Current Environment:

Study Setup | Overview

Initiate early study activities

Start IRB application

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

An optional free and confidential scientific review for investigator-initiated clinical research is offered through the ICCTR. The intention of the review is to enhance the scientific rigor of the study and expedite IRB review by anticipating and addressing issues that stand to be raised during IRB review. Contact Leah Cheng to learn more about this scientific review.

Review consent/assent policy

Informed consent is a voluntary agreement to participate in research. It is not merely a document that is signed, but it is a process in which the subject understands the research and its risks. Obtaining informed consent is essential before any research procedure is performed. Assent is defined as a child’s affirmative agreement to participate in research. Read Boston Children’s IRB guidelines on consent and assent.

Develop informed consent/assent documents

Find informed consent templates that comply with the 2019 Common Rule.

Determine if IND/IDE is required

A discussion with a regulatory specialist from the Office of Research Regulatory Support, Education and Quality can help discern if a study requires an Investigational New Drug (IND) or Investigation Device Exemption (IDE). To arrange a regulatory consultation, contact 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 the Delegation of Authority grid VPN symbol for 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.

Project management and study coordination

Project management and study coordination 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 contact Cindy Williams, DNP, RN, PNP, NE-BC, co-director, ICCTR Clinical Research Operations Center; nursing director, ETU.

Confidentiality plan

Subject confidentiality refers to protecting data from unauthorized disclosure. Investigators are required by the IRB to create a plan for ensuring subject confidentiality. A Certificate of Confidentiality helps researchers protect the privacy of human research participants enrolled in biomedical, behavioral, clinical and other forms of sensitive research. Certificates protect against compulsory legal demands, such as court orders and subpoenas, to identify information or characteristics of a research participant.

Privacy plan

Privacy refers to the right of an individual to control their data and not to have it divulged by others against their wishes. The IRB requires investigators to describe the steps that will be taken to protect and assure the privacy of the subject.

Submit study protocol

IRB/CHeRP application

Principal investigators submit their protocol application through CHeRP, an electronic gateway provided for the submission, review, approval and tracking of research protocols at Boston Children’s.

Scientific review through the principal investigator’s department/division

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).”

Trial registration and results reporting promote the public good by ensuring the existence, design and results of clinical trials are publicly available. Please review the Boston Children's policy VPN symbol to understand registration and reporting requirements. 

Create study documents

Regulatory tools and templates

Access regulatory tools and templatesVPN symbol

Develop storage system for study documents

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. Clinical Research Informatics Technology (CRIT) can create a blank SharePoint site for the study team to build and store documents.

Create Manual of Operations (MOO)

A study Manual of Operations (MOO) is a document or 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.

Create regulatory binder

Advarra eRegulatory Management System (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.

Create data management plan

Planning your data capture and storage is an essential component of study implementation.

Develop a Data Management Plan

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. 

Plan for subject clinical management

Participants enrolled on clinical trials must receive the same high-quality care found elsewhere at Boston Children’s. There also are specific Boston Children’s policies in place to protect study subjects, such as the IRB’s Research Blood Drawing Guideline. Communication and coordination with subjects’ clinical care team improves study compliance and supports patient safety.

Review the IRB research blood drawing guideline VPN symbol 

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.

Create study order set(s)

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

It is very important to create a detailed system for screening and enrolling study subjects. Informing physician and nurse colleagues about research studies is important. They can often help accrue study subjects and help work through the logistics of launching a study in a clinical environment.