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POGO Satellite Manual

7.0 Research

7.1 Preamble

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Childhood cancer outcomes have shown truly remarkable improvements in the past three decades. Key to this success has been the large-scale participation in multi-centre clinical trials based on the concept that research is a core component of childhood cancer care.

For patients registered on clinical trials, any therapy or management delivered in any setting is considered part of the clinical trial protocol. Thus, rigorous requirements around assessment of patients, delivery of care, recording of interventions and compliance with regulatory requirements are required in all settings – including POGO Satellite Clinics. To meet these requirements, POGO Satellite Clinics must comply with the regulations of the National Cancer Institute (NCI) Office of Human Research Protections (OHRP), Health Canada, the Children’s Oncology Group (COG) and other regulatory bodies.

Failure to comply with the specified regulatory requirements would lead to one of two outcomes: Either the patient would not be enrolled on the relevant clinical trial OR the patient could not receive treatment in the POGO Satellite Clinic.

Ideally, pediatric oncology patients and their families should not be forced to choose between accessing the POGO Satellite Program and enrolling on clinical trials.

This section of the POGO Satellite Manual is intended to define the structure of research participation by POGO Satellite Clinic patients – specifically, in Phase II and III trials conducted by COG and other cooperative groups. The goal of this process is to allow children registered on clinical trials to receive components of care closer to home while still allowing for compliance with all aspects of clinical research within the POGO Satellite Clinic.

In addition to this section, the following are essential elements to the conduct of COG and non-COG trials at POGO Satellite Clinics:

  • Master research agreement between each tertiary hospital and its relevant POGO Satellite Clinic community hospital(s)
  • Tertiary hospital delegation of Research Ethics Board (REB) oversight to the Ontario Cancer Research Ethics Board (OCREB) for specific pediatric oncology Phase II and III studies
  • POGO Satellite Clinic community hospital delegation of REB oversight to OCREB for their role as tertiary hospital affiliates for the conduct of specific pediatric oncology Phase II and III trials
  • Per-study addenda to master research agreement implemented by tertiary hospitals in compliance with COG and other cooperative group studies, which extend to the relevant POGO Satellite Clinic community hospital(s)
  • Access to the overall study protocol document

Primary author Dr. Paul Gibson, Pediatric Oncology Group of Ontario, Toronto, McMaster Children’s Hospital, Hamilton Health Sciences, Hamilton with input from Dr. Jacqueline Halton, CHEO, Ottawa, Dr. Carol Portwine, McMaster Children’s Hospital, Hamilton Health Sciences, Hamilton, Dr. Mark Greenberg, Pediatric Oncology Group of Ontario, The Hospital for Sick Children, Toronto, Ms. Carla Bennett, Pediatric Oncology Group of Ontario, Toronto, Dr. Sarah Alexander, The Hospital for Sick Children, Toronto, and Ms. Catherine Deveault, The Hospital for Sick Children, Toronto.

Originally published: December 13, 2016. Reviewed and updated in January 2022 by COG Principal Investigators of the POGO Provincial Research Ethics Board (REB) Principal Investigator (PI) Task Force and Ms. Entela Zaffino, The Hospital for Sick Children, Toronto. Final review by Dr. Paul Gibson and Ms. Carla Bennett, Pediatric Oncology Group of Ontario, Toronto.

Disclaimer: Source Accuracy

You are welcome to download and save a local copy of this document in the Word and/or PDF formats provided. As the POGO Satellite Manual is subject to ongoing revisions and updates by POGO, we recommend you regularly check the online version posted at https://www.pogo.ca/satellite-manual/ to ensure you have the most up-to-date content. In the event of any inconsistency between the content of a local copy and the online version of the POGO Satellite Manual, the content of the online version shall be considered correct. Please see also the POGO Satellite Manual Disclaimer.

Record of Updates
Version NumberDate of EffectSummary of Revisions
12/24/2022Original version posted.
7.2 Investigator Responsibilities
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In this Section

  • 1.1 History and Overview
  • 1.2 Acknowledgements
  • 1.3 Committees and Working Groups
  • 1.4 POGO Satellite Manual Disclaimer
  • 2.1 Principles of POGO Satellite Clinic Care
  • 2.2 Eligible Patients
    • 2.2.1 Children Eligible for Chemotherapy Administration in a POGO Satellite Clinic
    • 2.2.2 Children Eligible for the Management of Complications in a POGO Satellite Clinic
    • 2.2.3 Children Eligible for Supportive Care in a POGO Satellite Clinic
  • 2.3 Scope of POGO Satellite Clinic Practice
  • 2.4 Expanded POGO Satellite Clinic Practice
  • 3.1 Safe Handling, Administration and Disposal of Chemotherapy Agents
    • 3.1.1 Personal Protective Equipment
    • 3.1.2 Preparation, Transport and Storage
    • 3.1.3 Administration of IV Hazardous Drugs
    • 3.1.4 Administration of Oral Hazardous Drugs
    • 3.1.5 Disposal of Equipment/Personal Protective Equipment used to Administer Hazardous Drugs
    • 3.1.6 Safe Handling for Pharmacy
    • 3.1.7 References
  • 3.2 Accidental Exposure/Spills
  • 3.3 Extravasation Management
    • 3.3.1 Prevention and Management of Extravasations
    • 3.3.2 Antidotes and Treatments for Extravasation
    • 3.3.3 Sample Extravasation Documenting Tool
    • 3.3.4 References
  • 3.4 Injecting SC Medication Via an Insuflon
  • 3.5 Chemotherapy Administration Reference List
  • 3.6 Central Venous Catheter Care
  • 3.7 Chemotherapy Quick Reference
    • 3.7.1 Rapid Hydration
    • 3.7.2 Provider Guide: Prevention and Management of Irinotecan-Induced Diarrhea
    • 3.7.3 Capizzi Methotrexate
    • 3.7.4 Erwinia Asparaginase
  • 4.1 Management of Fever and Neutropenia
    • 4.1.1 Routine Order Sample Sheet
    • 4.1.2 Sample Fever Cards
    • 4.1.3 Criteria for low-risk designation. Risk categorization refers to risk of bacteremia and serious complications, including mortality.
  • 4.2 Pentamidine Administration
    • 4.2.1 Inhaled Pentamidine
    • 4.2.2 Intravenous Pentamidine
  • 4.3 Antiemetics
  • 4.4 Treatment of Varicella-Zoster Infections
  • 4.5 Immunization of Children with Cancer
  • 4.6 Transfusion
  • 4.7 Clinical Circumstances that Warrant Consultation with the Specialized Childhood Cancer Program
  • 5.1 Palliative Care Overview
  • 5.2 Communication
  • 5.3 Settings of Care
  • 5.4 Symptom Management
  • 5.5 End of Life
  • 5.6 When a Child Dies at the POGO Satellite Clinic
  • 5.7 Appendix: Sample Bereavement Materials
    • 5.7.1 Reconciling Your Grief
    • 5.7.2 Funeral Arrangement Checklist
    • 5.7.3 Helping Children Who Grieve
    • 5.7.4 Coping with the Holidays
    • 5.7.5 The Grief Experience
  • 5.8 References
  • 6.1 Goals and Objectives
  • 6.2 Participant Site Selection
    • 6.2.1 Tertiary Hospital Site Selection
    • 6.2.2 Community Hospital Site Selection
  • 6.3 POGO’s Roles
    • 6.3.1 PHIPA, Privacy and Research
  • 6.4 Funding
    • 6.4.1 Funding Support for Tertiary Hospital Activity
    • 6.4.2 Funding Support for Community Hospital Activity
  • 6.5 Infrastructure and Formal Requirements
    • 6.5.1 Specialized Childhood Cancer Program Partners’ Role in the POGO Satellite Program
    • 6.5.2 POGO Satellite Clinic Partners’ Role in the POGO Satellite Program
  • 7.1 Preamble
  • 7.2 Investigator Responsibilities
  • 7.3 Training Requirements
    • 7.3.1 General Training for Conduct of Research
    • 7.3.2 Protocol-Specific Training
  • 7.4 Research Activities That May Be Completed in POGO Satellite Clinics Under Supervision of DSI
  • 7.5 Research Activities to be Completed in Specialized Childhood Cancer Programs Only
  • 7.6 Recognition and Reporting of Adverse Events (AEs)
  • 7.7 Data Transfer
  • 7.8 Pharmacy Drug Accountability
  • 7.9 Site Inspections and Quality Assurance
  • 8.1 Pediatric Oncology Shared Care Initial Data Transfer Sheet
  • 9.1 POGO Satellite Clinic Preparedness Checklist
  • 9.2 POGO Satellite Clinic Quality Assurance Checklist
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