Good data practices

A John Michael Raj

Lecturer
Department of Biostatistics
St. John’s Medical College
Bangalore
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 Data Collection
– What you need to know: numbers or stories

– Where the data reside: environment, files, people

– Resources and time available

– Complexity of the data to be collected

– Frequency of data collection

– Intended forms of data analysis

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 Data Collecting Methods

Primary data collection

Secondary data collection

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 Secondary Data
• Use available data, but need to know

– how the measures were defined

– how the data were collected and cleaned

– the extent of missing data

– how accuracy of the data was ensured

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 Primary Data
• Original data:
– be sensitive to burden on others
– pre-test, pre-test, pre-test
– establish procedures and follow them
(protocol)
– maintain accurate records of definitions
and coding
– verify accuracy of coding, data input

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 Case report form
Official clinical data-recording document or
tool used in a clinical study

PAPER RDC/RDE (Remote Data Capture,

Remote Data Entry)

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 CRF
Collects relevant data in a specific format
 in accordance with the protocol
Allows for efficient and complete data
processing, analysis and reporting

Facilitates the exchange of data across

projects and organizations esp. through
standardization

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 Developing CRF
– Collect data with all users in mind

– Collect data outlined in the protocol

– Be clear and concise with your data

questions

– Avoid duplication

– Request minimal free text responses

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 Contd..
– Provide units to ensure comparable values

– Provide instructions to reduce

misinterpretations

– Provide “choices” for each questions

• allows for computer summarization

– Use “None” and “Not done”

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Sample CRF

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DATA ENTRY
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 Processing of Questionnaires or CRF’s
before data entry
• Questionnaires should be labeled with a
unique case number (an ID)

• A code book describes the variable name,

meaning, and coding of each variable
categories
– With numerical information, don’t make any
calculations before data entry (BMI)
– Record dates; don’t calculate age before
data
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 Code Book
• The name assigned to the variable
• What the variable represents (i.e., its label)
• How the variable was measured (e.g. nominal,
ordinal, scale)
• For scale variables: The variable's units of
measurement
• For categorical variables: If coded numerically,
the numeric codes and what they represent
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VARIABL LEGAL
VARIABLE LABEL VALUE LABEL TYPE MEASURE
E NAME RANGE
idno Identification number String

doa Date of assessment Date Date

age Age (years) Numeric 20-60 Continuous

sex Gender 1-male, 2- female Numeric 1,2 Nominal

1-unmarried, 2-
ms Marital status married,3- widow, 4- Numeric 1,4 Nominal
seperated/divorced

smk smoking 0-no, 1-yes Numeric 0-1 Nominal

number of cigarettes
smknum Numeric Discrete
smoked per day

alc alcohol consumption 0-no, 1-yes Numeric 0-1 Nominal

gravida Gravida Numeric Ordinal

ht Height(cm) Numeric 100 - 200 Continuous

wt Weight(kg) Numeric 30 - 100 Continuous

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 DATABASE MANAGEMENT
SOFTWARES
• DBMS
• Open clinica
• Oracle Clinical
• SAS
• SPSS
• EPI DATA
• Microsoft Access, Excel
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DATA ENTRY USING

MICROSOFT EXCEL
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 Errors in data entry
• Transposition (ex: 39 becomes 93)

• Copying errors (0 copy as an “o” letter)

• Consistency errors: two or more responses are

contradictory ( sex: man, pregnancy=yes)

• Range errors: answers outside of probable or

possible values (ex: height=3metres)

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 Requirements for a successful data preparation in
Excel
• Place all Variables name in the first row only

• Variable name in each column should be

– unique, simple, 1-word name
– 8 characters or less with no spaces, beginning with a letter

• Variables are either numeric or character

• Do not combine character data with numeric data in the same

column
– Do not put “NA”, “will get”, “<20”, or “?” in a numeric column
– Do not use a dot to represent missing data in a numeric column

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 Requirements for a successful data preparation in
Excel
• Missing numeric data should have blank cells

• Be sure Excel stores your numeric data as numbers and not as

text

• Delete ALL extraneous columns and rows (e.g. summary

statistics, notes, coding key)

• Check your date formats. It may look right in excel, but it will
be imported according to the internal representation, which may
not be in right format
– You can use DD/MM/YYYY

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Recommendations for efficient data management and
analysis

• One row per case

• Don’t waste columns combining other columns (e.g. height,

weight, BMI)

• Keep variable names short & unique. Start with a letter and use
only letters, numbers, & underscore. No spaces. LowerCase is OK

• Be completely and utterly consistent (e.g. M, m, F, f=4 genders)

• For yes/no variables, it is helpful to use, 1 - yes and 0 - no

• Missing character and numeric data should have blank cells

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Recommendations for efficient data management and
analysis

• Enter cases and controls or treatment groups in the same

spreadsheet and under one variable(column)
(TREATED: 0=no, 1=yes ; GROUP: 1=Drug A, 2=Drug B)

• Create a simple guide (or code key) using a word processor

to explain variables labels, value coding, and how missing
values were entered. Be consistent

• Think about the analysis before collecting any data

• Have a biostatistician review the coding before data entry

and again after the first 10 patients have been entered

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Use of EpiData

Questionnaire
design and entry

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 Introduction to EpiData

– Data entry and documentation

– Free program

– Based on EpiInfo

– Windows format

– No limit on No. of observation

(tested with>100,000)
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 What is EpiData

• EpiData is a program for data entry and

documentation of data

• EpiData is limited in its ability to analyze

data

• EpiData creates a database as a .REC file

(and implements EpiInfo version 6 file
structure)

• The software is FREE!

-Available at http://www.epidata.dk

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 EpiData (I)

– Creating questionnaire

– Controlled data entry

– Documenting and printing data

– Comparing of 2 data files

– Importing and exporting data

– Simple analysis
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 EpiData (II)

• Simple surveys – one questionnaire

• Complicated surveys – few questionnaires

If there is ID – possible to merge data

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 EpiData files

• .QES file
- Questionnaire

• .REC file
- Actual data

• .CHK file
- Any defined checks

• Other notes or log files

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 EpiData workflow

1.Define Data 4.Enter Data

2.Make Data File 5.Document
3.Set up Checks 6.Export Data

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 Creating Questionnaire(1)
• Define data
• Can either open .QES file or create one

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 Creating questionnaire(2)

• Type in Microsoft word

• Cut and paste from Word documents

• Preview questionnaire
-(click Make data file ► preview data form)

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 Structure of questionnaire

Three sections:

- Field name (variable)

- Text describing field

- Input definition (data format)

(number/letters/date)

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 Field name (variable)

• No more than 8 characters

• Begin with a letter

• No spaces or punctuation marks

• No underspace

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 Field Name (II)
• Automatic:
• If we are not specifying the variable name, EpiData
automatically
• Generates the variable
name based on question

• It uses the first 10 letters

of the question

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 Automatic field names

• Text in curly brackets { } used in preference

• Common words skipped (what, the, and, etc.)

• If question starts with number, “N” is inserted

before the number

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Automatic field names examples

Question: Field name:

Did you {eat ice cream} EATICECREAM
What is your name? ISYOURNAME
2.Age N2AGE

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 Variable type
• Define variable types using “Pick list” or “code
writer”

• Choose type of variable:

- Numeric
- Text
- Date
- Boolean (yes/no)
- Soundex
- Autonumber (ID no.)

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 Numeric & Text variables
Numeric:
• Numerical information

• Hold integers (whole numbers) or numbers with a decimal point

• Length (max. 14 digits and 12 decimals )

• <#>, <##.#>

Text:
• Information of text and/or numbers

• Holding information (e.g. names, addresses)

• No mathematical operations

• Length (80 characters)

• <_>
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 Other variables
• Boolean variables:
- These are logical variables; there are only two possible answers: yes / no
- <Y>
• Date variables:
- Hold information on dates
- <DD/MM/YYYY>
- System variable:
Today date: date of the data entry
- <Today-dmy>
• Soundex:
- Coding of words (anonymous, e.g. A-123)
- code to limit orthographic errors (e.g. Rome and Roma)
- <S >
• Auto identification number (system variable)
- Counts the records entered
- <IDNUM>

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 Make data file from
Questionnaire

• To create Data file

– Enter questionnaire file name
(trial.qes)
– Enter data file name (trial.rec)
– OK
– Creates .REC file

• To view data file

– Preview data form
– Enter OK

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 Checks (I)
• Once Data file is created:
Checks ► choose Trial.REC file
• Why do we need checks?
– Reduce errors in input by declaring range
– Checks help with data entry
– Save time by skipping unwanted entry of
characteristics
– Add value labels in the checks
– to prevent duplicates
• What are checks?
– Basic
– Advanced

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 Checks (Basic)
• Range, legal
– 1-3, 9 (9 for missing)
– First range then individual numbers

• Jumps
– Jumps is used to skip the current fields that
are not applicable

• Must Enter
– Data must be entered in field

• Repeat
– Show data from previous record

• Value Label
– Click “+” to add label
– Add text to explain label values
– Look at the screen forms as shown

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 Checks(Advanced)

• Advanced
– To prevent duplication in unique ID
(identification ) number, you can do as

Checks ► Edit ► Key Unique 1

• Conditional jumps can also be

used by

if… then… endif structure

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 Data Entry (I)
• Enter data ► Choose trial.REC file
• Dates:
- 24/08/2012 – type 240812 or 24/8/12
• Value Labels:
Press F9 to view the value
labels during data entry

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 Data Entry (II)
• Record navigation:

• Delete records:
- Click cross to delete
- Record marked for deletion, but can be recovered

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 Document Tools

• File Structure
• Data entry notes (.NOT file)
- Use to write comments during data
entry
- e.g. difficult to read handwriting etc
• View Data
• List Data
• Codebook
- Basic descriptive statistics on all
variables
• Validate duplicate files
- Check consistency after double entry

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 Export to standard statistical
software programs

• Click “Export data” button

• Choose Stat. software program

• Including Excel, Stata, SPSS

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 References

• Lauritsen JM & Bruus M. EpiData (version 3.1). A

comprehensive tool for validated entry and
documentation of data. The EpiData Association
Odense Denmark, 2004.

• Lauritsen JM, Bruus M. EpiTour – An

Introduction to data entry and documentation of
data by use of EpiData. The EpiData Association,
Odense Denmark, 2005.

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www.epidata.com

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