CMRSC Division of Hematology/Oncology

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CMRSC Division of Hematology/Oncology

• Training
• Standard Operating Procedures for Good Clinical
  Practice at the Investigative Site
• Section
• GENERAL ADMINISTRATION

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Training Tips

• Job Aids, such as forms, checklists, etc.
  contained in the procedure will be pointed out at
  the applicable section of the training. It will
  look like this Job aid! Form/Checklist Name
• You may need to look in the actual procedure when
  trying to answer a quiz question.

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CMRSC 1.0 SOP on SOPs Preparing, Maintaining
and Training

• Purpose
• To describe the preparation, maintenance, and
  training for the written procedures that the
  CMRSC follows to ensure compliance with all FDA
  regulations and guideline, and the policies and
  procedures of CCHMC for all clinical trials
  conducted within the Hem/Onc Division.

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CMRSC 1.0 SOP on SOPs Preparing, Maintaining
and Training

• Preparing new SOPs or revising an existing SOP
• When? Changes in regulation, guidelines,
  policies, procedures, research practice
• How? Standard format (see procedure)
• Approval? Division Director
• Communication? All team members get copy of new
  SOP
• History? Previous versions archived

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CMRSC 1.0 SOP on SOPs Preparing, Maintaining
and Training

• Reviewing an existing SOP
• How often? - Annually
• Who? - Research Manager or designee
• Training on new/revised SOPs
• Degree of training/format determined by Research
  Mgr.
• Provided to all CMRSC members
• Training must be documented, with date of
  training and relevant SOP(s).
• Job aid! Training Compliance Form

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CMRSC 1.1 Responsibilities of the Research Team

• Purpose
• To define the responsibilities of the research
  team, as delegated by the PI(s), for conducting
  clinical studies in Hem/Onc administrative
  accountability as well as general
  responsibilities of the research team members are
  defined

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CMRSC 1.1 Responsibilities of the Research Team

• Administrative responsibilities (PI, Research
  Mgr., Research Nurse/CRC, Business Mgr.)
• Hiring and training
• Assign trained research nurse and clinical
  research coordinator to manage each study
• Manage the business aspects of studies (budgets,
  contracts)
• Design study recruitment strategies and track
  study enrollment
• Communicate with the IRB as needed

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CMRSC 1.1 Responsibilities of the Research Team

• General Responsibilities (All CMRSC Members,
  PIs, Managers, Pharmacy)
• Conduct clinical trials according to FDA
  regulations and guidelines, and these SOPs.
• Ensure that the PI is informed of all
  study-related activities
• Ensure safety and welfare of study subjects
  know the protocol and the drug
• Disclose personal, professional, or financial
  interests if involved with the research

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CMRSC 1.1 Responsibilities of the Research Team

• Individual Responsibilities PI
• Complete FDA form 1572 for each study
• Financial interest disclosure
• No financial interest Form 3454
• Existing financial interest Form 3455
• Supervise members of the research team
• Document the delegation of responsibilities
• Job aid! Delegation of Responsibility Form
• Be knowledgeable about study protocols and
  investigational articles
• Fulfill specific sponsor requirements
• Meet with sponsors representatives (monitors,
  etc)
• Meet with auditors (internal, sponsor, FDA)

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CMRSC 1.1 Responsibilities of the Research Team

• Individual Responsibilities Research Nurse, CRC,
  Data Manager, Research Manager
• Develop organizational aids and checklists to
  facilitate study conduct
• Enroll subjects in studies and manage their
  participation
• Maintain the regulatory and study files
• Participate in quality assurance activities
  (monitoring visits, internal audits, sponsor
  audits, FDA audits)
• Individual Responsibilities All CMRSC members
• Other duties as assigned according to federal
  regulation and guidelines, and CMRSC SOPs

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CMRSC 1.2 Training and Education

• Purpose To describe the process and
  documentation required for the initial and
  on-going education of the PI and research staff
  in Good Clinical Practices (GCPs) and the ethical
  conduct of research conducted at CCHMC
• Scope This SOP applies to the those CMRSC
  members who participate in the hiring,
  orientation, and on-going training of CMRSC staff
  (PIs, Administrators, Research Manager, Research
  Nurse, CRCs)

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CMRSC 1.2 Training and Education

• CMRSC staff orientation will include
• Orientation to policies and procedures of the
  CMRSC
• Orientation specific to their duties and
  responsibilities
• Orientation to research ethics, regulations, and
  conduct
• Job aids! Orientation Checklist for New Employees
  and CMRSC Clinical Trials Competencies for
  CRC/Research Nurse
• This includes
• NIH Human Participants Protection Education for
  Research Teams
• OHRP Training Module for Assurances
• Shipping of Diagnostic Specimens and Dry Ice (for
  only those CMRSC members who will be shipping
  diagnostic specimens)

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Go take the quiz!

• CMRSC SOPs - General Administration Section Quiz