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POGO Satellite Manual

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

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  • Discussion and documentation of consent/s for study
  • Providing ongoing answers to participants’ questions about a study
  • Enrollment on study
  • Discussion and documentation of continued study participation
  • Documentation of study completion and/or withdrawal
  • Delivery of Cancer Therapy Evaluation Program (CTEP)-supplied investigational agents
  • Protocol-specified disease assessment, including radiologic evaluations, bone marrow assessments, biopsies, etc.
  • Collection of study-specific biologic samples for banking, pharmacokinetics, etc.
  • Communicating any new information about the study to study participants and their families
  • Housing and storing of any and all documentation required for monitoring and audits
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.
7.6 Recognition and Reporting of Adverse Events (AEs)
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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
    • 2.1.1 POGO Satellite Care Decision Flowchart
  • 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
    • 3.7.5 Crisantaspase (Rylaze) Asparaginase
    • 3.7.6 Nelarabine
  • 4.1 Management of Fever and Neutropenia
    • 4.1.1 Routine Order Sample Sheet
    • 4.1.2 Sample Fever Cards
    • 4.1.3 Outpatient Fever and Neutropenia in POGO Satellites
  • 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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