Design of Data Entry Systems Pam Kellogg, Research Informatics, Family Health International

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1 Design of Data Entry Systems Pam Kellogg,, Family Health International 1

2 Data Entry Design Topics CRFs Annotated CRFs Record Layouts Data Dictionaries Code lists Data entry screens Testing QA Documentation 2

3 CRFs Upon receipt of a final copy of the CRFs, the Data Programmer will begin the database design of CRFs used for data entry 3

4 Final Copy of CRFs 4

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6 Annotation of CRFs Use a standard convention in the naming of variables e.g. the first two letters of the item refers to the name of the CRF Assign variable names to all header (center number, participant number, date) information on each page of a CRF Use a standard convention in the naming of code(s) e.g. a three letter prefix_code name You may want to use color coding to differentiate your variables and codes 6

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9 Record Layout What the database structure should be CRF name Variable name assigned on the CRF Variable name description Variable type (e.g., numeric, character, date) Code name if one is assigned to variable 9

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12 Code(s) Set of codes and corresponding values are assigned to items Suggested to create individual code(s) per protocol or study May require data entry of codes or values Example of a code: codes 0, 1 and 2 for values no, yes and not applicable Use a uniform naming convention for code(s) 12

13 Code assigned to an item Values of 1=Yes, 2=No 13

14 Data Dictionary What the database structure actually is Generated from your data entry system design program Compare to record layout for QA 14

15 Exclusion Form 15

16 Adverse Event Form 16

17 Data Entry Screen (Study Page) Electronic software generated representation of a CRF Serves as a data entry screen to store data Typically data is stored as one record Some CRFs require design of data storage of multiple records 17

18 One Record Per Participant 18

19 Multiple Records Per Participant Rows of data are entered Rows repeat Each row creates a record 19

20 Data Retention One record per participant CRF One record in one table Each row is a unique subject Row 1 shows the record for PN (Participant Number) #1150, Row 2 shows record for PN #

21 Multiple Records Per Participant Multiple records stored in one table Each row entered creates an additional record for the same participant PN #2026 has three rows of data or three records 21

22 Multiple Records Per Participant - Design Another example of design and data retention of a CRF with multiple records per participant Each group of repeating rows create a new table A participant may have one record in multiple tables 22

23 Multiple Records Per Participant - Retention Main Table QUDATE2 4/21/2006 3/21/2006 TODAY Table QUSID QUTIMES 4 2 QUMEUSE1 TRUE FALSE QUMEUSE2 TRUE FALSE QUMEUSE3 FALSE FALSE QUMEUSE4 TRUE FALSE QUMEUSE5 FALSE FALSE Another example of retention of multiple records Multiple records stored in separate tables Main Table and TODAY 23

24 Testing of Data Entry Page Enter one or two participants per CRF Enter all items Enter multiple records for a participant on multiple record CRFs Extract the data entered and check for integrity Create a dataset and check for accuracy 24

25 Quality Assurance Check Check that all items on the CRFs, record layouts and in the database software system match Check that all data types are correct for each item created Check page(s) created for accuracy Check for correct data structure for each CRF 25

26 Documentation of Design Document your Work by placing a set of the final CRFs, the record layouts, test data, dataset results and various system generated reports in a Study Notebook 26