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
• 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:
– 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.
– 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?
• Every Day
• In preparation for an audit/reivew
• During an audit/review
• Orienting new staff
• Annual training
 Where do you use SOP’s?
• 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.)

• 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?
• 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
• 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!