Regulatory Express_Dec. 2018

Dear reader,

Times flies, the last issue of "Regulatory Express" in 2018 is coming. We bring you four articles about "MHRA Joint Statement", "Recommendations from CTTI",  "Updated International Standards for Clinical Trial Registeries".

Meanwhile, two Inspections Metrics Reports are sharing with SPECIAL YOU.Details see below.

We only part to meet again.

致读者：

时光飞逝，2018年最后一期“法规速递”和你见面了。此次为大家带来“MHRA的联合声明”、“CTTI的建议”、“更新的临床试验注册国际标准”四篇文章.

同时和你分享的还有两篇“Inspections Metrics Report”.

再会。

1.      MHRA Joint Statement on Seeking and Documenting Consent Using Electronic Methods (eConsent)

MHRA关于使用电子方法（电子知情同意）获取和记录知情同意的联合声明

(The MHRA and the Health Research Authority (HRA), Sep 2018)

Summary:

The MHRA and the Health Research Authority (HRA) have published a joint statement on seeking and documenting consent using electronic methods (eConsent).  eConsent enables potential research participants to be provided with the information they need to make an informed decision via a tablet, smartphone or digital multimedia. It also enables their informed consent to be documented using electronic signatures.  The use of eConsent has the potential to improve participants’ understanding of what is involved in taking part in research and to make recruitment and consent procedures more efficient. 

摘要：

MHRA和卫生研究局（HRA）发表了关于使用电子方法（eConsent）获取和记录知情同意的联合声明。eConsent使潜在的研究参与者能够通过平板电脑，智能手机或数字多媒体获得他们所需的信息，继而做出知情决定。 这还使他们的知情同意能够使用电子签名进行记录。 eConsent的使用有可能提高参与者对参与研究的理解，并提高招募和同意程序的效率。

The statement confirms that electronic methods may be used for seeking, confirming and documenting informed consent for participation in research and is supported and endorsed by the UK health departments.  It also sets out the legal and ethical requirements for eConsent, and joint expectations regarding the use of electronic signatures in Clinical Trials of Investigational Medicinal Products (CTIMPS).  This approach can supplement the traditional paper-based approach or, where appropriate, replace it. 

该声明证实，电子方法可用于获取，确认和记录参与研究的知情同意书，并得到英国卫生部门的支持和认可。 它还规定了eConsent的法律和伦理要求，以及在研究性药品临床试验（CTIMP）中使用电子签名的共同期望。 这种方法可以补充传统的纸质方法，或者在适当的时候取代它。

Clinical Trials of Investigational Medicinal Products (CTIMPs) should follow the guidelines below.

• Participants must be informed of the nature,      significance, implications and risks of the trial in an interview with the      investigator, or another member of the investigating team.

• The interview should involve two-way communication in      real time and allow confirmation of the participant’s identity.

• Information about the trial does not have to be in      writing and can be provided to potential participants using electronic      methods. However, special attention should be paid to the information      needs of specific patient populations and those of individual      participants.

• Informed consent must be recorded ‘in writing’.      Electronic methods for documenting consent can be considered to be in      writing. 

• A copy (physical or electronic) of the signed consent      form should be provided to the participant.

• For type A trials, which involve risks no higher than      that of standard medical care any simple electronic signature may be used      (including typewritten or scanned eSignatures).

• For all type B and C trials including phase I healthy      volunteer trials, eSignatures that involve tracing the participant’s      handwritten signature using a finger or a stylus or biometric eSignatures      should be used as these allow direct comparison with eSignatures/wet-ink      signatures used previously for audit purposes or GCP inspection.      Typewritten or scanned images of handwritten signatures should not      normally be used

• In clinical trials that are conducted remotely it may      not always be possible to verify that the participant is who they say they      are. In such circumstances it may be preferable to use an advanced or      qualified electronic signature

研究性药品（CTIMPs）的临床试验应遵循以下指导原则：

·         必须在与研究者或研究团队的另一位成员交谈时告知参与者试验的性质，意义，影响和风险。 

·         交谈应实时进行双向沟通，并确认参与者的身份。

·         有关试验的信息不必是书面的，可以使用电子方法提供给潜在的参与者。 但是，应特别注意特定患者人群及其个体参与者的信息需求。 

·         必须采用“书面”的方式记录知情同意。记录同意的电子方法可以被认为是书面的。

·         应向参与者提供一份已签署同意书的副本（纸质或电子）。

·         对于涉及风险不高于标准医疗的A类试验，可以使用任何简单的电子签名（包括打字或扫描的电子签名）。 

·         对于包括I期健康志愿者试验在内的所有B类和C类试验，应使用涉及使用手指或触针或生物识别eSignature可追踪参与者手写签名的eSignature，因为上述eSignature允许与以前使用的eSignature/湿墨签名进行直接比较以满足稽查目的或GCP检查要求。手写签名的打印或扫描图像通常不应该使用。

·         在远程进行的临床试验中，可能并不总是可以验证参与者的真实身份。 在这种情况下，最好使用高级或合格的电子签名。 

Key Takeaways:

• The joint statement clarifies HRA and MHRA expectations      with regards to the use of electronic methods for seeking, confirming and      documenting informed consent for participation in research.

• This guidance aims to promote best practice where      eConsent is used for clinical trials, ensuring continued provision of key      information in a clear way to trial participants.

• The use of electronic methods to provide information      may not be appropriate for everyone.  Alternative methods for the      provision of information and/or documentation of consent should be      available for those unable or unwilling to use electronic methods.

关键信息：

·         联合声明阐明了HRA和MHRA对使用电子方法获取，确认和记录参与研究的知情同意的期望。 

·         本指南旨在推广eConsent用于临床试验的最佳实践，确保以明确的方式向试验参与者提供关键信息。

·         使用电子方法提供信息可能不适用于每个人。 对于无法或不愿意使用电子方法的人，应采用提供信息和/或同意文件的替代方法。

References:

Improving how we collect and document consent - MHRA

2.      CTTI Releases Recommendations on Decentralized Clinical Trials

CTTI发布关于分散临床试验的建议

(The Clinical Trials Transformation Initiative (CTTI), Sep 2018)

Summary:

The Clinical Trials Transformation Initiative (CTTI) has released their recommendations on Decentralized Clinical Trials (DCT).  DCTs are defined as those executed through telemedicine and mobile/local healthcare providers (HCPs), using procedures that vary from the traditional clinical trial model (e.g., the investigational medical product is shipped directly to the trial participant).  They are also known as Virtual Trials, Site-Less Clinical Trials, Digital Trials, or Remote Clinicals.

摘要：

临床试验转化倡议（CTTI）已经发布了关于分散临床试验（DCT）的建议。 DCTs被定义为通过远程医疗和移动/当地医疗保健提供者（HCP）执行，使用与传统临床试验模型不同的程序（例如，研究医疗产品直接运送到试验参与者）。 它们也被称为虚拟试验，无地点临床试验，数字试验或远程临床试验。

The recommendations provide guidance on:

• DCT Approaches and Protocol Design

• Telemedicine State Licensing Issues

• Drug Supply Chain

• Mobile Healthcare Providers Investigator Delegation and      Oversight

• Safety Monitoring

这些建议提供了以下方面的指导： 

·        DCT方法和方案设计

·        远程医疗国家许可问题 

·        药品供应链 

·        移动医疗服务提供者研究者职责分配和监督 

·        安全性监查 

The use of these recommendations could offer sponsors, CROs, and others many advantages, including improved recruitment and retention, greater participant diversity, and a more comfortable and convenient research experience for participants.

这些建议的使用可以为申办方，CRO等提供许多有利条件，包括改进招募和保持参与者，增加参与者的多样性以及为参与者提供更舒适和方便的研究体验。

Who is CTTI?

The Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by Duke University and the U.S. Food and Drug Administration in 2007, comprises more than 80 member organizations—representing academia, clinical investigators, government and regulatory agencies, industry, IRBs, patient advocacy groups, and other stakeholders.

CTTI是谁?

临床试验转化倡议（CTTI）是由杜克大学和美国食品和药物管理局(US FDA)于2007年共同创立的公私合作伙伴关系，由80多个成员组织组成-代表学术界，临床研究人员，政府和监管机构，行业，IRB，患者倡导团体和其他利益相关方。

Key Takeaways:

• These new recommendations offer guidance on overcoming      legal, regulatory, and practical hurdles for planning and conducting      decentralized clinical trials

• A key concept within the recommendations is that DCTs      do not have to be fully decentralized but can incorporate various      procedures and activities that are common in traditional studies.

关键信息：

·         这些新建议为规划和开展分散临床试验提供指导，以克服法律，法规和实际操作中的障碍 

·         建议中的一个关键概念是，DCT不必是完全的分散，而是可以纳入传统研究中常见的各种流程和活动。 

References:

CTTI Press Release

Recommendations: Decentralized Clinical Trials