Perinatal , an initiative of the ON TRACK Network. This site brings together resources and tools to support maternal and perinatal trials, and associated long-term follow-up studies.Links
Consensus Statements and Checklists
Protocol Development
Outcomes
Reporting
Data and Safety Monitoring
Knowledge Synthesis
Regulatory Authorities
Ethics
Study Design & Statistics
Templates & Guides
Data Management
(CDRH), a coordinating centre for clinical research, hosted by the Liggins Institute and supporting the ON TRACK Network. In collaboration with the Department of Obstetrics and Gynecology, and Department of Paediatrics: Child and Youth Health, University of Auckland.
We provide a comprehensive range of data management services for randomised trials and clinical studies, including online databases, custom randomisation, drug distributution and web dashboards for study monitoring. Our systems will help you streamline setting up and running your trial.
Contact: researchhub@auckland.ac.nz +64221885920
Randomisation and databases: www.ligginstrials.org
CDRH Guides
- Planning a Trial
- Clinical Trial Terminology
- Study Protocol
- Ethics
- Trial Committees
- Authorship
- Data Sharing
- Māori Responsiveness
- Standard Operating Procedures
Randomisation
Data Management
Analysis
- Normal Distribution Calculator
- OpenEpi - Open Source Statistics
- Medcalc Calculators
- Diagnostic Test Calculator
- Agreement Statistics Calculator
- New Zealand Index of Deprivation
- Trial Analysis
- Data Cleaning
Follow-up
- Bayley Scales Age Calculator
- NZ Travel Calculator
- Definitions for Follow-up Studies
- Middlemore Parking and Clinic Bookings
- Middlemore Neonatal Research Parking Instructions
- WHO Child Growth Standards (0-5 years)
- WHO Growth Reference 2007 (5-19 years)
- AAP Pediatric BP Calculator
- Bayley 4
CDRH Admin
- Redmine
- University of Auckland Staff Intranet
- Space statistics
- LiFePATH Admin
- CDRH Randomisation Demo (code:991000tst)
- CDRH Data Environment
Consensus Statements and Checklists
Protocols
Outcomes
- COMET - Core Outcome Measures in Effectiveness Trials
- COS - Prevention of Preterm Birth
- Neonatal Infection Case Definition (Brighton Collaboration)
Reporting
- CONSORT 2010 - Reporting Parallel Group RCTs
- CONSORT 2010 - Extension to Cluster RCTs
- CONSORT 2010 - Extension to Noninferiority / Equivalence RCTs
- StRONNG Checklist - Reporting of Neonatal Nutrition and Growth
- STROBE Statement - Reporting Observational Studies
- STROBE Statement - Explanation & Elaboration
- STARD 2015 - Diagnostic Accuracy Studies
- TIDieR Checklist - Reporting of Interventions
- Very Preterm Birth Studies (Pediatrics 2016)
Analysis
Data & Safety Monitoring
- DAMOCLES - Charter for Clinical Trial Data Monitoring Committees
- ERCIN 2011 - Standards Requirements for GCP-Compliant Data Management in Multinational Clinical Trials
- NAESS 2019 - Neonatal Adverse Event Severity Scale (INC)
Synthesis & Translation
- PRISMA-P 2015 - Preferred Reporting for Systematic Review and Meta-analysis Protocols
- PRISMA 2009 - Preferred Reporting Items for Systematic Reviews and Meta-analyses
- PRISMA-IPD 2015 - Preferred Reporting Items for a Systematic Review and Meta-analysis of Individual Participant Data
- PRISMA Extension 2015 - Network Meta-analyses
- PRISMA-C Extension 2016 - Systematic Reviews and Meta-analyses of Newborn and Child Health Research
- PRISMA-DTA - Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies
- MOOSE - Reporting of Meta-analysis of Observational Studies in Epidemiology
- GRADE - Grading Quality of Evidence and Strength of Recommendations
- GRADE - Non-Randomised Studies
- GRADE Handbook
- Cochrane Handbook 2019 - Systematic Reviews of Interventions
- AGREE II - Assessing Quality and Reporting of Practice Guidelines
- PROSPERO Registration of Systematic Reviews - Checklist
- RoB2 - Cochrane Risk of Bias Tool for RCTs
- ROBINS-I - Risk of Bias In Non-randomized Studies of Interventions
- Risk of Bias Tool for Observational Studies
- Meta-analysis of Animal Studies
- Median to Mean Calculator
- WHO Guideline to Rapid Reviews
Laboratory
Training
- NIH Protecting Human Subjects certificate
- NIH GCP course
- ROCHE GCP course (runs best in Firefox)
- Cultural Competency
- Infection control
- Definition of Research and Audit
- Classification of Observational Studies
Key Links
ANZ
- Australia & New Zealand Clinical Trials Register (ANZCTR)
- Health and Disability Ethics Committees NZ (HDEC)
- Health Research Council NZ (HRC)
- IMPACT Clinical Trials Network
- MedSafe NZ
- Neonatal Unit Contacts NZ
- Online Forms NZ (HDEC / SCOTT)
- DHB Research Contacts
- Therapeutic Goods Agency (TGA) Australia
- Kidz First Neonatal Research
- Cure Kids Portal
- Ministry of Health NZ
- ACC Act 2001: Clinical Trials
- NEAC Ethical Standards 2019
- Report on Maternity Web Tool
International
