and providing sufficiently documented evidence to GCP inspectors on the validation process and qualification of electronic systems. The sponsor may rely on the qualification documents provided by the seller if the credit-sponsor`s qualification activities have been deemed appropriate. However, the proponent may also be required to conduct additional qualification/validation activities on the basis of a documented risk assessment. With respect to good clinical practice (PCG) trials of business and academic studies, inspectors found increasing discrepancies with GCP standards, given the non-standard contractual agreements and related procedures.
The objective of this series of questions and answers is therefore to highlight aspects of the increase in the frequency of GCP inspections, which should therefore be avoided by improving contracts between sponsors and IT system providers. The sponsor/THE COURONNE should, in certain circumstances, determine the scope of each party`s oversight under the GCP. This should be justified in the organization of clinical implementation and the nature of the product and protocol under review and ensure compliance with PCGs. A number of tasks include access, verification, collection and/or analysis of data, much of which contains personal data, and in some cases contact with potential subjects or topics. Data protection legislation must be respected in addition to legislation and guidelines for clinical trials. Directive 95/46/CE4 sets out requirements for the protection of individuals for the processing of personal data and the free movement of personal data. The specific requirements of local legislation, which clearly define provisions relating to the protection of personal data, ethical verification and informed consent, should be met. In the future, it would be useful for E-MF to be available via secure Internet links. This would help to avoid unnecessary travel when accessing the TMF. This approach has advantages over the provision of e-TMFs via email, DVD, etc., as only one version of the e-TMF must be available, which can be constantly updated for current trial versions.