Biostats Initial Meeting Checklist

Initial Meeting Checklist

The best time to engage a biostatistician is very early in the research planning stage. In general, if you feel the need for a biostatistician at any time during the course of a study, contact us immediately. Before meeting with one of our biostatisticians, we require some information that will help us better understand our role in the study. Below is an outline of some issues that should be clearly thought out before the meeting.

Copy of protocol if available
Copy of some closely related publications
Research objectives—primary and secondary
Identify primary study unit (e.g. patient, family, animal)
Study design
1. Clinical trial or other experimental study
2. Retrospective study based on charts
3. Individually Matched Case-Control study
4. Inclusion/exclusion criteria
5. Randomization schedule if applicable
Blinding/Masking?
Multi-center Study?
List of variables relevant to analysis
1. Primary outcomes (e.g., glucose level)
2. Concomitants (e.g., age, height, weight)
Time points when interventions occur or variables are measured
Research hypotheses or goals for analysis
Provide a clean data file (see below)
Accepted file formats: Excel, SPSS, Access, SAS
Progress to date
Time constraints / Deadlines
Expected presentations, publications, etc
Authorship of presentations / publications

Example of Clean Data File

There are n=10 subjects (ID) with measurements/observations x1, x2 and x3. As a general rule, each row should contain a patient's complete record. If more than one row is needed, please contact the biostatistician with which you are working. All missing values should be left blank.

ID	x1	x2	x3
1	Yes	2	1
2	No		5
3		4	7
4	No	3	1
5	Yes	2	5
6	No	2
7	No	2	6
8	No	2	6
9		6	9
10	Yes	5	2