In order to convey to the GCRC Biostatistians the global view of the time line and information to be collected on subjects, the researcher is requested to complete the following table and forward this table to chris-aston@ouhsc.edu prior to the initial meeting. We have found that having for examination this information together with any preliminary draft of proposal greatly expedites the exchange between researchers and statisticians so that we may be of most assistance in preparing application to GCRC or in development of protocols.

The demographic variables for Birth Date (Age), Gender and Ethnicity information are entered as to be collected at first time as examples of how table may be completed. Any other demographic variables could be added and also checked as collected at first time. The date of each exam should be included for each visit.

Primary outcome variables are the variables of most interests (those that directly answer the research question(s)). This is usually a small set of variables. Secondary outcome variables are any other outcomes of interest. Other variables are any other variables to be collected. These are often variables that may be examined as covariates.

Measurement column is used for quantitative variables such as height, weight, systolic blood pressure, etc. If units associated with measure, enter units under this column. If quantity does not have units (e.g. scores on some instruments), just enter X. If units unknown, enter "?". Categorical column is used for classification variables such as cancer stage, smoker/non-smoker, etc. Enter the number of categories in the classification if known, or "?" if not sure of number of categories. If unsure of whether variable is measurement or categorical, enter "?" in both columns. For some studies all variables are captured at the first time after entry into study. In this case only checks under Time 1 would be made for all variables. For studies in which value for a variable is captured at follow up times there would be a check in that variable row under the time column for each time value is to be obtained.

Note that this is intended as a working document that may change after discussion of power/sample size issues. Details of time between data capture time will be contained in final protocol rather than in this table.

In addition to furnishing this table we ask that before first meeting you consider the questions in the document "Preparing for Meeting with GCRC Statistician". Note that in completing this table you will have answered the question, "What are the Response Variables?" that is contained in that document.



Variable Name

Measurement

(Units)

Categorical

(# of Categories)

Data Collection Time(s)

1

2

3

4

5

6

7

8

9

10

11

12

Date of Exam m/d/yr X X X X X X X X X X X X
Demographic Variables
Date of Birth m/d/yr X
Age Yrs X
Gender 2 X
Ethnicity 4 X
Primary Outcome Variables
Secondary Outcome Variables