Research

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Protocol Development

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The Experimental Therapeutics & Interventional Trials (ET/IT) Center at Boston Children’s Hospital has the resources and expertise to help you design an outstanding clinical trial.

After you request a meeting with ET/IT Center, we can help you fine-tune objectives, hone research questions and hypotheses, assess the feasibility of the study, identify collaborators and arrange consultations. We are particularly interested in working with junior investigators and their mentors to help design the best possible studies.

The Navigator Program, sponsored by the ET/IT Center, is a concierge-like service offered to expedite the planning, implementation, and completion of interventional trials. The Navigator Program is customized to you and your study but uses standardized processes, tools, templates, and guidelines.

At a glance: Quick links to clinical trial resources

The ET/IT Center can help connect you to the wide variety of clinical research resources available at Boston Children’s and in the Longwood Medical Area.

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Consult clinical research experts

The Biostatistics and Quantitative Sciences Center can help you design your experiment, develop the measurement plan, relate the analysis to your objectives, plan and/or conduct analysis and interpret your results. Involve a biostatistician early in your study planning process. Check with your manager to see if there is a dedicated biostatistician for your division/department. If you are working with a nurse scientist, he or she can connect you with the biostatistician. If you do not have access to a dedicated biostatistician, complete this on-line request to be matched with one.

The Clinical Research Information Technology (CRIT) provides leadership and innovative information technology services to clinical investigators at Boston Children’s. CRIT shares technical skills and resources, enhances collaboration and improves the efficiency of clinical research applications development. Currently, CRIT can provide a variety of technical solutions to you, including systems for clinical trials data management (REDCap and InForm) and subject randomization.

The Investigational Drug Service provides comprehensive investigational drug services including inventory management, drug accountability, and assistance with research protocol development, blinding, randomization and drug formulation. If you’re planning on utilizing a study drug, please seek consultation with Rocky Anzaldi, R.Ph., early in the process of designing your research study.

The Intellectual Property, Technology, and Innovation Development Office (TIDO) can offer guidance if you’re developing a new therapy, diagnostic, or device. TIDO works with you to translate Boston Children's research and clinical ideas into new therapies, diagnostics, and devices through the protection and licensing of intellectual property. TIDO can also connect you with industry partnerships, when appropriate.

Build your team

You may have questions about who should make up your study team, i.e. a study coordinator, a research nurse or both? We can help. If you’re conducting an FDA regulated trial, the finalized FDA document provides guidance to investigators regarding the delegation of research responsibilities. Should there be an audit, this is the standard to which investigators are held during a FDA regulated research study.

Study Conduct Phase
Study Closeout and Analysis

 

Get investigator training

Boston Children’s requires specific training for clinical investigators and their study teams including the Collaborative Institutional Training Initiative (CITI) Basic Biomedical Research for Investigators and Key Personnel training course. You will need an active CITI certification on file in order to participate in research.

If you are a new PI or a PI transitioning to Boston Children’s from another center, you are required to meet with the ET/IT Center to review Boston Children’s policies and procedures. This meeting is required before the Institutional Review Board (IRB) can give final approval to a study. In addition, the Office of Sponsored Programs (OSP) has specific training requirements for Principal Investigators (PIs) that must be completed before a new PI is awarded a grant number.

Boston Children’s accepts any of the following three courses to satisfy its Good Clinical Practice (GCP) training requirement:

  1. CITI online GCP training courses
  2. GCP training offered by NIH Institutes, including NIAID and NIDA.
  3. Any of the the TransCelerate-recognized GCP courses

It is advisable that you complete these training requirements as early on in the process as possible, to prevent delays in receiving grant awards or IRB approval.

Harvard Catalyst provides additional training and education resources.

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Navigate regulatory requirements

An essential part of conducting research is ensuring your study is compliant with federal, state, local and hospital regulations and policies. Depending on the type of research that you are conducting, different types of regulatory review and approval must be granted before you begin.

It may be necessary for you to file an application with the FDA for an investigational new drug (IND) or investigational device exemption (IDE).

An IND application is required if you are conducting research to change current indications, approved dosing, or existing labeling for a drug that is already on the market, or to get FDA approval for a new drug. IDEs are required for investigational devices that have significant risks, will be implanted in patients, or that will be used to support or sustain life. For more information, please visit the Boston Children's Regulatory site.

Boston Children’s has resources to help you determine whether you will need to file an IND/IDE, and to help you do so if needed. The IND/IDE Review Group (IIRG) has been created to bring together available resources at Children’s that facilitate the IND/IDE submission, approval and study initiation processes, and to support the investigator in the conduct of the study.

You must register clinical trials and submit summary results to ClinicalTrials.gov. In addition, the International Committee of Medical Journal Editors (ICMJE) requires trial registration in order for research results generated by a clinical trial to be published. Boston Children’s offers guidelines and policies to help you register your trial correctly.

Studies involving human subjects require you to develop a data safety monitoring plan. Some studies require the investigator to develop a data safety monitoring board.

A study regulatory binder will be key to storing and organizing required or useful study documents and correspondence. An up-to-date regulatory binder facilitates the effective and efficient management of studies and may decrease procedural errors, and may also maintain continuity in the event of staff changes. Study regulatory binders are not required, but are considered best practice and are highly recommended. While the entire research team should be familiar with your study regulatory binder, one (or two) person(s) should be designated to maintain and update it.

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Budgets, contracting and funding

Securing funding and finalizing a study’s budget is a critical, but challenging, step in the lifespan of a clinical trial.

The Clinical Trials Business Office (CTBO) oversees contract and budget development and negotiation for industry-sponsored clinical trials, investigator-initiated studies, and other sponsored clinical research, regardless of the source of funding. The CTBO manages the business requirements of engaging in clinical research at Boston Children’s, including making insurance coverage determinations, coordinating charges for routine- and research-related care, invoicing sponsors, and ensuring compliance with state and federal billing regulations.

Funding opportunities are available through the Office of Sponsored Programs (OSP). Compile all application materials and submit them to a grant officer at OSP for institutional review and approval. Make sure to complete your PI assurance form, the conflict of interest form, and other required documents found at the OSP website. Please note that it can take upwards of two weeks for the OSP to review, approve, and forward your application.

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Submit study protocol

Your study protocol is the master document that defines, in detail, your plan for proposed research. It serves to define the primary aims of your study and provides the blueprint for how the research will be conducted. There are several available resources to help you through this step:

Boston Children’s protocols are required to undergo Departmental Scientific Review at the Departmental/Divisional level. Your protocol is automatically submitted to your division for review when you submit your IRB application through CHeRP.

It is common that the IRB review will respond with questions, comments and suggestions intended to strengthen your study and ensure optimal participant safety. Your study cannot begin until you have addressed all questions/concerns from the IRB review(s) and your responses have been approved by the IRB. The IRB will notify you when your study is released for implementation.

Study Conduct Phase
Study Closeout and Analysis

 

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* To access this service you must be on the Boston Children's network or logged in through VPN.

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