1. FDA Framework for Real World Evidence Program
(FDA Dec 2018)
Summary:
The FDA has unveiled a new framework discussing how the agency will use real world evidence (RWE) and real-world data (RWD) to help companies win new indications for approved drugs and biologics, expand labels or satisfy post-approval study requirements.For the purposes of this framework, FDA said it defines RWD and RWE as follows:
RWD are data "relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.”
RWE is the “clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD.”
FDA公布了一个新框架，讨论将如何使用真实世界证据（RWE）和真实世界数据（RWD）来帮助公司为批准的药物和生物制剂赢得新的适应症，扩展标签范围或满足批准后的研究要求。 为了达到此框架的目的，将RWD和RWE定义如下：
RWD是“与患者健康状况和/或定期从各种来源收集的医疗保健相关的数据”。
RWE是“关于从RWD分析中获得的医疗产品的使用和潜在益处或风险的临床证据”。
In implementing this new strategic framework, they'll work on identifying relevant standards and methodologies for collection and analysis of RWD.The framework calls on FDA to develop new guidance on considerations for designing clinical trials that include pragmatic design elements as one tool for generating evidence of effectiveness for regulatory decisions. They'll also evaluate the potential role of observational studies in contributing to the body of evidence for demonstrating drug and biologic product efficacy.
在实施这个新的战略框架时，他们将努力确定收集和分析RWD的相关标准和方法。 该框架呼吁FDA制定关于设计临床试验考虑因素的新指南，其中包括作为产生监管决策有效性证据的工具之一的实用设计要素。 他们还将评估观察性研究在为证明药物和生物制品疗效提供证据方面的潜在作用。
For determinations on how to use RWE, the agency said it will consider the following on a case-by-case basis:
Whether the RWD are fit for use
Whether the trial or study design used to generate RWE can provide adequate scientific evidence to answer or help answer the regulatory question
Whether the study conduct meets FDA regulatory requirements (e.g., for study monitoring and data collection)
为了确定如何使用RWE，FDA表示将根据实际情况考虑以下内容：
RWD是否适合使用
用于生成RWE的试验或研究设计是否可以提供足够的科学证据来回答或帮助回答监管问题
研究实施是否符合FDA监管要求（例如，用于研究监查和数据收集）
FDA intends to use this three-part approach to evaluate individual supplemental applications, as appropriate, and more generally to guide FDA's RWE Program.
FDA意欲通过使用这“三部曲”方法酌情评估各自的补充申请，更广泛地指导FDA的RWE计划。
Key Takeaways:
This Framework is aimed at leveraging information gathered from patients and the medical community to inform and shape the FDA's decisions across their drug and biologic development efforts.
The goal is to develop a path for ensuring that RWE solutions are an integral part of the drug development and regulatory life cycle at the FDA.
RWE program will evaluate the potential use of RWE to support changes to labeling about drug product effectiveness, including adding or modifying an indication, such as a change in dose, dose regimen or route of administration; new populations; or the addition of comparative effectiveness or safety information.
关键信息：
该框架旨在利用从患者和医学界收集的信息，为FDA在其药物和生物开发工作中的决策提供信息并改善其决策。
目标是制定一条路径，以确保RWE解决方案是FDA药物开发和监管生命周期不可分割的一部分。
RWE计划将评估RWE的潜在用途，以支持药品标签中有效性信息的变更，包括增加或修改适应症，如剂量，剂量方案或给药途径的变化；新适应证人群；或增加相对有效性或安全性信息。
References:
FDA Framework for Real World Evidence Program
FDA Will Allow Observational Studies to Support Effectiveness Determinations, New Framework Says – RAPS
2. EMA Advises on Use of eSource Direct Data Capture in Clinical Trials
(EMA 18 Oct 2018)
Summary:
The EMA has outlined its views on eSource direct capture of clinical trial data in response to questions from Novartis.Novartis is among the companies interested in the potential of the technology but, having piloted the approach in several clinical trials, it has found that opinions on its acceptability vary globally.Novartis’ claims that pilot projects linked eSource DDC to a 45% reduction in manual queries compared to conventional electronic data capture trials, an estimated 38% decline in source data verification monitoring time and data becoming available for cleaning 14 days sooner.In light of those findings, Novartis wrote to EMA to get its take on the potential for eSource DDC to improve data quality and what sponsors should consider before adopting the technology.Below are some excerpts from the EMA Response:
EMA针对诺华提出的问题概述了其对eSource直接捕获临床试验数据的观点。 诺华是对该技术潜力感兴趣的公司之一，但在几项临床试验中试用该方法后，发现全球对这种技术的可接受性的意见各不相同。 诺华声称，链接eSource DDC的试点项目与传统的电子数据捕获试验相比，手动查询减少45%，源数据核对监查时间估计下降38%，可提前14天进行数据清理。 鉴于这些发现，诺华写信给EMA，以期获得EMA 对eSource DDC提高数据质量的潜力的认同，以及申办方在采用该技术之前应该考虑什么的建议。 以下是EMA答复的部分摘录：
Current Standard: Site staff record clinical data on paper or in electronic medical records. The data are then transcribed into electronic case report forms (eCRF) for later analysis by the sponsor.
Source direct data capture (DDC):Site staff to capture data at the point of care in a format this is validated for use in clinical trials.
现行标准：研究中心工作人员在纸质或电子病历中记录临床数据。 然后将数据转录成电子病例报告表（eCRF），供申办方进行后续分析。
源直接数据捕获（DDC）：研究中心工作人员以一种格式捕获医疗点的数据，该格式已被验证可用于临床试验。
When designing the system there are some fundamental aspects to be respected:
The ability of the physician to record clinical information in the patient medical record should not be limited or constrained; such information should be recorded in line with the current practice at the study center.
The integrity of the medical records shouldn't be compromised.
The sponsor should have access only to pseudonymised information mandated by the protocol.
在设计系统时，对以下基本方面需予以尊重：
医生在患者病历中记录临床信息的能力不应受到限制或约束；这些信息应根据研究中心的现行做法进行记录。
医疗记录的完整性不应该受到损害。
申办者只能查阅研究方案规定的信息，且信息已被假名化处理。
Other aspects for consideration include:
investigators having to use different eSource systems for the various clinical trials conducted by different sponsors/vendors in parallel: if the systems are not compatible for data transfer into the medical records this would increase data dispersion, deplete medical records, increase workload for the site personnel and might potentially be in breach of national requirements for the upkeep of medical records;
temporary technical non-usability of the eSource DDC tools (e.g. battery life of a tablet);
ideally, the system should allow automatic (real-time) transfer of the captured eSource DDC data to the respective sections of the EMR management systems.
其他应予以考虑的方面包括：
研究者不得不同时使用不同的eSource系统进行由不同的申办方/合同研究组织开展的各种临床试验：如果这些系统与医疗记录中的数据传输不兼容，这将增加数据分散，损耗医疗记录，增加研究中心工作人员的工作量，并可能违反国家对维护医疗记录的要求；
eSource DDC工具暂时在技术上的不可用性（例如，平板电脑的电池寿命）;
理想情况下，系统应允许自动（实时）将捕获的eSource DDC数据传输到EMR管理系统的各个部分。
The system should also fulfil the following requirements:
a site qualification procedure should be conducted before deploying the system in any given site;
IT help desk support, accessibility (eg. 24/7);
continuous accessibility and control of the eSource data by the investigator/its institution during and after completion of the study;
security and traceability of the data;
each individual piece of information needs to be pseudonymised prior to transfer from the investigator/institution to the sponsor, and the hospital will need to be the sole holder of the link to the records.
该系统还应满足以下要求：
在将系统部署到任何指定的研究中心之前，应对研究中心资质进行确认；
IT支持，可访问性 （如 24/7）；
研究人员/其机构在研究期间和完成之后可持续访问和控制eSource数据；
数据的安全性和可追溯性；
信息在从研究者/研究机构转移至申办方之前，需要对其进行假名处理，医院应成为记录链接的唯一持有人。
EMA agreed that direct transcription into an eCRF “seems likely to improve data quality” and stated the technology can be made compliant with GCPs. However, EMA also highlighted that the benefits to sponsors must not come at the expense of physicians. That means physicians must continue to be able to record clinical information in patient medical records without any constraints. In the long term, EMA wants to see systems that automatically pull data into eCRFs from medical records.
EMA同意直接转录成eCRF“似乎可能会提高数据质量”，并表示该技术可以与GCPs兼容。 但是，EMA还强调，申办方的获益不能以牺牲医生为代价。 这意味着医生必须继续能够在没有任何限制的情况下在患者医疗记录中记录临床信息。 从长远来看，EMA希望看到自动将数据从医疗记录中提取到eCRF中的系统。
Whatever the system, sponsors will need to comply with certain existing rules. That means eSource DDC must meet International Conference on Harmonization source data requirements and national rules, and that sponsors are responsible for ensuring the system works as intended.
无论系统如何，申办方都需要遵守某些现有的规则。 这意味着eSource DDC必须符合国际协调会议的源数据要求和国家规则，并且申办方负责确保系统按照预期工作。
Current Guidance covering eSource Data:
Guidance for Industry Electronic Source Data in Clinical Investigations – FDA
Guidance for Industry Computerized Systems Used in Clinical Investigations - FDA
Use of Electronic Health Record Data in Clinical Investigations -FDA
MHRA Position Statement and Guidance Electronic Health Records - MHRA
Key Takeaways:
EMA sees no theoretical obstacles to the use of the technology in a way that complies with good clinical practices (GCPs), but thinks sponsors must look closely at the disadvantages before moving to eSource data capture.
It is part of the EMA GCP working groups agenda for 2018 to continue working on the development of the following document: Guideline on Electronic Systems and Electronic Data in Clinical Trials.
To be acceptable, an eSource DDC system and application should be customized in line with legal requirements and ICH GCP, validated, secure and maintained.
eSource DDC has become an area of high interest within the industry as it stands to potentially save time and decrease errors in the capture of clinical data.
关键信息：
EMA认为遵从GCP要求使用该技术没有理论上的障碍，但认为申办方在转向eSource数据采集之前必须仔细观察存在的缺点。
EMA将继续制定以下文件：《临床试验中电子系统和电子数据指南》，这也是2018年EMA GCP工作组议程的一部分。
为了能被接受，eSource DDC系统和应用程序应根据法律要求和ICH GCP而定制，经过验证，安全和定期维护。
eSource DDC已成为行业内高度关注的领域，因为它可能节省时间并减少捕获临床数据过程中的错误。
3. EMA Provides Q&A on Sponsors Contracting Third Parties to Conduct Trial Related Duties
(EMA Dec 2018)
Summary:
The EMA has updated the Q&A website, with some new questions and answers.Question 11 below relates to the sponsor contracting third parties to conduct trial related duties on behalf of an investigator.
EMA更新了Q&A网站，并提供了一些新的问题和答案。 以下问题11涉及到申办方与代表研究者履行试验相关职责的第三方签署合同时的问题。
Question 11:Is it allowed that the Sponsor contracts third parties to conduct trial-related duties and functions that are clearly responsibility of the investigator?
是否允许申办方与履行试验相关的职责，且明确为研究者职责的第三方签署合同？
Answer:
The sponsor of a clinical trial may, in particular cases, consider it necessary to provide the investigational site with personnel to be involved directly in the conduct of the clinical trial. This is usually done by the Sponsor in order to provide additional resource to the trial site or personnel with particular experience or skill to conduct specific procedures of the trial. These personnel may consist of single individuals or of people belonging to a contracted company/organization. In both cases this “contracted personnel” is only employed for the purpose of the clinical trial under the responsibility of the investigational site/Principal Investigator/Institution.Particular consideration should be made when the “contracted personnel” is involved not only in administrative procedures but also in procedures that require direct and practical management of trial subjects which are tasks under the exclusive responsibility of the Principal Investigator.The GCP-IWG recognizes that a clarification about this practice is required to avoid misinterpretation of the requirements and non-compliance and in order to guarantee clear separation of roles and responsibilities between investigator and Sponsor and ensure their independence, in accordance with ICH-GCP principles.
临床试验的申办方，在某些情况下，可能认为有必要向研究中心提供直接参与临床试验的人员。 这通常是由申办者给研究中心提供额外的资源，或是具有特别经验或技能的可执行试验特定程序的人员。 这些人员可由个人或隶属于合同公司/组织的人员组成。 在这两种情况下，该“合同人员”仅由于研究中心/主要研究者/机构负责的临床试验的目的而被雇佣。 当“合同人员”不仅涉及行政管理程序，而且涉及进行直接和实际管理试验受试者的程序时，而这些是属于主要研究者专有的职责，应予以特别考虑。 GCP-IWG认识到，需要对这一做法作出澄清，以避免误解要求和不遵守规定，并确保研究者和申办方之间的角色和职责明确分开，并根据ICH-GCP原则确保其独立性。
In the recent revision of ICH-GCP (R2) the following points were added regarding this practice:
4.2.5 The investigator is responsible for supervising any individual or party to whom the investigator delegates trial-related duties and functions conducted at the trial site.
4.2.6 If the investigator/institution retains the services of any individual or party to perform trial-related duties and functions, the investigator/institution should ensure this individual or party is qualified to perform those trial-related duties and functions and should implement procedures to ensure the integrity of the trial-related duties and functions performed and any data generated.
在最近对ICH-GCP（R2）的修订中，关于这种做法增加了的以下几点说明：
4.2.5研究人员负责监督其委托的任何个人或一方在研究中心履行的与试验有关的职责。
4.2.6如果研究者/研究机构保留任何个人或缔约方履行与试验相关职责的服务，研究者/研究机构应确保该个人或缔约方有资格履行与试验相关的职责，并应执行程序以确保所履行的与试验相关职责和所产生的任何数据的完整性。
The Sponsor can contract directly some activities belonging to the Institution/Hospital e.g centralized analysis, archiving or central reading of image.
申办者可以就属于机构/医院的一些活动直接签署合同，例如集中分析，归档或中央阅读图像。
The Sponsor cannot delegate tasks related to the medical care of the subjects that are specific of the Investigator (e.g. IMP dispensing/administration, AE/SAE evaluation), because the Investigator is responsible for all the trial medical activities.
For this type of tasks, even if the Sponsor may need to be involved in the process of selection of the organization providing services and/or personnel (e.g. because the Institution and the clinical investigator site do not have resources for third parties selection), the contractual arrangements should not be made directly between the organization and the Sponsor.
A contract/written agreement should be in place between the Institution/Hospital/Investigator and the single individual(s) or the organization which will provide the service/personnel.
The contract between the Sponsor and the Institution/Hospital/Investigator should mention the involvement of this external organization or personnel. The contract should specify that the investigator is responsible for the oversight of the personnel of the external organization.
申办方不能将研究者特定的与受试者的医疗护理相关的任务（例如， IMP分发/管理，AE/SAE评估）委托给他人，因为研究者负责所有的试验医疗活动。
· 对于这类任务，即使申办方可能需要参与提供服务和/或人员的组织的选择过程（例如， 由于研究机构和临床研究中心没有第三方选择的资源），仍然不应直接在第三方组织和申办方之间进行合同签署。
· 机构/医院/研究者应与提供服务/人员的单个个人或组织之间订立合同/书面协议。
· 申办者与研究机构/医院/研究者之间的合同中应提及该外部组织或人员的参与。 合同中应明确，研究者负责对外部组织人员的监督。
The involvement of external parties should be submitted to and approved by the Ethics Committee before the start of the activities of “contracted personnel”, as required by local regulations.
根据当地法规的要求，外部各方的参与应在“签约人员”活动开始前提交并经伦理委员会批准。
Key Takeaways:
In particular on contracting an individual or party to perform trial-related duties and functions the following points should be fulfilled:
Considerations should be made to ensure the protection of subject confidentiality and the Informed Consent Form should reflect this point.
The personnel appointed for the procedure should be identified and its tasks should be documented on the contract/delegation log.
In general, relationship and communications between Principal Investigator and organization or personnel should be independent from the Sponsor and should not go through the Sponsor in order to guarantee the independence of clinical trial conduct.
关键信息：
特别是在签约个人或当事人履行与试验有关的职责时，应当履行以下几点：
应考虑保护受试者的机密性，知情同意书应反映这一点。
应明确任命执行该程序的人员，其任务应记录在合同/职责分工表上。
一般而言，为保证临床试验的独立性，主要研究者和组织或人员之间的关系和沟通应独立于申办者之外，不得由申办者批准通过。
References:
EMA Clarifies Sponsor Role In Contracting For Investigator Sites – Pink Sheet
4. EMA Releases Final Guideline on Trial Master Files
(EMA 06 Dec 2018)
Summary:
The EMA has released a final guideline on Clinical Trial Master Files (TMF), effective June 18, 2019.The legislation does not differentiate between paper and electronic TMFs (eTMFs).Therefore, all basic requirements are the same for both formats or when used in combination as a hybrid TMF.
EMA发布了临床试验主文件（TMF）的最终指南，该指南于2019年6月18日生效。指南没有区分纸质和电子TMF（eTMF）。 因此，对于两种格式或者当两者组合使用作为混合TMF时，所有基本要求都是相同的，。
This guideline is intended to assist the sponsors and investigators/institutions in complying with the requirements of the current legislation (Directive 2001/20/EC and Directive 2005/28/EC), as well as ICH E6 for GCP, regarding the structure, content, management and archiving of the TMF.
本指导原则旨在帮助申办方和研究者/研究机构遵守现行立法（指令2001/20/EC和指令2005/28/EC）以及GCP的ICH E6中关于TMF结构、内容、管理和存档的要求。
The guidance also applies to the legal representatives and contract research organization (CROs), which according to the ICH GCP guideline includes any third party such as vendors and service providers to the extent of their assumed sponsor trial-related duties and functions.
指导原则也适用于法定代表人和合同研究组织（CRO），即根据ICH GCP指导原则，包括任何承担申办方试验相关职责和职能的第三方，如供应商和服务提供商。
The main topics covered in the guideline are:
TMF Structure and Contents
Security and Controls
Scanning or transfers to other media
Archival and retention
指导原则涵盖的主要主题是：
TMF结构和内容
安全和管控
扫描或转移到其他媒介
存档和保存
Some differences from the draft Guideline:
Some content location has been rearranged to better align with topic headings
Specifies that when a CRO is used to manage the eTMF that appropriate pre- qualification checks should be performed prior to contracting the CRO.
Additional examples have been provided under essential document section (data management, statistics and delegation log)
Added a recommendation for periodic test retrieval of information to confirm the on-ongoing availability and integrity of the data.
Added a section describing certified copies and appropriate QC checks of theses copies
The section on validation of digitization and transfer process has been significantly shorted in the final version (no longer detailing the steps of validation)
与指导原则草案有一些不同：
对一些内容位置进行了重新安排，以更好地与主题标题保持一致
指明在使用CRO管理eTMF时，应在与CRO签署合同之前进行适当的预验证检查。
在基本文件部分（数据管理，统计和委托日志）下提供了其他示例
增加定期测试检索信息的建议，以确认数据的持续可用性和完整性
增加了关于核证副本的描述和适当QC检查这些副本的章节
最终版本中关于数字化和传输过程验证的部分明显缩短（不再详细说明验证步骤）
Key Takeaways:
This document finalizes the draft guidance released April 2017 which provides guidance for implementing and maintaining a TMF that complies with the regulatory requirements.
To ensure continued guidance once the EU Clinical Trial Regulation (536/2014) comes into application, this guidance already prospectively considers the specific requirements of the Regulation with respect to the TMF.
Documents and records in the TMF should collectively permit confirmation of compliance with the protocol and GCP and the integrity of data collected without the need for additional explanation from the sponsor, CRO or investigator/institution staff.
关键信息：
本文件最终确定了2017年4月发布的指南草案，该文件为实施和维护符合法规要求的TMF提供了指导。
为确保在EU临床试验法规（536/2014）实施后继续提供指导，本指导原则已预先考虑了法规对TMF的具体要求。
TMF中的文件和记录应可共同确认对研究方案和GCP的依从性以及所收集数据的完整性，无需申办者、CRO或研究者/研究机构工作人员的额外解释。
References:
EMA Unveils Revised Final Guideline on Clinical Trial Master File – RAPS
5. Guidance on Good pharmacovigilance practice (GPvP)
(MHRA 28 Jan 2019)
Summary:
The MHRA has updated their Guidance on Good pharmacovigilance practice (GPvP)with information on how to prepare for an inspection.
MHRA已经更新了关于良好药物警戒实践（GPvP）的指南，其中包含如何准备检查的信息。
Step 1: Inspection notification
The majority GPvP inspections are announced and are typically scheduled on a quarterly basis. As part of the inspection notification, the pharmacovigilance system master file (PSMF) will be requested. The MAH must acknowledge they have received the notification and provide details of the relevant contact person for future correspondence about the inspection.
Although rarely done, MHRA GPvP inspectorate can arrive at, and enter UK sites relating to the conduct of pharmacovigilance activities without notifying the MAH first. In this instance, on arrival at site the lead inspector will identify the most appropriate person on site as a point of contact and will explain the purpose and logistics of the inspection.
第一步：检查通知
大多数GPvP检查都是事先公布的，通常按季度安排。 作为检查通知的一部分，将要求提供药物警戒系统主文件（PSMF）。 上市许可证持有人（MAH）必须告知他们已收到通知，并提供相关联系人的详细信息，以便将来与检查有关的沟通联系。
· 虽然很少这样做，但MHRA GPvP检查员可以在不事先通知MAH的情况下到达并进入进行药物警戒活动有关的英国现场。在这种情况下，到达现场后，首席检查员将在现场确定最合适的联系人，并将解释检查的目的和后勤安排。
Step 2: Pre-inspection documents
Prior to the inspection the lead inspector will contact the MAH and QPPV and provide the draft plan as well as any specific requirements of the team.
MAHs can expect to receive requests for documentation prior to the inspection and throughout.
They expect any documents listed in the PSMF to be readily available for inspection. This includes (but is not limited to):
procedural documents (such as SOPs, working instructions and guides)
outputs from pharmacovigilance activities such as safety review meeting minutes
documented product safety reviews
audit risk assessments
agreements in place with partners and service providers
第二步：检查前文件
· 在检查之前，首席检查员将联系MAH和QPPV，并提供计划草案以及团队的任何具体要求。
· MAH在检查之前和整个过程中都可能收到提交文档的要求。
· 检查员希望PSMF中列出的任何文件都可以随时查阅。 这包括（但不限于）：
程序性文件（如SOP、工作说明和指南）
药物警戒活动的输出结果，如安全性审查会议记录
产品安全性审查的记录
稽查风险评估
与合作伙伴和服务提供商达成的协议
Step 3: Inspection location
To achieve the objectives in reviewing the pharmacovigilance system, inspectors will aim to be flexible with the plan and to accommodate changes as required, if possible. It is always preferable to conduct face to face interviews, however the inspection team can accommodate interviews by telephone if interviewees are unable to attend the site, provided facilities are adequate to support this.
Remote inspections
Routine and triggered inspections may be conducted by inspectors remotely. These inspections are conducted through review of requested documents including evidence to support pharmacovigilance activities and submissions. The document review is supplemented with telephone interviews.An onsite inspection may be triggered following the remote inspection, should any significant non-compliance or concerns that require further investigation be identified.
第三步：检查地点
为了实现审查药物警戒系统的目标，检查员的目标是对计划保持灵活性，并尽可能根据需要进行修改。最好进行面对面的访谈，但是如果受访者无法出席现场，在设施足以支持的情况下，检查组可以通过电话进行访谈。
远程检查
常规和触发检查可由检查员远程进行。 这些检查是通过审查要求的文件，包括支持药物警戒活动和申报资料的支持文件。 文件审查与电话访谈互为补充。 如果发现需要进一步调查的任何重大不合规或担忧，远程检查后可能会触发现场检查。
Key Takeaway:
The MHRA has added this information to their guidance page in order to increase transparency about how companies are notified of an inspection and what a company's next steps should be once the MAH receives a notice of inspection.
关键信息：
MHRA已将此信息添加到其指导页面中，以提高透明度，包括关于如何向公司传达检查通知，以及一旦MAH收到检查通知，公司应该采取的下一步行动。
6. Optimizing Mobile Clinical Trials by Engaging Patients and Sites.
(CTTI 21 Feb 2019)
Summary:
The Clinical Trials Transformation Initiative (CTTI) has released recommendations on Optimizing Mobile Clinical Trials by Engaging Patients and Sites. The patient-focused recommendations in this document apply to all trials using mobile technologies, from traditional to fully decentralized.The recommendations in this document emphasize considerations that are unique to or particularly important for trials that incorporate mobile technologies.
临床试验转化计划（CTTI）发布了通过吸引患者和研究中心来优化移动临床试验的建议。 本文件中以患者为中心的建议适用于所有使用移动技术的试验，从传统模式到完全分散的模式。 本文件中的建议强调了对于纳入移动技术的试验而言独特或特别重要的考虑因素。
They are designed to assist research sponsors in:
Engaging patients and sites in planning clinical trials using mobile technology, including protocol design, technology selection, and pilot testing.
1. Engage patients and investigative site personnel early and often in planning clinical trials using mobile technologies.
2. Select mobile technologies based on requirements of the study and needs of the intended user population, starting with the aspect or experience that the assessment is intended to measure.
3. When planning a trial using mobile technologies, identify and conduct necessary feasibility and/or pilot studies with sites and a representative patient population.
建议旨在帮助研究发起人：
让患者和研究中心参与使用移动技术计划临床试验，包括方案设计，技术选择和试点测试。
1. 尽早并经常吸引患者和研究者参与计划使用移动技术的临床试验。
2. 从评估计划测量的方面或经验开始，根据研究的要求和预期用户人群的需求选择移动技术。
3. 在计划使用移动技术进行试验时，确定并进行必要的可行性和/或与研究中心和有代表性的患者人群开展试点研究。
Maximizing value and minimizing burden for study participants, including recommendations for setting participant expectations, protecting privacy, returning individual data, enhancing participant-site interactions, and providing technical support.
1. The informed consent process should involve an ongoing, interactive conversation with participants.
2. Account for patients’ health literacy and technical literacy in all communications.
3. Be prepared to collaboratively identify and evaluate privacy risks.
4. Ensure participants understand the implications for their privacy and confidentiality of the mobile technologies used.
5. Set clear expectations with participants about safety monitoring during the trial.
6. Provide participants with easy access to technical support.
7. Be mindful that mobile technologies can change the way sites and participants interact during a trial.
8. Identify ways to return value to participants throughout the trial, including return of outcomes data collected by mobile technologies.
最大化研究参与者的价值并最小化负担，包括设定参与者期望，保护隐私，返回个人数据，加强参与者-研究中心互动以及提供技术支持的建议。
1. 知情同意过程应该涉及与参与者进行持续的交互式对话。
2. 在所有的沟通交流中对参与者的健康素养和技术素养予以说明。
3. 做好准备，合作识别和评估隐私风险。
4. 确保参与者了解所使用的移动技术对隐私和保密性的影响。
5. 对参与者在试验期间的安全监查设定明确的预期。
6. 为参与者提供方便轻松的技术支持。
7. 注意移动技术可以改变试验期间研究中心和参与者的互动方式。
8. 确定在整个试验期间向参与者返回价值的方法，包括返回移动技术收集的结果数据。
Addressing challenges for investigative sites, from contracting and budgeting recommendations, to evaluating site readiness for mobile clinical trials and implementing effective and streamlined training.
1. Clearly delineate responsibilities and consider alternate payment structures in contracts.
2. Be prepared for the additional time and cost required to incorporate mobile technology into clinical trials.
3. Ensure sites have appropriate infrastructure to conduct mobile clinical trials.
4. Develop effective training modules for site staff around selected mobile technologies.
5. Streamline and standardize training across sponsors.
6. Put plans and policies in place to handle technology issues, malfunctions, and loss.
应对研究中心的挑战，从合同和预算编制的建议，到评估研究中心对流动临床试验的准备情况，以及实施有效和简化的培训。
1. 明确界定责任并考虑合同中的替代付款结构。
2. 准备将移动技术纳入临床试验所需的额外时间和成本。
3. 确保研究中心有适当的基础设施进行移动临床试验。
4. 针对选定的移动技术为研究中心工作人员开发有效的培训模块。
5. 精简和标准化申办方之间的培训。
6. 制定计划和政策来处理技术问题，故障和损失。
Key Takeaways:
· New recommendations on Engaging Patients and Sites have the potential to help sponsors, CROs, and other stakeholders gain the full benefits of using mobile technologies in clinical trials, including remote participation, increased protocol adherence, and participation by a more diverse population.
· The recommendations are intended to complement other CTTI recommendations in the Mobile Clinical Trials (MCT) Program, which also includes projects focused on Novel Endpoints, Mobile Technologies, and Decentralized Clinical Trials.
关键信息：
· 关于吸引患者和研究中心的新建议有可能帮助申办方，CRO和其他利益相关者在临床试验中获得使用移动技术的全部益处，包括远程参与，增加方案依从性以及更多样化人群的参与。
· 这些建议旨在补充移动临床试验（MCT）计划中的其他CTTI建议，其中还包括关注新型终点，移动技术和分散临床试验的项目。
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