SOP’s: The 5 W’s and One H
Tiffanie M. Markus, PhD, CCRP
Assistant Director, Cardiovascular Clinical Research
Vanderbilt University Medical Center
February 7, 2013
Objectives
• To understand the importance of established
SOP’s
• To discuss how to develop new SOP’s for their
research team
• To identify ways to successfully implement
new SOP’s
SOP’s are an integral part of any
successful research program
The 5 W’s and H
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What are SOP’s?
Who needs SOP’s?
When do you use SOP’s?
Where do you use SOP’s?
Why are SOP’s important?
How to establish SOP’s for your group?
What is an SOP?
• Standard Operating
Procedures (SOP’s) are a set
of written instructions that
document a routine activity
within your
company/division/work
group.
Who Needs SOP’s
• Everyone who touches research!
• Although not required by FDA, they are implied:
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•
Ex. - 21 CFR312.53 the investigator will “ensure that
all associates, colleagues, and employees assisting in
the conduct of the study (ies) are informed of their
obligations in meeting the above commitments.”
SOP’s are found throughout ICH GCP Guidelines.
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Ex. - ICH GCP 2.13 -“Systems with procedures that
assure the quality of every aspect of the trial should
be implemented.”
When do you use SOP’s?
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Every Day
In preparation for an audit/reivew
During an audit/review
Orienting new staff
Annual training
Where do you use SOP’s?
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Sponsor’s site selection
Training new staff
Guiding all staff in daily processes
Monitor’s review
– Confidential Documents (internal review only)
• FDA or other regulatory body’s review
– Confidential Documents (internal review only)
Example disclosure:
Why are SOP’s important?
• Consistency
• Research quality & integrity
• all research being done follows ICH GCP, and institutional
policies to protect the rights and welfare of human study
participants.
• Written documentation of proper procedures
Why are SOP’s important?
(cont.)
• Toolbox for staff
• Documentation of staff training
• Can be used to standardize your practice
versus adapting to every sponsor’s requests
• Can be a pitfall if not followed
– If you have SOP’s you are expected to follow them
– You don’t what an FDA finding that you didn’t’
follow your own procedures
How to establish SOP’s for your group?
• Identify your needs
• Divide by functional groups
– Study Coordination, Regulatory, Data Mgmt…
• Make a plan
– Team approach?
– Lead author?
• Draft Ideas
– Outline relevant categories
– Outline steps
How to establish SOP’s for your group?
(cont.)
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Check against other guidelines
Review, Review, Review
Approve
Implement/Training
Let’s Get Started
• Make a list of Big Ticket Items (consider your weakest links)
– Informed Consent Process
– Assessing Sponsor Protocol Feasibility
– Safe Handling of Study Medications
– Subject Recruitment Process
– Regulatory Files and Subject Records
– Managing Sponsor CRO Audits
– Serious Adverse Event Reporting
– Responsibilities of the Clinical Research Team
– Investigational Drug Dispensing, Return, and Transport
– Trial Recruitment Expectation
– Managing FDA Inspections
• Prioritize
Suggested Elements?
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State the purpose of the document
State the scope of the document
State who is responsible for following the procedures
Identify the other guidelines/policies that relevant to the
topic
Define specialized terms
Outline instructions/procedures
Version control
Document review/approval process
Appendix: referenced documents
Get something on paper
• Consider your team/company setup
– What approach is going to work best?
• Create work groups to draft documents?
–One group to create all
–Divide topics across several groups/teams
–Utilize existing experts in your company
»Similar task?
• Assign a lead author?
–Then take to a group for feedback/review
Get something on paper (cont.)
• Brainstorm
– Think about how you do each step
– Consider what you know should happen in a
perfect world
– Look for more efficient ways to do things
– Start with main categories
– Drill down into the steps for each category
• Name responsible parties by role not name
Check Your Facts
• Most difficult part! Most important part!
– Review against other relevant guidelines/policies
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FDA guidelines and CFR
GCP & ICH
IRB policy
Departmental policies/SOP’s
VUMC or company SOP’s
SOP Review Process
• Involve those who will do it everyday
– Better insight
– Better buy-in
• Involve leadership
– Key players with distinct expertise
– Upper management
SOP Approval
• Establish an approval process
– Who will review?
– Who will make decisions?
– Who will sign-off?
– Who is responsible for maintaining?
– Who is responsible for revisions?
– How to document?
Implementation
• Should not be a surprise!
• Decide how to present to your group
– Group presentation/training
– Individual review of documents
• Paper copies
• Online review system (Learning Exchange, etc.)
– Must allow for tracking completion
• Should never happen without follow up face to face
conversations
Implementation (cont.)
• Regular Review (annually, etc.)
– Request staff feedback
– Keep all previous versions
• Accessible
– Binders
– Central Portals
– Online Systems
Documentation
• Approval Process
– Sign and Date
• On actual document
• Separate Approval document
• Version Control (History of Changes; # & date)
– Track revisions from document to document
• On actual document
• Separate Approval document
• Effective Date
• Staff Training
– Sign and Date
• Signature log (paper or online system)
Helpful Resources (free)
• Working Practice Guidelines (WPG)
– Step by step instructions on how to do a specific job
– Should change more often then SOP’s
• SOP development assistance
– Your not alone and should not re-invent the wheel
– Other VU or company departments
– Duke Global Health Institute
(http://globalhealth.duke.edu/resources/sops)
– NCI (retired website, but SOP’s still available for download)
(https://cabig.nci.nih.gov/community/workspaces/CTMS/Mee
tings/SIGs/Best_Practices/SOPs/SOPs)
Comments & Questions?
Thank you!