Combined with work experience, this paper described the project process of clinical research pro-jects and ethical review points, and pointed out that clinical research projects should be submitted to peer reviewers prior to ethical review. The ethics committee would review the projects in accordance with legality, scientificity, feasibility, ethics, and other points in detail. Accurately grasp of the balance between innovations and ethics ensure the standardized development of clinical research.

OBJECTIVE:To provide reference for performing quality control and protecting the subjects’rights and interests. METHODS:233 severe adverse events (SAE) cases reported by our hospital during Jan. 2012-Jun. 2015 were collected and ana-lyzed statistically in respects of subjects’gender and age,department,drug/equipment types,SAE types,relationship of SAE with drug/equipment,comorbidities,etc. RESULTS:The incidence of SAE in male was higher than female(71.2% vs. 28.8%);SAE mainly occurred in people over the age of 50(189 cases,81.1%);the incidence of SAE in cardiology department was the highest (137 cases,58.8%);main SAE type was hospitalization(183 cases,78.5%);most of SAE had nothing to do with studied drugs (164 cases,70.4%);more than half of the subjects suffered from other comorbidities(128 cases,54.9%). CONCLUSIONS:In order to ensure the quality of drug clinical trial data and safety of subjects,the investigator should strengthen the management of the elderly subjects and those suffering from comorbidities,to ensure that each SAE case is timely processed and accurately record-ed and reported.

Objective To explore the value of contrast-enhanced ultrasound(CEUS) in diagnosis of placental accrete,placental increta and placental percreta. Methods Twenty suspected patients of placental accrete, placental increta and placental percreta were examined with CEUS after routine ultrasound examination. Sono Vue was injected intravenously as bolus and a real time CEUS was performed to observe the characteristics. Results Comparison of 15 CEUS cases with uterine curettage, 8 cases had a clear relationship between the residual disease of the uterine cavity and uterine wall,7 cases had a thin thickness (2-4 mm) between the residual disease of the uterine cavity and uterine wall. Five of the 20 cases performed cesarean cesion,3 cases of the uterine serosa of placenta affixing part were very thin,incomplete and rough, demonstrating placenta increta and placenta percreta, 1 case of uterine rupture showed non-invasiveness between uterine wall and uterine serosa,and 1 case of placenta increta pathologically proven, initially suspected gestational trophoblastic disease by the CEUS. Conclusions CEUS provides an important diagnostic message for placental accrete, placental increta and placental percreta by showing the different characteristics of the perfusion image.

Objective The sirolimus-eluting stent (SES) has dramatically reduced the rate ofrestenosis in comparison to that with the bare-metal stent (BMS).This study aimed to evaluate the short-term efficacy and safety of Firebird stent implantation for patients with coronary heart disease (CHD). Methods From Apri12006 through July 2007, 155 patients (mean age 58.93～10.27 years) with CHD were implanted with Firebird stent or Cypher select stent at Daxing Hospital. Patients were followed up for one year. All-cause mortality, major adverse cardiac events (MACE, including cardiac death, myocardial infarction, recurrence of angina pectoris, heart failure, revascularization, and adverse arrhythmia) and stent thrombosis were compared between the 2 groups. Results Of the 155 consecutive patients, 147 patients were revascularized completely. Of these patients, 48 (with 59 lesions) were treated with Firebird stent, 59 patients (with 75 lesions) with Cypher select stent. The demographic characteristics were similar in the 2 groups. All the angiographic and procedural results were not significantly different between the 2 groups. All-cause mortality, myocardial infarction, recurrence of angina pectoris, MACE and stent thrombosis were almost identical between the 2 groups before discharge, at 6 months and at one year .Conclusion The short-term efficacy and safety of Firebird stent are similar to that of the cypher select stent for the treatment of patients with CHD.

The quality control problems of 49 institutional level medical device clinical trials in hospital from 2016 to 2021 were summarized, and the causes of the problems were analyzed from the perspective of all parties involved in the clinical trial. The improvement measures were discussed, which including improving the management system, strengthening the training of researchers and optimizing the selection method, strengthening the responsibility and regulation consciousness of applicants, and formulating the selection basis of applicants and so on. All the above aims to ensure the quality of clinical trials and provide reference for clinical trial managers and implementers.
Quality Control ; Research Design