Biostatistics & Study Design — Information & Consultations
Spectrum support for Clinical Research is divided into four stages, the first of which is DESIGNING YOUR STUDY.
This stage includes tasks and activities that occur early in the design & development of a study, such as:
- biostatistics consultations
- informatics consultations
- bioethics consultations
- identifying co-investigators and collaborators
- exploring funding opportunities
Spectrum, in association with the Department of Health Research and Policy – Center for Innovative Study Design (CISD), offers a free one-hour consultation for help with all aspects of study design, including ethics, biostatistics and data collection.
Discussion topics of interest:
- Statistical design, sample size and power
- Statistical analysis of preliminary data (limited availability)
- Other data management issues (e.g. validation) – data entry services not available
- Advice on analyzing data
- Statistical analysis of data (limited availability)
- Formulating a statistical analysis plan
- Organizing your data for capture into a database
- Statistical support for Data Safety Monitoring Board (limited availability)
- Advice on responding to journal review
- Help in designing a cancer clinical protocol
Prior to your appointment:
- Review Guidelines for Pre-Award Statistical Consultation with SPCTRM (pdf)
- In order to assist you with preparing your data collection tools, see Guidelines for Describing Data as it Relates to Data Collection and Analysis. These codes will help you, and if applicable, your biostatistician when it is time to evaluate/analyze the data. – Data Submission (pdf)
- Example for building your code book/data dictionary – Sample Form (pdf)
- Data collection code book – Variable Information (xls)
Resources
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Clinical Trial Methodology and Software
Locally developed methodologies and software
Next Steps
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Request a consultation
Your initial consultation should be scheduled through Study Navigator