Maternal & Perinatal Research Coordinating Hub

AuthorshipWelcome to the Maternal & Perinatal Research Coordinating Hub, a coordinating centre for maternal and perinatal clinical trials and studies, 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. 

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

HUB Templates

• Site Activation Checklist
• Maternal Consent
• Infant Consent
• Protocol

HUB Guides

• Document Version Control (NIH) 
• Participant Information Sheet - Examples
• Maternal & Perinatal Research Coordinating Hub
• Bayley Scales Age Calculator

Randomisation

• Simple Randomisation Plans

Data Management

• REDCap FMHS 
• Variable Naming Conventions

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
• Very Preterm Birth Studies - Pediatrics 2016
• STARD 2015 - Diagnostic Accuracy Studies

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
• PROSPERO Registration of Systematic Reviews - Checklist
• ROBINS-I - Risk of Bias In Non-randomized Studies of Interventions

Analysis

• Classification of Observational Studies - Lancet 2002
• Determining Adequate Sample Size - 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

Web Links

• OpenEpi - open source statistics
• IMPACT Clinical Trials
• Australia & New Zealand Clinical Trials Register
• Global Obstetrics Network (GoNET)
• 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 NZ
• Therapeutic Goods Agency (TGA) Australia
• MedSafe NZ
• Liggins Clinical Trials
• International Prospective Register of Systematic Reviews (PROSPERO)
• Neonatal Unit Contacts NZ