12/6/2011

1

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

33

12/6/2011

2

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.”

44

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

55

Various MOP Styles

One Document

• Define style• Advantages• Disadvantages

The best kind of mop is the one that people will USE.

66

Modular Approach

• Define style• Advantages• Disadvantages

Hybrid Approach

• Define style• Advantages• Disadvantages

MOP Styles

12/6/2011

3

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

77

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

88

• 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

99

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

12/6/2011

4

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”

1010

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

1111

What are your thoughts, experiences and recommendations regarding MOPs?

12/6/2011

5

Managing Team Contributions

13131313

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

1414

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

1515

12/6/2011

6

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)

1616

Who does what?

EMMES – DSC2 • Data management• Various collaborative contributions for

tasks related to data submissions• Advantage EDC User’s Guide (separate)

1717

1818Nidadsc2help@emmes.com

12/6/2011

7

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

1919

Common MOPSections Study synopsis & flow Study Entry Treatment/Intervention Follow-up/Retention Participant Situations Documentation Regulatory

2020

Avoid Redundancy

Training & Monitoring• Avoid redundancy with training plan, QA

plan, and other procedurals

Data Management• Avoid redundancy with Advantage EDC

Guide

2121

12/6/2011

8

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

2222

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

2323

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

2424

12/6/2011

9

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

improvements2525

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

2626

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!

2727

12/6/2011

10

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

2828

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

2929

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

3030

12/6/2011

11

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

3131

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

3232

3333

12/6/2011

12

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

3434