Training Plan

1. 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 • 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: • 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 !!!

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

9. Setting the Stage 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

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

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

14. Defining Terms Importance of defining terms in the training plan Common understanding of words Acronym mania

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?

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

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

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

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 PlanLocal 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

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

24. Training PlanProtocol 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 PlanProtocol 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 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 • 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 • Email 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

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 What options work for you?

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

36. Staff Training Completion Log Show the Project Aware STCL 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 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: 305-243-8028 Rverdeja@med.miami.edu

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