שטוטאקוי, אתר מאמרים אישי

4.8.5 The examiner or any person appointed by the examiner should fully inform the applicant or, if the applicant is unable to give informed consent, the applicant`s legally acceptable representative on all relevant aspects of the review, including written information and favourable opinion of the IRB/IEC. 4.1.2 The examiner must be fully aware of the appropriate use of test products as described in the minutes, in the examiner`s current brochure, in product information and in other sources of information provided by the proponent. The investigator must follow the randomization procedures of the study, if it exists, and ensure that the code is broken only in accordance with the protocol. If the study is blinded, the investigator must immediately document any premature disinfirmation (for example. B, accidental de-blindness, de-blindness due to a serious adverse event) of the (s) examination product (s) and explain it to the promoter. 4.2.6 If the examiner retains the services of an individual or party performing process-related tasks and tasks, the examiner/institution should ensure that that person or entity is qualified to perform these process-related tasks and tasks and apply procedures to ensure the integrity of the tasks and functions performed in the audit, as well as the data generated. 4.4.1 Prior to the initiation of proceedings, the examiner/institution should have written the IRB/CIS approval/favourable opinion for the test minutes, the written agreement form, the updating of the consent form, the recruitment procedures for applicants (e.g. B ads) and any other written information to provide to subjects. 4.4.3 During the review, the auditor/institution should make all documents available to the IRB/CIS. 4.9.0 The examiner or institution should keep appropriate and accurate source and experimental documents containing all relevant observations on each participant at the site.

Source data must be available, readable, at the same time original, accurate and complete. Changes Source data should be traceable, not to hide the original input and be explained when needed (for example. B on an audit trail). 4.5.4 The examiner may waive or amend the protocol to eliminate an imminent risk to subjects without prior NI/CIS/favourable notice. If, for any reason, the study is discontinued or suspended prematurely, the investigator or institution must immediately inform the subjects, ensure appropriate treatment and follow-up of the subjects and, if necessary, inform the national regulatory authorities. In addition: 4.10.2 The investigator must immediately submit to the proponent, the IRB/CIS (see 3.3.8) and, if necessary, to the institution, written reports on changes that significantly affect the course of the study and/or increase the risk to the subjects. 4.2.5 The examiner is responsible for tracking any person or party to whom the examiner delegates tasks and tasks related to the process to the test site. 4.4.2 As part of the examiner/investigative body`s written request to the IRB/CIS, the auditor/institution should make an updated copy of the examiner`s brochure available to the IRB/CIS. When the examiner`s brochure is updated during the trial, the examiner or institution must provide the IRB/IEC with a copy of the updated review brochure. 4.8.1 When knowingly obtaining and documenting consent, the auditor should comply with existing regulatory requirements and comply with the CCPs and ethical principles that originated in the Helsinki Declaration.