ICCTR Services | Overview
Biostatistics & Research Design
We provides biostatistical and methodological expertise and scientific leadership through collaborative relationships with Boston Children's investigators.
Our services include:
- full biostatistical project support, tailored to your study and resources
- long-term collaborations with our faculty researchers
- study design and grant preparation, including power and sample size
- short-term consultations with our staff
Learn more about our biostatistics and research design services.
Case Report Form Design
ICCTR staff can provide templates for and/or assist in the development of case report forms to allow for efficient and consistent data collection and to facilitate the development of a study database based on the study protocol.
Clinicaltrials.gov Support
We are available to assist investigators with Clinicaltrials.gov requirements.
Data & Safety Monitoring
Study monitoring services are available for investigators in need of independent data monitoring at an economical price.
IND/IDE Consultation & Support
We are prepared and available to support investigators who are planning to conduct a clinical research study where the investigator will hold an IND or IDE. In addition, we are available to support investigators planning to conduct multi-institutional pediatric clinical trials.
IRB Pre-Review
We offer a voluntary protocol review hat is designed is to strengthen protocols for interventional trials in terms of scientific rigor, study design, compliance with research regulations and feasibility.
Navigation Services
We offer a navigation service specifically designed to move basic science concepts into early phase clinical research studies. This service was built on the hypothesis that having an expert and experienced interventional clinical research team to coordinate and integrate the appropriate resources in a structured approach could expand opportunities for, and accelerate translational research by:
- lowering the barriers for investigators to develop human subjects protocols and for physician scientists conducting interventional trials
- providing practical and comprehensive education in the principles of good clinical practice (GCP) to investigators and study teams
- providing an experienced, trained, and certified interventional trials team
- speeding IRB and other regulatory approval (i.e. FDA)
- enhancing scientific quality
Learn more about our navigation services.
Project Management & Study Initiation
ICCTR staff can serve as overall project manager and also a study coordinator to work closely with the PI to plan study start-up and serve as front line manager for all aspects of study implementation. ICCTR project managers will supervise study staff, coordinate across departments and divisions within Boston Children's and across hospitals for those studies operating at multiple locations.
ICCTR staff can also provide templates for and also assist in the development of case report forms to allow for the efficient and consistent data collection and to facilitate the development of a study database based on the study protocol.
Regulatory Affairs
One of the major challenges that researchers face when beginning a clinical research project, is navigating through the regulatory approval process. An essential part of responsibly conducting research is ensuring that your study is in compliance 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 your project. If you have any questions about regulatory process for your clinical research project, contact Deborah Stapleton.
Survey Design & Management
Survey and questionnaire design
ICCTR staff advises investigators on all aspects of survey design, including determining the appropriate sampling procedure, selecting the data collection method (i.e., in-person or telephone interviews, mail surveys, web surveys) and determining detailed survey implementation features. Questionnaires can be reviewed with regard to their design and the wording of the questions. If new measures need to be created, ICCTR staff can advise investigators on how to establish reliable and valid measures. In accordance with best survey practices, all changes are made to minimize survey errors (sampling, coverage, nonresponse, measurement, and processing errors).
Web-based surveys
ICCTR staff provides guidance to investigators with regard to the implementation of web-based surveys. Based on the complexity of the survey ICCTR staff can recommend different web survey software for programming web surveys. ICCTR has also staff available to program web surveys. As with CRFs, these surveys must meet a minimal design standard for ICCTR programming services.
Survey data analysis
In general, ICCTR staff can help prepare quality-control and survey implementation reports including descriptive tables, graphs, and other statistical analyses. All report methods are current with best practices in survey research. In case the survey protocol included complex sampling methods (strata and clusters), ICCTR staff can perform statistical analyses that account for the complexity of the sampling methods to guarantee efficient estimates. Depending on the amount of data available for respondents and non respondents, we can provide non-response bias analyses.