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What should an SOP contain?
2nd part
Accurate step-by-step description of how the
task will be carried out
Who is responsible for each step
Writing SOPs: Intro
Writing SOPs is not an
easy process
Very time-consuming
Involves analysis of
your processes
pays big dividends
when complete
Writing SOPs: General Tips
A formal document -describes procedures that will be
followed to accomplish various tasks
Style of the text should be clear, concise, brief and
specific to the subject
Should be written to provide instructions for
completion of certain procedures
Mustn’t be ambiguous or confusing
Statements concerning procedures to be followed
should be made categorical
use of words - 'must' and 'will'
e.g. 'the following procedure must/will be
performed'
Writing SOPs: General Tips
Important to use words - “will” or “shall” to
describe procedural steps
Best to avoid words such as “should,” “could,”
and “may.”
Why?
These words convey a since of option
SOPs are not optional
Writing SOPs: General Tips
The word 'may' is to be used only when the
conditions are stated
e.g. 'the investigator may enter a patient into
the study without patient consent only in an
emergency and when the patient is
unconscious'
How to write?
Stopping problem!!
•Start at the beginning
•Follow the task through to the end
•Then stop
Sounds easy
1 Purpose.................................................................................................2
2 Scope ................................................................................................. 2
3 Abbreviations .......................................................................................2
4 Definitions.............................................................................................3
5 Responsibilities.................................................................................... 5
6 Procedure............................................................................................ 6
6.1 Clinical Trials, phase I-III ................................................................. 6
6.2 Adverse Events Reported Spontaneously on Marketed Products7
6.3 Post-Marketing Studies ................................................................... 9
6.4 Named Patient Supplies.................................................................. 9
7 References..........................................................................................
Historical or expired SOPs whose new versions have been issued - properly
archived with ‘ARCHIVED’ stamp on original SOP
Should be kept in a designated place with controlled entry called ‘Archives’
can be retrieved from the ‘Archives’ for the purpose of reference or audit
whenever reqd with a proper documentation and the SOPs should be re-
archived after the job is finished.
A management designated person called ‘Archivist’ should be responsible
for managing archives
All photocopies of expired SOP - destroyed immediately after its new
version comes in effect
to reduce confusion for staff in working by existence of 2 different methods floating
simultaneously
Step-by-step approach
Step 6 - Training of the SOPs
Training on SOPs is often last thing that people think about once SOP is written
When SOP goes into effect there is often a great sense of relief
frequently case that staff does not receive adequate training on the SOPs-
purpose of SOPs - remains unfulfilled
QA/ Monitors / CR Managers & management should see to it that there is
continuous training of SOPs among staff
trainings should be documented properly and all records - training log must
be maintained in the staff training record
effective date - must be 2-3 days after it is authorized
Give sufficient time for staff to read & understand the SOP before it is
Investigator Patient
Clinical
Trial
Regulatory Ethics
Authorities Committee
Sponsor
The End………