BioBanking Core

Websites

People/Centres/Societies

  • HumGen International McGill-based centre of genomics and policy with ample resources concerning ethical, legal and social issues in human genetics and applications like biobanking. http://www.humgen.org/int/
  • International Society for Biological and Environmental Repositories http://www.isber.org/
  • United States and Canadian Academy of Pathology http://www.uscap.org/

Workshops/Courses/Programs
  • Canadian Tumour Repository Net Biobank Certification Workshop: Some presentations from the Canadian Tumour Repository Net Biobank Certification Workshop are now available for viewing on the CTRNet website. All presentations are available in PDF format and should not be copied or reproduced. Others will be posted as they become available. You will find them listed under “Education Resources” via the following link http://www.ctrnet.ca/resources
  • See HumGen International/Events http://www.humgen.org/int/

Documents

 

 

 
This information is by no means complete – please contact us
to provide other, relevant contributions.

Clinical Trials

Websites

  • Canadian Institutes for Health Research
    http://www.cihr-irsc.gc.ca/
  • Cochrane Collaboration
    An international, independent, not-for-profit organisation of over 28,000 contributors from more than 100 countries, dedicated to making up-to-date, accurate information about the effects of health care readily available worldwide. http://www.cochrane.org/
  • European Medicines Agency Paediatric Research Network.
    Find information related to development of a European network of existing national and European networks, investigators and centres with specific expertise in the performance of studies in the paediatric population.
    http://www.ema.europa.eu/ema/index.jsp?curl=pages/partners_and_networks/general/
    general_content_000303.jsp&murl=menus/partners_and_networks/
    partners_and_networks.jsp&mid=WC0b01ac05800862c3
  • International Forum of Standards for Research in Children (StaR Child Health)
    StaR Child Health is a group of methodologists, clinicians and policy makers who seek to enhance the quality, ethics and reliability of paediatric clinical research by promoting the use of evidence-based standards or guidance for clinical studies with children http://www.ifsrc.org/
  • Medicines for Children Research Network (UK)
    The NIHR MCRN has been created to improve the co-ordination, speed and quality of randomised controlled trials and other well designed studies of medicines for children and adolescents, including those for prevention, diagnosis and treatment. http://www.mcrn.org.uk/
  • Medicines for Children Research Network(Netherlands)
    The network is set up to improve the speed, quality and integration of clinical drug research in children, ultimately resulting in improved patient care. http://www.mcrn.nl/
  • USA National Institute of Child Health & Development Maternal-Fetal Medicine Research Network
    http://www.bsc.gwu.edu/MFMU/index.html
  • World Health Organization searchable database of registered clinical trials
    If you are interested in information on trials in children, check (√) the box “Search for Clinical Trials in Children” http://apps.who.int/trialsearch/AdvSearch.aspx
  • World Health Organization Essential Medicines for Children program
    At present, many medicines are not developed for children or available in suitable dosage forms; and when they are they are not reaching the children who need them most. The 'make medicines child size' campaign is an effort to change that reality. http://www.who.int/childmedicines/en/

People/Centres/Societies

Workshops/Courses/Programs

Documents

Risk of Bias in Paediatric Trials

 

 

 
This information is by no means complete – please contact us
to provide other, relevant contributions.

Data Management Core

The objective of MICYRN’s Data Management Core is to support multi-centre collaboration in maternal-child health research by developing a sound data management strategy. Paper has been the traditional means by which information is collected, but suffers from many limitations when compared with electronic web-based solutions. However issues of health information privacy, data security, and regulations regarding electronic documents may make these electronic solutions complex and often expensive to implement. A national data management strategy focused on the needs of maternal and child health research is being developed to help overcome these barriers. An integrated and coordinated data management strategy will enable clinical research with faster study start-up, reduced overall costs, improved data quality, and will leverage knowledge and experience from multiple sites.

MICYRN has adopted principles of (1) use and enhancement of existing data management initiatives and expertise; (2) use and enhancement of existing open source EDC, CDMS/CTMS solutions with non-restrictive licensing policies to ensure broad dissemination and benefit to MICYRN and Canadian clinical research; and (3) use of existing, proven infrastructure and data management practices.

MICYRN’s Data Management Core is based in Edmonton at the Women and Children’s Health Research Institute.  Several data management systems are offered – you can arrange to see web-based demonstrations and discuss features to suit your needs. 

Whether you want advice on acquiring software and hardware for your own purposes, or you want data management and hosting services, contact:

Dr. Lawrence Richter (DM Core Chair)  Lawrence.Richer@albertahealthservices.ca  or,

Rick Watts B.Sc., FICR, CSci, Team Lead, Clinical Research Informatics (780) 248-1170 or rick.watts@ualberta.ca

Ethics

Websites

  • Resources - Under development

People/Centres/Societies

  • HumGen International  McGill-based centre of genomics and policy with ample resources concerning ethical, legal and social issues in human genetics
    http://www.humgen.org/int/

Workshops/Courses/Programs

Documents
  • Canadian Ethics Harmonization:micyrn initiative

    Ethics Best Practices for Research with Children and Youth  http://www.pediagen.org
    Pediagen.org  A module of the HumGen International website that focuses on genetic research involving children. This module presents a listing of the international, regional and national normative documents pertaining to pediatric genetic research. It also offers a selective literature on the legal, ethical and social issues raised by this unique type of research. PediaGen should be considered as a useful research tool to find relevant information on different themes, such as biobanking, genetic testing, genetic screening and gene therapy. http://www.pediagen.org

This information is by no means complete – please contact us
to provide other, relevant contributions.

Health Services Research

Websites

  • Resources - Under development
  • On February 18 and 19, 2010, the Canadian Child & Youth Health Coalition (CCYHC), in partnership with the Canadian Institutes of Health Research – Institute for Human Development, Child & Youth Health (CIHR-IHDCYH), hosted an invitational workshop entitled “A Health Services Research Agenda: Building Capacity within the Maternal, Child, & Youth Sector”.
  • Workshop Presentations at  http://www.ccyhc.org/work_indicators_rfa.html
  • Workshop Report at http://www.ccyhc.org/work_indicators_rfa.html

 

 

 
This information is by no means complete – please contact us
to provide other, relevant contributions.

Knowledge Translation

Information is provided based on a knowledge translation (KT) needs assessment and environmental scan conducted by MICYRN in 2008. See the 2009 report Knowledge Translation Needs Assessment. Please contact us to update or provide new information.

Websites:

People:

  • David Johnson, University of Calgary/Alberta Children‘s Hospital (also, Kelly Mrklas)
  • Sharon Straus (University of Toronto/University of Calgary-Medicine)
  • Carole Estabrooks/Anne Sales/Greta Cummings (University of Alberta-Nursing)
  • Jeremy Grimshaw (University of Ottawa/OHRI-Medicine)
  • Ian Graham (University of Ottawa/CIHR/OHRI; Vice President KT at CIHR)
  • Terry Klassen (University of Alberta-Medicine, Pediatrics)
  • Shoo Lee (Mount Sinai Hospital, Ontario)
  • Melanie Barwick (University of Toronto/Hospital for Sick Children-Health systems/psychology)
  • John Lavis (McMaster University-Clinical epidemiology/biostatistics and health policy; Canada Research Chair in KT)
  • Shannon Scott (University of Alberta/Stollery Children‘s Hospital-Nursing)
  • Mandy Newton (University of Alberta/Stollery—Pediatrics)
  • Janet Curran (Dalhousie University/IWK-Medicine, Pediatrics)
  • Martin Osmond/Amy Plint (University of Ottawa/CHEO-Medicine, Pediatrics)
  • Francine Ducharme (McGill University/Ste Justine –Medicine)
  • Jacqueline Tetroe (University of Ottawa/ICEBeRG/OHRI/CIHR)

Workshops/Courses/Programs

Workshops/Seminars:
  • PERC- annual meeting, presentations by Jeremy Grimshaw, Shannon Scott; focus on Emergency medicine, pediatrics
  • EPIQ-Evidence-based Practice for Improving Quality (Maternal/Infant care)—seminars
  • OHRI-Summer Institute (University of Ottawa)
  • ICEBeRG (Improved Clinical Practice through Behavioral Research Group) at University of Ottawa—annual summer school in KT with Grimshaw & Graham
  • University of Laval (Quebec City) –focus on KT and policy change, healthcare services

Courses/diplomas/degrees: Canadian

  • University of Alberta: INTD690-Research Utilization (graduate level) with Carole Estabrooks (nursing, gerontology)
  • University of Ottawa: Graduate diploma in Health Services and Policy Research (HSR6120 Knowledge Transfer For Health Services and Policy Research) with Ian Graham
  • OTC--Ontario Training Centre in Health Services and Policy Research (Partnership with Lakehead, Laurentian, McMaster, Ottawa and York Universities) offers a diploma in Health Services and Policy Research at each of the listed universities
  • University of Toronto—Health Services Research, MSc or PhD (includes
    • Knowledge Translation and Information Behavior in Health Care and
    • Knowledge Transfer and Exchange: The Art and Science of Making Research Relevant and Increasing Utilization‖)
  • Dalhousie, Memorial, UNB and UPEI in partnership with the ARTC Atlantic Regional Training Centre offers a Master‘s Degree in Applied Health Services Research
  • University of Calgary—CHAPS-Centre for Health and Policy Studies (post-graduate)
  • UBC-Centre for Health Services and Policy Research
  • Western Regional Training Centre for Health Services Research (joint program by University of Alberta, University of Manitoba and UBC (Master‘s and PhD programs)
  • The Executive Training for Research Application (EXTRA) Program –CHSRF
  • Capacity for Applied and Developmental Research and Evaluation in Health Services and Nursing (CADRE)—CHSRF
  • OHRI-―Cognitive and behavioral theories for knowledge translation‖—credit course (University of Ottawa)
  • Université Laval-Interdisciplinary, doctoral program in health services research

Documents:

Longitudinal (Cohort) Studies

  • Resources - Under development

Methodology

Websites

  • Canadian Paediatric Surveillance program http://www.cps.ca/English/surveillance/index.htm
  • Cochrane Collaboration An international, independent, not-for-profit organisation of over 28,000 contributors from more than 100 countries, dedicated to making up-to-date, accurate information about the effects of health care readily available worldwide. http://www.cochrane.org/
  • EQUATOR Network An international initiative that seeks to improve reliability and value of medical research literature by promoting transparent and accurate reporting of research studies http://www.equator-network.org/
  • International Forum of Standards for Research in Children (StaR Child Health) StaR Child Health is a group of methodologists, clinicians and policy makers who seek to enhance the quality, ethics and reliability of paediatric clinical research by promoting the use of evidence-based standards or guidance for clinical studies with children http://www.ifsrc.org/

People/Centres/Societies

Workshops/Courses/Programs

 

 

 
This information is by no means complete – please contact us
to provide other, relevant contributions.

Regulatory Affairs

Websites

  • Resources - Under development

Research Coordinators

Websites

Workshops/Courses/Programs
  • Webinars on Good Clinical Practice guidelines For access Contact Us

Documents

Standard Operating Procedures

Regulatory authorities require that clinical researchers use standard operating procedures (SOPs) to ensure that their research is conducted in a manner that protects the rights and safety of study subjects and the integrity of research data.

The N2 SOPs have been developed to be a national standardized set of operating procedures that are applicable to any therapeutic area. The goal was to develop one set of well-written SOPs that would cross all therapeutic areas in any given institution or research environment. N2 will ensure the SOPs are externally reviewed by an independent expert every year or sooner as dictated by changes in the regulations of guidance documents.

The following SOPs are available on the N2 website:

  • SOP Administrative Management
  • Research Team Roles and Responsibilities
  • Research Team Training
  • Clinical Research Protocol Feasibility and Site Selection
  • Study Initiation Activation
  • Informed Consent Forms
  • Research Ethics Board (REB) Submissions and Ongoing Communication
  • Informed Consent Process
  • Subject Recruitment and Screening
  • Management of Investigational Drug Products and Medical Devices
  • Management of Biological Specimens
  • Serious Adverse Reaction (SAR) Reporting in Clinical Trials
  • Study Monitoring and Communication
  • Clinical Data Management
  • Investigator Study Files and Essential Documents
  • Study Close-Out
  • Audits and Inspections
  • Clinical Trial Application
  • Confidentiality and Privacy
  • Acronyms and Glossary of Terms

The following SOPs tools are available on the N2 website:

  • N2_Tool_SOP-01-SOPDistRecord
  • N2_Tool_SOP-01-SOPReviewRecord
  • N2_Tool_SOP-01-TaskDelTrainingDoc
  • N2_Tool_SOP-02-03-EmplAssessment Checklist
  • N2_Tool_SOP-02-03-Orient-Checklist
  • N2_Tool_SOP-02-03-TaskDelegationForm
  • N2_Tool_SOP-02-TaskDelResTeam
  • N2_Tool_SOP-03-15-Personnel Documentation (2)
  • N2_Tool_SOP-03-ProtocolSkillsAssess
  • N2_Tool_SOP-03-TrainingDoc
  • N2_Tool_SOP-04-CLIN STUDY FEAS CHECK
  • N2_Tool_SOP-04-SiteSelectionVisitCheck
  • N2_Tool_SOP-05-StudyActivationChecklist
  • N2_Tool_SOP-07-REB SUBMISSION LETTER
  • N2_Tool_SOP-07-REBSubmissionChecklist (2)
  • N2_Tool_SOP-08-ICF VERIFICATION LIST CONF
  • N2_Tool_SOP-08-REF CONF VER PROT OR AMEND
  • N2_Tool_SOP-09-RecruitmentPlanOutline
  • N2_Tool_SOP-10-DrugAccountLog
  • N2_Tool_SOP-10-DrugDispensingLog
  • N2_Tool_SOP-12-PatientAEAssessmen Form(PAR)
  • N2_Tool_SOP-12-SAE-SafetyLetterTrackingLog
  • N2_Tool_SOP-13-SiteMonitoringVisitChecklist
  • N2_Tool_SOP-13-TelephoneContactRecord
  • N2_Tool_SOP-15-ESSENTIALDOCS
  • N2_Tool_SOP-16-StudyCloseoutChecklist

Additional Resources

The following additional resources are available on the N2 website:

  • Clinical Studies Agreement Best Practices
  • Health Canada pre-inspection package
  • GCP training module (ppt)
  • GCP training module test questions
  • N2 SOP training presentation
  • REB Submission Letter template
  • Reference for a Verification of a Protocol or a Protocol Amendment
  • Recruitment plan outline
  • List of Essential Documents for the Conduct of a Clinical Study
  • Study Closeout Checklist
  • Attendance Training Log

The N2 website also has links to Canadian clinical trial registries, N2 contacts and job postings.

 

 

 
This information is by no means complete – please contact us
to provide other, relevant contributions.

Teams & Networks

Websites

For activity related to Canadian Research Networks, see Registries/Networks.

Training & Professional Development

Websites

  • Canadian Child Health Clinician Scientist Training Program http://cchcsp.ca
    Training Upcoming Leaders in Paediatric Sciences (TULIPS)

Workshops/Courses/Programs

 

 
This information is by no means complete – please contact us
to provide other, relevant contributions.