SOP’s: The 5 W’s and One H

Tiffanie M. Markus, PhD, CCRPAssistant Director, Cardiovascular Clinical Research

Vanderbilt University Medical CenterFebruary 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/Meetings/SIGs/Best_Practices/SOPs/SOPs)

Comments & Questions?

Thank you!