RIHES JJ: Required Training Version 7.0 Effective Date 27 JAN 2011 Boonlure Pruenglampoo 15 Jan 2014 วันพุธที่ 15 มกราคม พ. ศ 2557 RIHES-JJ Version 7.0 1

Applies to:  All personnel involved in the conduct of the trial – data collection, document and specimen management. วันพุธที่ 15 มกราคม พ. ศ 2557 RIHES-JJ Version 7.0 2

 New staff must be trained within 60 days of starting the study.  Training certificates must be sent to the RCU for tracking.  The RCU will notify staff when their training is about to expire. วันพุธที่ 15 มกราคม พ. ศ 2557 RIHES-JJ Version 7.0 3

DAIDS Training Requirements Course NameDescription Who should take this course? Human Subjects Protection (HSP) Ensure compliance with GCP, FDA Regulations, EU Directives and ICH Guidelines. Training that meets this requirement: CITI HSP/GCP Training NIAID GCP Learning Center Individuals needing to complete the HSP requirement. Good Clinical Practice (GCP) Ensure compliance with GCP, FDA Regulations, EU Directives and ICH Guidelines. Training that meets this requirement: CITI HSP/GCP Training NIAID GCP Learning Center Individuals needing to complete the GCP DAIDS requirement. Renew at least every 3 years วันพุธที่ 15 มกราคม พ. ศ 2557 RIHES-JJ Version 7.0 4

DAIDS Training Requirements Course NameDescription Who should take this course? DAIDS Adverse Experience Reporting System (DAERS) Learn how to report AEs through the DAERS. This is a Web-based system that supports expedited reporting to DAIDS and access to safety data by DAIDS and its collaborators. Individuals accessing the DAERS system. DAIDS Protocol Registration System (DPRS) Learn how to prepare, submit, and track Protocol Registration documents. Navigate and use the DAIDS Protocol Registration System (DPRS) for electronic submissions. Individuals accessing the DPRS system. วันพุธที่ 15 มกราคม พ. ศ 2557 RIHES-JJ Version 7.0 5

Good Clinical Laboratory Practice: GCLP  All Lab staff  Training:  DAIDS online training (English)  DAIDS sponsored network meetings (EN)  DAIDS regional meetings (English/Thai) วันพุธที่ 15 มกราคม พ. ศ 2557 RIHES-JJ Version 7.0 6

DAIDS Policy Training Requirements DAIDS does offer online training for the following policies: Clinical Quality Management Plan: CQMP Critical Events Essential Documents HSP and GCP Training Requirements Manual of Operational Procedures วันพุธที่ 15 มกราคม พ. ศ 2557 RIHES-JJ Version 7.0 7

DAIDS Policy Training Requirements (Con’t) DAIDS does offer online training for the following policies: Onsite Monitoring Policies on Enrolling Children (including Adolescents) Protocol Registration Source Documentation Storage and Retention of Clinical Research Records วันพุธที่ 15 มกราคม พ. ศ 2557 RIHES-JJ Version 7.0 8

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วันพุธที่ 15 มกราคม พ. ศ 2557 RIHES-JJ Version

IND studies  All staff involved in IND studies must be trained in:  21 CFR 11 Electronic records and signatures  21 CFR 312 Investigational new drugs  21 CFR 50 Protection of Human Subjects  21 CFR 54 Financial Disclosure  21 CFR 56 IRBs วันพุธที่ 15 มกราคม พ. ศ 2557 RIHES-JJ Version

SPU Staff  See SOP RIHES-SPU-RM-001 for IATA training requirements.  Staff are also required to be trained in LDMS. IATA :Renew at least every 2 years วันพุธที่ 15 มกราคม พ. ศ 2557 RIHES-JJ Version

CL Staff  See RIHES-CL-G007 for training requirements. วันพุธที่ 15 มกราคม พ. ศ 2557 RIHES-JJ Version

Clinical Pharmacology Quality Assurance Program  Clinic, SPU and Pharmacy staff who handle PK specimens must be trained in CPQA.  Training:  FSTRF website  HANC website  Staff who are not fluent in English must receive an in-house training from their supervisor. Renew at least every 2 years วันพุธที่ 15 มกราคม พ. ศ 2557 RIHES-JJ Version

Universal Precautions/Post Exposure Prophylaxis  Staff who work directly with participants, conduct physical exams and/or handle specimens must comply  Comply by:  GCLP Training  Training on RIHES-FF  RCU will arrange one RIHES-FF training/year  Unit heads responsible for organizing other hands- on training for their staff.  New staff must complete paper or online training before beginning work if there is no live training scheduled. วันพุธที่ 15 มกราคม พ. ศ 2557 RIHES-JJ Version

Radiation Safety Training  These requirements are set by the RIHES Radiation Safety Officer.  Unit heads will determine who needs to be trained. วันพุธที่ 15 มกราคม พ. ศ 2557 RIHES-JJ Version

Study-Specific Training  All study staff must be trained in the protocol and SSP, before initiation of the protocol  New staff must be trained on study procedures on the protocol, SSP and all procedures for which the staff will be responsible within 60 days of starting the study. วันพุธที่ 15 มกราคม พ. ศ 2557 RIHES-JJ Version

Study-Specific Training  For IND studies, staff must be trained BEFORE their name is added to the FDA 1572 and registered with PRO. วันพุธที่ 15 มกราคม พ. ศ 2557 RIHES-JJ Version

Other Training Options  Staff SHOULD NOT wait for the annual Thai trainings to be trained if it means that they will not be in compliance of this SOP.  Study coordinators can arrange to do an in-house training on these topics first and then staff can join the live trainings as they are scheduled.  In-house trainings must have a training log. วันพุธที่ 15 มกราคม พ. ศ 2557 RIHES-JJ Version

Tracking and Documentation of Training  All trainings taking place at RIHES, must have a log of participants.  People trained in HSP, GCP, IATA, UP/PEP will receive certificates and those certificates must be sent to the RCU.  Training logs will be kept in the RCU. วันพุธที่ 15 มกราคม พ. ศ 2557 RIHES-JJ Version