SOP’s: The 5 W’s and One H

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/Meetings/SIGs/Best_Practices/SOPs/SOPs)

Comments & Questions? Thank you!

SOP’s: The 5 W’s and One H