The monitor or monitors should, in accordance with the proponent`s requirements, ensure that the study is properly conducted and documented by carrying out the following activities when necessary for the study and the site of the trial: the sponsor should appoint a qualified medical staff, ready to provide advice on the medical issues or problems related to the study. If necessary, external consultants may be appointed for this purpose. 5.5.2 The proponent may consider establishing an independent data monitoring committee (IDMC) to assess the progress of a clinical trial, including safety data and critical points of effectiveness at regular intervals, and to recommend that the proponent continue, modify or discontinue a study. IDMC should have written operating procedures and keep written records of all of its meetings. Like your auto or medical insurance, websites, CROs and sponsors typically provide clinical study insurance to protect themselves or the parties involved in a clinical trial. The sponsor should document quality management activities. The proponent should pass on quality management activities to those involved in or affected such activities to facilitate risk review and continuous improvement while conducting clinical trials. The proponent should identify risks to critical testing processes and data. Risks must be taken into account both at the system level (. B for example, standard operating procedures, computer systems, staff) only at the clinical studies level (. B for example, experimental design, data collection, informed consent procedures).
Sponsors, CROs and websites have a responsibility to comply with the study protocol, laws and regulations of the authorities. Data from a clinical trial belongs to the trial sponsor, unless the agreement provides for something else. 5.13.2 The proponent must determine acceptable storage temperatures for the test product or products, storage conditions (for example. B light), storage times, fluids and replenishment processes and, if necessary, product fusion devices. The promoter must inform all interested parties (for example. B monitors, examiners, pharmacists, warehouse managers) of these findings. (c) approval or favourable opinion of the IRB/CIS and, at the proponent`s request, an updated copy of the minutes, the written consent form and any other written information to be provided to applicants, procedures for the use of goods and documents relating to the payments and compensation available to participants, as well as any other documents that the IRB/IEC may have requested. When sponsors carry out audits as part of the implementation of quality assurance, they must take into account: 5.14.1 The promoter is responsible for the procurement of the examiner (s) to the (s) product (s).
5.17.3 The proponent should provide the regulator with all safety updates and periodic reports required by current regulatory requirements. The use of an examiner, sub-auditor, vendor or other research staff who has been excluded from the FDA for conducting trial studies is prohibited. The site must do everything in its power to ensure that no one used in the study has been blocked or investigated for possible closures during the study.