When Should The Contractual Agreement Between The Sponsor And The Investigator Be Signed

It is often necessary for the sponsorship company to provide the examiner or its employees with proprietary information and it is important for the business interests of the company that the confidentiality of this information be protected. It is recommended that a confidentiality agreement be in place prior to the implementation of a CTA. Written confidential information should be labelled as such and oral communications should be reduced to the letter and « confidential » stamp. Access to confidential information (including protocol) must be subject to rigorous monitoring and each reviewer should have a control plan in place. All agreements must have a time frame before the information can be treated confidentially by the Foundation. Our default language is only that information obtained by the sponsor can be treated confidentially for a period of three (3) years after the termination of a contract. 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. Although the promoter may directly conclude certain activities of the institution/hospital, such as .B centralized analysis, archiving or centralized reading of images, the promoter cannot delegate any tasks related to the medical management of subjects that are specific to the examiner (for example. B dose administration and PMI administration, AE/CAS assessment), as the auditor is responsible for all medical activities of the study. For this type of task, although the sponsor may be involved in the organization selection process, services and/or staff (for example,.B the institution and the clinical audit site should not be involved in resources for the selection of third parties), contractual agreements should not be concluded directly between the organization and the sponsor. The sponsor should implement a system to manage quality at all stages of the testing process.