The CRC provides core services in areas that are outlined in greater detail below. Some require funding and some are provided at no cost. Click here for a list of our free vs. reimbursed services. CRC Menu of Services.
Protocol/Grant Proposal Development
CRC staff can review protocols and grants to ensure that the study aims and objectives are well defined, measurable and feasible within the proposed study design and that the methods proposed are appropriate.
CRC staff also work collaboratively with investigators in the development of grant applications and contribute to the writing of various sections including research aims, data collection and data management methods, sample size and power, and statistical analysis methods and interim monitoring. CRC staff efforts toward implementation of the project would be ordinarily included in the budget proposal for the grant.
CRC staff can provide advice on the most efficient, valid, and feasible study design (cohort, case control, prospective, retrospective, cross sectional, randomized clinical trial, etc.) to achieve the aims as well as advice on selection of the sample from the target patient population, choice of control group(s), strategies for recruitment and retention, data collection methods, forms and database design, randomization and stratification procedures, data and safety monitoring procedures, and quality control procedures.
Cost Impact/Effectiveness/Health Economics Research Design
CRC staff advises on how to design rigorous economic evaluations including cost impact, cost-effectiveness, cost-benefit analysis and other types of economic evaluations of health care programs, policies and clinical interventions.
Sample Size and Power Calculations
CRC staff can provide calculation of statistical power, detectable effects, required sample size and attained statistical precision.
Statistical Analysis Methods
CRC staff can advise on the appropriate statistical analysis methods for evaluating the proposed aims and hypotheses.
CRC staff can provide investigators with randomization schemes and assignments for single- and double-blind studies. CRC staff work in conjunction with the Research Pharmacy for the implementation of investigator-initiated randomized trials involving drug or placebo products for quality assurance.
Project Management and Study Initiation
CRC staff can serve as overall project manager and/or 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. CRC Project Managers will supervise study staff, coordinate across departments and divisions within CHB and across hospitals for those studies operating at multiple locations. CRC staff can also provide templates for and/or 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.
Case Report Form Design
CRC 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.
Survey and Questionnaire Design
CRC staff advises investigators on all aspects of survey design. This includes 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, CRC 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).
CRC staff provides guidance to investigators with regard to the implementation of web-based surveys. Based on the complexity of the survey CRC staff can recommend different web survey software for programming web surveys. CRC has also staff available to program web surveys. As with CRFs, these surveys must meet a minimal design standard for CRC programming services.
Qualitative Research Design
Investigators can consult with CRC staff on the use of qualitative methods, such as focus groups, semi-structured interviews or cognitive interviews used in questionnaire development. We can advise on the advantages and disadvantages of each method and help in choosing the best one for a given research project. If necessary, CRC staff can guide the investigator in moderating focus groups or conducting interviews to minimize interviewer bias.
Guidance on Cost Impact/Effectiveness/Health Economics Data Analyses
CRC staff provides guidance with statistical and econometric analysis of proposed economic evaluations, such as cost impact, cost-effectiveness and cost-benefit analysis. We can provide guidance in the initial stages of project development as well with the analyses of already collected data
Survey Data Analysis
In general, CRC 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). CRC 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.
Qualitative Data Analysis
CRC staff can advise on how to analyze qualitative data including transcribing and coding focus groups and interviews. Depending on the amount of data, the use of qualitative analysis software by the investigator might be necessary. CRC staff can guide investigators on how to present qualitative data results and prepare them for a manuscript.
Cost Impact/Effectiveness/Health Economics Data Analysis
CRC staff conducts analysis of cost and outcomes data to address specific questions about cost, cost-effectiveness and other economic impacts of health care policies or clinical interventions.
Creation and Use of Adjustments for Survey Data
CRC staff advises on the handling and cleaning of data after the completion of the survey. Necessary post survey adjustments such as sampling, non-response and post-stratification weights, can be developed. We can also advise on how to analyze survey data that is collected within a complex survey design.
Data Management and Data Entry
In conjunction with project management, data management services include development of tools as simple as subject ID assignment logs to more complex services of overall project data management activities, i.e. data management procedures, data entry, staff training, support and supervision, data cleaning, QC and resolution of edit queries, development and production of customized data reports, database maintenance/troubleshooting, data set preparation for interim and final data monitoring and safety reporting, etc. Data entry can also be provided as part of a larger project and involvement from the CRC.
Data Interpretation, Data Analysis, and Manuscript Preparation
CRC staff can provide interpretation of statistical analysis results, including interpretation of previously published results as well as results of ongoing analyses. This includes guidance on statistical graphics and tabular displays of data.
CRC statisticians, epidemiologists, survey methodologists, and project managers also work collaboratively with investigators to perform interim or final data analyses, write data and safety monitoring board reports, and collaborate on writing manuscripts and preparing abstracts and presentations for scientific meetings.
Behavioral Science Core and Psychometrician Services
The Department of Psychiatry staff can provide consultation for investigators who wish to include behavioral outcomes on grants, protocols and manuscripts. Also, psychometrician services are available to collect data for protocols that have neuropsychological, psychiatric, psychological or other behavioral outcomes.
The Clinical Research Center is committed to providing the Children's Hospital, Boston research community with seminars and courses to promote professional development in clinical research.
Metabolism and Nutrition
The CTSU Nutrition Staff provides research diets, nutrition assessment, nutrition education, body composition measurements (including bioelectrical impedance analysis), indirect calorimetry, and dietary intake analysis. In addition, the CTSU has a metabolic kitchen and a dining room
Clinical Research at Waltham
The ambulatory CTSU at Waltham is adjacent to the Waltham Infusion Center and has three exam/consult rooms for study visits; infusion nurses available to assist with patient-related collections, measurement acquisition, and medication delivery; and collection and processing of samples for courier delivery to Boston. Equipment is available to coordinate visits such as a hot box, EKG, and a -20 C freezer.
Clinical Research Lab Services
There are research lab technicians available to gather and process samples during the hours of operation at the CTSU. In addition to basic processing, batched assay testing is available through the MGH Clinical Laboratory.
Ambulatory/Inpatient Nursing Services
The CTSU nursing staff assist with protocol development and implementation and provide expertise related to care of volunteers throughout the duration of the study visit.
The CRC staff offers monitoring services for investigators in need of independent monitoring. CRC monitors are experienced clinical research professionals that have completed competency-based monitoring education. Priority for monitoring is given to faculty acting as the regulatory sponsor of an IND or IDE clinical trial to aid those investigators with fulfilling federal regulatory requirements to perform safety monitoring. The numbers of staff that monitor studies is small. Therefore, studies are monitored on a first come, first served basis. Please click here for further information.