Perinatal Research Hub

• • • Welcome to the Perinatal Research Hub, a central coordinating centre for clinical trials and studies in maternal and perinatal health, hosted by the Liggins Institute and supporting the ON TRACK Network. 

The Hub is a collaboration between the Liggins Institute, Department of Obstetrics and Gynecology, and Department of Paediatrics: Child and Youth Health, University of Auckland. 

Contact: Dr Chris McKinlay +64274725099, c.mckinlay@auckland.ac.nz 

HUB Templates

HUB Guides

• • Document Version Control (NIH) 

Randomisation

• • Simple Randomisation Plans

Data Management

• REDCap FMHS 

Analysis

• • Classification of Observational Studies - Lancet 2002
  • Determining Adequate Sample Sizes - Pediatrics 2012
  • Factorial RCTs - BMC Medical Research Methodology 2003
  • Stepped Wedge RCTs - BMJ 2015
  • Accounting for Multiple Births in Neonatal and Perinatal Trials - J Pediatrics 2010

Training

• • NIH Protecting Human Subjects certificate
  • ROCHE GCP course
  • NIH GCP course

Consensus Statements and Checklists

Protocol Development

• • SPIRIT 2013 Statement

  • SPIRIT 2013 Explanation and Elaboration

Outcomes

• • COMET - A Core Outcome Set for Evaluation of Interventions to Prevent Preterm Birth

Reporting

• • TIDieR Checklist - Reporting of Interventions
  • CONSORT 2010 - Reporting Parallel Group RCTs
  • CONSORT 2010 - Extension to Cluster RCTs
  • CONSORT 2010 - Extension to Noninferiority and Equivalence RCTs
  • StRONNG Checklist - Standardised Reporting of Neonatal Nutrition and Growth
  • STROBE Statement - Reporting Observational Studies
  • STROBE Statement - Explanation & Elaboration

Data and Safety Monitoring

• •  DAMOCLES - Charter for Clinical Trial Data Monitoring Committees

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
• MOOSE - Reporting of Meta-analysis of Observational Studies in Epidemiology
• GRADE - Grading Quality of Evidence and Strength of Recommendations
• AGREE II - Assessing Quality and Reporting of Practice Guidelines

Web Links

• OpenEpi - open source statistics
• IMPACT Clinical Trials
• Australia & New Zealand Clinical Trials Register
• Global Obstetrics Network
• Core Outcomes Initiative (COMET)
• Trial Forge UK
• Clinical Trials Alliance Australia (ACTA)
• Health and Disability Ethics Committees NZ (HDEC)
• Health Research Council NZ (HRC)
• Cochrane Neonatal
• Cochrane Pregnancy
• NIH Clinical Research Toolkit
• ICH GCP
• National Maternity Monitoring Group
• Therapeutic Goods Agency (TGA) Australia
• MedSafe NZ
• Liggins Clinical Trials