SOP- how, why, who.. please check facts if you want to use it

1. STANDARD OPERATING
PROCEDURE (SOP)
Surabhi Jain
Clinical Data Manager

2. SOP- DEFINITION
• A Standard Operating Procedure (SOP) is a set of written instructions that
documents the routine activities followed by an organization.

3. WHO NEEDS IT
• EVERYONE!!!!
• Though not required by FDA, they are implied:
• Example: 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.
• Example - ICH GCP 2.13 -“Systems with procedures that assure the quality of every
aspect of the trial should be implemented.”

4. WHY DOES YOUR ORGANIZATION
NEED SOP

5. WHY DOES YOUR ORGANIZATION
NEED SOP
• Minimizes variation
• Promotes quality
• Indicates compliance
• Valuable for reconstructing project activities
Reduces work effort, along with improved comparability and credibility.

6. SOP
• Purpose of SOP : to ensure reproducible and correct performance
• It is a Controlled document and needs a regulated system for
Preparation
Approval
Distribution
Revision
Training
Standardize
Maintain
Improve

7. WHEN DO YOU USE SOP’S?
Every Day
In preparation for an audit
During an audit
Familiarizing new staff
Annual training

8. WHERE DO YOU USE YOUR SOP!
Wherever you go whatever you do whenever you do
• Sponsor’s site selection
• Training new staff
• Guiding all staff in daily processes
• Monitor’s review
• FDA or other regulatory body’s review

9. HOW TO ESTABLISH SOP?
• Identify requirements
• Divide by functional groups
• Study Coordination, Regulatory, Data Management etc.
• Make a plan
• SOP Team
• Prime author
• Draft Ideas
• Outline relevant categories
• Outline steps

10. HOW TO ESTABLISH SOP?
• Check against other guidelines
• Review, Review, Review……………………
• Approve
• Implement/Training

11. WRITING STYLES
• Concise
• Step-by-step
• Easy-to-read format
• Information must be unambiguous
• Active voice and present verb tense should be used
Avoid term "you"

12. SOP GENERAL CONTENT
• Purpose
• Scope
• Responsible
• Definitions
• Instructions/ Procedure
• Version Control
• Effective Date
• Appendix

13. SOP GENERAL FORMAT
• Title Page
• Table of Content
• Text
• Author/ Reviewer
• Change History/ Changes done
• Effective date

14. CHECK YOUR SOP
• FDA guidelines and CFR
• GCP & ICH
• IRB policy
• Departmental policies/SOP’s

15. SOP REVIEW PROCESS
• Involve those who will do it everyday
• Better insight
• Better buy-in
• Involve leadership
• Key players with distinct expertise
• Upper management

16. SOP APPROVAL PROCESS
• Who
o will review?
o will make decisions?
o will sign-off?
o is responsible for maintaining?
o is responsible for revisions?
• How to document?

17. SOP IMPLEMENTATION
• Group Training
• Online Training

18. ACCESSIBILITY
• Accessible to all
• Every time
• Older versions must be removed