Transcript Study Start-Up SOP Presentation

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:
1. 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):
2. Review comments from research team and
determine feasibility through whatever
communication method (meetings, e-mails,
memos) is most effective.
3. 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:
o Meet with study personnel and review their
qualifications
o Assess the facilities of the research site
o 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
1. Identify key personnel likely to be involved in
conducting the study
2. Complete the Confidentiality Agreement (if
applicable) and return to sponsor
3. Get critical study documents from the sponsor
(protocol, Investigator’s Brochure, case report
forms, sample budget, draft contract)
4. 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):
5. 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:
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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
6. 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:
1. Meet with the sponsor/CRO representative to
review the protocol, Investigator’s Brochure,
and communication plan for the
sponsor/CRO/clinical site
2. Tour areas of research facility and other areas
of interest
Following up after the pre-study site visit:
1. 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:
o Prepare site personnel for implementation of the
protocol
o Review study drug administration and accountability
o Provide instruction in any specialized procedures
o 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:
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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:
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Provide the sponsor with an update on any studyrelated issues
Follow-up after the site initiation meeting:
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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:
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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:
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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