Our second CQAF Quarterly Meeting for Y2020 still went virtually to maintain social distance and reduce/prevent the spread of Coronavirus (COVID-19).
为保持社交距离并尽量减小/避免COVID-19的传播，CQAF的二季度会仍然采用虚拟会议的模式召开。
Our CQAF Q2 2020 meeting was held in the afternoon of 25th May and we were pleased to have Sean Xu from Zigzag Associates as the host of the meeting. About 160 CQAF members from approximately 60 organizations, including pharmaceutical companies, clinical trial institutions and contract research organizations, joined the meeting online.
CQAF二季度会在2020年5月25日下午召开，我们很高兴邀请来自Zigzag Associates的徐晓刚先生来主持此次会议；一共有大约160位来自60多家医药公司或临床试验机构或研究合同组织的会员参会。
We would like to take this opportunity to thank our speakers, who shared their experience and insights on the following topics during the meeting: HGRAC Inspection Experiences Sharing and Discussion, HGRAC Inspection at Central Lab and Bioanalytical Lab, Impact of COVID-19 on Central Lab Operation and Solution, and Inspections in COVID-19.
我们借此机会感谢各位讲者为我们带来的经验分享，此次会议的讨论内容包括：人类遗传资源管理办公室（遗传办）检查经验分享与讨论 ，遗传办对于实验室的检查，新冠疫情对中心实验室影响以及应对措施，和疫情下国内外检查新方式&经验讨论。
Let’s take a look at the summary of our discussions:
让我们一起来回顾下主要讨论和分享的内容：
Topic 1: HGRAC inspection and preparation人类遗传资源管理办公室检查与准备
Presented by: Leong Cheong Guan, Amgen
HGRAC main focus are the human genetic samples and personal data been collected for utilization in clinical researches by foreign companies.
人类遗传资源管理办公室主要关注人类遗传样本和个人数据的收集并用于外国公司开展的临床试验。
For the investigator site inspection, the sponsor should ensure adequate monitoring on the essential documents at the investigator site. The reason is the HGRAC investigator site inspection is unannounced. Maintaining the readiness of investigator site binder is critical for the possible future inspections.
对于研究中心的检查，申办方应确保CRA在研究中心对于必备文件的监查活动。因为人遗办没有针对研究中心的核查出台或发布通知。维护研究中心的文档对于将来的核查是非常重要的工作。
For the sponsor inspection, the sponsor should ensure to prepare the list of studies that involved in the collecting the subject human genetic samples, for their research used, whether it is clinical study research, or pre-clinical research (Pre-clinical research that also involves in the samples collection for exploratory research or future research. HGRAC does not just look at the clinical studies, but also includes all the pre-clinical research or early discovery research that involved in any samples collection from patients. HGRAC requires all the researches that involved in samples collection (including patient data) to submit the application for approval) that not involved in any investigator product (This is the pre-clinical or early discovery research before the First-In-Human (FIH) study, that does not involve investigator product treatment). That also includes investigator initiation study (IIS) if it is required to collect the subject samples for future research.
对于申办方的检查，申办方要确保提供一份所有要求收集受试者人类遗传资源样本的研究清单，无论是临床研究还是不涉及研究产品（对于临床前或早期发现的不涉及研究产品的研究，是指首次在人类中进行的研究（FIH）之前的早期阶段）的临床前研究（临床前研究也包括用于探索性或未来研究的样品收集。HGRAC不仅着眼于临床研究，还包括所有涉及从患者身上收集样本的临床前研究或早期发现研究。HGRAC要求所有与样本采集有关的研究（包括患者数据）都需要提交申请并获得批准）。这同样适用于研究者发起的需要收集受试者样本以供将来使用的研究。
In addition, HGRAC inspectors always review the contract and subject agreement (ICF) to ensure that the subjects are volunteering to participate into the clinical research, and the subjects are clearly aware of the research risk and have known of that their data would be used in the research.
另外，人遗办检查员还会审阅合同和知情同意书，以确保受试者是自愿参加临床研究的，并清楚知晓研究的风险，以及他们的数据会被用于研究中。
Topic 2: HGRAC Inspection at Central Lab and Bioanalytical Lab遗传办对于实验室的检查
Presented by: Lan （Helen） He, Covance
Helen gave an overview of HGRAC inspection at third-party laboratory. She introduced the role of third-party laboratory in HGRAC relevant activities. The presentation included details of HGRAC inspection at laboratory, including notification, preparation, documentation review by inspectors and close-out meeting. In addition, inspection focusing areas and opportunities for improvement were also summarized in the presentation.
贺岚女士总结了近期遗传办对实验室检查的情况。她介绍了第三方实验室在遗传办流程中所扮演的角色，以及遗传办检查通知和准备的流程，检查时审阅的文件和记录，和关闭会议。另外，她同时对遗传办检查的关注点，以及关于遗传办工作的改进空间进行了总结。
Topic 3: Impact of COVID-19 on Central Lab Operation and Solution新冠疫情对中心实验室影响以及应对措施
Presented by: Yanping Liu, Covance
Tracy presented the impact of COVID-19 on central laboratory operations and solutions. Her presentation covered various aspects that may impact central lab operations and provided the corresponding solutions. It included issues and solutions for the transportation of collection kits and patient samples, and delay of sample analysis and solutions. The presentation also addressed how central lab can meet sponsor’s expectation during COVID-19, for example, accommodation of sponsor’s audit remotely by using secure document sharing tool, utilization of e-signature for study documents review and approval, video and audio conferences, and etc.
刘艳萍女士介绍了新冠疫情对中心实验室影响以及应对措施。她从采血盒和受试者样本的运输问题，以及受试者样本检测的延期问题等几方面深入剖析了新冠疫情对实验室的影响以及可采取的应对措施。另外，她也总结了实验室如何在新冠疫情影响下更好的满足客户的要求，并提出了诸如使用安全的文件共享工具接受申办方的远程稽查，使用电子签名审阅和批准文件，运用视频和音频会议系统等多种可借鉴的解决方案。
Topic 4: Remote/Virtual Inspection experience sharing 远程/虚拟检查分享
Presented by: Xiaohui Gu, Pfizer
Remote/virtual inspection approaches have been discussed by different authorities for several years. During recent pandemic, we saw an increased number of remote/virtual inspection cases shared by different companies. In this session, MHRA guidance of "Good Practice (GxP) inspections during the COVID-19 outbreak" was discussed. In addition, we discussed one recent EMA remote/virtual PV inspection (published on internet by Novartis colleagues), which described the company arrangements and feedbacks of this kind of inspection. Other Agencies, such as FDA/MHRA/PMDA performed remote/virtual inspections globally as well. We expected more remote/virtual inspection practices in the future, and companies need to get ready for it.
许多不同的监管当局在过去都讨论过远程/虚拟的检查方式。在最近的疫情期间，我们看到越来越多的公司分享了他们接受远程/模拟检查的例子。在本次分享中，我们一起回顾了MHRA关于COVID-19期间的检查指南文件。同时也一起讨论了诺华同事分享在网上的近期接受EMA PV远程/虚拟检查的经验，文章描述了公司对此类检查的安排及反馈。其他监管机构例如FDA/MHRA/PMDA均在全球进行不同程度的远程/虚拟的检查。我们预见将来会有更多的远程/虚拟的检查，公司需要在这方面做好准备。
Presented by: Chao Fu, Bayer
A NMPA inspection case was shared by Chao Fu which focused on the general inspection process and impressive observations during the inspection. The inspection was conducted by CFDI from 20 to 25 Apr 2020 during COVID-19 pandemic. The overall inspection process did not change in comparison with the previous one, except for some novel changes in particular areas, such as the preparation for the inspection was more focused (e.g., requested for specific documents prior to the inspection); inspectors were more reasonable to accept appropriate clarifications/explanation; inspectors had higher level of understanding of clinical trial quality management (for example, sponsor’s oversight especially for the outsourced activities were asked during the inspection); and in general the inspection was performed according to the site’s working time.
付超分享了一个在疫情期间NMPA检查的案例，重点介绍了检查的大致流程和检查过程中令人印象深刻的地方。此次检查发生在COVID-19疫情期间，由CFDI于 2020年4月20日至25日间进行。整个检查流程较以往的NMPA检查流程未见明显变化，只是在特定方面显示出了较新颖的变化，例如检查员的检查准备更有针对性（比如检查前特定文件的索要）；检查员的行为更趋合理，能够接受合适的澄清和解释；检查员对临床试验质量管理的理解层次更高（比如，在检查期间询问申办方对临床试验，尤其是对试验中的外包活动的监管行为）；此外，此次检查大致是按照研究中心的工作时间进行的。
Presented by: Luke Liu, Novartis
Luke Liu from Novartis shared another CFDI inspection case during the pandemic, and the inspection process and inspectors' approaches were similar. During the sharing, a quick survey of the hot topic regarding " request of audit report during inspections" was raised to the audiences. According to the survey result, four companies shared their experience in handling inspector’s request of audit report during recent CFDI inspections, and all of them managed it through clarifying their audit processes and/or strategies with the inspectors without providing the audit report.
来自诺华的Luke Liu也分享了一个疫情期间接受CFDI检查的案例，检查的流程与趋势与上述类似。针对热门话题“检查员要求申办方提供稽查报告”，在参会者中进行了一次快速调查。根据调查结果，四家公司分享了他们如何应对近期检查员要求提供稽查报告的经验，他们都通过与检查员解释申办方稽查的流程和/或稽查的策略从而避免向检查员直接提供稽查报告。
-----------------------------------------------------------------------------------------------------------
Upcoming CQAF Events
2020 China GCP Sharing --- Jun. 11, 2020
CQAF 10’year anniversary / 2020 Annual Meeting --- Sep, 2020
------------------------------------------------------------------------------------------------------------
We welcome you to join us to propose topics and/or act as a speaker to share your experience in the future quarterly meeting. Please feel free to provide your thoughts via the following link or QR code:
关于上述的分享PPT，请登陆会员账户，点击下方第二页。
关于如何注册和登陆会员账户，请参见 CQAF Website User Guide
沪公网安备 31011202013414号