Release date: 2015-09-02 The 117th Announcement issued by the CFDA urges the sponsors to conduct self-examination. What is most confusing for everyone is the extent to which the audit will be investigated. What kind of mistakes will lead to administrative penalties? In general, falsifying data is unacceptable. Those deliberate and repeated violations that result in untrue data in the filings, serious impact on the safety of patients, and serious damage to the rights of patients often result in administrative penalties from the authorities. The following is a list of the most frequently discovered problems in the audit. 1 Informed consent form Since informed consent is the most important document to protect patient rights, issues related to informed consent are issues that require great attention. E.g: 1) Informed consent was not revised in time after the revision of the trial protocol. 2) After the revised informed consent form has been approved by the ethics committee, it will be used. 3) The patient failed to sign the revised informed consent in time. 4) The process of informed consent was not recorded in the original medical record. This is known to everyone now, but for those clinical studies that were completed 7 or 8 years ago, many sponsors did not understand this. Some sponsors often think that they can sign an informed consent form. 5) The content of the informed consent form does not cover all the contents stipulated by relevant laws and regulations. Some informed consent designs are too simple. Some researchers believe that too complicated informed consent forms difficult for patients to read and is more difficult to sign, so it is often required to simplify the content of informed consent. However, the content of the informed consent form must cover all of the GCP's requirements for informed consent, otherwise the patient cannot be considered fully informed. For example, ICH E6 requires that the informed consent form must cover 20 items and need to be checked one by one. 6) Clinical studies were initiated before the subjects did not sign the informed consent form. It should be noted that the screening process can only be started after the patient has signed the informed consent form. However, some pre-screening began before the signing of the informed consent form. Be cautious about such pre-screening, and it is best to make it clear in the program. In fact, some programs require the use of some special or laboratory tests prior to patient screening. 7) The version of the informed consent form used is not an approved version of the Ethics Committee. 2 did not report in accordance with the requirements of the ethics committee In general, the ethics committee stipulates which events need to be reported to the ethics committee in time, for example: 1) Unexpected, related serious adverse events (including those occurring in other centers) 2) Major program violations at the Center that may affect the safety of the subject. 3) Serious adverse events occurred in the center. 4) Due to the quality of the test, the applicant was notified that the point was temporarily suspended from the group and was not reported to the ethics committee in time. 5) After the applicant terminated the clinical study at this point because of a serious violation of the GCP, it did not report to the ethics committee in time. Many ethics committees do not require researchers to report serious adverse events at other centers. 3 data retention issues For example, the clinical research data were not saved until 5 years after the end of the clinical study, and the screening and enrollment registration forms of the subjects were not saved. 4Discovery related to drug management Good drug management is one of the most important aspects to ensure the quality of clinical research, but it is the most easily overlooked part of CRA work. Many CRA spend a lot of time on raw data verification, and often ignore the inventory of drugs. Any mistakes in the counting of drugs are not only serious mistakes, but also obvious. From the receipt of medicines, to the distribution and recycling of medicines, to the destruction of medicines, each piece of medicine must be recorded on different forms, and finally every piece of medicine must be right. 5 Audit around the researcher's authorization form Eligibility of personnel involved in clinical research is a prerequisite for the protection of the subject's rights. Around the researcher authorization form, you can check some questions: 1) The resume and medical license of the researcher (whether the resume is within two years? Is there a record of GCP training? Is there any clinical research experience?). 2) Training records: including GCP training records and project-related training records. 3) Is the authorization form completed? Is anyone engaged in work other than the authorization form? 4) The signature of the authorization form is checked against the original medical record and the signature on the document. 6 The original medical record is incomplete For example, the patient's physical examination record is not signed by the investigator; the adverse event is only recorded in the adverse event report form, and there is no record in the original medical record; the information recorded in the medical record report form is inconsistent with the original medical record record; Not recorded; the patient's vital signs were not recorded on the original medical record. 7 The main investigators did not personally operate and manage clinical research. For example, the investigator did not provide guidance and training to the Study Coordinator or research nurse; the investigator did not read letters or communications from the CRA, sponsor or ethics committee; did not evaluate adverse events. 8 program violations For example, physical examination, laboratory examination, electrocardiogram examination, etc. were not performed according to the requirements of the program; adverse events or serious adverse events were not reported according to the requirements of the program; laboratory inspection reports were not reviewed in time and abnormal values ​​were judged; Strictly adhere to the inclusion exclusion criteria; distribute clinical research drugs to unqualified patients; the doses of the dispensed drugs are inconsistent with the doses required by the program. These are the problems that are often found in audits, but not all of them. Although it is not that the audit found a problem that negates the work of the entire center, repeated, deliberate mistakes and data fraud are unacceptable. Source: Pharmaceutical Economics Hearing Aid,Hearing Assist,Hearing Aid Devices,In Ear Hearing Aids Shenzhen Sunshine Technology Co.,Ltd , https://www.yatwinsz.com