MGH Faculty and Staff
CRP supports all clinical research studies, providing staff and/or services to manage your study from beginning to end according to Good Clinical Practice, federal, state, and institutional regulations and guidelines. We can also facilitate survey research, large-scale data set analyses, and submission of BIG NIH applications.
CRP Services include:
Project Design - 4-6 hours free
- Choosing type of study (case-control, cohort, trial, etc)
- Sampling strategy, selection of controls
- Design of survey instruments
- Identification of existing databases
- Measurement, quality control
- Recruitment, retention, and logistical issues
- Data and Safety Monitoring
- Qualitative data collection (focus groups, interviews, etc.)
- Qualitative data management (transcription, coding, and analysis)
- Incorporation of genetics and genomics into your research
- Help in arranging collaborations
- Help in accessing available resources for genotyping, sequencing, and genetic epidemiology
- Choosing statistical methods
- Multivariable modeling
- Other statistical analyses
- Interpreting results
- Responding to reviews
- Sample size planning
- Formulation of testable research hypotheses
- Sample size estimation and power analysis
- Design of both observational and experimental human studies
- Estimation of risk and risk adjustment
- Data collection methodologies and study implementation
- Help translating basic science discoveries into clinically applicable tools for the diagnosis or treatment of human diseases
- Help exploiting clinical discoveries that require greater elucidation in basic science laboratories
- Survey Design and validation
Protocol Development - flat fee
- Work with the PI to prepare the application
- Respond to the IRB's comments, questions and make changes to the consent form
- Make changes to the consent form
Project Execution - flat hourly rate
Short or long term assistance on specific projects
- Creation of source documents that facilitate systematic data collection and/or aid in protocol execution
- Obtains informed Consent
- Collection of subject data; completion of data collection forms and submission to sponsor
- Maintenance of IRB/Regulatory documents
- Performance of study procedures; specimen collection and processing
- Coordination of subject study visits with other hospital services
- Administration of investigational medications, phlebotomy
- Screen potential subjects using CAS or LMR
- Recruit subjects using RPDR and RSVP for Health
- Coordination of monitoring visits by sponsor representative
Project Management - free
One point of contact for the project
- Assitance with BIG NIH applications (PPG, K12, K23 & 24, etc)
- Working with PCRO on Budget Development
- Subject Tracking, Sponsor Invoicing & Revenue Capture
- Monitoring recruitment/budget projection
- Advise on multicenter study coordination
- Assistance with IND/IDE applications
