Standard Operating Procedures

(SOP)

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 Learning objectives

• Understand why and when SOPs are needed

• Describe how to develop and use them
• Describe what “must SOPs” have

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 LET’S HAVE FUN !
Solving a riddle & folding a sheet of paper

Move 2 matches to get the formula right

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 LET’S HAVE FUN !

Solution of the riddle

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 Case Study #1

• A study comparing Rapid Diagnostic Tests (RDTs)

with conventional microscopy for diagnosis of
malaria
• Two lab assistants were hired to read the blood
smear microscopy and to determine:
– Positivity for malaria parasites
– Approximate % RBCs infected
• No SOP training was provided
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 Case study #1 (continued)

• Routine Quality Assurance visit to site

• Discussed with two lab assistants on how they
read the slides

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 Reading blood smears
Assistant 1 Assistant 2
Used distilled water Used rain water
Read slide once to determine Read slide three times to
positivity determine positivity
Read slide twice and took Read slide three times and
average to determine % took the highest number to
determine %
Destroyed original paper with Kept all records of readings
counts
Are the results comparable?
How does this affect the study?
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Are SOPs required in the conduct
of clinical trial?
Why ?

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 The Reasons
• Consistency – uniformity
• Efficiency – timeliness
• Proficiency – training tool
• Continuity – in case of personnel turnover
• Transparency – audit trail → allows
reconstruction of the course of events.

Prerequisite for GCP compliance

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 Case study #2

A research used monkeys as subjects.

The monkeys will be divided into 2 groups:
- Group 1: 0.5 mg/kg bw
- Group 2: 0.8 mg/kg bw
The drug will be injected intramuscularly

What are the SOPs needed for this research

?
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 Key procedures in research
Think about…

• Is it a routine procedure?
• If the procedure is performed
inconsistently, will this affect performance,
safety and/or quality of the work?

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 Common SOPs needed ……

• Informed consent
• Interaction with ethics committee
• SAE reporting
• Management of IMP, e.g. receipt, storage,
dispensing, accountability, and disposition of IMP
• Management of TMF including long-term archiving
• Managing monitoring, inspections, audits and
misconduct

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 Common SOPs needed ……

• Sample management
• Selection and deployment of staff
• Training and re-training of staff
• Calibration and maintenance of equipment
• Interactions with sponsor e.g. contract
agreement, discontinuation of contract (including
budgeting and resource planning)
• Etc.

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 What are the questions an SOP
should answer?
 WHAT has to be done

 WHO has to do what

 HOW has it to be done

 WHEN has it to be done

 WHERE has it to be done

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 Exercise #1

Follow the instructions:

1. Draw 3 triangles.
2. Draw 2 small circles
3. Draw one big circle.
4. Draw 6 straight lines.
5. Draw a C on its side.

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What figure do you come up with?

OR

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 Exercise #1

Follow the instructions to draw the head of a

cat
1. Draw 3 triangles representing the ears and
nose;
2. Draw 2 small circles representing eyes;
3. Draw one big circle as the face;
4. Draw 6 straight lines, 3 on either side as
whiskers;
5. Draw a letter C to represent the mouth.

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 Characteristics of a good SOP

• Content and language is understandable

• Simple and easy to follow instructions
• Logical and step by step
• Clear and unambiguous
• Coherent and complete

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 Who should write the SOPs ?

Someone who
• is directly involved and understand in
performing the procedure, process or
“owns” the system
• appreciates all the implications of the
procedure
• knows how to write SOPs

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 Who should review & approve SOPs?

Reviewed by
• Individuals other than the original writer
• One or more individuals with appropriate expertise with
the process

Approved by
• Principal investigator / authorized designee
• Signature of approval indicates that an SOP has been
both reviewed & approved

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 Format of SOPs
• Title
• Author(s)
• Date of authorisation/authorising person
• Version
• Date of Revision
• Aim/Objective
• Scope/Applicability
• Procedure
• Responsibilities
• Applicability to other SOPs
• Glossary/definitions
• References
• Attachments
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 Tips – writing SOPs
• Write in a manner and language that is appropriate to
the personnel conducting the procedures.
• Start sentence with an action verb
• Get directly to the point; avoid wordy sentences
• Complete - containing all the necessary information
• Objective - containing facts, not opinions
• Coherent - showing a logical thought process &
sequentially listing all steps
• Support with pictures, flow diagrams and examples for
calculations, as necessary
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 KISS
Keep It Short & Simple….

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 Tips – writing SOPs

• Effective Writing: be clear and concise

Unclear:
The volume of diluent should be recorded in the
nurse’s chart
Clear:
Record the volume of diluent in the nurse’s chart.

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 Tips – writing SOPs

• Level of detail
depends on the level of expertise of the individuals
performing the work

• Use generic names where possible

• Avoid “do this or alternatively do that” or “where

appropriate”. Instead give it as option 1 and 2 citing the
reason when option 2 will be used

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 What you shouldn’t forget about SOP?

 Be trained on the SOPs

 Have access to appropriate SOPs
 Responsible for complying with the
instructions given in them
 Document and communicate any deviation
from SOP to the principal investigator /
authorized designee

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 Exercise #3

Folding a sheet of paper to make a paper-boat

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 Folding a sheet of paper
1 2 3

4 5

6 7 8 9 10 11

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Final Words on SOPs…
SOPs should…
•Be useful to the organization &
employees!
•Document study methods
effectively & efficiently
•Support quality management
•Support staff training programs

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 Final Words on SOPs…

SOPs should not...

Be documents which exist only
because the regulations,
sponsors, monitors, auditors
require them!!!!!!

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Questions or Comments?

THANK YOU

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 Group activity

Making a fruit juice

Write an SOP
Practice it

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 Group activity

Making a cup of coffee

Write an SOP
Practice it

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