Below are the steps you'll go through with us during the study.
Step 1: Initiation
To request support, complete the online request form. Once the request form has been received, we will coordinate a meeting to discuss the support you will need.
In the initial meeting, we will gather study information, including title, description, study design, study site(s), aims, endpoints, data sources, sample sizes, study duration, data collection period, collaborating investigators, collaborating institutions, etc.
We will help you determine the appropriate services for your study requirements, such as IT management, data management, study management, analytic support, in-depth guidance and co-investigation.
Following your initial meeting, we will provide a summary report of what was discussed and send it to you and your team for validation. Once confirmed, we will begin working on the data management plan, statement of work and/or service plan.
Step 2: Statement of Work
BMIC and BIOSTAT will work with you and your team to determine an appropriate study plan, including:
- Data capture methods and logistics
- Best practices and general guidelines
- Storage (short- and long-term)
- Analysis plan
- Possible needs for an informatics Co-I
- Resources already available (Le Bonheur/UTHSC)
- Discuss reserving publication rights to informatics and biostatistical work
Step 3: Implementation
The implementation phase often will require the most attention from you as PI and/or the BIOSTAT/ BMIC co-investigator (if listed) to ensure that the informatics and statistical components are deliverable. This phase includes:
- Identifying available resources for the development of your study database
- Creating data capture forms
- Developing reports to demonstrate study progress and quality measurement
- Exporting data into your preferred statistical software package (e.g., R, SAS, SPSS, etc.)
- Advising best practices and regular guidelines for protected health information (PHI), HIPAA and FISMA compliance
Step 4: Completion