Presentation on theme: "CMRSC Division of Hematology/Oncology"— Presentation transcript:
1CMRSC Division of Hematology/Oncology TrainingStandard Operating Procedures for Good Clinical Practice at the Investigative SiteSection:STUDY START-UP
2CMRSC 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.
3CMRSC 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 ChecklistJob aid! Subject Expenses WorksheetJob aid! Employee Salary Expenses WorksheetJob aid! Budget Worksheet
4CMRSC 2.0 – Assessing Protocol Feasibility Procedure to assess feasibility (continued):Review comments from research team and determine feasibility through whatever communication method (meetings, s, memos) is most effective.Notify the sponsor of the site’s decision.
5CMRSC 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 qualificationsAssess the facilities of the research siteEvaluate the possibility of collaborating on the study
6CMRSC 2.1 – Pre-study Site Visit Preparing for the pre-study site visit:Job aid! Checklist of Activities Associated with the Pre-study Site VisitIdentify key personnel likely to be involved in conducting the studyComplete the Confidentiality Agreement (if applicable) and return to sponsorGet 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”)
7CMRSC 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, HIMSpecialized equipment (radiology, lab, etc)Meeting with ancillary personnel, visiting ancillary facilitiesJob aid! Sample Agenda for Pre-study Site VisitGet copies of current CVs and resumes for key site personnel involved
8CMRSC 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 siteTour areas of research facility and other areas of interestFollowing up after the pre-study site visit:Document the visit details with action itemsJob aid! Pre-study Site Visit Follow Up
9CMRSC 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 protocolReview study drug administration and accountabilityProvide instruction in any specialized proceduresProvide direction for CRF completion
10CMRSC 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.
11CMRSC 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 studyNegotiate the agenda with the sponsor, distribute to attendeesEnsure all documentation and materials associated with the study are provided to those involved in conducting the studyIf the initiation meeting is offsite (which is not uncommon for large, multi-site, pharmaceutical company-sponsored studies), make travel arrangements for attendees
12CMRSC 2.2 – Investigator and Site Initiation Meetings Participating in the site initiation meeting:Provide the sponsor with an update on any study-related issuesFollow-up after the site initiation meeting:Ensure that the sponsor or Contract Research Organization sends written documentation summarizing important agreements made during the meetingPrepare any final documents for IRB reviewIf still pending, prepare final budget and submit the signed clinical trial agreement.Create study files, track all documents
13CMRSC 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.
14CMRSC 2.3 – Protocol Start-Up Determine facility readiness:Ensure that the contract is executedEnsure that a final budget has been negotiated.Conduct in-service training for referring and support staff (physicians, nurses, lab technicians, etc)
15CMRSC 2.3 – Protocol Start-Up Determine site readiness:Review regulatory files for completenessEstablish the receipt of adequate investigational drug suppliesInventory supplies of case report forms, central lab suppliesDevelop or utilize sponsor-generated worksheets or checklists to assist in readinessReview study procedures with assigned research staffJob aid! Protocol Start-Up Checklist
16I’d rather be: But………Better take the Quiz! CMRSC SOPs - Study Start-Up Section Quiz