山东第一医科大学附属中心医院

I期临床试验研究中心

Ⅰ期临床试验研究中心于2016年8月建成并投入使用，病房及配套区域2000余平方米，设置研究床位100张。制定了完善的管理制度、标准操作规程和应急预案以保障受试者安全，质量管理体系满足国家药品监督管理局（NMPA）和美国FDA的要求。

配备研究人员40余人，包括主要研究者（PI）5人，全职研究医生3人，Sub-I 2人，项目管理8人，药师4人，研究护士18人；另有兼职研究医生20余人，兼职研究护士100余人。设立了受试者接待室、知情同意室、急救室，配套有18台心电监护仪和中央区工作站、吸引器、急救车等抢救设备设施；设置专用试验药房和生物样本处理和储存室，配备低温离心机、超低温冰箱、医用冰箱等储存设备，使用松下的温度监控系统和生物样本管理系统，保证试验药物和生物样本的安全；建立了本中心庞大的健康人、病人受试者库，能够在三个月至半年时间内完成新药健康人或病人单次给药耐受性、药代动力学、食物影响、药物相互作用。

截至目前，Ⅰ期临床试验研究中心已完成健康志愿者BE试验项目100余项，包括了普通片剂、胶囊剂、口腔崩解片、混悬剂、缓控释制剂、注射剂等剂型；生物药物的PK研究3项；创新药剂量探索、PK、DDI、IB期临床试验20余项，申报FDA的仿制药试验1项。

合作的申办方包括了Sun Pharma、Dr. Reddy、Sandoz、齐鲁制药、先声药业、正大天晴、江苏恒瑞、扬子江等大型中外制药企业。

近三年，先后接受了国家药监局审核查验中心组织的近20个项目的临床试验现场核查，未见真实性问题；免核查批准上市项目近20个。

Phase I Clinical Trial Research Center(CTRC-I)

Jinan Central Hospital Affiliated to Shandong First Medical University

Jinan central hospital established its Clinical Trial Research Center for Phase I (CTRC-I) in August 2016, with the capacity of 100 beds and 2,000 square meters trial area. The CTRC-I has established a sound management system, SOPs, and contingency plans for the safety of subjects and in compliance with the requirements of NMPA and FDA.

Five principal investigators (PI) and more than 40 full-time researchers work for the CTRC-I, including three full-time research doctors, two Sub-I, eight project managers, four pharmacists and eighteen research nurses. Besides, more than twenty part-time research doctors and 100 part-time research nurses are available for future projects. The CTRC-I is also equipped with a subject reception room, an informed consent room and an emergency room, together with 18 sets of ECG monitors, central station workstations, sputum aspirator and ambulance cars. Moreover, trial pharmacies and biological sample processing and storage rooms are equipped in CTRC-I, along with low-temperature centrifuges, ultra-low temperature refrigerators, medical refrigerators and other storage equipment managed by Panasonic's biological sample monitoring system to ensure the safety of test drugs and biological samples. Besides, the CTRC-I has established a database of healthy and patient subjects, which could support the completion of single-dose tolerance, pharmacokinetics, food effects, and drug-drug interaction (DDI) trials of healthy or patient subjects within three to six months.

The CTRC-I has completed more than 100 BE projects of drugs in healthy volunteers, including ordinary tablets, capsules, orally disintegrating tablets, suspensions, sustained-release preparations, injections and other dosage forms. Three pharmacokinetic (PK) stus of biopharmaceuticals and over twenty projects of innovative drugs, including drug dose exploration, PK, DDI and phase Ib, also have accomplished. Besides, one generic drug trial project was declared to the FDA. The CTRC-I is in cooperation with many domestic and foreign pharmaceutical companies including Sun Pharma, Dr. Reddy, Sandoz, Qilu Pharmaceutical, Zhengda Tianqing, Jiangsu Hengrui, Yangtze River, etc. Additionally, over twenty clinical trial projects have passed on-site inspection by the NMPA without major findings in the past three years, and nearly twenty projects were approved with free inspection.