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1 Regulatory Inspection and Quality Improvement of Korean IRBs Young-Mo KOO, AMC, Seoul, KOREA Jeong Mi KIM, KFDA, Seoul, KOREA

2 Trends in the globalization of clinical trials Nature Review 7:13-14,

3 Status of Clinical Trials 3

4 Status of Clinical Trials (2007)

5 Regulations for Clinical Trials Pharmaceutical Affairs Law Enforcement regulation of Pharmaceutical Affairs Law Guidance for GCP Guidance for INDs Guidance for Accredited Clinical Institutes

6 History of KGCP Established as of December 28, 1987 Enforced since October 1, 1995 Revised as of January 4, 2000 Harmonize with ICH guideline E6 Protect the rights and safety of subjects Clarify the responsibility of investigator Reinforce the function of IRB

7 Essential Elements in Clinical Trials Protocol approved by KFDA Only at the accredited clinical sites Qualified investigator defined in the Enforcement regulation of Pharmaceutical Affairs Law Protect the right and safety of subjects Informed consent before enrolling subjects

8 IND Process Pre-IND Consultati on Optional Consultation KFDA Process Submission Review Approva l Protocol CMC Preclinical IB IRB Process ; Parallel review with KFDA process Approval timeline : 30 days Contract With Hospital Submission Review Protocol, ICF IB, CRF, CV Approva l

9 Accredited Clinical Institutes Purpose Guidance of Accredited Clinical Institutes to ensure the quality and integrity of data Number of Accredited Clinical Institutes : 124 training hospitals ( )

10 What are necessary to be accredited? Appropriate facilities and equipments Pool of personnel to support the clinical study Activities of IRB Education program of GCP Structures and activities to manage the clinical study 10

11 KFDA s New Inspections Program Begins in 2007 Check-list for Inspection to facilities Categories - Routine : every other year - Directed : protocol-based, for-cause Based on - Annual report, safety report - Notification on the completion of clinical trial

12 Types of inspections Surveillance inspections Directed inspections

13 Surveillance inspections Period : every other year Oversee the entire Accredited Clinical Institutes Inspection teams 2 or 3 investigators (included headquarters, field investigators) Examine to determine whether they conform to current KFDA regulations and IRB/institution's own written procedures

14 Pre-Inspection During Inspection Post Inspection 2weeks 1~3 days 2weeks letter 진행 종료 report f/u 실태조사자 site visit ( 확인서 ) 출장복명 위반사항분류 사전제출문서 document review 내부자문회의 확보 interview 행정처분등 recommendation 14

15 Procedures Contact, schedule the site visit Issue a notice of inspection Interview to obtain information about the IRB's policies and procedures IRB s procedures and membership rosters are examined IRB's performance is evaluated by tracking one or more studies - annual report, notification on the complet ion of clinical trial, IND safety reports

16 During the inspection, review Records of IRB membership IRB procedures and guidelines Minutes of IRB meetings for the past 3 year Documents related to the studies given by the clinical investigator to the IRB Documents related to the studies sent by the IRB to the clinical investigator Any other materials about these studies

17 After an inspection Conduct an exit interview with responsible institutional and IRB representatives Discuss the findings from the inspection If deficiencies are found, issue a written Inspectional Observations to the most responsible IRB representative

18 Following a written Inspectional Observations An informational letter : that identifies deviations from statutes and regulations for which voluntary corrective action is sufficient. Occasionally, such letters request a response from the IRB. A Warning Letter : that identifies serious deviations from applicable statutes and regulations. A Warning Letter generally requests prompt correction by the IRB and a formal written response to the Agency.

19 Directed inspections unscheduled inspections focused on the IRB s review of a specific clinical trial or trials. result from a complaint, clinical investigator misconduct, or safety issues pertaining to a trial or site.

20 defined in the Enforcement regulation of Pharmaceutical Affairs Law Administrative penalties 위반사항 행정처분내용 1 차 2 차 3 차 4 차 식약청장이지정하지아니한기관에서임상시험실시 당해품목임상시험업무정지 6 월 당해품목회수폐기 피험자동의규정미준수 당해품목임상시험업무정지 3 월및임상시험책임자변경 당해품목임상시험업무정지 6 월및임상시험책임자변경 당해품목임상시험업무정지 9 월및임상시험책임자변경 당해품목회수폐기및 임상시험실시기관지정취소 피험자보호규정미준수 당해품목임상시험업무정지 3 월및임상시험책임자변경 당해품목임상시험업무정지 6 월및임상시험책임자변경 기타식약청장이정한임상시험관리기준미준수 경고 당해품목임상시험업무정지 1 월 당해품목임상시험업무정지 3 월 당해품목임상시험업무정지 6 월 임상시험책임자가임상시험실시기준미준수 경고 임상시험배제 3 월 임상시험배제 6 월 임상시험배제 9 월 20

21 Findings of Inspection

22 Suggested corrective actions (1) For institutions 1.support IRB s independence 2.provide archiving storage 3. properly manage trial drugs 22

23 Suggested corrective actions (2) For IRBs 1.non-affiliated members attendance 2.writing minutes 3. continuing review & its frequency 4. PI s reports to IRB 5. member training 23

24 For investigators 1.ICF signatures 2.CRF documentation 3. delegation/authorization documentation 4. prescription documentation 5. delay in SAE report 24

25 Thank you for your attention. 25

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<C0D3BBF3BDC3C7E8B1E2BABBB9AEBCAD2E687770> 임상시험문서의이해 1. KGCP 별표의개요 (Ⅰ) 2. 임상시험실시전에확보되어야하는기본문서의종류, 목적및보존장소 (Ⅱ) 3. Ⅱ에추가하여, 임상시험실시중에확보되어야하는기본문서의종류, 목적및보존장소 (Ⅲ) 4. Ⅱ와 Ⅲ에추가하여, 임상시험이완료 ( 조기종료포함 ) 된후에확보되어야하는기본문서의종류, 목적, 및보존장소 (Ⅳ) 5. TMF 5.1. TMF 구성 5.2.