Specs column layout

The specifications for a Syncrony V2 EDC should be laid out as follows:

Column A: Type

Column B: Variable name

Column C: Label name

Column D: Extended description

Column E: Note

Column F: List

Column G: Display

Column H: Value

Column I: Format

Column J: Options

Column K: Calculation

Column L: Edit checks

Column M: Conditions

Column N: actionsV3

Naming fields

Use CDISC conventions when possible.

Generally, write field names as a declarative statement and end the name with a colon. E.g. ‘Blood pressure:’ rather than ‘Blood pressure?’

We are developing a collection of standard fields (including ranges and edit checks) to use.

Try to keep names short, to avoid clunkiness and overlapping text. This is important when filling out Input Detail in checkboxes; try to keep all checkbox options fairly short and about the same length as each other. Common abbreviations like HR for heart rate are fine to use as part of a longer name, but generally a field name shouldn’t be just an abbreviation.

Use the Oxford comma, unless the list items have a combined relationship

Contents of fields

Numeric

For numeric fields, give step size (e.g. 1, 0.1, 0.01), decimal place limits, and range if there is one.

We are developing a list of standard ranges for common physiological tests.

Text

Fill in type format with ‘text’ for inputs requiring a single word or small phase. Fill in type format with ‘textarea’ for an input requiring sentences or descriptions.

Minimize unnecessary capitalization. It’s correct to use capital letters when referring to a previous field. e.g. ‘Specify Other antiplatelet’ for a textbox that comes up after you select ‘Other antiplatelet’ in a previous field.

It is important not to assign two variables on the same sub-section the same variable name. Consider using prefixes based on sub-section to make sure you don’t reuse variable names accidentally. For example, you could call Heart Rate MH_HR on the Medical History subsection and B_HR on the Baseline section.

Other, Specify

‘Other’ field names should include what they’re referring to and end in ‘specify. For example, a field that comes up when a user selects ‘Other antiplatelet’ should be named ‘Other antiplatelet, specify’ rather than ‘Specify other antiplatelet’ or ‘Specify other’ or ‘Other, specify’. Be consistent!

Dropdown fields

We are developing standard lists of options for common fields, e.g. classes of medication (especially antiplatelets and anticoagulants) and types of adverse event.

Standard variables TBD

type

variable

label

display

value

format

calculation

Demographics

SEX

Gender

DM_BC1

Specify childbearing potential:

DM_BC2

Specify the medically acceptable birth control in use

date/stringdate

BRTHDT

Date of birth

dd-mmmm-yyyy

AGE

Age

RACE

Race

RACEOTH

If Race is other, specify

unit-measure

HEIGHT

Height

in|cm

unit-measure

WEIGHT

Weight

lbs|kg

readonly

BMI

Body Mass Index

round|(2)

bmi|WEIGHT|HEIGHT

SIGNDT_IC

Has the patient signed and dated the informed consent?

date/stringdate

DTIC

Date of informed consent

Medical History

CAD

Coronary Artery Disease

CHF

Congestive Heart Failure

Myocardial Infarction

ANG

Angina

ARRH

Arrhythmia

ARTH

Atherosclerosis

VALVE

Valve disorders - stenosis and insufficiency

CARD

Cardiac

CARDOTH

Cardiac, other

CARDSP

Cardiac, other - specify

GANGR

Gangrene/Ischemic ulcer of the study limb

HYPTENS

Hypertension

CHOL

Hypercholesterolemia

PUL

Pulmonary Disease

Pulmonary Embolism

RENAL

Renal disease:

ESRD

DIAL

Dialysis

TDIAL

Type of dialysis

Chronic|Acute

DIALDY

Dialysis duration (years)

DIALDM

Dialysis duration (months)

DIAB

Diabetes

SMOK

Smoking

Medications

ASP

Aspirin

APLTS

Antiplatelet

HEPA

Anticoagulants

Adverse Events

autocalculated

AE_ID

Adverse Event ID

AE_SDATE

Start date

AE_AWARED

Site awareness date

AE_SEV

Adverse Event severity

AE_ANT

Was this an anticipated Adverse Event?

AE_ONGO

Is event ongoing?

AE_LOC

Event location

AE_LOC_OTH

Location other, specify

AE_DEVICE

Relationship to investigation device

AE_PROC

Relationship to procedure

AE_TRT

Treatment or action taken

AE_OUTC

Outcome

AE_DTH

Cause of death

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