Data field definitions
This document includes the definitions and explanation of the data fields to be completed
when submitting a record for registration on the ANZCTR. The information requested isbased on the definitions and set requirements for trial registration from the International
Committee of Medical Journal Editors (ICMJE) and World Health Organization (WHO) Trial
Registration Data Set.
Mandatory data items for trial registration with the ANZCTR are marked in BOLD
and with an asterisk (*).
Data item

Definition / explanation

Step 1: Titles & IDs
Public title *The public title of the study is intended for the lay public and should
be in easily understood language. An informative public title should
include at least 2 of the following components: participants,
intervention/exposure, and main outcome of the study. Acronyms
should be defined at first use. This field will be displayed on themain search page of the WHO ICTRP Search Portal.

Scientific title *The scientific title is intended for use in grant and ethics
applications. It should contain information on the participants in the
study, the intervention(s)/exposure(s) and the primary outcome(s)to be assessed.

Secondary IDs *Identifying numbers issued by authorities other than the ANZCTR if
any. This includes:
Trial registration numbers issued by other registries (bothPrimary and Partner Registries in the WHO Registry
Network, and other registries)∗ Identifiers assigned by the sponsor (record sponsor nameand sponsor-issued trial number (e.g. protocol number))∗ Identifiers issued by funding bodies, collaborative researchgroups, etc.
∗ This does not include ethics identification numbers – theseshould be provided in the relevant Ethics section in Step 9.
∗

All secondary identifiers will have 2 elements: an identifier for theissuing authority (e.g. NCT, ISRCTN) plus a number.
It is possible that the trial may not have a secondary ID. Please
include the text ‘Nil known’ if you do not know of any secondary
IDs.
Enter only one secondary ID and issuing authority per box. Click“Add new secondary ID” to add more boxes if necessary. There isno limit to the number of Secondary ID entries (boxes) that can be
added.

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UTN

The Universal Trial Number (UTN) is a unique number which aims
to facilitate the unambiguous identification of clinical trials
registered in Primary Registries in the WHO Registry Network anddisplayed on the WHO ICTRP Search Portal. A UTN should beobtained from https://trialsearch.who.int/utn.aspx early in thehistory of a trial and should be used every time the trial is identified.

Trial acronym

A trial acronym is a word formed from the initial letters of theseveral words in the name, which identifies the specific trial, e.g.
ACT (Angioplasty Compliance Trial). If there is no trial acronym
then please leave this field blank.

Linked study record

If this trial is linked to a parent study, sub-study or follow-up study
then please provide the identifying number (or citation if no
identifying number available) for the linked study.

Step 2: Health condition
Health condition(s)or problem(s)studied *Primary health condition(s) or problem(s) studied (e.g. depression,breast cancer, medication error). For studies conducted in healthy
volunteers, enter the health area under investigation and/or thehealth condition(s) for which the intervention may be indicatedand/or the health condition(s) being prevented.
Enter only one health condition or problem per box. Click “Add newhealth condition” to add more boxes. The form allows a maximumof 20 entries (boxes).

Condition category
and conditioncode *

Choose the most appropriate condition category (1st level) andcondition code (2nd level) from the list. Note: the full list isavailable at the end of this document.
Click “Add new condition category/code” to add more boxes ifnecessary. The form allows a maximum of 10 sets of entries.

Step 3: Intervention/exposure
Study type *Choose the appropriate study type from the list.
Interventional: Any research study that prospectively assigns
human participants or groups of humans to one or more healthrelated interventions to evaluate the effect on outcomes.
Interventions include, but are not restricted to, drugs, cells andother biological products, surgical procedures, radiologic
procedures, devices, behavioural approaches, process-of-carechanges, preventive care, diagnostic procedures.
Observational: A study in which no experimental intervention ortreatment is applied. The investigator observes the effect of a risk
factor, diagnostic test, or treatment on a particular outcome, e.g.
the relationship between smoking and heart attacks. It involves
observing without altering or influencing that which is being
observed. For example, in an observational study the researchers
examine and report on what is happening, without controlling thecourse of events. Certain outcomes are measured but no attempt

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is made to affect the outcome (i.e. no treatment or experimental
intervention is given).
Patient registry

For observational studies only, check the ‘Patient registry’ box if
this record describes a study that is considered to be a patient(Only available
registry. A patient registry is an organised system that useswhenobservational methods to collect uniform data (clinical and other)
Observational isselected for ‘Study prospectively for a population defined by a particulardisorder/disease, condition (including susceptibility to a disorder),type’ in step 3)
or exposure (including products, health care services, and/or
procedures) and that serves a predetermined scientific, clinical, or
policy purpose. Patient registries may be single purpose or ongoing data collection programs that address one or morequestions.

Target follow-up
duration(Only available
when patientregistry is
selected in step
3)
Description ofintervention(s) /exposure *For patient registries, the anticipated time period over which eachparticipant is to be followed. Provide a number and select a unit oftime (weeks, months, years).

Describe the specific intervention(s) being studied. Please provide
sufficient detail so that information will be meaningful to ANZCTR
users (refer to TIDieR checklist).
Brief name: Provide the name or a phrase that describes theintervention. If there are multiple intervention arms, please labelwith subheadings (e.g. Arm 1, Arm 2, etc.). Note: there is aseparate field below for details of comparator/control treatment(s).
Intervention names should be consistent throughout the form.
Avoid using alternative intervention names for clarity.
For drug trials:
Provide the International Non-proprietary Name (INN) of each drug
(not brand/trade names). For an unregistered drug, the genericname, chemical name, or company serial number is acceptable.
For each intervention drug, please also specify:- the dose administered, e.g. 5mg once daily;- the duration of administration, e.g. 4 weeks;- the mode of administration, e.g. oral tablet, intravenous
infusion.
For non-drug trials:
For each intervention, briefly describe:- any physical or informational materials that will be used in theintervention, including those provided to participants or used inintervention delivery or in training of intervention providers;- each of the procedures, activities, and/or processes used,
including any enabling or support activities;- who will deliver the intervention and if relevant, their expertise,e.g. dietician with minimum 5 years’ experience;

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- the mode of delivery (such as face to face or by some othermechanism, e.g. internet or telephone) and whether it will be
provided individually or in a group;- the number of times the intervention will be delivered and overwhat period of time including the number of sessions, theirschedule, and their duration, intensity, or dose; e.g. 8 x 1
hour sessions, once/ week for 8 weeks, then once/month for 4
months.
- the location where the intervention occurs, e.g. urban antenatal
clinic, participant’s home, high school, etc.
For all trials:
If the intervention is planned to be personalised, titrated or
adapted to individuals or groups of individuals in the intervention
arm, then describe what, why, when, and how this will occur.
If intervention adherence or fidelity will be assessed, describe how
and by whom, and if any strategies will be used to maintain or
improve fidelity, describe them.
For observational studies:
Provide a brief description of the condition observed and/or the
exposure. The duration of observation must also be described.
Intervention code *Choose the most appropriate intervention code(s) from the list. The
form allows a maximum of 3 entries. Click “Add new interventioncode” to add more boxes.
Note that only the first 3 codes are available for observational
studies.
Not applicable: study in which no experimental intervention ortreatment is applied. This selection is not available forinterventional studies.
Diagnosis / prognosis: study designed to evaluate one or moretests aimed at identifying a disease or health condition, or
determining a patient’s prognosis.
Early detection / screening: study that involves the systematic
examination of a group of participants, in order to separate wellpersons from those who have an undiagnosed pathologic condition
or who are at high risk. It could also refer to the initial evaluation of
an individual, intended to determine suitability for a particulartreatment modality or to detect specific markers or characteristics
that may require further investigation.
Prevention: study designed to assess one or more interventions
aimed at preventing the development of a specific disease or
health condition.
Treatment: drugs: study designed to assess the effect(s) of one ormore chemical or biological agents including vaccines.
Treatment: surgery: study designed to assess the effect(s) of one
or more manual or operative surgical techniques, whether in thefields of cosmetic, elective, experimental, plastic, or replacement
surgery (performed to diagnose, treat, or prevent disease or otherabnormal conditions).

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Treatment: devices: study designed to evaluate the use of any
physical item used in medical treatment whether it be an
instrument, piece of equipment, machine, apparatus, appliance,material or other article, and whether it is used alone or in
combination with the intention of preventing, diagnosing, treating,and curing a disease or condition. Examples include: artificial
limbs, contact lenses, ventilators, catheters, implants, vibration
therapy machines.
Treatment: other: studies that do not fall under the broad definitionsof drug, surgical, or device trials. Examples include interventions
such as exercise, physiotherapy, cognitive therapy, special diets,
herbal medicines, web-based treatments, motivational classes,
music therapy, stem cell interventions.
Rehabilitation: studies designed to evaluate one or moreinterventions which aim to restore the physical or mental health,function and quality of life in participants who have had or are
currently suffering from an illness or injury. Rehabilitation may be
performed through physical therapy (e.g. physiotherapy,
chiropractic) and/or education (e.g. diet and exercise
advice/counselling).
Lifestyle: studies designed to investigate the effect of interventions
which relate to a way of life or style of living. Interventions may aim
to alter the attitudes, habits and values of a person or group, andhow these participants cope with their physical, psychological,
social, and economic environments on a day-to-day basis.
Examples include diet and nutrition plans, exercise or physicalactivity programs, quit smoking programs.
Behaviour: studies designed to assess the effect of interventions
which aim to elicit or modify mental or physical actions, responses
or conduct in a person or group. Examples of behaviouralinterventions include cognitive behavioural therapy, exercise
behaviour interventions, and breast feeding behaviouralinterventions.
Other interventions: studies that do not fit under any of the above
categories. This should only be selected when no other options areadequate. Examples include prayer, singing, driving.
Comparator /control treatment *For controlled trials, the identity of the comparator/control arm
should be clear. The comparator/control(s) is/are the treatments
against which the study intervention is being compared (e.g.
placebo, no treatment, active control).
If an active control is used, be sure to provide the specific name of
the treatment. For each comparator/control treatment, describe thedetails as applicable, following the TIDieR Checklist (e.g. dose,
duration, mode of administration, etc).
If the study is uncontrolled then please enter the text “No control
group” or similar.

Control group *A "control" group is the type of treatment to which the intervention
is being compared, also known as a "comparator" group. Choose

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the most appropriate description of the study’s control group fromthe list.
Placebo: an inactive or sham treatment that has no treatment value
is given to the control group, such as sugar pill or saline solution.
Active: when the control treatment is active. This includes standard
care, alternate forms of treatment, no treatment given, or if patientsact as their own control (crossover study).
Uncontrolled: when there is no control group, as in single group
trials. The same intervention is applied to all subjects in the study.
Historical: a group of people who received their care in the past,i.e. not at the same time as the people receiving the intervention.
This selection is not applicable for randomised controlled trials. The
source and time period that historical data was collected needs tobe described in the ‘Comparator / control treatment’ field.
Dose comparison: the comparator group receives the same
treatment as the intervention group, but in a different dose.
Step 4: OutcomesPrimary outcome(s), Primary outcome(s) is the outcome(s) which provides the primaryassessment method measure of the effectiveness (or lack of effectiveness) of theand timepoint(s) *intervention. In many studies, more than one variable is used as a
primary outcome measure. The primary outcome should be theoutcome used in sample size calculations, or the main outcome(s)used to determine the effect of the intervention(s).
Provide specific names of all primary outcomes, one at a time, e.g.
“% with Beck depression score > 10” rather than just “depression”.
All outcomes should be provided in an objective form without
indicating suspected or hypothesised results, e.g. “Change in blood
glucose” or “proportion of participants with a reduction in blood
glucose” rather than “reduced blood glucose”.
Methods to be used for the assessment/measurement need to be
included / described, e.g. serum assay, MRI scan, 100mm visual
analogue scale. If a questionnaire is used, the name of thequestionnaire should be provided (if validated) or indicate whether
it was designed specifically for the study.
For adverse events provide examples of known/possible adverse
reactions/events and how they will be assessed.
For each outcome provide all timepoints at which it is assessed inthe ‘Timepoint’ box. Timepoints should be specific, for example “7days post commencement of intervention” rather than just “7 days”.
For primary outcomes assessed at multiple timepoints, please also
specify the primary timepoint, if applicable, e.g. “1 hour, 3 hours(primary timepoint) and 6 hours post dose”.
Enter only one primary outcome per box. Click “Add new primary
outcome” to add more boxes if the study has multiple primary
outcomes. The form allows a maximum of 3 sets of entries for the
primary outcome and timepoint.

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Examples:Primary Outcome 1: Hospital length of stayAssessment method: assessed by data linkage to medical records
Timepoint: at one year after randomisation
Primary Outcome 2: Depression
Assessment method: Hospital Anxiety and Depression Scale
Timepoint: Baseline, 6 weeks (primary timepoint) and 12 weeks
after intervention commencement
Secondaryoutcome(s),assessment method
and timepoint(s) *Secondary outcomes are events, variables, or experiences that areof secondary interest or that are measured at timepoints ofsecondary interest.
A secondary outcome may involve the same event, variable, or
experience as the primary outcome, but measured at timepoints
other than those of primary interest (e.g. primary outcome: allcause mortality at 5 years; secondary outcome: all-cause mortality
at 1 year, 3 years), or may involve a different event, variable, or
experience altogether (e.g. Primary outcome: all-cause mortality at
5 years; Secondary outcome: hospitalisation rate at 5 years).
Methods to be used for the assessment/measurement need to be
included / described. For each outcome, also provide all timepoints
at which it is assessed in the ‘Timepoint’ box.
Enter only one secondary outcome per box. Click “Add new
secondary outcome” to add more boxes if the study has multiple
secondary outcomes. The form allows a maximum of 40 sets ofentries for the secondary outcome(s) and timepoint(s).
If there are no secondary outcomes then enter the text ‘Nil’.
Examples:Secondary Outcome 1: Knee pain
Assessment method: 100mm Visual Analogue Scale (VAS)
Timepoint: at 6 months after randomisation
Secondary Outcome 2: Quality of life
Assessment method: SF-36 Quality of Life Questionnaire
Timepoint: Baseline, and at 4 and 8 weeks after interventioncommencement

Step 5: Eligibility
Key inclusion
criteria *Summary of key inclusion criteria of patient characteristics that
determine eligibility for participation in the study.

Minimum age *Specify minimum age of eligible study participants. Enter thenumber and choose the appropriate unit from the list. If there is no
minimum age limit leave the box for the number blank and select“No limit” from the unit of measurement list.
 Years
 Months

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 Weeks Days Hours
 No limit
Maximum age *Specify maximum age of eligible study participants. Enter thenumber and choose the appropriate unit from the list. If there is no
maximum age limit leave the box for the number blank and select“No limit” from the unit of measurement list.
 Years
 Months
 Weeks
 Days Hours
 No limit

Sex *Choose the appropriate selection for sex of the study’s participants.
 Males Females Both males and females

Can healthy
volunteers
participate? *Indicate whether healthy volunteers may participate in this study.
Studies where the Inclusion Criteria requires pregnant women or
those with any condition, including non-debilitating conditions (e.g.
myopia, smoking, etc.), are not considered healthy volunteer
studies and should respond “No” to this question.
 Yes
 No

Key exclusion
criteria *Summary of key exclusion criteria of patient characteristics that
determine eligibility for participation in the study. These should not
simply be the opposite of the inclusion criteria.

Step 6: Study design
Purpose of the study*

Choose the most appropriate purpose of the study from the list.

(Mandatory whenInterventional isselected for‘Study type’ instep 3)

Prevention: study designed to assess one or more interventions
aimed at preventing the development of a specific disease or
health condition.

Treatment: study designed to evaluate one or more interventions
for treating a disease, syndrome or other health condition(s).

Diagnosis: study designed to evaluate one or more interventions
aimed at identifying a disease or health condition.
Educational / counselling / training: study designed to assess one
or more interventions in an educational, counselling or training
environment.

Allocation tointervention *Choose the appropriate type of allocation to intervention.
Randomised controlled trial means that allocation of subjects into
different groups (i.e. intervention and control) was random or by amethod based on chance.

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(Mandatory whenInterventional isselected for‘Study type instep 3’)

Allocation
concealment(Only available
whenInterventional isselected for‘Study type’ instep 3)

Non-randomised trial means that allocation of subjects into
different groups (i.e. intervention and control) is expressly ordeliberately done, and is not random or by chance.
Note: Trials with quasi-randomisation allocation procedures suchas allocation by hospital record number, birth date or alternatedays of the week, do not qualify as a randomised trial. Therefore,
these studies should be classified as non-randomised trials.
Only applicable for randomised controlled trials.
Allocation concealment means that the person who determined if asubject was eligible for inclusion in the trial was unaware, when thisdecision was made, to which group the subject would be allocated.
Allocation was concealed if it was done by, for example:
1. sealed opaque envelopes
2. numbered containers
3. central randomisation by phone/fax/computer
4. allocation involved contacting the holder of the allocation
schedule who was “off-site” or at central administration site.
If concealment was not carried out, the text “Allocation is notconcealed” should be stated for this section.

Sequence generation(Only available
whenInterventional isselected for‘Study type’ instep 3)Only applicable for randomised controlled trials.
This is the method used to create the random order for the
allocation of subjects into different groups. Examples of the random
order generation include (but are not limited to):1. Simple randomisation using a randomisation table from astatistic book
2. Simple randomisation using a randomisation table createdby computer software (i.e. computerised sequence
generation)
3. Simple randomisation using procedures like coin-tossing
and dice-rolling
4. Permuted block randomisation
5. Dynamic (adaptive) random allocation methods such as
Minimisation
If stratified allocation was employed in the study, specify factor(s)used for the stratification. Examples of factors that can be used forstratification include centre, age, gender or previous treatment.
Quasi-randomisation allocation procedures or inappropriate
randomisation methods such as allocation by hospital record
number, birth date or alternate days of the week, do not qualify as
a random order generation.

Masking / blinding(Only available
whenInterventional isselected for

Masking / blinding is when the person in question (participant,therapist/clinician, assessor or data analyst) did not know whichgroup the participant had been allocated to. For trials in which key
outcomes are self-reported (e.g. visual analogue scale, pain diary),
the assessor is considered to be blinded if the subject was blinded.

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‘Study type’ instep 3)

Open (masking not used) - all involved in the study know theidentity of the intervention assignment. Participant,therapist/clinician, assessor and data analyst are not blinded.
Blinded (masking used) - when one or more of the parties(participants, therapist/clinician, assessor or data analyst) is/are
blinded or unaware of the intervention assignment.
If "Blinded (masking used)" option was chosen above, please tick
who is/are blinded (choose all that apply), from the list.
 the people receiving the treatment/s (participants)
 the people administering the treatment/s (therapist/clinician) the people assessing the outcomes (assessor)
 the people analysing the results/data (data analyst)

Assignment(Only available
whenInterventional isselected for‘Study type’ instep 3)Choose the most appropriate description of the study’s assignment
from the list.
Single group: all participants receive the same intervention
throughout the study. Trials in which participants are assigned toreceiving one of two or more interventions are not single groupstudies. Crossover trials are not single group studies.
Parallel: different groups of participants receive different
interventions during the same time span of the study.
Crossover: all participants receive all the interventions in random
order or in a specific sequence (non-randomised) during the study.
They act as their own control.
Factorial: participants are randomly allocated to receive either nointervention, one or some interventions, or all interventions
combined. For example in a 2x2 factorial trial of diet and exercise
for weight loss, participants would be allocated to: diet alone,
exercise alone, both diet and exercise, or neither. In this way it ispossible to test the independent effects of diet and exercise on theoutcome, i.e. weight loss.
Other: None of the selections provide an appropriate description of
the study’s assignment. If "Other" is selected for the study's
assignment, please give a brief description of the study's
assignment in the "Other design features" field below.

Other design features Briefly describe other design features if “Other” is selected for
Assignment above.
(Only available
whenInterventional isselected for‘Study type’ instep 3)Phase*(Mandatory whenInterventional isselected forPhases of investigation generally only apply to drug trials for the
purposes of this registration form.
Not applicable: this selection is for a non-drug trial.
Phase 0: includes exploratory, first-in-human trials. Phase 0 trials
are also known as human micro-dosing studies and are designed

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‘Study type’ instep 3)to speed up the development of promising drugs or imaging agentsby establishing very early on whether the drug or agent behaves inhuman subjects as was anticipated from preclinical studies.
Exploratory trials are conducted before traditional dose escalationand safety studies and gives no data on safety or efficacy, being bydefinition a dose too low to cause any therapeutic effect.
Phase 1: includes initial study to determine the metabolism andpharmacologic actions of drugs in humans, the side effects
associated with increasing doses, and to gain early evidence ofeffectiveness; may include healthy participants and/or patients.
Trials are often dose ranging/escalating trials which are done todetermine the maximum dose of a new medication that can besafely given to a patient.
Phase 1/Phase 2: for trials at a combined stage of phases 1 and 2.
Phase 2: includes controlled clinical studies conducted toevaluate/test the effectiveness of a new drug/medication orintervention for a particular indication or indications in patients withthe disease or condition being studied and to determine thecommon short-term side effects and risks.
Phase 2/Phase 3: for trials at a combined stage of phases 2 and 3.
Phase 3: includes expanded controlled and uncontrolled trials after
preliminary evidence suggesting effectiveness of the drug has
been obtained, and are intended to gather additional information toevaluate the overall benefit-risk relationship of a new
drug/medication or intervention, including possible adverse
reactions. It is also to provide an adequate basis for physician
labelling.
Phase 3/Phase 4: for trials at a combined stage of phases 3 and 4.
Phase 4: post-marketing study to delineate additional information.
Trials are done to monitor the toxicity, risks, utility, benefits andoptimal use after the efficacy of the drug/medication or intervention
has been proven.

Type of endpoint(s)(Only available
whenInterventional isselected for‘Study type’ instep 3)Choose the most appropriate study endpoint(s) from the list.
Safety: to show if the intervention is safe under conditions ofproposed protocol/use.
Efficacy: to measure an intervention’s influence on a disease or
health condition.
Safety/efficacy: combination of safety and efficacy.
Bio-equivalence: scientific basis for comparing generic and brandname drugs.
Bio-availability: rate and extent to which a drug is absorbed orotherwise available to the treatment site in the body.
Pharmacokinetics: the action of a drug in the body over a period oftime including the process of absorption, distribution andlocalisation in tissue, biotransformation, and excretion of thecompound.
Pharmacodynamics: action of drugs in living systems.

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Pharmacokinetics / pharmacodynamics: combination ofpharmacokinetics and pharmacodynamics.
Statistical methods /analysis

Provide a brief description of how the number of participants
needed to achieve study objectives was determined, including
clinical and statistical assumptions supporting any sample size
calculations.
A brief summary of the statistical methods and/or analysis plan to
be used to evaluate the data also need to be provided.

Purpose(Only available
when
Observational isselected for‘Study type’ instep 3)

If the study is an observational study, choose the most appropriate
purpose of the study from the list.
Natural history: study designed to investigate a disease orcondition through observation under natural conditions (i.e. without
intervention).
Screening: study designed to assess or examine persons orgroups in a systematic way to identify specific markers or
characteristics (e.g. for eligibility for further evaluation).
Psychosocial: study designed to observe the psychosocial impactof natural events.

Duration(Only available
when
Observational isselected for‘Study type’ instep 3)
Selection(Only available
when
Observational isselected for‘Study type’ instep 3)

If the study is an observational study, choose the most appropriate
duration of the study from the list.
Longitudinal: study in which participants are evaluated over long
period of time, typically months or years.
Cross-sectional: study in which participants are evaluated at aparticular point in time.
If the study is an observational study, choose the most appropriate
sample selection of the study from the list.
Convenience sample: participants or populations are selected at
the convenience of the investigator or primarily because they wereavailable at a convenient time or place. The investigators makelittle or no effort to ensure that the sample is an accurate
representation of some larger group or population.
Defined population: participants or populations are selected basedon predefined criteria.
Random sample: participants or populations are selected bychance in a manner such that all samples of a population have an
equal chance of being selected.
Case control: participants or populations are selected to match
control participants or populations in all relevant factors except forthe disease; only the case participants or populations have thedisease.

Timing(Only available
when
Observational is

If the study is an observational study, choose the most appropriate
timing of the study from the list.
Retrospective: study that observes events in the past.

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selected for‘Study type’ instep 3)

Prospective: study that observes events in real time (may also
occur in future).
Both: study that combines retrospective and prospective
observation.

Step 7: Recruitment
Recruitment status * Choose the most appropriate description of the study’s current
recruitment status from the list.
Not yet recruiting: participants are not yet being recruited
Recruiting: open for recruitment and the first participant has beenenrolled
Active, not recruiting: closed to recruitment and participants arebeing treated or examined
Completed: the study has concluded normally; participants are nolonger being treated or examined (i.e. follow-up and data collection
are complete)
Withdrawn: study halted prematurely, prior to enrolment of firstparticipant
Suspended: there is a temporary halt in recruitment and enrolment
but potentially will resume
Stopped early: recruiting or enrolling participants has haltedprematurely and will not resume
Data analysis?
(Only available
when Stopped
early is selectedfor ‘Recruitment
status’ in step 7)
Reason for early
stopping/ withdrawal(Only available
when Withdrawn
or Stopped early
is selected for‘Recruitment
status’ in step 7)
Date of firstparticipant
enrolment *Choose the most appropriate option from the dropdown menu: No data analysis planned Data collected is being analysed Data analysis is complete

Please tick all that apply: Lack of funding/staff/facilities Participant recruitment difficulties
 Safety concerns
 Other reasons/comments(please specify)

This is defined as the date of randomisation of the first participant
for randomised trials. For non-randomised studies, it is defined as
the date that the first participant commences
treatment/intervention/ exposure.
Anticipated date (dd/mm/yyyy) is mandatory if recruitment has notstarted.

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Actual date (dd/mm/yyyy) is mandatory once recruitment has
started.
For studies involving secondary analysis of data, please specify the
anticipated/actual start date of data collection.
Date of lastparticipant enrolment

The anticipated date (dd/mm/yyyy) that recruitment into the study
will cease.
The actual date (dd/mm/yyyy) that the final participant wasenrolled into the study. This is mandatory for studies which havecompleted recruitment.
For studies involving secondary analysis of data, please specify the
anticipated/actual end date of data collection.

Date of last datacollection

The anticipated date (dd/mm/yyyy) of last data collection for lastparticipant.
The actual date (dd/mm/yyyy) of last data collection for lastparticipant.

Target sample size * The total number of participants the investigators plan to enrol
before closing the trial to new participants.
Note: This is a “number only” field.
Accrual to date

The total number of participants who have been enrolled into thestudy to date. This is mandatory for studies with ongoingrecruitment, and for studies with suspended recruitment.
Note: This is a “number only” field.

Final sample size

The final number of participants enrolled into the study at close ofrecruitment. This is mandatory for studies which have completed
recruitment.
Note: This is a “number only” field.

Recruiting in Australia Tick this box if your study is/was or will be recruiting from within(Recruitment sites)
Australia.
Recruitment states *(Mandatory when
‘Recruiting inAustralia’ isselected in step 7)
Recruitment hospitals(Only available
when ‘Recruitingin Australia’ isselected in step 7)

Tick the boxes corresponding to all recruiting states within
Australia.

NSW

VIC

QLD

ACT


NT



SA



TAS



WA

Type the full name of the recruiting hospital(s), and click on thematching option that appears on the list to add it to this form. E.g.
instead of "RPA", please enter "Royal Prince Alfred Hospital". If thesite you wish to enter does not appear, then please email us at
info@anzctr.org.au.

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Recruitment
postcode(s)(Only available
when ‘Recruitingin Australia’ isselected in step 7)
Outside Australia(Recruitment sites)Type the four-digit postcode for the suburb where recruitment will
occur, and click on the matching option that appears on the list to
add it to this form.

Tick this box if your study is/was or will be recruiting from countries
outside Australia.
Select the appropriate recruitment country from the drop-down listand enter the state/province of recruitment (free text).
If there is more than one country of recruitment outside Australia,
please click on the “Add new country” button.

Step 8: Funding & Sponsors
Funding source(s) *Major source(s) of monetary or material or infrastructure support
for the study, including in-kind support.
Funding type: choose the most appropriate type from the list.
 Government body
 Hospital University
 Commercial sector/industry
 Charities/societies/foundations
 Other collaborative groups
 Self funded/unfunded Other
Note: The selection ‘Self funded/unfunded’ applies to studies which
are either funded by an individual person or not funded at all.
Name of funding source: enter only one per box.
Country of funding source: choose the appropriate country fromlist.
Click “Add new funding source” to add more boxes if the study has
multiple funding sources. The form allows maximum of 20 sets ofentries.

Primary sponsor *The individual, organisation, group or other legal person taking on
responsibility for securing the arrangements to initiate and/or
manage a study, including arrangements to ensure that the designof the study meets appropriate standards and to ensure
appropriate conduct and reporting. The primary sponsor is normallythe main applicant or principal investigator for regulatory
authorisation or funding to begin the study. The primary sponsor is
responsible for ensuring that the trial is properly registered. It may
or may not be the main funder.
Primary sponsor type: choose the most appropriate type from thelist.
 Government body
 Hospital University

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 Commercial sector/industry
 Charities/societies/foundations
 Other collaborative groups Individual OtherName of primary sponsor: enter only one name of the study’s
primary sponsor.
Country of primary sponsor: choose the appropriate country fromlist.
The form allows only one entry for primary sponsor. For additionalsponsors, please refer to the secondary sponsor(s) section.
Secondarysponsor(s) *Additional individuals, organisations or other legal persons, if any,that have agreed with the primary sponsor to jointly take on
responsibilities of sponsorship. A secondary sponsor may haveagreed to form a group with the primary sponsor in which the
responsibilities of sponsorship are allocated among the membersof the group and/or to act as the sponsor’s legal representative in
relation to some or all of the trial sites. A secondary sponsor may
take responsibility for the accuracy of trial registration information
submitted.
Note: The primary and secondary sponsors should not be thesame.
Secondary sponsor type: choose the most appropriate type fromthe list.
 Government body
 Hospital University
 Commercial sector/industry
 Charities/societies/foundations
 Other collaborative groups Individual Other NoneName of secondary sponsor: enter only one name of the study’s
secondary sponsor per box.
Country of secondary sponsor: choose the appropriate country
from list.
Click “Add new secondary sponsor” to add more boxes if the study
has multiple secondary sponsors. The form allows maximum of 20
sets of entries for the secondary sponsor(s).

Other collaborator(s)Additional individuals, organisations or other legal persons, if any,that have agreed with the primary sponsor to jointly take on
responsibilities of sponsorship. A collaborator may have agreed toform a group with the primary sponsor in which the responsibilitiesof sponsorship are allocated among the members of the group
and/or to act as the sponsor’s legal representative in relation tosome or all of the trial sites.
Collaborator type: choose the most appropriate type from the list.

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 Government body
 Hospital University
 Commercial sector/industry
 Charities/societies/foundations
 Other collaborative groups Individual OtherName of collaborator: enter only one name of the study’s
collaborator per box.
Country of collaborator: choose the appropriate country from list.
Click “Add new other collaborator” to add more boxes if necessary.
The form allows maximum of 20 sets of entries.
Step 9: Ethics & Summary
Ethics application
status *Select the appropriate option from the list.
Not yet submitted: You intend to submit to at least one ethics
committee, but have not yet done so. Note: If this option is
selected it is mandatory to provide the date which the trial’s primarysponsor or their representatives intend to submit an ethics
application in the ‘Submit date’ field.
Submitted, not yet approved: You have submitted an application toat least one ethics committee, but have not yet received approval.
Note: If this option is selected it is mandatory to provide the datewhen the ethics application was submitted in the ‘Submit date’field.
Approved: You have received full ethical approval for this study
from at least one ethics committee. Note: If this option is selected it
is mandatory to provide the date when the ethics approval was
granted in the ‘Approval date’ field.
Not required: Ethics approval not required for this study. Note: If
this option is selected it is mandatory to provide the reason(s) why
ethics approval is not required in the ‘Public notes’ field in Step 9 of
the form.

Ethics committee
details*(mandatory, except
when ‘Not required’
selected for Ethics
application status)

Please also provide the following information:
Country of ethics committee: please choose the appropriate
country from list first.
Name of ethics committee: please select ethics committee fromdrop-down menu. Note if your ethics committee is not available
from this list, please select ‘Other (ethics committee name notavailable in list)’ and then the name of the ethics committee willneed to be manually entered below.
Contact details of ethics committee: if the ethics committee isselected from the drop-down above, this will automatically beentered. If the ethics committee is not available from the dropdown, please manually enter the website or the full address of thenamed ethics committee, including street number and name,suburb/town city, postcode and state/province (where applicable).

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Alternatively PO Box/Locked Bag/Private Bag addresses are also
permitted.
Submit date: enter the date that the ethics committee application
was submitted, or is planned to be submitted. Note: This field ismandatory when either ‘Not yet submitted’ or ‘Submitted, not yet
approved’ has been selected for ethics application status above.
Approval date: enter the date that the ethics committee application
was approved. Note: This field is mandatory when ‘Approved’ hasbeen selected for ethics application status above.
Approval ID: enter the approval ID assigned to the ethics
application by the ethics committee at the time of granting
approval. Note: This field is not mandatory.
Click “Add new ethics committee” to add more boxes if the study
has received approval from multiple ethics committees. The form
allows a maximum of 50 sets of entries.
Brief summary *Short description of the primary purpose of the study, including abrief statement of the study hypothesis, intended for the lay public.
Ensure that the information provided in the brief summary is
consistent with study design, intervention description and study
outcomes provided in the form. This information may be displayedon other websites (such as Australian Clinical Trials:
https://www.australianclinicaltrials.gov.au/) to facilitate recruitment.

Trial website

If the study has a trial website, enter the web address/URL(Uniform Resource Locator) in this section. Otherwise, pleaseleave blank.

Trial relatedpresentations /publication list

Please note that it is no longer possible to add trial relatedpresentations/publications in this field. Please add these in Steps
11 (Data sharing statement) and/or 12 (Summary results) instead.
It is still possible to remove text from this field.
This field will only appear for trials registered prior to 2024 with preexisting information in this field.

Public notes

This field is for any extra, miscellaneous text you would likeincluded within the trial registration record which is not relevant
elsewhere on this form. Anything placed here WILL be publicly
viewable.

Private notes

This field is for any extra, miscellaneous text you would likeincluded within the trial registration record which is not relevant
elsewhere on this form. Anything placed here will NOT be publicly
viewable, but will be available to ANZCTR staff.

Attachments

Please note that it is no longer possible to add attachments to thisfield. Please use the study-related documents field in Step 11(Data sharing statement) and/or the publications fields in Step 12(Summary results) instead. It is still possible to remove
attachments from this field if necessary. Attached files WILL
remain publicly available via your trial’s ANZCTR registration
record.

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This optional section was previously used to upload any relevant
documents (e.g. trial protocol, ethics approval forms, blank clinicalrecord forms). Files are in PDF or Word with a maximum size of
15MB per file. It is the responsibility of the registrant to ensure thatany uploaded documents continue to comply with copyright
regulations.
Step 10: Contacts
Principal
investigator *Title, name, address, country, telephone number and email
address of the principal investigator of the study.
Functional/institutional contact details should be provided.
Address should include work organisation/affiliation, street number
and name, suburb/town city, postcode and state/province (whereapplicable). Alternatively PO Box/Locked Bag/Private Bag
addresses are also permitted.
Telephone numbers should be entered in the format +countrycode, area code, number, for example:+61 2 9562 5333 (for Sydney, Australia)+1 310 8298781 (for Santa Monica CA, USA)
Note: The information provided here is functional and not personal;
therefore it is recommended to provide institutional and not
personal information. By providing this information the registrant
consents that the information provided can or may be published ona public website. Once provided, the information cannot be
redacted or anonymised, even to comply with new privacy
legislation such as the European General Data Protection
Regulation (GDPR). Note that while the current contact information
may be modified at any time, all information published on the
ANZCTR remains in the public domain, whether as part of the audit
trail in historical versions of the record or in the most recent versionof the record.

Contact person for
public queries *Title, name, address, telephone number and email address of thecontact person who will respond to general queries, including
information about current recruitment status. Functional/institutional
contact details should be provided.
Address should include work organisation/affiliation, street number
and name, suburb/town city, postcode and state/province (whereapplicable). Alternatively PO Box/Locked Bag/Private Bag
addresses are also permitted.
Telephone numbers should be entered in the format +countrycode, area code, number, for example:+61 2 9562 5333 (for Sydney, Australia)+1 310 8298781 (for Santa Monica CA, USA)
Note: The information provided here is functional and not personal;
therefore it is recommended to provide institutional and not

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personal information. By providing this information the registrant
consents that the information provided can or may be published ona public website. Once provided, the information cannot be
redacted or anonymised, even to comply with new privacy
legislation such as the European General Data Protection
Regulation (GDPR). Note that while the current contact information
may be modified at any time, all information published on the
ANZCTR remains in the public domain, whether as part of the audit
trail in historical versions of the record or in the most recent versionof the record.
Contact person for
scientific queries *Title, name, address, telephone number and email address of thecontact person for scientific inquiries about the trial (e.g. principal
investigator, medical director for the study). For a multi-centre
study, enter the contact information for the lead principal
investigator or overall medical director. Functional/institutional
contact details should be provided.
Address should include work organisation/affiliation, street number
and name, suburb/town city, postcode and state/province (whereapplicable). Alternatively PO Box/Locked Bag/Private Bag
addresses are also permitted.
Telephone numbers should be entered in the format +countrycode, area code, number, for example:+61 2 9562 5333 (for Sydney, Australia)+1 310 8298781 (for Santa Monica CA, USA)
Note: The information provided here is functional and not personal;
therefore it is recommended to provide institutional and not
personal information. By providing this information the registrant
consents that the information provided can or may be published ona public website. Once provided, the information cannot be
redacted or anonymised, even to comply with new privacy
legislation such as the European General Data Protection
Regulation (GDPR). Note that while the current contact information
may be modified at any time, all information published on the
ANZCTR remains in the public domain, whether as part of the audit
trail in historical versions of the record or in the most recent versionof the record.

Step 11: Data sharing statement
Will individual
participant data(IPD) for this trial beavailable (including
data dictionaries)? *Indicate whether there is a plan to make individual participant data(IPD) publicly available for this trial. IPD refers to raw line-by-line
data collected from each participant.
 Yes; IPD and related data dictionaries are/will be available No; IPD will not be available
Note: the option of ‘Undecided’ is no longer able to be selected
due to a recent decision by the International Committee of Medical
Journal Editors (ICMJE).

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No IPD sharing
reason/comment

Provide reasons/comments for why the IPD are not planned to beshared.

(Only available
when ‘No’ isselected forprevious field)
What data will beshared? *(Mandatory when
‘Yes’ is selected for
IPD question in
Step 11)When will data beavailable (start andend dates)? *(Mandatory when
‘Yes’ is selected for
IPD question in
Step 11)Available to whom? *(Mandatory when
‘Yes’ is selected for
IPD question in
Step 11)Available for whattypes of analyses? *(Mandatory when
‘Yes’ is selected for
IPD question in
Step 11)How or where candata be obtained? *(Mandatory when
‘Yes’ is selected for
IPD question in
Step 11)

Please describe what data will be shared e.g. all of the individual
participant data collected during the trial, after de-identification;individual participant data underlying published results only, etc.

Please outline the timeframe of data availability, i.e. beginning andend dates for when the data is expected to be available, e.g.
Immediately following publication, no end date; Beginning 3
months and ending 5 years following main results publication; no
end date determined etc.

Please specify who can/will be able to access the data, e.g.
anyone who wishes to access it, only researchers who provide amethodologically sound proposal, case-by-case basis at thediscretion of Primary Sponsor, etc.
Please clarify if there is a specific type of analysis for which thedata are/will be available, e.g. any purpose, only to achieve theaims in the approved proposal, for IPD meta-analyses, etc.

Please specify how/where data are/will be shared e.g. unrestricted
access via web address (provide link), access subject to approvals
by Principal Investigator (provide email or other contact details),
etc.

What supporting
Please provide details of all types of supporting information that will
documents are/will be be shared. To add a supporting document, please click on the ‘Add
available?
New Supporting Document +’ button. Choose the appropriate
type(s) from the drop-down list in the ‘Type’ column:
 Analytic code
 Clinical study report Data dictionary
 Ethical approval Informed consent form
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 Statistical analysis plan
 Study protocol
 Other (please specify)†† If ‘Other’ is selected, please note that it is mandatory to specify

the other type of document that is/will be available in the ‘Other
details’ column.

Once ‘Type’ has been selected, please indicate how thecorresponding document can be obtained, e.g. citation, link, email,other, attachment. Note that it is mandatory to provide details for atleast one of these.
If no other supporting documents are/will be made available,please click ‘next step’ to proceed.
For citations, it is mandatory to provide the year of publication, afull citation or direct link to the citation.
For other details, use this field to describe how the document is/willbe available if no citation, link, or attachment is available or thisdocument is not available via email request.
For any attachments uploaded, please note it is the responsibilityof the registrant to ensure that any uploaded documents comply
with copyright regulations. All files attached will be publicly
available via the trial ANZCTR registration record. Attached files
cannot exceed the maximum size of 35MB per file.
Step 12: Study results
As per WHO recommendations, study results need to be made publicly available in a timely
manner following study completion. Please provide details of all types of study results thatare available by clicking on the ‘Add New Study Result +’ button. Choose the appropriate
type(s) from the drop-down list in the ‘Type’ column:
 Appendices Basic results (using this template) Book Conference abstract
 Conference poster Funder report Interim results article
 Plain language summary Protocol
 Statistical analysis plan
 Study results article
 Supplementary materials
 Thesis Other files
Once ‘Type’ has been selected, please indicate whether the results have been peer
reviewed and how they can be obtained, e.g. DOI, citation or other details, attachment.
Note that it is mandatory to provide details for at least one of these.
For any attachments uploaded, please note it is the responsibility of the registrant to ensurethat any uploaded documents comply with copyright regulations. All files attached will be
publicly available via the trial ANZCTR registration record. Attached files cannot exceed the
maximum size of 35MB per file.
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Condition categories and Condition codes
Condition category (level 1)
Alternative and complementary medicine

Anaesthesiology

Blood

CancerCondition code (level 2)
Spiritual care
Herbal remedies
Other alternative and complementary medicine
Anaesthetics
Pain management
Other anaesthesiology
Haematological diseases
Anaemia
Clotting disorders
Normal development and function of platelets and erythrocytes
Other blood disorders
Any
Biliary tree (gall bladder and bile duct)
Bladder - transitional cell cancer
BoneBowel - anal
Bowel - back passage (rectum) or large bowel (colon)
Bowel - small bowel (duodenum and ileum)
Brain
BreastCervical (cervix)
Children's - brain
Children's - leukaemia & lymphomaChildren's - other
Head and neck
Hodgkin's
KidneyLeukaemia - acute leukaemia
Leukaemia - chronic leukaemia
Liver
Lung - mesothelioma
Lung - non small cell
Lung - small cell
Lymphoma (non Hodgkin's lymphoma) - high grade lymphoma
Lymphoma (non Hodgkin's lymphoma) - low grade lymphoma
Malignant melanoma
Myeloma
Neuroendocrine tumour (NET)Non melanoma skin cancer
Oesophageal (gullet)
Ovarian and primary peritoneal
Pancreatic
Penile (penis)
Prostate
Sarcoma (also see 'Bone') - soft tissue
StomachTesticular
Thrombocythaemia
Thyroid
Womb (uterine or endometrial cancer)
Other cancer types

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Condition category (level 1)
Cardiovascular

Diet and nutrition
Ear

Emergency medicine
Eye
Infection

Inflammatory and immune system

Injuries and accidents

Human genetics and inherited disorders

Mental health

Metabolic and endocrine

Musculoskeletal

Condition code (level 2)
Coronary heart disease
Diseases of the vasculature and circulation including thelymphatic system
Hypertension
Other cardiovascular diseases
Normal development and function of the cardiovascular system
Obesity
Other diet and nutrition disorders
Deafness
Other ear disorders
Normal ear development and function
Resuscitation
Other emergency care
Diseases / disorders of the eye
Normal eye development and function
Acquired immune deficiency syndrome (AIDS / HIV)
Sexually transmitted infections
Other infectious diseases
Studies of infection and infectious agents
Rheumatoid arthritis
Connective tissue diseases
Autoimmune diseases
Allergies
Other inflammatory or immune system disorders
Normal development and function of the immune system
Fractures
Poisoning
Burns
Other injuries and accidents
Down's syndrome
Cystic fibrosis
Other human genetics and inherited disorders
Depression
Schizophrenia
Psychosis and personality disorders
Addiction
SuicideAnxiety
Eating disorders
Learning disabilities
Autistic spectrum disorders
Other mental health disorders
Studies of normal psychology, cognitive function and behaviour
Diabetes
Thyroid disease
Metabolic disorders
Other metabolic disorders
Other endocrine disorders
Normal metabolism and endocrine development and function
Osteoporosis
Osteoarthritis
Other muscular and skeletal disorders
Normal musculoskeletal and cartilage development and function

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Condition Category (level 1)
Neurological

Oral and gastrointestinal

Physical medicine / rehabilitation

Public health

Renal and urogenital

Reproductive health and childbirth

Respiratory

Skin

Surgery
StrokeOther

Condition code (level 2)
Dementias
Transmissible spongiform encephalopathies
Parkinson’s disease
Neurodegenerative diseases
Alzheimer’s disease
Epilepsy
Multiple sclerosis
Other neurological disorders
Studies of the normal brain and nervous system
Inflammatory bowel disease
Crohn’s disease
Other diseases of the mouth, teeth, oesophagus, digestive system
including liver and colon
Normal oral and gastrointestinal development and function
Physiotherapy
Speech therapy
Occupational therapy
Other physical medicine / rehabilitation
Epidemiology
Health promotion/education
Health service research
Other public health
Kidney disease
Pelvic inflammatory disease
Other renal and urogenital disorders
Normal development and function of male and female renal andurogenital system
Fertility including in vitro fertilisation
Contraception
Abortion
Fetal medicine and complications of pregnancy
Normal pregnancy
Mammary gland development
Menstruation and menopause
Breast feeding
Antenatal careChildbirth and postnatal careComplications of newborn
Other reproductive health and childbirth disorders
AsthmaChronic obstructive pulmonary disease
Sleep apnoea
Other respiratory disorders / diseases
Normal development and function of the respiratory system
Dermatological conditions
Normal skin development and function
Other skin conditions
Surgical techniques
Other surgery
Ischaemic
Haemorrhagic
Conditions of unknown or disputed aetiology (such as chronic fatigue
syndrome/myalgic encephalomyelitis)
Research that is not of generic health relevance and not applicable tospecific health categories listed above

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