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Protocol Implementation

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Presentation on theme: "Protocol Implementation"— Presentation transcript:

1 Protocol Implementation
Training Plan Development for Protocol Implementation Presented by: Rosa Verdeja, M.Ed. (Florida Node) Liz Buttrey (NIDA CTN CCC) September 29, 2010

2 Presentation Outline The Training Process Tools Goal of training
Understanding the process of transferring skills Setting the stage Tools Developing a training plan Creating a training matrix Measuring competency Tracking training completion

3 Training: An Ongoing Process
THE GOAL Competency on Performance

4 Transferring Skills Process
Trainer Feedback System Trainee

5 Transferring the Skills
The Trainer: Plans the training Identifies subject matter experts Develops written reference materials (& updates) Implements a Model-Practice-Feedback system Tracks overall training completion Needs Patience!

6 Applying the Skills The Trainee: Knowledge transfer and ownership
Develops local SOPs Practices Role play Audio-recordings Standardized participant walk-through Performance Applies knowledge in real time

7 Feedback Systems Feedback System: Reminders
Triggers needs for improvement Questions from the sites Quality of data QA findings Reminders Coach staff along Listen behind the questions Identify communication barriers/ use of other venues Timing of information: relevance impacts learning Patience !!! QA may also show deficiencies in training Listen behind the question—give example (2 sites same question on ecrf---seems they are getting a query that wasn’t there before)

8 Transferring Skills Process
Trainer Feedback System Trainee THE GOAL Competency on Performance 8

9 Setting the Stage 9 9

10 Getting Started Obtain comprehensive protocol knowledge
Work as a team during development phase Create a training team Hold regular development meetings Determine preliminary modules Identify presenters Designate one person from the LT to Oversee and coordinate the training development plan Execute and follow-up on tasks Maintain training system at a Lead Team level Proper protocol implementation: -adhere to protocol. -manual of operations and proceedures

11 Getting Going Heavy Front-load work Develop training plan *
Develop staff training requirements matrix * Develop manual of operations & procedures (MOP) Identify & coordinate presenters Develop training timeline great deal of coordination Develop & maintain training completion log * for training verification Proper protocol implementation: -adhere to protocol. -manual of operations and proceedures Matrix—I will go over later in detail 11

12 Keep in Mind Structure should be solid from inception
Training Plan Training Matrix Common repository for information E.g., Livelink Access to tools and training resources enables independence

13 Training Tools 13 13

14 Defining Terms Importance of defining terms in the training plan
Common understanding of words Acronym mania Washing Machine Importance of defining terms - define in training plan Common understanding of words Acronym mania 14

15 Training Plan—Answers what?
Protocol Dictates Training Requirements The training plan must answer: Who are you training? What are the required training topics? Who is responsible for delivering training? How/Who is assuring competency? How is training completion documented? How/Who is tracking training completion? How/Who trains incoming staff members? Proper protocol implementation: -adhere to protocol. -manual of operations and proceedures

16 What Guides a Training Plan
Protocol Dictates Training Requirements Broad procedural plans Manual of Operations & Procedures (MOP) Outlines specific step-by-step study procedures Guides protocol-specific training needs Importance of versions and change logs Should trigger training needs Appendices Address refreshers Reduce MOP versions Example of appendices addressing refreshers

17 Developing a Training Plan
Training Plan Outline Introduction Outline of required trainings Local Protocol Specific Training Matrix Measuring competency Proof of completion Staff Training Tracking System Training of new/incoming staff Example of appendices addressing refreshers

18 Training Plan—Staff Roles
Develop List of Site Staff Roles (template suggestion) Define role responsibility of each site staff (CTN) Site Principal Investigator (PI) Site Study Coordinator (SC) Site Research Assistant (RA) Site Interventionist/counselor Site nurse, physician, etc Other (e.g., receptionist?) Define role responsibility of each node staff University PI Node Quality Assurance (QA) monitor Typically the SC, or a designee, should be the person in charge of be responsible for monitoring the training for all site staff members and update the staff training completion log accordingly. 

19 Training Plan—Type of Trainings
Type of Training Requirements Local Training Local IRB requirements Required of all study staff in order to conduct quality research with human subjects (HSP) (GCP) Must issue a certificate Other (e.g., Universal Precautions) Protocol Specific Introductory Pre-training National Training/Investigator Meeting Post training

20 Training Plan Who is Responsible…?
…for training delivery? Local Training Site Protocol Specific Training Lead Team …for ensuring staff is properly trained? PI Affirms staff qualifications SC Coordinates & documents training completion QA Monitors & verifies completion 20

21 Training Plan Local Training
Sites must be in compliance with their local IRB requirements Lead Team or Node may provide acceptable options for obtaining local training requirements Human Subjects Protection (HSP) Good Clinical Practice (GCP) Universal Precautions, etc. Training Plan should provide a general description of each local training requirements module Training Plan specifies required evidence of completion RTS: keeper of regulatory evidence (HSP, CV, License)

22 Protocol Specific Training
Pre Training National Training Post Training … Courtesy of the Lead Team 22 22

23 Training Plan Protocol Specific Training
Pre-Training General study overview Getting a head-start prior to National Training / Investigators Meeting / All-hands Meeting

24 Training Plan Protocol Specific Training
National Training Gathering in one place: meeting of colleagues Delivery of protocol specific training Study implementation procedures Study visit procedures Documentation Regulatory binder, etc Intervention (may be hands on) Data capturing systems (may be hands on)

25 Training Plan Protocol Specific Training
Post Training Follow-up on training needs identified during National Training Provide training refreshers Deliver specific training closer to specific implementation date (e.g., before follow-up study visit) Newly developed sessions triggered during implementation

26 Developing a Training Plan
Training Plan Outline (sample) Introduction Outline of required trainings Local Protocol Specific Training Matrix Measuring competency Proof of completion Staff Training Tracking System Training of new/incoming staff Example of appendices addressing refreshers 26 26

27 Training Matrix Lists Training Modules
Local Protocol Specific Training Pre-training National Training Post-training Specifies training requirements for each study staff role Lists presenters, date, time, length

28 Creating a Training Matrix
Sharing a Training Matrix (sample) Use of colors Numbering modules Definition of symbols (R,S,O) R= Required, S= Suggested, O= Optional Version control Some dates may be TBD Ability to add modules for post-training Common repository, (e.g., Livelink) current version

29 Delivering Training Local Trainings Pre-Training National Trainings
Sites are responsible Pre-Training Webinars Conference Calls/PPT presentations, videos Release of MOP National Trainings PowerPoint presentations Use of audience device (interactive/assess) Suggestions/Questions Box Hands on Pre-Post Trainings Webinars Conference calls messages On-site training of newly hired staff Site Coordinator’s role in training/ensuring training of new staff. Tools: Training Plan Training Matrix Staff Training Completion Log Checklists 29

30 Measuring Competency It is ultimately the Site PI the one responsible for ensuring that site study personnel are trained and qualified to perform the assigned study responsibility

31 Measuring Competency Individual Staff Responsibilities Log (template)
31

32 Measuring Competency Individual Staff Responsibilities Log (template)
With my signature, I affirm the above staff member is trained and qualified to perform the responsibilities I have assigned to him/her for this protocol. Site PI Signature Site PI Printed Name Date 32

33 Measuring Competency Individual Staff Responsibilities Log (template)
With my signature, I affirm the above staff member is trained and qualified to perform the responsibilities I have assigned to him/her for this protocol. Site PI Signature Site PI Printed Name Date 33 33

34 Options for Measuring Competency
Devices for general sessions Immediate audience comprehension feedback (polls) Allows presenter to correct information on the spot Individualize comprehension assessment Checklists, observations, write-evaluation for specific intervention training Quizzes after presentations Quizzes based on MOP (survey monkey?) Randomized Participant walkthrough PI & SC role in supervision (honor system) QA monitor verification Devices for general sessions The interactive communication devices require approval from the NIDA CCTN. They have been used for several National Training Sessions. Teams approved to use devices should make use of all device capabilities to increase our return on investment. Benefits and utilization should include Documenting individual attendance, participation & competency Real-time data: presentation-specific polling assessments with verification of primary learning objective comprehension Direct post training efforts May be used to verify National Training completion based on quiz scoring What options work for you?

35 Training Completion Documentation
Regulatory Binder RTS Roll Call Attendance Sign-in Sheet Local Training Pre-Training National Training Post-Training

36 Staff Training Completion Log
Staff Training Completion Log (template) Created using the Training Matrix Each site has its own tab Site staff (name and role) Node staff (name and role) Completion marks Check marks Date of completion Show the Project Aware STCL 36

37 Staff Training Completion Log
Uses of Staff Training Completion Log Site Coordinator uses it to monitor and document site staff training Serves as evidence of training in the site Regulatory Binder QA monitors can easily review Lead Team monitors overall training of staff Cost-Analysis studies may use it to analyze amount and time of training 37

38 Evidence of Training Staff Training Completion Log
Regulatory binder & RTS (Regulatory Tracking System EMMES) CV’s for e/ investigator listed on the Appropriate licenses for e/investigator listed IA Certification of Human Subject Protection (HSP) Individual Staff Responsibility Log * Signature Sheet & Delegation of Responsibility Log (keep updated) * Access to data capturing systems (EDC) Electronic signature form (designed by individual vendor

39 New Staff Training Staff hired as addition or replacement after the national training Site Coordinator oversees training: Follows the training plan Uses the training matrix Updates Staff Training Completion Log Use of a site “master trainer” for specific training needs

40 Wrapping up Training is an ongoing process
Feedback system Need for solid structure and foundation Plan Matrix System for measuring competency Tracking training documentation Patience ! Tools  see next page 40

41 Template Tool Box Site Roles & Responsibilities —Template
Training Plan — Sample Training Matrix — Sample Individual Staff Responsibilities Log — Sample Staff Training Completion Log — 2 Templates

42 Any Questions or Comments
? 42

43 Thank You Rosa E. Verdeja, M.Ed. National Protocol Implementation
CTN 0032 and Project Aware Dept of Epidemiology & Public Health University of Miami Miller School of Medicine CRB Room 1028, Tel:

44 Clinical Trials Network ∙ Dissemination Library
National Drug Abuse Treatment Clinical Trials Network ∙ Dissemination Library A copy of this presentation will be available electronically after the meeting from: CTN Dissemination Library and NIDA Livelink https://livelink.nida.nih.gov


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