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A New Look at A New Look at Manual of Procedure (MOP) Manual of Procedure (MOP)
DevelopmentDevelopment
"This training has been funded in whole or in part with Federal funds from the National Institute on Drug Abuse, National Institutes of Health, Department of Health and Human Services, under Contract No.HHSN271200522081C."
Dikla (Dee) Blumberg, PhDProtocol Specialist
NIDA CTN Clinical Coordinating Center
Produced by: Liz Buttrey, NIDA CTN CCC Training Office
Aimee Campbell, PhD, MSWResearch Scientist
New York State Psychiatric Institute
NIDA CTN Greater New York Node
MOP Purpose and starting point
A discussion of MOP styles
Survey feedback review
Training Objectives
Survey feedback review
Managing MOP development
Writing style recommendations/reminders
Development timelines & updates22
MOP Purpose
Guide to study methods and implementation Should explain how to execute the protocol accurately
and consistently• Clear step by step completion process needed to
achieve desired purpose Although research staff receive training – the goal is
for the vast majority of answers to be found in the MOP
MOP vs. SOPs• Overall protocol implementation vs. addressing site
specific issues
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Where to Begin?
Contrasting the protocol vs. mop• Protocol says
What and why we are doing Broad language Broad language
o “ideally the assessment should be completed by xyz timeframe”
• MOP saysHow and when we do it Specific language
o “the follow-up window goes from 14 days before the target date to 30 days after the target date.”
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Establish a template for content style Determine writing team structure
• One coordinator
Where to Begin?
One coordinator• Delegation of writing assignments• Contribution by the Lead Team (Lead
Node(s), CCC, DSC2)
Establish timeline and milestones
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Various MOP Styles
One Document
• Define style• Advantages• Disadvantages
The best kind of mop is the one that people will USE.
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Modular Approach
• Define style• Advantages• Disadvantages
Hybrid Approach
• Define style• Advantages• Disadvantages
MOP Styles
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Comprehensive MOP
A Comprehensive MOP - A continuous document with one table of contents.
•Advantages• One stop shop for questions• Ability to refer to other sections
•Disadvantages• Potentially cumbersome & overwhelming for end users
Various MOP Styles
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ywithin one manual
• Hyperlinks or defer to other pages for expanded explanations
• Easy to search the electronic document
• Simplified version control management
g• Process to up-version is time consuming
• Modifications are batched and updates occur less frequently
• Documents over 200 pages become challenging to format and are more prone to corruption
Modular MOP
A Modular MOP – A series of individual, stand alone, content-specific documents
•Advantages• Easy to print and work with task specific procedures
• Process to up version is fast &
•Disadvantages• Utilization requires training• Requires dedicated staff member to manage updates
Various MOP Styles
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• Process to up-version is fast & efficient
• Develop and refine MOP in real-time application
• Avoids document corruption
member to manage updates, versions, dissemination, and communication
• Sites must be proactive about utilizing current module version
• Information may potentially be found in multiple modules
Hybrid MOP
A Hybrid MOP – Each module is a stand alone document with its own table of contents. All modules are combined into one electronic document with a comprehensive table of contents and module links.
•Advantages •Disadvantages
Various MOP Styles
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Advantages• Same advantages as the comprehensive
• Easy to print and work with a task specific module
• Appendices are included with each specific module
Disadvantages• Same disadvantages as the comprehensive
• Extreme complexity in formatting the multiple table of contents, appendices
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Survey said..
“Sometimes they are not very specific & leave too much to interpretation”“Some provide too many details about how to do things at the local site”“C i I l d th i t i l i“Concise- Includes the main topics leaving many of the details to the local sites”“Ability to rapidly find information, broad and basic information first, with easily found details”
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Survey said..
Different people have different preferences…
Important to find a style that is suitedImportant to find a style that is suited for your specific team, resources, and study, and aim for a balance that will satisfy most (if not all) of your staff
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What are your thoughts, experiences and recommendations regarding MOPs?
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Managing Team Contributions
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Who does what?
MOP Collaboration Coordinator• Often the Project Director
Often benefits from an assistant coordinator
M ll ti / dit• Manages all sections/edits• Manages initial versioning• Prompts deadlines• Handles production
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Who does what?
Lead Node• Overview• Inclusion/Exclusion criteria/• All study specific methods and procedures• Recruitment, consent, assessment,
follow-up and retention• General study logs
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Who does what?
EMMES – CCC • Safety (adverse events)• Regulatory documentation• Biological testing• Supplies• Protocol violations• Study documentation• Responsible for version control (in collaboration
with the LT)
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Who does what?
EMMES – DSC2 • Data management• Various collaborative contributions for
tasks related to data submissions• Advantage EDC User’s Guide (separate)
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Getting it Written
Copying other MOPs is discouraged Avoid redundancy with the protocol and other
written procedurals (e.g., EDC User’s Guide) Outline entire MOP first Outline entire MOP first Review with team for section content
development Assign tasks and deadlines
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Common MOPSections Study synopsis & flow Study Entry Treatment/Intervention Follow-up/Retention Participant Situations Documentation Regulatory
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Avoid Redundancy
Training & Monitoring• Avoid redundancy with training plan, QA
plan, and other procedurals
Data Management• Avoid redundancy with Advantage EDC
Guide
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MOP Writing Style
Needs vary by MOP style Maximize use and information accessibility
• Use short identifiable steps and place in order of performanceperformance
Avoid long narratives• Number tasks where order matters• Bullet tasks where order is not essential• Determine digestible portions - EX: the baseline
assessment section may in fact be multiple sections
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MOP Writing Style
Use figures, images, tables and flowcharts whenever possible
Include separate boxed text thatInclude separate boxed text that highlights common pitfalls/reminders to aid audience through smooth completion
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General Section Instructions Identify staff members involved Prepare a section outline to assure it is
well organized and well suitedI l d t d i Thi i Include notes and warnings. This is where conceptual information would be appropriate (not in the itemized list)
Be very clear in your writing • Clarity was a top item reported in the
survey
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General Section Instructions
Proceed with step by step instructions beginning each with a verb – EX: openbottle, press button, notify staff
bmember Have somebody who hasn't ever done
the task try following the instructions.• This helps to identify assumptions and missing
information.• This user acceptability testing almost always brings
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Logs and Documents
How to set up MOP to include Logs• In appendices• At the end of each module• As a stand alone document
Determine how study staff will access and utilize each log and where it should be stored
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Timeline
Establish the MOP development timeline early• Draft MOP completion date
Minimum of 7 weeks before Investigator Meeting
• Review staff and timeframe Minimum of 5 weeks before Investigator Meeting
• Revisions and finalization Minimum of 4 weeks before Investigator Meeting
• Final MOP completed Minimum of 3 weeks before Investigator Meeting
• Investigator Meeting (major milestone) Massive User Acceptability Testing opportunity Major revisions should be expected and are GREAT!
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Investigator Meeting Recommendations Define the MOP as a work in progress Encourage feedback – Avoid defensiveness
Incentivize the review/feedback Define their role as active user acceptability testers Develops a team cohesion and collaborative spirit
Research staff will be able to identify areas of need that Lead/CCC/DSC2 may have missed
Designate one MOP revision recorder during the meeting and throughout MOP development and refinement
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Investigator Meeting Recommendations Discuss the next milestone
• Recommend: Estimated first Site Initiation Visit• Conduct a call for comments/revisions and set a due
date• In coordination with site pre-implementation
preparation
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Post-initiationChanges
Need for changes post-initiation• Especially during the first 3-6 months
MOP style will help determine how to MOP style will help determine how to manage changes and versioning
May need to distribute interim guidelines prior to new MOP version
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What drives MOP Updates?
Protocol violations Frequently asked questions Client trends or changes Client trends or changes New regulations Unforeseen events/situations
• EX: city or state specific criminal justice procedures
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MOP Goal
Research staff should automatically turn to the MOP first when questions or uncertainties arise
If this doesn’t happen, the fault lies in the execution of the MOP
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Clinical Trials Network · Dissemination Library
NationalNational DrugDrug AbuseAbuse TreatmentTreatment
A copy of this presentation will be available
electronically after the meeting from:
http://ctndisseminationlibrary.org
CTN Dissemination Library
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