writing sops
TRANSCRIPT
Writing SOPs
Dr. Ammar Raza
Clinician, Clinical Affairs Manager & Teacher
Basic Principle in CR…..
Write down what you do, do what is written down!
What we will discuss today… Background What is an SOP? Why an SOP?
Importance of SOPs What should an SOP contain? Writing SOPs: Intro Writing SOPs: General Tips How to write a SOP?
Stopping Problem!! Who writes an SOP?
What format should be used? Before & After Writing……. What should SOP cover?
Step-by-step Approach
Background
Performing CTs is a complicated business Bound by regulations & GCP, with the
overriding concern of protecting safety and welfare of study subjects
Sites must follow each protocol exactly & meet other sponsor demands
Best way to ensure that all these conditions are met is formulate and follow standard operating
procedures (SOPs)
What is an SOP?
An ESSENTIAL Document The who, what, when, how, and why of
clinical research operations Ensures consistency, compliance, and
accountability of personnel Organizations without clinic-specific SOPs
run a high risk of GCP non-compliance and poor productivity
What is an SOP?
Critical tools in successful business operations for all those involved in doing CTs, investigative sites sponsors IRBs SOPs are critical to compliance and high
performance standards
What is an SOP?
ICH-GCP guidelines defines SOPs“Detailed, written instructions to achieve
uniformity of performance of a specific function”
Just that …..The “procedures” & processes that you use and “operate” under that have been “standardized” to ensure that
you do them the same way each time
Why SOPs?
Performing CR is a COMPLICATED business It is bound by regulations and GCP
overriding concern of protecting safety and welfare of study subjects
Sites must follow each protocol exactly + meet other sponsor demands
Best ways- formulate and follow SOPs They are essential for standardizing processes, for
ensuring regulatory & organizational policy requirements r met for training new personnel for managing workload
Why SOPs?
Because study protocol is usually a brief document…… it can give details of how each procedure is to be done, who will do it etc.
Provide a historical record of steps in the how, why and when
Serve as a training tool for teaching users
Importance of SOPs
Every good quality system is based on its Standard Operating Procedures (SOPs)
SOPs are necessary for a clinical research organization pharmaceutical company a sponsor a contract research organization an investigator site an ethics Committee or any other party involved in CR
To achieve maximum safety and efficiency of the performed TASKS
Importance of SOPs
Audits have shown sponsor/CRO files are missing important info
in several areas with respect to sponsor/CRO training no monitor CVs (75% of 226 sites) no evidence of training in SOPs (57%) No evidence of training in the therapeutic area
(53%) no evidence of training in GCP (36%) and no evidence of adequate experience
Importance of SOPs
During of selection of CROs First thing done
Look for SOPs quality of SOPs compliance with SOPs other QA systems (e.g. internal auditing,
proficiency testing), determine exactly which SOPs (i.e. sponsor or
CRO) will be used
What should an SOP contain?
Two parts 1st part: Outline or summary – includes
description of the aim or purpose scope when it should be reviewed and known risks associated with the task in
question
Contd…
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!!
Most writers - no problem getting started Sometimes follow thro’ needs more info
Most difficult thing for most –”to stop”
•Start at the beginning •Follow the task through to the end•Then stop
Sounds easy
Avoid long, complex sentences & paragraphs- make SOP difficult to follow
Avoid Stopping problem!!
Begin by identifying the purpose of your SOP’s
1. will help to focus your energy 2. set limitations on the necessary content
Create an outline of what is actually done on a day-to-day basis
Develop the skeleton i.e. the structure of the SOPs important to design your SOPs to achieve
specific results
Designing
Some design options: Simple steps Hierarchical steps Graphic procedures
Who writes?
Sound, hands on experience and knowledge of the tasks
Take input from a no. of number greatly enhance usefulness
of the procedures Writing SOPs doesn't require a
degree in ‘alchemy’ Most important things author of
a SOP can bring to word processor common sense logic
Who writes?
Must convey a clear instruction Not only must the user understand the instruction
must also be prepared to carry it out The logical step is to let the user, as far as possible,
write the SOP, in collaboration with the Trial Manager / Investigator or CRA
Brings in familiarity, ownership and prevent awakwardness
An improved sense of responsibility for obligation to use and comply with the SOP
What format should be used?
"Just spill your guts to your computer and don't worry about the format"
Format can always be added later If there is a fool proof template that can be
given - might help ease some of anxiety of novice author
Format…example
Table of contents
1 Purpose.................................................................................................22 Scope ................................................................................................. 23 Abbreviations .......................................................................................24 Definitions.............................................................................................35 Responsibilities.................................................................................... 56 Procedure............................................................................................ 66.1 Clinical Trials, phase I-III ................................................................. 66.2 Adverse Events Reported Spontaneously on Marketed Products76.3 Post-Marketing Studies ................................................................... 96.4 Named Patient Supplies.................................................................. 97 References..........................................................................................
Annexures/ Appendices/ Attachments: Forms / checklists Change log
What format should be used?
Easier to edit SOPs with default formatting rather than a doc that has many extra tabs and returns added in an attempt to emulate accepted format
Many new authors - involved in correct formatting - content suffers
Don't rely on spell check to find all misspelled words If you use "fur" instead of "for," spell check will blithely
accept it Use grammar check with care- not find all goofy little
grammar faux pas that can occur when normal people put word to page
If a word is changed using the Replace command, be sure to individually approve each replace. Universal replacement is quick and easy - sometimes too easy - and produces fodder for News
Before & After Writing…….
Identify need for new SOP Gather Input for SOP Create SOP Review and Approve SOP Provide training on SOP and distribute
SOP to relevant audience Revision and Deviations of SOPs Quality Assurance Glossary
What should SOP cover?
The no. of SOPs The arrangement of material in SOPs The level of detail in the SOPs Depend upon entirely on the organization and its related role in CT e.g., the SOPs at the
sponsor’s site will be different than those at the Trial Site requirement and role of the staff members executing their work Brief outline which in general all the SOPs must cover-
· A descriptive title and indication of the SOP’s position in the total collection.· Date when the SOP became operative· The edition number and a statement that this edition replaces an earlier edition from an earlier date· The exact distribution of SOPs· The signature of the person responsible for writing the SOP· The signature of the person responsible for authorising the SOP· In some contexts the purpose of the SOP
What should SOP cover?
Title sufficient information about the contents placed prominently on page
to allow the user to identify find it easily
Distribution list directs - to place where it will be used distributed at all related places of its function strict check should be kept on nos. of SOPs
issued and distributed at each working area
What should SOP cover?
Singatures Signature of the person
responsible for writing - shows that - SOP is complete & correct
Should an auditor or for that matter any one else have a query about the content of SOP, this would be the person in contact
Signature of the person responsible for authorizing - shows that SOP is operative
Step-by-Step Approach
8 steps1. Mapping the SOP 2. Use of language and Scripting the SOP3. Editorial responsibilities of SOPs4. Authorizing the SOPs5. Distributing and Archiving the SOPs6. Training of the SOPs7. Alteration in SOPs8. Review of the SOPs
Step-by-step approach Step 1 - Mapping SOPs
Process mapping – laying out all the steps in a currently used process analyzing -with goal of making it more efficient and easier to follow
Involves taking each step in process & “mapping” it into a process chart All people - involved in doing task should be involved in mapping it into a process
chart - free and open discussion. Often discovered during this process - involved people do not do things same
way & have very different ideas about how current process works and how it should be done in the future
SOPs cover all aspects of a CTprotocol preparationethical approvalassessing and monitoring trial sitessafety data reportingchecking data integrityclinical report writingdatabase preparationvalidating computer systems
all the records are generally created electronically FDA’s Draft Guideline - ‘Computerized System used in Clinical Trials’
Step-by-step approach
SOPs do not have to “fit into a box”. Formats can vary. Presentation techniques such as flow charts, diagrams, narratives, tables and bulleted lists should be considered in addition to the traditional text and paragraph formats. Presentation might vary, and should address conditions pertinent to the individual environment. Procedures should be presented in a format that will work for the institution and address specific needs in various ways. The goal is to have an easily understood procedure that the Clinical Research Staff will clearly understand and utilize.
Step-by-step approach Step 2 - Use of Language & Scripting the SOP
written in the language which is understandable by the staff or people dealing with it
If for regulatory purposes or for foreign auditors language has to be in a foreign language, an authorized translation of the SOP in the local language which is understandable by its users must be readily available at the working area
Authorities, clients & colleagues must be prepared to accept translations- after all- not primary target
must communicate their message effectively -must be crystal clear on who is to do what.
almost seems too obvious to write, but many SOPs are difficult to read.
Step-by-step approach
The rule of thumb for writing instructions in SOPs is these- Use short active sentences Use simple words & terms where possible Write sentences as instructions:’ do this, do that’ Write instructions in right order-so operator knows
when to do appropriate task Separate instructions from gen info ,either
typographically or by putting gen info in a foot note Limit amount of info per page-max 10 different
actions Use diagrams wherever appropriate Give sources and references at the end
Step-by-step approach
Step 3 - Editorial Responsibilities of SOPs It is possible for each dept or section to write, authorize
&produce SOP’s in isolation. For company or sponsor----advantageous to give someone editorial responsibilities
Management decides whether or not to edit SOP’s. Suitable editors might be an interdepartmental GCP committee or some of the QAU (Quality Assurance Unit) personnel
Their duties would include checking a new SOP for- Style and format The edition number Consistency of content in context with relevant SOPs from
other departments Compliance with policy, ICH GCP and other regulatory
requirements
Step-by-step approach Step 4 - Authorizing the SOPs
No SOP is a SOP without proper authorization Purpose is to decide on an appropriate method for a given
procedure, standardize the performance of the procedure & communicate these decisions to everyone involved
Most effective authorization is done by someone with organizational influence, specialist insight and knowledge of ICH GCP
Rational approach - let management, in its policy, mandate use & production of SOPs
Same policy -can delegate responsibility for authorization to person in charge of each specialist area defined as ‘management ’in this special context
Departmental SOPs then specify which named individuals are empowered to authorize SOP’s in their area
Step-by-step approach Step 5 - Distributing & Archiving the SOPs
Each dept or for that matter section (e .g sponsor ’site or Trial site) administers its own collection of SOPs & must identify (by the management) who is responsible for their distribution and withdrawal
Responsibility for typing and copying of SOPs will depend on capacity in different depts When requisite no. of SOPs have been produced, before distribution, they should be
stamped ‘DO NOT COPY’ and ‘CONTROLLED COPY’ with coloured stamp, or some other technique to distinguish between the original from photocopied versions.
original SOP should be kept by QA or a responsible management representative in a secure place
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
actually implemented in system. effective date should be clearly specified - so that staff is aware of it
Also staff training on FDA’s 21 CFR Part 11 and related guidelines on electronic records should be undertaken
Formal and continuous training sessions should be taken by the QAU, CRA and CR Managers
increase SOP awareness among staff and also continuous review will help in amending SOP, if reqd
Step-by-step approach Step 7 - Alterations in SOPs
When a mistake in an SOP is found, it is tempting to alter the text by hand
especially tempting when the SOP is newly issued or if the change is only in the distribution list
Such alterations are dangerous as no one knows whether comments appear in all SOPs of that edition how long they have existed there whether anyone has modified their working routine as a result, or
whether data has been compromised Detection of such actions must prompt inquiry- if alteration is
necessary- will need to update electronic SOPs- must be a secured system of change control and
rights to modify SOPs should be properly reflected in audit trail procedure of updating a SOP must reflect in the appropriate SOP both
electronically and manually (if practiced)
Step-by-step approach Step 8 - Reviews of SOPs
should be regularly reviewed and updated to ensure that they encourage efficient working practices that comply with the ever increasing requirements, improvements and government regulatory framework that have to operate within
Prudent for management to introduce a scheme for automatic review - date of next review should be reflected so that everybody is aware of next review date and are
ready with their suggestions and improvements If no changes are necessary this decision should be
recorded but still version no. should be changed to reflect that review did happen
Parties in a Clinical Trial
Sponsor
Investigator Patient
Regulatory Authorities
Ethics Committee
ClinicalTrial
The End………
Thanks for the Attention…….
Pl feel free to discuss or ask questions
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