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Regulatory Support | Overview

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Regulatory support is provided by the ICCTR Office of Research Regulatory Support, Education and Quality (ORRSEQ). Regulatory tools, templates, SOPs and policies are available to help sponsor-investigators navigate the complex pathways that today accompany clinical and translational research. The regulatory support provided is central to the organization’s commitment to clinical research compliance with Good Clinical Practice, Massachusetts law, institutional policies and government regulations.

Sponsor-investigator support services

One of the major challenges that researchers face when beginning a clinical research project is navigating the regulatory approval process. An essential part of the responsibility of conducting research is ensuring that a study is in compliance with federal, state, local and hospital regulations and policies. Available services include but are not limited to:

  • Early Regulatory Strategy Development: Early interaction with regulatory staff is encouraged as a means to develop a regulatory strategy that is appropriate for the complexity of the research project.
  • Preclinical Testing and GMP Manufacturing:  Regulatory guidance and support is available to research teams developing and executing preclinical studies or manufacturing investigational products.
  • Regulatory Submissions and Maintenance:  Full preparation, submission and maintenance of regulatory applications to the FDA is available at the sponsor’s request.
  • FDA Meetings and Inspections: ORRSEQ staff is available to prepare, schedule and facilitate meetings with the FDA. Also, ORRSEQ staff is available to help prepare sponsor-investigators and their study teams for FDA inspections. This information sheet details the available resources and services for preparing for an FDA inspection. Furthermore, ORRSEQ staff can assist with the implementation of responses to audit findings.
  • Regulatory Education: Regulatory education and training for investigators, trainees and study staff is available upon request.
  • Study Monitoring: Study monitoring is an important component of study conduct in FDA-regulated clinical research. It ensures compliance with the protocol, Good Clinical Practice, state, federal and local regulations, and institutional policies. Also study monitoring offers protection to the Sponsor-Investigator and the institution. In many cases, a developed study monitoring plan is a required element of NIH grant applications. Study monitoring begins in the protocol development phase when a monitoring plan is developed and monitoring continues through to study close-out. Please see below for more information about monitoring services available through ORRSEQ.

Monitoring services

ORRSEQ offers monitoring services for the Boston Children’s Sponsor-Investigators in need of independent monitoring. Study monitors are experienced clinical research professionals who have completed competency-based monitoring training. The number of staff that monitors studies is small. Therefore, studies are monitored on a first-come, first-served basis. If Boston Children’s personnel are not available to monitor a study, the names of experienced individual monitors or contact information for companies that offer monitoring is provided. ORRSEQ uses a risk-based approach to monitoring, which is a common practice in clinical research in the United States. Risk-based monitoring assesses all risks related to a study, which informs the development of a proper plan for risk management, including systematic monitoring and controlling/mitigating risks through the conduct of the study. The intensity and frequency of monitoring varies across studies and among sites depending on the phase of the trial, complexity of the protocol, disease being evaluated, experience of the investigator and study team, number of subjects enrolled, site performance, and sponsor monitoring SOPs. Likewise, the number and location of sites and rate of enrollment are considered when monitoring a study.

The monitoring cost is dependent on elements such as the phase and complexity of the trial, risk posed to human subjects, number of sites, and number of enrolled subjects. The monitoring services that are offered to Boston Children’s sponsor-investigators are intended to be a service. The pricing has been structured to be as economical as is feasible. The rate for study monitoring is $90.00 per hour. The costs include: development of the monitoring plan, time spent conducting the monitoring visits, report preparation, and time to meet with sponsor-investigators and study teams to review the findings and develop corrective action plans, where needed. Sponsor-investigators are also responsible for the costs associated with travel for monitoring multi-center studies. The monitoring staff will work with sponsor-investigators to create a monitoring budget. To discuss study monitoring for your protocol, please contact Maggie Malsch.

Regulatory tools & templates

Explore tools and templates to help you manage regulatory documentation for your research study.

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Regulatory support contacts

Ashley Kuniholm

About the ORRSEQ

The ORRSEQ serves as a resource for the clinical research community at Boston Children’s Hospital. The ORRSEQ staff provides investigator support and operational assistance for FDA-regulated studies and studies where the investigator serves as the sponsor.

Our quality plan

Consistent with the shared values of Boston Children's Hospital, quality and safety are a top priority of the ICCTR leadership and staff. The quality plan is a foundational structure of the ICCTR providing a dynamic framework for the ongoing assessment and improvement of ICCTR services. The plan ensures investigators, study subjects and families, institutional leaders, and regulatory agencies that the ICCTR leaders and staff are committed to providing the highest level of clinical research support and to continuously striving to improve the services provided to the Boston Children's clinical research community.

Performance is measured through key indicators related to scientific rigor, data quality and integrity, compliance with Good Clinical Practice (GCP), subject safety, regulatory compliance, cost measures, and investigator satisfaction. Continuous quality improvement is, in part, driven by leadership, mentorship and staff advocacy, along with a heavy emphasis on staff education and certification. The ICCTR’s quality measures focus on structures, processes and outcomes that have a demonstrated relationship to positive study conduct and outcomes.

Education for the Boston Children's clinical research community

The ICCTR provides education and mentoring to the Boston Children's clinical research community on research principles, design, methods and study implementation best practices. The ICCTR aims to provide an integrated, useful, scientifically accurate and comprehensive educational curriculum with course offerings that are designed to enhance the quality of clinical research at Boston Children's and prepare for the future, as the institution increases the volume of translational and early phase studies.

The staff of the ICCTR is a consolidated group of research professionals who are knowledgeable and skilled in all aspects of clinical research, including biostatistics, database development and data management, study startup, study navigation and operations, research regulatory support and project coordination. ICCTR staff, investigators, clinical research professionals, members of the ICCTR Education Committee and content experts from inside and outside the institution participate in the development and delivery of the annual Boston Children's clinical research educational curriculum.