Study Setup | | Boston Children's Hospital

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 (Biomedical Engineering, Nursing, Radiation Safety, etc.).
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.
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. Find additional information and optional training.
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 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.
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.
Departmental/Divisional review	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.
Optional scientific review	An optional free and confidential scientific review for therapeutic trials 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 Cindy Williams to learn more about this scientific 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 the Boston Children's ClinicalTrials.gov policy to understand registration and reporting requirements.

Create study documents

Regulatory tools and templates	Access regulatory tools and templates.
Create electronic shared folder for study documents	Establishing a shared electronic folder such as a SharePoint site can help the investigator and the study team maintain organized study documents that are accessible to all team members. The Clinical Research Information Technology (CRIT) team can help create electronic shared folders for study 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. Finally, the MOO serves as the SOP reference that study monitors and auditors use during QC site visits or audits. The study MOO may be maintained in hard copy or electronic format. Download guidelines for developing the MOO.
Create regulatory binder	The Regulatory Binder is a template and guidance document for tracking documentation associated with studies involving human subjects. It is designed to help study sites achieve and maintain regulatory compliance and adhere to high standards of practice in the conduct of research involving human subjects.
Determine process for tracking study-related charges	Investigators should contact the Clinical Trials Business Office (CTBO) to establish an electronic process using EPIC for tracking and reconciling study-related charges at the end of each study visit.

Create data management plan

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

Developing a data management plan guideline	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 the Boston Children's policy for study document retention and storage	Please review the Boston Children's policy regarding study record retention and storage to ensure compliance.

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	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.