4.3.2 During and after a participant`s participation in a study, the investigator or institution should ensure that a subject is properly medicalized for adverse events, including clinically significant laboratory results, as part of the study. The examiner or organization should inform a subject when it is necessary to provide medical care for intercurrent diseases that the examiner is aware of. 4.6.1 Responsibility for the responsibility for investigative products at the test site (s) rests with the auditor/institution. 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. The evaluation of the adequacy of monitoring by an examiner The FDA focuses on four main areas: (1) if people, 2) that the study staff were adequately trained in the performance of the delegated tasks and that the study was well understood, (3) whether there was appropriate follow-up and participation in the implementation of the study, and (4) if there was appropriate follow-up or supervision of third parties involved in conducting a study to the extent that it was reasonably possible. 4.4.3 During the review, the auditor/institution should make all documents available to the IRB/CIS. 4.8.4 None of the oral and written information relating to the proceedings, including the informed consent form, should contain a language that results in the person or the legally acceptable representative of the person resigning or appearing to waive his or her legal rights or that the examiner, institution, promoter or representatives appear to be released or released from liability in the event of negligence. This section of the guide explains the investigator`s responsibility to monitor the completion of the clinical examination and to protect the rights, safety and well-being of participants in clinical trials of drugs and medical devices. 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. 4.5.2 The examiner should not make a derogation or modification of the minutes without the consent of the proponent and without prior authorization and the documented approval or notice of the IRB/CIS on an amendment, unless it is necessary to eliminate a direct or imminent risk to the subjects or if the amendment involves only logistical or administrative aspects of the audit (e.g., amendment. B of surveillance), change of phone number( 2.
What is adequate training? The auditor should ensure that all staff interested in the studies are adequately trained, including new staff recruited after the start of the study to cope with the unforeseen workload or replace outgoing staff. The examiner must ensure that staff:- are familiar with the purpose of the study and protocol- Do you need an adequate understanding of the specific details of the protocol and the attributes of the control product, in order to perform the tasks assigned to them- When regulatory requirements and acceptable standards for conducting clinical trials and protecting individuals are responsible for the performance of delegated tasks or have been trained, Persons who are responsible for the performance of delegated tasks and, if necessary, receive additional training If the promoter trains the investigators to carry out the study, the investigator must ensure that the staff receive the training of the sponsor; information (for example. B training material) from this training, which is relevant to the role of staff in the study.