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

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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.

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In clinical research, the International Conference on Harmonisation (ICH) defines SOPs:

"detailed, written instructions to achieve uniformity of the performance of a specific function".

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SOPs

ISO

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With a good procedure

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Having a good SOP…..

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Furthermore, SOPs…

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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 SOP’s:

•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.

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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:

SOP TITLE: Obtaining Informed Consent Version # 1.0SOP NUMBER: 1.1 Page 1 of 2

Author: Anna Applegate, MS Date Reviewed: June 10, 2011

Date Implemented: June 20, 2011 Reviewed By: Pablo Rubenstein, MD

University of California, San FranciscoDepartment of Surgery

513 Parnassus Avenue San Francisco, California 94143

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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 investigator-designated site staff who will perform the informed consent process (person obtaining consent).

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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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Example:

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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 subject’s 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 subject’s 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 subject’s 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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Now that your SOP is done, may you readily IMPLEMENT it?

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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/researchfunding/sop/pages/intro.aspx

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