POGO Satellite Manual

7.2 Investigator Responsibilities

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Principal Investigator

The tertiary hospital principal investigator (PI) (also known as the Qualified Investigator [QI] in Health Canada terminology) at the tertiary hospital specialized childhood cancer program retains overall responsibility for the conduct of the research, including oversight of the study activities at the POGO Satellite Clinics. The PI can delegate specific components of the research process to the Designated Satellite Investigator (DSI) provided all essential elements listed in Sub-Section 7.1 Preamble are in place.

Designated Satellite Investigator (DSI)

The lead physician at the POGO Satellite Clinic program will assume the role of Designated Satellite Investigator (DSI). The DSI will be included on the study delegation at the relevant tertiary hospital specialized childhood cancer programs. The DSI’s role includes oversight of all therapy administered as part of a clinical trial at the POGO Satellite Clinic.

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 Number Date of Effect Summary of Revisions
1 2/24/2022 Original version posted.
1.0 Introduction
1.1 History and Overview
1.2 Acknowledgements
1.3 Committees and Working Groups
1.4 POGO Satellite Manual Disclaimer
2.0 Scope of POGO Satellite Program
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
3.0 Chemotherapy Administration
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
4.0 Supportive Care Practice Tools
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
5.0 Palliative Care
5.0 Palliative Care
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
6.0 POGO Satellite Program Administration Documents
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
7.0 Research
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
8.0 Appendix 1: Communication Tools
8.1 Pediatric Oncology Shared Care Initial Data Transfer Sheet
9.0 Appendix 2: Reporting Formats
9.1 POGO Satellite Clinic Preparedness Checklist
9.2 POGO Satellite Clinic Quality Assurance Checklist