Developing Effective Standard

Operating Procedures (SOPs)

Florinna Dekovic, MT (ASCP) BB, CQA(ASQ)
QA and Operations Lab Manager,
Human Islet & Cellular Transplant Facility
(HICTF)
GMP Core
University of California, San Francisco
email: DekovicF@LabMed2.ucsf.edu

Presentation Objectives
Understand benefits of well written SOPs
Know what to consider before writing an SOP
Learn basic parts of an SOP
Synch your SOP with training
Identify ways to manage your SOPs

What is an SOP?
A structured guidance document that details a
series of steps for achieving an expected
outcome.
An SOP describes technical and fundamental
operational elements.
A set of written instructions for routine activities
followed by an organization.

In clinical research, the

International Conference on Harmonisation (ICH)
defines SOPs:

"detailed, written instructions to achieve

uniformity of the performance of a
specific function".

SOPs
ISO

With a good procedure

Having a good SOP..

Furthermore, SOPs

Checklist - Organizing your SOP Writing Effort

1. Identify key elements of the operation.
2. Identify authors.
3. Are there experts who know the procedures well?
4. Controls needed?
5. Verify regulations and compliance requirements.
6. Know the expected outcomes.
7. Hardware, software, materials and equipment?
8. Forms or other documentation involved?
9. Be attentive of other SOPs that should be referenced.
.

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Take your cue from within

your department:

Someone should determine what processes need to be

documented in SOPs.
SOPs are best authored by knowledgeable staff or
subject-matter experts
A team approach is OK especially for multi-tasked
processes
The experience requirement for performing an activity
should be noted in the section on personnel qualifications.
Input is highly important from the potential users of the
SOP.

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Before starting your 1st SOP

envision the BIGGER picture
How are the SOPs going to be laid out, maintained
and managed?
Estimate the total number of SOPs needed.
Are baseline policies for instructions, clear?
Are there related regulatory aspects to consider?
Who is going to approve the final SOPs?
Are the authors on the same page with
management?

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Also.
Consider the SOPs:
Scale and complexity
Number of steps involved
Amount of detail necessary within each step
Is a decision tree involved?

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Where to begin?

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SOP authorship
Who can help you write parts of SOP, or,
the entire document?
Identify your staff resource(s).
Identify help early on.
Get buy in: 1st author, 2nd author, etc.

Aim for Quality!

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Figure out the length

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Basic Parts
of an SOP

The Header
Title
Purpose
Scope
Personnel Responsibilities (or Personnel Roles)
Definitions and Abbreviations (or Acronyms)
Safety; Quality Control
Materials
Forms and Documentation

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Parts of an SOP, continued:

Special Notes
Procedure
Corrective Actions
Other SOP References
Procedural References
Appendix
Tracking Section
Annual Reviews

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the HEADER
____________________________________
Indicates that the SOP is a controlled document
Name of the organization; department or division
Location or address
Title
SOP #
Version #
Author (s)
Reviews (either in header or at the end of the SOP)

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Example:

University of California, San Francisco

Department of Surgery
513 Parnassus Avenue San Francisco, California 94143
SOP TITLE: Obtaining Informed Consent
SOP NUMBER: 1.1

Version # 1.0
Page 1 of 2

Author: Anna Applegate, MS

Date Reviewed:

June 10, 2011

Date Implemented: June 20, 2011

Reviewed By: Pablo Rubenstein, MD

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the TITLE
_____________________________________
clearly identifies the activity
readily identifies the focus of the
procedure

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Example of an SOP TITLE:

Obtaining Informed Consent

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Less effective SOP TITLES:

Process for Procuring Informed Consent

An SOP on how to Obtain IC

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the PURPOSE
_____________________________________
Briefly describes the rationale for
performing the procedure or activity
If multiple purposes use bullets

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Example:

PURPOSE: To make sure that informed consent

is obtained from each subject in accordance with
all regulatory, ethical and [insert facility name]
Institutional Review Board (IRB) requirements.

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Additional example:

PURPOSE: It is the policy at UCSF to make

sure that informed consent is obtained from
each subject in compliance with all regulatory
and ethical requirements, and in accordance
with the Committee for Human Research
(CHR).

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the SCOPE
_____________________________________
Explains the limitations and span of actions
required in the SOP
Exact range

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Example:

SCOPE: This SOP applies to the informed

consent process for all research performed
in the Department of Surgery.

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Example:

SCOPE: The informed consent process that

is managed in the UCSF Department of
Surgery is in accordance with the CHR and
21CFR Part 312 which is the Federal Code
of Regulations that governs all IND
research.

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the PERSONNEL
RESPONSIBILITIES
____________________________________

Identifies the staff responsible for performance

Job title (s)
Limitations and span of actions
Exact range or capacity of scope
and responsibilities are narrowed down

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Example:

PERSONNEL RESPONSIBILITIES:

Principal Investigator, Sub-investigators, Study

Coordinator and/or other principal investigatordesignated site staff who will perform the
informed consent process (person obtaining
consent).

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Example:

PERSONNEL RESPONSIBILITIES:

The following trained staff may obtain consent:

Principal Investigator
Sub-investigators
Study Coordinator
Other principal investigator-designated site staff
in the Department of Surgery

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SAFETY
_____________________________________

Include any health and safety information

Caution information
Use of PPEs
Use the statement: follow Universal Precautions
Reference waste disposal for biohazardous
materials
Mention red Sharps containers

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DEFINITIONS, ABBREVIATIONS
_____________________________________
Abbreviations, in alphabetical order
Definitions, alphabetically
- Brief
- No pictures (place in Appendix)
- No diagrams (place in the Appendix)

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Example:

DEFINITIONS:
Informed consent--Verbal and written acknowledgement
of willingness to participate in clinical research.
Legally authorized representative--A person granted
medical power of attorney for a person unable to make
decisions about their healthcare.

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QUALITY CONTROLS
_____________________________________
Cite compliance standards
Reiterate good lab practices
If an instrument, device or reagents are used,
indicate the QC ranges for acceptable use
and/or expected values.

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Example:

QUALITY CONTROL:
Always check that you have the most current
version of the Informed Consent. Otherwise, do
not proceed with the SOP.

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Example:

QUALITY CONTROL:
Always verify the potential subjects name,
birthday and other identifiers.
For blood draws:
- use vacutainer tubes that are in-dated.
- check that the tubes are acceptable for use.

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MATERIAL, SUPPLIES, REAGENTS,

EQUIPMENT
_____________________________________

Mention essential supplies

Note special equipment
Indicate reagents
List pharmacy items
List software to use
Note special materials designated for the SOP

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FORMS and DOCUMENTATION

_____________________________________

List every FORM to be completed

Itemize special LABELS that are
necessary

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SPECIAL NOTES
_____________________________________

Note pertinent information that is not

part of the procedure in this section
Brief statements
List them in the order applicable to the
PROCEDURE section.

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Example:

SPECIAL NOTES:
Ascertain that a translator is available if
potential study subject does not speak
English.
Conduct consent in a quiet area, free of
distractions.

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SPECIAL NOTES:
Written informed consent will be obtained
before any research related procedures are
performed.
If during the course of the research trial, the
informed consent form is revised, subjects will
be re-consented using the revised IRB
approved consent form, if applicable.

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PROCEDURE:
Person obtaining IC will:
1)Obtain the most recent IRB approved informed consent form.
2)Check the version date in the footer of the form.
3)Obtain permission from the potential subjects primary or
attending physician.
4)Introduce yourself to the potential subject and legally authorized
representative (if applicable).
5) Discuss and explain the following points:
- what clinical research is and why you are approaching
them.
- why people generally volunteer to participate in research.
- what they can expect if they choose to participate in clinical
research (general)
- how participating affects their regular care and
relationship with their primary care provider.

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6) After explaining the general principles of research, ask the

potential subject (or legally authorized representative) if they
want to hear the details about the particular research.
7) Provide ample time to the potential subject, or legally
authorized representative to completely read and/or listen to
the consent form being read to them and time to ask
questions.
8) Fully answer all questions.
9) Acknowledge the potential subject/legal representative
verbalized understanding of the research and research related
procedures.

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10) Instruct the subject/legally authorized representative to

initial each page of the informed consent form and sign and
date the last page of the consent form.
11) The person obtaining informed consent will sign and date
the last page of the consent form.
12) Give a copy of the fully signed consent form to the
subject/legal representative.
13) Make a copy for the subjects medical records and
research file.

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Different PROCEDURE section formats

Simple Steps format:

Good for a SHORT procedure
No decision tree
Straight - forward
Short sentences
Numbered

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Different PROCEDURE section formats

Categorized Steps:
An extension of the simple steps format
Tasks are broken down into groups of processes
Works better for tasks that require additional
detail
Or require sub-steps within each primary step
Decision tree needed

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Different PROCEDURE section formats

Linear Flow Chart

For tasks where activities must be done in a
specific order
Flow diagrams for step by step directions
Defined expectations are visual
Decision tree present

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Different PROCEDURE section formats

Annotated pictures:
Pictures can dramatically reduce the need for
written explanations
For people who are more visual.
If language is an issue.
Pictures can make excellent work site reminders.

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Wrap your SOP by including these

sections:
Corrective Actions
Other SOP References
Procedural References
Appendix
Tracking Section

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Your SOP
Is
considered a
DRAFT
until it is
VALIDATED
and
APPROVED!

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Validate your SOP

Validation means:
To establish the soundness of; corroborate.
To confirm that steps in the SOP are
accurate.

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References
http://funding.niaid.nih.gov/researchfundi
ng/sop/pages/intro.aspx

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