5.5.6 The proponent or other owners of the data must retain all essential sponsor documents specific to the trial version (see 8. Essential documents for conducting a clinical study). 5.5.12 The institution (or institutions) should inform the auditor or auditors in writing of the need to keep the recordings and inform the institution (s) in writing when audit records are no longer required. 5.1.1 The sponsor is responsible for the implementation and maintenance of quality assurance and quality control systems with written SOPs to ensure that tests and data are generated, documented (recorded) and reported in accordance with protocol, THE PAG and applicable regulatory requirements. 5.16.2 The proponent should immediately inform all relevant auditors/institutions and the regulator of findings that could affect the safety of the subjects, jeopardize the completion of the study or change the IRB/CIS`s approval/favourable opinion on the continuation of the study. 5.4.1 The promoter should, if necessary, use qualified persons (. B biostatistics, clinical pharmacologists and physicians), where appropriate, at all stages of the experimentation process, from protocol design and FRCs and analysis planning to analysis and development of preliminary and definitive clinical trial reports. Clinical studies conducted under U.S. Food and Drug Administration (FDA) regulations require a contract between the site and the study sponsor or clinical research organization (CRO).
This contract is commonly referred to as the Clinical Trial Agreement (CTA). Contracts are written in legal language that could be at a reading level until the 35th year. (Pfeiffer – Windschiegl, 2016). The insensitivity of the website`s language or agreement can lead to an accidental infringement and serious legal and financial consequences for the website and the investigator. 5.14.3 The proponent should ensure that the written procedures include instructions that the examiner/institution handling and storing test products must follow for the review and documentation of this review. Procedures must be treated with adequate and safe reception, handling, storage, distribution, purchase of products not used by Denten and return to the promoter of unused test products (or an alternative provision, if approved by the promoter and in accordance with applicable regulatory requirements). The purpose of this section is to demonstrate that the research website is in accordance with the law, that participating physicians and institutions are qualified to conduct research, and that the institution informs the proponent of the approval (or refusal) of the Institution Review Board (IRB) /Ethics Committee (EC). The proponent should assess the risks identified on the basis of existing risk controls, taking into account: 5.1.4 Agreements reached by the proponent with the investigator or institution and all other parties to the clinical trial should be concluded in writing, under the protocol or in a separate agreement.