Research|研究设置

StartIRB应用

CHeRP(Children's Hospital Electronic Research Portal) is an electronic gateway, provided by the Research Administration Office, for the submission, review, approval and tracking of research protocols at Boston Children’s Hospital. CHeRP allows researchers to complete all required IRB protocol forms online and move protocols through all required reviews electronically, including scientific review, department/division sign-off, IRB pre-review, IRB review and any necessary ancillary reviews (Drug and Device, Nursing, Radiation Safety, etc.).

Additional and optional Clinical Research Operations Center scientific review

ICCTR提供了针对研究人员发起的临床研究的可选的免费和机密科学评论。审查的目的是通过预测和解决IRB审查期间要提出的问题来增强研究的科学严谨性，并加快IRB审查。接触Leah Chengto learn more about this scientific review.

审查同意/同意政策

知情同意是参加研究的自愿协议。这不仅是签署的文件，而且是主题了解研究及其风险的过程。在执行任何研究程序之前，获得知情同意是必不可少的。同意被定义为儿童的肯定协议，以参与研究。阅读有关波士顿儿童IRB的指南consent and assent.

制定知情同意/同意文件

寻找知情同意模板这符合2019年的共同规则。

确定是否需要IND/IDE

与研究法规支持，教育和质量办公室的监管专家的讨论可以帮助辨别研究是否需要研究新药（IND）或调查装置豁免（IDE）。要安排监管咨询，请联系Ashley Kuniholm, research regulatory affairs coordinator.

Organize data safety monitoring board/data safety monitoring plan

Studies involving human subjects may require the sponsor-investigator to develop a data safety monitoring plan (DSMP) to oversee human subjects’ safety. Some studies require the sponsor to develop a data safety monitoring board (DSMB), an independent group of experts who oversee the trial.Download a DSMB charter template.

Organize a study team

When organizing a study team, investigators need to consider the array of study activities that need to be completed. Careful consideration must be given to activities that require licensure. Refer to theDelegation of Authority gridfor a list of both common study activities and categories of staff that are eligible to conduct the activities, based on compliance with FDA guidance, Massachusetts state law and Boston Children's policies.

项目管理与学习协调

项目管理与学习协调are offered through the ICCTR. Project management is a customized approach to study management, guidance and education. Study assistance is based on the complexity of the study and investigator experience. Hours of highly-trained clinical research professionals can be purchased rather than an investigator independently hiring and training study staff. For further information, please contactCindy Williams, DNP, RN, PNP, NE-BCICCTR临床研究操作中心联合导演；护理总监ETU。

Confidentiality plan

主题机密性是指保护数据免受未经授权的披露。IRB要求调查人员制定确保主题机密性的计划。保密证书有助于研究人员保护人类研究参与者的隐私，该参与者参加了生物医学，行为，临床和其他形式的敏感研究。证书可以防止强制性法律要求，例如法院命令和传票，以确定研究参与者的信息或特征。

Privacy plan

隐私是指个人控制其数据的权利，而不是将其违背其意愿透露透露。IRB要求调查人员描述将采取的步骤来保护和确保主题的隐私。

IRB/CHeRP application

首席调查人员通过CHeRP, an electronic gateway provided for the submission, review, approval and tracking of research protocols at Boston Children’s.

科学审查通过首席调查员/部门

After an investigator’s IRB application has been submitted in CHeRP, it is automatically routed to the investigator’s home department or division for scientific review. Please note, for studies using the Clinical Research Operations Center and/or the ETU, investigators will need to submit an application through Harvard Catalyst, which serves as Scientific Review. Select “Request CRC Services (Protocol Review)。”

Clinicaltrials.gov

Trial registration and results reporting promote the public good by ensuring the existence, design and results of clinical trials are publicly available. Please review theBoston Children's ClinicalTrials.gov policyto understand registration and reporting requirements.

Regulatory tools and templates

Accessregulatory tools and templates.

开发研究文件的存储系统

Establishing a Boston Children’s compliant shared document platform such as a SharePoint site can help the investigator and the study team maintain organized study documents that are accessible to all team members.临床研究信息学技术（CRIT）can create a blank SharePoint site for the study team to build and store documents.

Create Manual of Operations (MOO)

研究的操作手册(MOO)是一个文档啊r a compilation of documents that describe in complete detail the science, methods, and procedures for implementation of a clinical research study. The MOO is an essential tool that promotes accuracy and consistency in study implementation across different study sites and across all research staff over time. It serves as the primary reference guide used for staff training prior to study start-up, throughout study implementation and for staff training whenever turnover occurs.

创建调节活页夹

侵入性管理系统（EREG）is an electronic regulatory binder maintenance system used to collect and manage protocol, staff, and institution documentation. eReg supports 21 CFR Part 11 compliant document management and approval of documents using electronic signatures. eReg allows users to store essential protocol documents, staff credentials, and organizational regulatory tracking documents and share documents between protocols. Documents that require signatures can be routed for electronic signature, and users receive notifications when their electronic signature is required.

制定数据管理计划

A Data Management Plan (DMP)is a written document that describes the data to be acquired or generated during the course of a research study, how the data will be managed, described, analyzed, and stored. The mechanisms that will be used at the end of the study to share and preserve the data are also described in the DMP.

Review theIRB research blood drawing guideline

The Boston Children’s IRB has provided this guideline for investigators to consider when designing a protocol that involves drawing blood from human subjects for research purposes.

创建研究顺序集

Clearly written study orders are essential to ensure accurate study implementation. There are locations in Boston Children’s that use paper orders, others that strictly use PowerChart and still other areas that work from a combination of paper and electronic orders. When you develop order sets, it is highly recommended that you work with a nurse from the clinical area where the study will be conducted.

Establish procedure for screening and enrolling patients

创建一个详细的系统来筛选和注册研究主题非常重要。向医师和护士同事告知研究研究很重要。他们通常可以帮助累积研究科目，并帮助通过在临床环境中启动研究的后勤工作。