CMRSC Division of Hematology/Oncology

1. CMRSC Division of Hematology/Oncology Training Standard Operating Procedures for Good Clinical Practice at the Investigative Site Section: GENERAL ADMINISTRATION

2. 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.

3. 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.

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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)

10. 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

11. 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)

12. 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)

13. Go take the quiz! • CMRSC SOPs - General Administration Section Quiz