Sample Clinical Data Manager's Assignments

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PART A: Using the data below and from the protocol customize the database to accommodate the clinical test data.  The database should be set up for double entry purposes:

1. All significant Entry Form cells should have data validation properties.
   Go to "Data", choose "Validation", and input settings.
2. You should create double entry fields with a validation formula restricting input of data not identical to the data of first entry.
3. You should set up input messages and error alerts.
4. You should divide the patients into 3 separate groups for entry according to dose.
5. You should enter automatic formulas for calculation of healing rates and comparison between the groups right in the same entry sheets.
6. You should protect all cells that should not be changed by person who performs the entry.
7. You will need to check data for logic, consistency and validity.
   
   In case you find mistakes or entries that are illogical, you should report this to your Supervisor.

Clinical Test Data headings:   

Glucose (mmol/l), Calcium (mg/dL), Albumin (g/dL), Total Protein, Sodium (mEq/L), Postassium (mEq/L), Bicarbonate (mEq/L), Chloride (mEq/L), BUN (mg/dL), Creatinine, ALP (u/L), ALT, AST, Bilirubin, WBC (109/L), RBC (109/L), Hemoglobin (g/dl), Hematocrit (%), Platelet Count (109/L), MCV (fL), MCH (pg), MCHC (g/dL), RDW, Neutrophils (%), Lymphcytes (%), Monocytes (%), Eosinophils (%), Basophils (%), Total Cholesterol (mg/dl), LDL-C (mg/dl), HDL-C (mg/dl), TG (mg/dl), APO (B) (mg/dl)

PART B:

Very Low Density Lipoprotein Cholesterol (VLDL-C) must be calculated from the collected lipid data.

You will need add a column to calculate the VLDL-C:
VLDL-C = (TC) – (HDL-C) – (LDL-C)


PART C:

For the Lipid panel (see below), the data must be normalized. This is done by measuring the % change from Baseline (visit 2). The % change over baseline can be calculated by the following manner:

% change over Baseline = (((study value – baseline value)/ Baseline) X 100)

LIPID PANEL
Total Cholesterol (mg/dl)
LDL-C (mg/dl)
HDL-C (mg/dl)
TG (mg/dl)     
APO (B) (mg/dl)
VLDL-C (mg/dl)


PART D:

1. Conduct the double data entry. Your partner (or yourself) for double data entry should enter the data for the second time and the database should find mistakes by verifying validity of the data entered.
2. You have to use CRF forms
   
   The Senior researcher of your group must review the database.