Data Management

Links

• File sender
• Random Number Generator
• Sealed Envelope: Random Permuted Blocks

Randomisation Number Schema (Study ID)

Use the format XXYYYY.ZZZ

• XX 2-digit trial number
• YYY 3-digit site code (can be used as REDCap DAG)
• ZZZ 3-digit randomisation number, sequential by site

The randomisation number should be saved as a string to avoid loss of trailing zeros. 

District	District Code	Site	Site Code
Northland	910	Whangarei Kaitaia Dargaville Bay of Islands	911 912 913 914
Auckland	920	Northshore Waitakere Auckland City Middlemore Starship	921 922 923 924 925
Waikato	930	Waikato Thames Tokoroa Taumaranui Te Kuiti	931 932 933 934 935
Lakes	940	Rotorua Taupo	941 942
Bay of Plenty	950	Tauranga Whakatane	951 952
East Coast	960	Gisborne Hastings	961 962
Taranaki	970	Taranaki Hawera	971 972
Mid-Central	980	Palmerston Nth Dannevirke Whanganui Levin	981 982 983 984
Wellington	990	Wellington Wairarapa Hutt	991 992 993
Tasman	810	Nelson Wairau	811 812
West Coast	820	Grey	821
Canterbury	830	Christchurch Ashburton Timaru	831 832 833
Otago	840	Dunedin Oamaru Clutha Dunstan	841 842 843 844
Southland	850	Queenstown Invercargill	851 852

Trial number	Trial name
10	Provide
11	HINT2
12	hPOD-Main
17	GEMS
18	Target
20	DIAMOND
21	pre-hPOD
23	OBLIGE
24	Latte Dosage
26	ProtectMe
27	CSteroid
28	FIIX
31	NeoGluCO
32	ACTORDS
33	Auckland Steroid trial
41	DoxAPrem
51	Latte
53	BEAD
54	PremHypoT

Variable Naming Convention

• CRF abbreviation: case insensitive, no numbers (optional)
• Underscore _
• Question number (2 digits or characters, use 0 placeholder, optional)
• Underscore _
• Sub-question number (2 digits or characters, use 0 placeholder, optional)
• Underscore _
• Short descriptor <=10 characters, can use camel case
• Underscore _
• Optional descriptor modifiers
  • Subject identifier (important if mother, child, father connected by same study ID)
    mo = mother
    fo = father
    ch = child
    pa = parent /caregiver
  • Variable type
    bn = binary (0,1)
    yn = yes no
    sp= specify (free text)
    dt = date
    dttm = date and time
• Underscore _
• Event identifier
  nA = Antenatal e.g. A, 20A, 36A : antenatal, 20 weeks antenatal, 36 weeks antenatal
  B = Birth
  nW= where n is a digit and W is weeks
  nM = where n is a digit and M is Months
  nY = where n is a number and Y is year

Variables should be limited to 28 characters so that a suffix or prefix can still be added. Do not include the unit of measure in the variable name (will be specified in study procedures).

CRF Label	Description
haf	Home and family questionnaire
dgr	Demographics
rnd	Randomisation, eligibility
pd	Paediatric examination
ef	Executive function battery
bse	Bayley social emotional questionnaire
dxa	DXA
bys	Bayley III scores
sdqp	Strengths and Difficulty Questionnaire, parent
sdqt	Strengths and Difficulty Questionnaire, teacher
brfpa	BRIEF, parent
brfte	BRIEF, teacher
brfp	BRIEF-P (preschool)
scq	Social communication questionnaire
phx	Past medical history
ffq	Food frequency questionnaire
ifq	Infant feeding history questionnaire
cat	Cognitive adaptive test
ath	Anthropometry
asq	Ages and stages questionnaire
trk	Tracking
ech	Echocardiography
grw	Growth
fld	Fluids
ant	Antenatal
bth	Birth
rsu	Resuscitation
lab	Laboratory
cus	Cranial ultrasound
sae	Serious adverse events form
neo	Neonatal outcomes
bry	Beery
aq	AQ (Autism questionnaire), child
abc	Movement ABC-2
vis	Vision
edu	Education
wdr	Withdrawal
pdv	Protocol deviations
con	Contacts
sc	Screening
cs	Consent
rg	Registration
dc	Discharge
echo	Echocardiography

Event Label	Description
Bk	Booking
W	Week
A	Antenatal week
B	Birth
PN	Postnatal week
N	Neonatal week
P	pregnancy
BP	before pregnancy
bs	baseline
M	month
D	day
y	year
R	Randomisation

Labels Group	Description
ys / yu / no / un	yes successful / yes unsuccessful / no
m / f / i	male / female / indeterminate (intersex)
un	unknown
in / ex	include / exclude
1/0	binary fields (1=yes)

Variable label	Description	Group
wt	weight	anthropometry
circ	circumference	anthropometry
hc	head circumference	anthropometry
hd	head	anthropometry
ht	height	anthropometry
lg	length	anthropometry
muac	mid upper arm circumference	anthropometry
sga	small for gestational age	anthropometry
adc	abdominal circumference	anthropometry
chc	chest circumference	anthropometry
acr	acromioradiale	anthropometry
tricepsf	triceps skinfold	anthropometry
subscapsf	subscapular skinfold	anthropometry
supiliacsf	suprailiac skinfold	anthropometry
bp	blood pressure	cardiovascular
dias	diastolic	cardiovascular
htn	chronic hypertension (pregestational)	cardiovascular
sys	systolic	cardiovascular
age	age	demographic
dob	date of birth	demographic
edd	estimated date of delivery	demographic
educat	education	demographic
elec	elective	demographic
emply	employment	demographic
eth	ethnicity	demographic
ga	gestation	demographic
pma	postmenstrual age	demographic
NHI	national health index	demographic
sex	sex	demographic
StudyID	Study number	demographic
dis	disease	disease
DM	diabetes melitus	disease
infect	infection	disease
rx	treatment	disease
etoh	alcohol	drugs
meds	medications	drugs
smokg	smoking	drugs
antibody	antibody	misc
grp	group	misc
med	medical	misc
num	number	misc
pc	percentile	misc
prob	problem	misc
date	date	misc
stat	status	misc
lft	left	misc
rht	right	misc
wk	week	time
hr	hour	time
sec	second	time
day	day	time
aph	antepartum haemorrhage	obstetric
grav	gravidity	obstetric
par	parity	obstetric
pet	preeclampsia	obstetric
prem	preterm	obstetric
ptb	preterm birth	obstetric
thrmc	threatened miscarriage	obstetric
top	termination of pregnancy	obstetric
infert	infertility	obstetric
gahtn	gestational hypertension	obstetric
hellp	HELLP syndrome	obstetric
rom18h	ruptured membranes >18 hours	obstetric
mgs04	magnesium sulphate	obstetric
acs	antenatal corticosteroids	obstetric
acsrpt	repeat antenatal corticosteroids	obstetric
labr	labour	obstetric
birthmode	mode of birth	obstetric
ga	gestational age at birth	obstetric
pma	weeks post LMP	obstetric