CMRSC Division of Hematology/Oncology Training Standard Operating Procedures for Good Clinical Practice at the Investigative Site Section: STUDY START-UP

CMRSC 2.0 – Assessing Protocol Feasibility Purpose: To determine the scientific, ethical, and financial merits of conducting the study. This SOP describes the steps for fulfilling the regulatory, medical, and ethical requirements for assessing the feasibility of implementing a protocol at CCHMC, Division of Hem/Onc.

CMRSC 2.0 – Assessing Protocol Feasibility Procedure to assess feasibility: Distribute the protocol and assessment tools to key research team members. Consider key team members outside the Hem/Onc Division (radiology, pharmacy, radiation oncology, neurology, genetics, etc.) Job aid! Protocol Assessment Checklist Job aid! Subject Expenses Worksheet Job aid! Employee Salary Expenses Worksheet Job aid! Budget Worksheet

CMRSC 2.0 – Assessing Protocol Feasibility Procedure to assess feasibility (continued): Review comments from research team and determine feasibility through whatever communication method (meetings, e-mails, memos) is most effective. Notify the sponsor of the site’s decision.

CMRSC 2.1 – Pre-study Site Visit Purpose: To describe the processes followed at this investigative site when the sponsor of a study conducts a pre-study site visit to: Meet with study personnel and review their qualifications Assess the facilities of the research site Evaluate the possibility of collaborating on the study

CMRSC 2.1 – Pre-study Site Visit Preparing for the pre-study site visit: Job aid! Checklist of Activities Associated with the Pre-study Site Visit Identify key personnel likely to be involved in conducting the study Complete the Confidentiality Agreement (if applicable) and return to sponsor Get critical study documents from the sponsor (protocol, Investigator’s Brochure, case report forms, sample budget, draft contract) Review the protocol to assess feasibility (follow SOP 2.0 “Assessing Protocol Feasibility”)

CMRSC 2.1 – Pre-study Site Visit Preparing for the pre-study site visit (continued): Determine agenda – ask the sponsor rep. who they will want to meet, what they will want to see. This could include special interest items such as: Treatment site, pharmacy, clinical lab, HIM Specialized equipment (radiology, lab, etc) Meeting with ancillary personnel, visiting ancillary facilities Job aid! Sample Agenda for Pre-study Site Visit Get copies of current CVs and resumes for key site personnel involved

CMRSC 2.1 – Pre-study Site Visit Conducting the pre-study site visit: Meet with the sponsor/CRO representative to review the protocol, Investigator’s Brochure, and communication plan for the sponsor/CRO/clinical site Tour areas of research facility and other areas of interest Following up after the pre-study site visit: Document the visit details with action items Job aid! Pre-study Site Visit Follow Up

CMRSC 2.2 – Investigator and Site Initiation Meetings Purpose: To describe the processes when the sponsor of a potential study conducts a study initiation meeting to: Prepare site personnel for implementation of the protocol Review study drug administration and accountability Provide instruction in any specialized procedures Provide direction for CRF completion

CMRSC 2.2 – Investigator and Site Initiation Meetings Site initiation meetings are arranged and led by the sponsor. It occurs after the pre-study site visit when all study arrangements have been completed, and the study is about to start. The purpose is to ensure that site study personnel receive final orientation of the study procedures and Good Clinical Practices (GCP) requirements.

CMRSC 2.2 – Investigator and Site Initiation Meetings Preparing for the site initiation meeting: Identify key clinical research personnel likely to be involved in conducting the study Negotiate the agenda with the sponsor, distribute to attendees Ensure all documentation and materials associated with the study are provided to those involved in conducting the study If the initiation meeting is offsite (which is not uncommon for large, multi-site, pharmaceutical company-sponsored studies), make travel arrangements for attendees

CMRSC 2.2 – Investigator and Site Initiation Meetings Participating in the site initiation meeting: Provide the sponsor with an update on any study-related issues Follow-up after the site initiation meeting: Ensure that the sponsor or Contract Research Organization sends written documentation summarizing important agreements made during the meeting Prepare any final documents for IRB review If still pending, prepare final budget and submit the signed clinical trial agreement. Create study files, track all documents

CMRSC 2.3 – Protocol Start-Up Purpose: To describe the steps for fulfilling the regulatory and clinical requirements of starting up a study. These steps include those from the time a sponsor selects a site for a clinical study until recruitment of subjects begins.

CMRSC 2.3 – Protocol Start-Up Determine facility readiness: Ensure that the contract is executed Ensure that a final budget has been negotiated. Conduct in-service training for referring and support staff (physicians, nurses, lab technicians, etc)

CMRSC 2.3 – Protocol Start-Up Determine site readiness: Review regulatory files for completeness Establish the receipt of adequate investigational drug supplies Inventory supplies of case report forms, central lab supplies Develop or utilize sponsor-generated worksheets or checklists to assist in readiness Review study procedures with assigned research staff Job aid! Protocol Start-Up Checklist

I’d rather be: But………Better take the Quiz! CMRSC SOPs - Study Start-Up Section Quiz