현재주소 : http://www.c3bird.org/network/curriculum
Training and Practice of Clinical Research related to Infectious Diseases
-
Includes expertise in clinical trials and training programs on SOPs for processing clinical trials
- Various regulations related to clinical trials; understanding and writing research plans; visits to clinical trial centers; practice courses for processing clinical trials.
- Upon developing draft training programs, confirm training hours and materials through simulation
- Improve problems raised through continuous feedback; update training materials
Week 1 Training Schedule (5 days)
- Theory
- Practice
| Content | |||||
|---|---|---|---|---|---|
| Time | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 |
| Topic | Understanding various regulations and research plans related to clinical trials | Outline of the clinical trial process and qualifications and duties of the investigator | Acquiring and managing consents and the communication between the researcher and IRB | Roles and responsibilities of the investigator in researcher-led clinical trials | Reporting and managing clinical trials |
| A.M. (9:00~12:00) |
Understanding regulations related to clinical trials | What to do before, during and after the clinical trial | Acquiring consents according to regulations/managing consents |
Attributes and Process of researcher-led clinical trials
Roles and responsibilities of the investigator for each process
|
Progress and safety report
Non-compliance report
|
| hat to remember when writing a research plan | ractice screening in clinical trials and writing consent forms | ommunicating with IRB/Reporting conflicts of interest/What to remember as researchers | |||
| What to consider in statistics and how to analyze statistics | Qualification requirements | Clinical trial records/Progress report | |||
| P.M. (13:00~17:30) |
Example research plans/Random assignments and blinding plans | Obtaining resources needed to conduct clinical trials/Patient protection obligations | Reporting on safety and non-compliance | What to comply with when operating a pharmacy under the clinical research center | What to report in case of SUSAR/What to remember when handling SUSAR |
| Theory and practice of research monitoring plans and randomizing samples | Complying with the plan and managing medical and pharmaceutical products | Designing a clinical trial and writing a synopsis | Operating a pharmacy under the clinical research center | ||
GCP Training
| GCP Training (Thailand) | |||||
|---|---|---|---|---|---|
| Week 1 | 1st Day 4/9 (Mon) |
2nd Day 4/10 (Tue) |
3rd Day 4/11 (Wed) |
4th Day 4/12 (Thu) |
5th Day 4/13 (Fri) |
| 09:00 ~ 10:00 |
Clinical Trials Observation | IVI Tour | |||
| 10:00 ~ 11:00 |
New Drug Development and Clinical Trials (Seunghwan Lee) |
Adverse Events (Hyewon Chung) |
Statistical Consideration (Woojoo Lee) |
||
| 11:00 ~ 12:00 |
Nonclinical Study, Bridging the Novel Idea to Clinical Study (Sin-Young Ryu) |
||||
| 12:00 ~ 13:00 |
Lunch | Lunch | |||
| 13:00 ~ 14:00 |
Lunch | Informed Consents (Seol Ju Moon) |
|||
| 14:00 ~ 15:00 |
Opening Ceremony | Early Phase Clinical Trials (Jaeseong Oh) |
Pharmacokinetics-Pharmacodynamics (Su-jin Rhee) |
||
| 15:00 ~ 16:00 |
Course Introduction (In-Jin Jang) |
Clinical Study Design (Sang Won Lee) |
Screening Observation | ||
| 16:00 ~ 17:00 |
Facility Tour (Ju-Yeon Lee) |
Late Phase Clinical Trials (Yunhee Choi) |
Protocol Review (Sang Won Lee) |
Sample Collection & Preparation (Sung Hee Han) |
|
| 17:00 ~ 18:00 |
|||||
| 18:00 ~ 19:00 |
Welcome Dinner | ||||
| GCP Training (Thailand) | |||||
|---|---|---|---|---|---|
| Week 2 | 6th Day 4/9 (Mon) |
7th Day 4/10 (Tue) |
8th Day 4/11 (Wed) |
9th Day 4/12 (Thu) |
10th Day 4/13 (Fri) |
| 09:00 ~ 10:00 |
Clinical Trials Observation | LG Chem Tour | |||
| 10:00 ~ 11:00 |
Data Management (Seunghwan Lee) |
Outline of HRPP (Ockjoo Kim) |
Internal Audit (Dong In Suh) |
Clinical Study Report (Jaeseong Oh) |
|
| 11:00 ~ 12:00 |
Lunch | Outline of IRB (Heung Woo Park) |
Bioassay (Seo Hyun Yoon) |
Closing Ceremony | |
| 12:00 ~ 13:00 |
Source Document (Yujung Jung) |
Lunch | |||
| 13:00 ~ 14:00 |
Lunch | Lunch | |||
| 14:00 ~ 15:00 |
Subject Management (Practice) (Bo Mi Kim) |
Monitoring (Mihyun Cho) |
Clinical Trials for Medical Devices (Jong-Hee Lee) |
||
| 15:00 ~ 16:00 |
|||||
| 16:00 ~ 17:00 |
Protocol Development (Practice) (Soyoung Lee) |
Protocol Development (Practice) (Soyoung Lee) |
|||
| 17:00 ~ 18:00 |
|||||
| 18:00 ~ 19:00 |
Farewell Dinner | ||||
GLP Training
| GLP Training (Thailand) | |||||
|---|---|---|---|---|---|
| Week 1 | 1st Day 4/9 (Mon) |
2nd Day 4/10 (Tue) |
3rd Day 4/11 (Wed) |
4th Day 4/12 (Thu) |
5th Day 4/13 (Fri) |
| 09:00 ~ 10:00 |
IVI Tour | Clinical Trials Observation | |||
| 10:00 ~ 11:00 |
New Drug Development and Clinical Trials (Seunghwan Lee) |
Adverse Events (Hyewon Chung) |
Statistical Consideration (Woojoo Lee) |
||
| 11:00 ~ 12:00 |
Nonclinical Study, Bridging the Novel Idea to Clinical Study (Sin-Young Ryu) |
||||
| 12:00 ~ 13:00 |
Lunch | Lunch | |||
| 13:00 ~ 14:00 |
Lunch | Pharmacokinetics-Pharmacodynamics (Su-jin Rhee) |
Informed Consents (Seol Ju Moon) |
||
| 14:00 ~ 15:00 |
Opening Ceremony | Early Phase Clinical Trials (Jaeseong Oh) |
Clinical Study Design (Sang Won Lee) |
||
| 15:00 ~ 16:00 |
Course Introduction (In-Jin Jang) |
||||
| 16:00 ~ 17:00 |
Facility Tour (Ju-Yeon Lee) |
Late Phase Clinical Trials (Yunhee Choi) |
Protocol Review (Sang Won Lee) |
Sample Collection & Preparation (Sung Hee Han) |
|
| 17:00 ~ 18:00 |
|||||
| 18:00 ~ 19:00 |
Welcome Dinner | ||||
| GLP Training (Thailand) | |||||
|---|---|---|---|---|---|
| Week 2 | 6th Day 4/16 (Mon) |
7th Day 4/17 (Tue) |
8th Day 4/18 (Wed) |
9th Day 4/19 (Thu) |
10th Day 4/20 (Fri) |
| 09:00 ~ 10:00 |
LG Chem Tour | ||||
| 10:00 ~ 11:00 |
Data Management (Seunghwan Lee) |
Outline of HRPP (Ockjoo Kim) |
Internal Audit (Dong In Suh) |
Clinical Study Report (Jaeseong Oh) |
|
| 11:00 ~ 12:00 |
Lunch | Outline of IRB (Heung Woo Park) |
Bioassay (Seo Hyun Yoon) |
Closing Ceremony | |
| 12:00 ~ 13:00 |
Source Document (Yujung Jung) |
Lunch | |||
| 13:00 ~ 14:00 |
Lunch | Lunch | Interview to NGS Professional | ||
| 14:00 ~ 15:00 |
Laboratory Diagnosis (Naery Yang) |
Biosafety Laboratory (1) (Hee Chan Lee) |
Clinical Trials for Medical Devices (Jong-Hee Lee) |
||
| 15:00 ~ 16:00 |
|||||
| 16:00 ~ 17:00 |
Clinical Biomarker (Sang Chun Ji) |
Biosafety Laboratory (2) (Won Jong Jang) |
|||
| 17:00 ~ 18:00 |
|||||
| 18:00 ~ 19:00 |
Farewell Dinner | ||||
Clinical Trial training
| Clinical Trial (Vietnam) | |||||
|---|---|---|---|---|---|
| Week 1 | 1st Day 3/22 (Thu) |
2nd Day 3/23 (Fri) |
|||
| 09:00 ~ 10:00 |
|||||
| 10:00 ~ 11:00 |
Opening Ceremony | How to Conduct Clinical Trials (Kyungho Jang) |
|||
| 11:00 ~ 12:00 |
Course Introduction (In-Jin Jang) |
||||
| 12:00 ~ 13:00 |
Lunch | Lunch | |||
| 13:00 ~ 14:00 |
Facility Tour (Ju-Yeon Lee) |
Clinical Trials for Medical Devices (Jong-Hee Lee) |
|||
| 14:00 ~ 15:00 |
|||||
| 15:00 ~ 16:00 |
New Drug Development and Clinical Trials (Kyungho Jang) |
||||
| 16:00 ~ 17:00 |
|||||
| 17:00 ~ 18:00 |
Welcome Dinner | ||||
| 18:00 ~ 19:00 |
|||||
| Ethics (Vietnam) | |||||
|---|---|---|---|---|---|
| Week 2 | 3rd Day 3/26 (Mon) |
4th Day 3/27 (Tue) |
5th Day 3/28 (Wed) |
6th Day 3/29 (Thu) |
7th Day 3/30 (Fri) |
| 09:00 ~ 10:00 |
Clinical Trials Observation | K-bio Tour | |||
| 10:00 ~ 11:00 |
SOPs on Clinical Trials (Hyewon Kim) |
Early Phase Clinical Trials (Jaeseong Oh) |
Screening Process (Observation) (Soyoung Lee) |
Data Management (Seunghwan Lee) |
|
| 11:00 ~ 12:00 |
|||||
| 12:00 ~ 13:00 |
Lunch | Lunch | Lunch | Facility Tour - Data Management Center | |
| 13:00 ~ 14:00 |
Pharmacokinetics-Pharmacodynamics (Su-jin Rhee) |
Late Phase Clinical Trials (Yunhee Choi) |
Adverse Events (Hyewon Chung) |
Lunch | |
| 14:00 ~ 15:00 |
Surrogate Biomarker (Sang Chun Ji) |
||||
| 15:00 ~ 16:00 |
Clinical Study Design (Sang Won Lee) |
Informed Consents (Seol Ju Moon) |
Protocol Development (Practice) (Soyoung Lee) |
||
| 16:00 ~ 17:00 |
Clinical Study Report (Jaeseong Oh) |
||||
| 17:00 ~ 18:00 |
Protocol Review (Sang Won Lee) |
||||
| 18:00 ~ 19:00 |
|||||
| Clinical Trial (Vietnam) | |||||
|---|---|---|---|---|---|
| Week 3 | 8th Day 4/2 (Mon) |
9th Day 4/3 (Tue) |
10th Day 4/4 (Wed) |
11th Day 4/5 (Thu) |
12th Day 4/6 (Fri) |
| 09:00 ~ 10:00 |
Tour | ||||
| 10:00 ~ 11:00 |
Statistical Consideration (Woojoo Lee) |
Outline of HRPP (Ockjoo Kim) |
Internal Audit (Dong In Suh) |
Special Lecture - Infectious Diseases Research Trends (Sungmin Kim) |
|
| 11:00 ~ 12:00 |
Outline of IRB (Heung Woo Park) |
||||
| 12:00 ~ 13:00 |
Lunch | Lunch | Closing Ceremony | ||
| 13:00 ~ 14:00 |
R (Practice) (Woojoo Lee) |
Lunch | Subject Management (Practice) (Bo Mi Kim) |
||
| 14:00 ~ 15:00 |
Monitoring | ||||
| 15:00 ~ 16:00 |
Monitoring & Reporting of AE (Practice) (Jeong Shil Choi) |
||||
| 16:00 ~ 17:00 |
Sample Collection & Preparation (Practice) (Sung Hee Han) |
||||
| 17:00 ~ 18:00 |
|||||
| 18:00 ~ 19:00 |
|||||
Ethics Training
| Ethics (Vietnam) | |||||
|---|---|---|---|---|---|
| Week 1 | 1st Day 3/22 (Thu) |
2nd Day 3/23 (Fri) |
|||
| 09:00 ~ 10:00 |
|||||
| 10:00 ~ 11:00 |
Opening Ceremony | How to Conduct Clinical Trials (Kyungho Jang) |
|||
| 11:00 ~ 12:00 |
Course Introduction (In-Jin Jang) |
||||
| 12:00 ~ 13:00 |
Lunch | Lunch | |||
| 13:00 ~ 14:00 |
Facility Tour (Ju-Yeon Lee) |
Clinical Trials for Medical Devices (Jong-Hee Lee) |
|||
| 14:00 ~ 15:00 |
|||||
| 15:00 ~ 16:00 |
New Drug Development and Clinical Trials (Kyungho Jang) |
||||
| 16:00 ~ 17:00 |
|||||
| 17:00 ~ 18:00 |
Welcome Dinner | ||||
| 18:00 ~ 19:00 |
|||||
| Ethics (Vietnam) | |||||
|---|---|---|---|---|---|
| Week 2 | 3rd Day 3/26 (Mon) |
4th Day 3/27 (Tue) |
5th Day 3/28 (Wed) |
6th Day 3/29 (Thu) |
7th Day 3/30 (Fri) |
| 09:00 ~ 10:00 |
Clinical Trials Observation | K-bio Tour | |||
| 10:00 ~ 11:00 |
SOPs on Clinical Trials (Hyewon Kim) |
Early Phase Clinical Trials (Jaeseong Oh) |
Screening Process (Observation) (Soyoung Lee) |
Data Management (Seunghwan Lee) |
|
| 11:00 ~ 12:00 |
|||||
| 12:00 ~ 13:00 |
Lunch | Lunch | Lunch | Facility Tour - Data Management Center | |
| 13:00 ~ 14:00 |
Pharmacokinetics-Pharmacodynamics (Su-jin Rhee) |
Late Phase Clinical Trials (Yunhee Choi) |
Adverse Events (Hyewon Chung) |
Lunch | |
| 14:00 ~ 15:00 |
Surrogate Biomarker (Sang Chun Ji) |
||||
| 15:00 ~ 16:00 |
Clinical Study Design (Sang Won Lee) |
Informed Consents (Seol Ju Moon) |
Protocol Development (Practice) (Soyoung Lee) |
||
| 16:00 ~ 17:00 |
Clinical Study Report (Jaeseong Oh) |
||||
| 17:00 ~ 18:00 |
Protocol Review (Sang Won Lee) |
||||
| 18:00 ~ 19:00 |
|||||
| Ethics (Vietnam) | |||||
|---|---|---|---|---|---|
| Week 3 | 8th Day 4/2 (Mon) |
9th Day 4/3 (Tue) |
10th Day 4/4 (Wed) |
11th Day 4/5 (Thu) |
12th Day 4/6 (Fri) |
| 09:00 ~ 10:00 |
Tour | ||||
| 10:00 ~ 11:00 |
Statistical Consideration (Woojoo Lee) |
Outline of HRPP (Ockjoo Kim) |
Internal Audit (Dong In Suh) |
Special Lecture - Infectious Diseases Research Trends (Sungmin Kim) |
|
| 11:00 ~ 12:00 |
Outline of IRB (Heung Woo Park) |
||||
| 12:00 ~ 13:00 |
Lunch | IRB Meeting (Observation) | Closing Ceremony | ||
| 13:00 ~ 14:00 |
Documents for IRB Submission (Jingshun Li) |
Lunch | |||
| 14:00 ~ 15:00 |
Monitoring | Lunch | |||
| 15:00 ~ 16:00 |
IRB System (JoungHyeon Park) |
||||
| 16:00 ~ 17:00 |
Major Comments from IRB; Cases (Seol Ju Moon) |
||||
| 17:00 ~ 18:00 |
|||||
| 18:00 ~ 19:00 |
|||||
Bioinformatic Training
| Bio-informatics Training (Vietnam) | |||||
|---|---|---|---|---|---|
| Week 1 | 4/16 (Mon) | 1st Day 4/17 (Tue) |
2nd Day 4/18 (Wed) |
4/19 (Thu) | 3th Day 4/20 (Fri) |
| 10:00 ~ 11:00 |
Introduction of Databases for Virus Study | Trimming the Sequence Sets | Road trip | Selection of best-fit substitution models using MEGA | |
| 11:00 ~ 12:00 |
How to Use the Databases | Selection of Best-fit Substitution Model | Construction of Maximum likelihood tree using MEGA | ||
| 12:00 ~ 13:00 |
Lunch | Lunch | Lunch | ||
| 13:00 ~ 14:00 |
Collection and Preparation of Genomic Sequences | How to Interpret the Results | How to Interpret the Results | ||
| 14:00 ~ 15:00 |
Introduction of Phylogenetic Analysis:MEGA7 | Visualization of Maximum Likelihood Tree | |||
| 15:00 ~ 16:00 |
Alignment of Sequence Sets | Calculation of Pair-wise Distances | |||
| Bio-informatics Training (Vietnam) | |||||
|---|---|---|---|---|---|
| Week 2 | 4th Day 4/23 (Mon) |
5th Day 4/24 (Tue) |
6th Day 4/25 (Wed) |
7th Day 4/26 (Thu) |
8th Day 4/27 (Fri) |
| 10:00 ~ 11:00 |
Introduction of Bayesian Phylogenetic Study | Coalescent Theory | Why and How Do We Use BEAST package? | Diagnosis of BEAST output results | How to improve the results |
| 11:00 ~ 12:00 |
How to Install BEAST Package | Selection of best-fit substitution models | Interpretation of BEAST output results | ||
| 12:00 ~ 13:00 |
Lunch | Lunch | Lunch | Lunch | Lunch |
| 13:00 ~ 14:00 |
Collection and Preparation of Sequence Sets for Bayesian Phylogenetic Study | Brief Introduction to BEAST package | Generation of BEAST input file | Free Practical session | Generation of BEAST input file (Long Run) |
| 14:00 ~ 15:00 |
|||||
| 15:00 ~ 16:00 |
Alignment of the Sequence Sets | How to use BEAUti | Running BEAST (Short Run) | Running BEAST (Long Run) | |
| Trimming the Sequence Sets | |||||
| GCP Training (Thailand) | |||||
|---|---|---|---|---|---|
| Week 3 | 9th Day 4/30 (Mon) |
5/1 (Tue) | 10th Day 5/2 (Wed) |
5/3 (Thu) | 5/4 (Fri) |
| 10:00 ~ 11:00 |
Diagnosis of BEAST output results (Long Run) | May Day | Introduction to Phylodynamics | ||
| 11:00 ~ 12:00 |
Summarization of Trees (Long Run) | ||||
| 12:00 ~ 13:00 |
Lunch | Lunch | |||
| 13:00 ~ 14:00 |
Introduction to Estimating Time-scales | Introduction to Phylogeography | |||
| 14:00 ~ 15:00 |
|||||
| 15:00 ~ 16:00 |
Visualization of Target Tree (Long Run) | Free Practical Session | |||
Biostatistics Training
| Statistics (Vietnam G2) | |||||
|---|---|---|---|---|---|
| Week 1 | 1st Day 4/16 (Mon) |
2nd Day 4/17 (Tue) |
3rd Day 4/18 (Wed) |
4th Day 4/19 (Thu) |
5th Day 4/20 (Fri) |
| 10:00 ~ 11:00 |
Clinical Research & Clinical Trials (Seunghwan Lee) |
Basic Statistics (Seokyung Hahn) |
Analysis of categorical variables (Myoung-jin Jang) |
Analysis of survival data (Yunhee Choi) |
|
| 11:00 ~ 12:00 |
|||||
| 12:00 ~ 13:00 |
Lunch | Lunch | Lunch | Lunch | |
| 13:00 ~ 14:00 |
Course Introduction (Seokyung Hahn) |
Analysis of Continuos variables (Myoung-jin Jang) |
Practicals using SPSS (Myoung-jin Jang) |
Practicals using SPSS (Yunhee Choi) |
|
| 14:00 ~ 15:00 |
Opening Ceremony | ||||
| 15:00 ~ 16:00 |
Course Introduction (In-Jin Jang) |
Introduction to SPSS (Myoung-jin Jang) |
Practicals using SPSS (Myoung-jin Jang) |
Problem-Solving and Discussion (Myoung-jin Jang) |
Problem-Solving and Discussion (Yunhee Choi) |
| 16:00 ~ 17:00 |
Facility Tour (Ju-Yeon Lee) |
||||
| 17:00 ~ 18:00 |
|||||
| Statistics (Vietnam G2) | |||||
|---|---|---|---|---|---|
| Week 2 | 6th Day 4/9 (Mon) |
7th Day 4/10 (Tue) |
8th Day 4/11 (Wed) |
9th Day 4/12 (Thu) |
10th Day 4/13 (Fri) |
| 10:00 ~ 11:00 |
Designing a Clinical trials (Yunhee Choi) |
Introduction to systematic reviews (Seokyung Hahn) |
Meta-analysis (Seokyung Hahn) |
Statiscal consultations (Seokyung Hahn) |
|
| 11:00 ~ 12:00 |
|||||
| 12:00 ~ 13:00 |
Lunch | Lunch | Lunch | Lunch | |
| 13:00 ~ 14:00 |
Statistical Plan in a clinical trial (Yunhee Choi) |
Practicals (Seokyung Hahn) |
Practicals (Seokyung Hahn) |
Practicals (Seokyung Hahn) |
|
| 14:00 ~ 15:00 |
Wrap-up | ||||
| 15:00 ~ 16:00 |
Problem-Solving and Discussion (Yunhee Choi) |
Problem-Solving and Discussion (Seokyung Hahn) |
Problem-Solving and Discussion (Seokyung Hahn) |
||
| 16:00 ~ 17:00 |
|||||
| Statistics (Vietnam G2) | |||||
|---|---|---|---|---|---|
| Week 3 | 11th Day 4/30 (Mon) |
12th Day 5/1 (Tue) |
13th Day 5/2 (Wed) |
14th Day 5/3 (Thu) |
15th Day 5/4 (Fri) |
| 10:00 ~ 11:00 |
Data Management (SeungHwan Lee) |
Holiday | SAP (Seonghae Yoon) |
R-graphics (Su-jin Rhee) |
Survey |
| 11:00 ~ 12:00 |
Closing Ceremony | ||||
| 12:00 ~ 13:00 |
Lunch | Lunch | Lunch | Lunch | |
| 13:00 ~ 14:00 |
Adverse Event & Statistics (Hyewon Jung) |
R-statistics (Jaeseong Oh) |
R-graphics (Su-jin Rhee) |
||
| 14:00 ~ 15:00 |
|||||
| 15:00 ~ 16:00 |
R-statistics (Jaeseong Oh) |
||||
| 16:00 ~ 17:00 |
|||||
R&D Training
| Research & Development (Vietnam G3) | |||||
|---|---|---|---|---|---|
| Week 1 | 1st Day 5/10 (Thu) |
2nd Day 5/11 (Fri) |
|||
| 10:00 ~ 11:00 |
How conduct Clinical Trials? (Kyungho Jang) |
||||
| 11:00 ~ 12:00 |
|||||
| 12:00 ~ 13:00 |
Lunch | ||||
| 13:00 ~ 14:00 |
New Drug Development and Clinical Trials (SeungHwan Lee) |
||||
| 14:00 ~ 15:00 |
Opening Ceremony | ||||
| 15:00 ~ 16:00 |
Course Introduction (In-Jin Jang) |
Facility Tour | |||
| 16:00 ~ 17:00 |
Clinical Research and Clinical Trials (SeungHwan Lee) |
||||
| 17:00 ~ 18:00 |
|||||
| 18:00 ~ 19:00 |
Welcome Dinner | ||||
| GCP Training (Thailand) | |||||
|---|---|---|---|---|---|
| Week 2 | 3th Day 5/14 (Mon) |
4th Day 5/15 (Tue) |
5th Day 5/16 (Wed) |
6th Day 5/17 (Thu) |
7th Day 5/18 (Fri) |
| 10:00 ~ 11:00 |
Clinical Trials Observation | Clinical Trials for Medical Devices (Jong-Hee Lee) |
KOICID meeting | KOICID meeting | KOICID meeting |
| 11:00 ~ 12:00 |
|||||
| 12:00 ~ 13:00 |
Lunch | ||||
| 13:00 ~ 14:00 |
How evalaute the project in Institute for Basic Science (Naeyang Jeong) |
Lunch | |||
| 14:00 ~ 15:00 |
Introduction of SNU R&DB Foundation (Sung Hoon Song) |
||||
| 15:00 ~ 16:00 |
How recruit researches in Institute for Basic Science (IBS) (Jun Young Lee) |
||||
| 16:00 ~ 17:00 |
|||||
| Research & Development (Vietnam G3) | |||||
|---|---|---|---|---|---|
| Week 2 | 8th Day 5/21 (Mon) |
9th Day 5/22 (Tue) |
10th Day 5/23 (Wed) |
11th Day 5/24 (Thu) |
12th Day 5/25 (Fri) |
| 10:00 ~ 11:00 |
Data Management (SeungHwan Lee) |
Buddha’s Day | Education system for Researchers in Clinical Trial (Anhye Kim) |
Structure of RFP & Proposal (Sang-In Park) |
Structure of Budget (Jeongsil Choi) |
| 11:00 ~ 12:00 |
|||||
| 12:00 ~ 13:00 |
Lunch | Lunch | Lunch | Survey | |
| 13:00 ~ 14:00 |
Patent (Kookhyun Kim) |
Introduction of KoNECT (Jeonghee Lee) |
Sample Management system (Dongseong Shin) |
Lunch | |
| 14:00 ~ 15:00 |
Introduction of KDDF (Yongchul Kim) |
Clinical Trial Management System (Yu Kyong Kim) |
|||
| 15:00 ~ 16:00 |
Experience of Patent as a Researcher (Min Kyu Park) |
||||
| 16:00 ~ 17:00 |
|||||
Laboratory work Training
| Lab Work (Laos) | |||||
|---|---|---|---|---|---|
| Week 1 | 1th Day 3/26 (Mon) |
2th Day 3/27 (Tue) |
3th Day 3/28 (Wed) |
4th Day 3/29 (Thu) |
5th Day 3/30 (Fri) |
| 09:00 ~ 10:00 |
K-bio Tour | ||||
| 10:00 ~ 11:00 |
Opening Ceremony | Early Phase Clinical Trials (Jaeseong Oh) |
Facility Tour (Ju-Yeon Lee) |
Data Management (Seunghwan Lee) |
|
| 11:00 ~ 12:00 |
Course Introduction | ||||
| 12:00 ~ 13:00 |
Lunch | Lunch | Lunch | Facility Tour - Data Management Center | |
| 13:00 ~ 14:00 |
New Drug Development and Clinical Trials (Jaeseong Oh) |
Late Phase Clinical Trials (Yunhee Choi) |
Adverse Events (Hyewon Chung) |
Lunch | |
| 14:00 ~ 15:00 |
Screening Process (Observation) |
||||
| 15:00 ~ 16:00 |
Clinical Study Design (Sang Won Lee) |
Informed Consents (Seol Ju Moon) |
Protocol Review (Sang Won Lee) |
||
| 16:00 ~ 17:00 |
Clinical Study Report (Jaeseong Oh) |
||||
| 17:00 ~ 18:00 |
Welcome Dinner | ||||
| 18:00 ~ 19:00 |
|||||
| Lab Work (Laos) | |||||
|---|---|---|---|---|---|
| Week 2 | 6th Day 4/2 (Mon) |
7th Day 4/3 (Tue) |
8th Day 4/4 (Wed) |
9th Day 4/5 (Thu) |
10th Day 4/6 (Fri) |
| 09:00 ~ 10:00 |
Isolation and identification of skin infection microbes 1. Catalase test and pigment production test |
Result analysis : Skin infection microbes |
Tour | Special Lecture - Infectious Diseases Research Trends (Sungmin Kim) |
|
| 10:00 ~ 11:00 |
Isolation and identification of skin infection microbes 2. plasma coagulase production test |
Result analysis : Respiratory infection microbes |
|||
| 11:00 ~ 12:00 |
Isolation and identification of respiratory infection microbes 1. Catalase test |
Result analysis : Enteric infection microbes |
|||
| 12:00 ~ 13:00 |
Lunch | Lunch | Lunch | Closing Ceremony | |
| 13:00 ~ 14:00 |
KOREA UNIVERSITY MUSEUM and Laboratory tour |
Isolation and identification of respiratory infection microbes 2. Hemolysis test and antibiotic test |
|||
| 14:00 ~ 15:00 |
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| Refreshment Break | |||||
| 15:00 ~ 16:00 |
Refreshment Break | Bio Safety Level 3 Laboratory tour | |||
| 16:00 ~ 17:00 |
Introduction and Project Overview | Isolation and identification of Enteric infection microbes 1. API 20E Kit |
|||
Week 2 Training Schedule (5 days)
- Theory
- Practice
- Q&A
| Content | |||||
|---|---|---|---|---|---|
| Time | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 |
| Topic | Managing and dispensing medical and pharmaceutical products for clinical trials | Managing pharmacy facilities and equipment for clinical trials | Overall operation of core labs and managing analytical equipment | Managing samples and visiting core labs | Visiting clinical trial center |
| A.M. (9:00~12:00) |
Acquisition and storage of medical and pharmaceutical products for clinical trials/Reviewing prescriptions before dispensing | Things to note about storage facilities | General practice guideline for core labs | Sampling and reception/Sample processing | Managing patients; collecting adverse events/responding to emergencies |
| Confirmation before dispensing medical and pharmaceutical products for clinical trials | Managing room temperature, refrigeration, and freezer/Managing the thermometer and BSC | Managing guidelines and documents on handling abnormal results of core labs | Sample storage and transportation/Sample disposal | Clinical trial center tour (ward, pharmacy, and core lab) | |
| P.M. (13:00~17:30) |
Cross-checking medical and pharmaceutical products for clinical trials/Returning medical and pharmaceutical products for clinical trials | Implication and development of SOPs and things to consider | Managing reagent refrigerator, low temperature freezer, and cryogenic freezer | Core lab tour/Urine drug concentration test/Platelet aggregation test | Wrap-up Q&A Survey |
| Practice dispensing medical and pharmaceutical products for clinical trials | Practice how to manage room temperature, refrigeration, and freezer | Managing centrifuge/drug concentration test kit | |||
※ Above training program is subject to changes, upon request by the trainees.
Training and practice for researchers who operate test facilities related to infectious diseases
- Training on how to operate test facilities and relevant SOPs.
- Develop training programs to help transfer basic research methods for infectious diseases in an effective way and directly perform tests.
- Includes education on safety, virus isolation and culture, virus titration, molecular virology test method (gene sequencing), animal tests (theory and practice).
- Theoretical courses on infectious diseases, including AI and Dengue.
Week 3 Training Schedule (5 days)
- Theory
- Practice
- Q&A
| Content | |||||
|---|---|---|---|---|---|
| Time | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 |
| Topic | Respiratory viruses | Mediated viruses (via rodents, mosquitoes, and ticks) | Animal tests and isolation and identification of bacteria | Isolation and identification of bacteria | Isolation and identification of bacteria |
| A.M. (9:00~12:00) |
Diverse hosts e.g. influenza (including AI)/MERS and how they are transmitted | Mediators of viruses e.g. Hanta/Zika/Dengue/SFTS and how they are transmitted |
Animal tests (calibration, blood collection, and administration)
Animal test technique (mouse, guinea pig, and etc.)
|
Confirm isolated bacteria from skin infection and isolate/identify bacteria from respiratory infection
Isolation and identification of respiratory bacteria(Hemolytic analysis and antibiotic susceptibility test)
|
Confirm and analyze bacteria from respiratory and enteric infection |
| Virus isolation and culture, titration | |||||
| Virus molecular epidemiology and gene evolution analysis |
|||||
| P.M. (13:00~17:30) |
Virus culture(cell and chicken milk cell) | Virus culture (cell) | Isolation and identification of bacteria | Isolation and identification of enteric bacteria (principle of API 20E KIT) | Wrap-up Q&A Survey |
| Viral titration (HA assay and plaque assay) | Viral titration (plaque assay) | Isolation and identification of bacteria from skin infection | |||
| Virus molecular epidemiology and gene evolution analysis (Gene collection, sorting, system dynamics, systematic geography) | (How to culture bacteria to test and practice producing plasma coagulase ) | Isolation and identification of enteric bacteria (principle of API 20E KIT) | |||
| Gene rearrangement/recombinant assay | |||||
※ Above training program is subject to changes, upon request by the trainees.
Develop and operate mutual training and exchange courses for basic and clinical researchers in Korea and abroad: offshore training at local sites (2017~2021)
-
2017 – What is the current status of the local center; transfer SOPs and know-how
- Topic:: What is the current status of the local center; transfer SOPs
| 1st Day 12/26 (Tue) | 2nd Day 12/27 (Wed) | 3rd Day 12/28 (Thu) | |
|---|---|---|---|
| Topic | Overview | Laboratory of Viruses | Clinical Research |
| 10:00~11:00 | Introduction to Virology (Mee Sook Park) |
Clinical Trials for New Drug Development (SeungHwan Lee) |
|
| 11:00~12:00 | The Biology of Influenza Virus (Mee Sook Park) |
How conduct Clinical Trials? (SeungHwan Lee) |
|
| 12:00~13:00 | Lunch | Lunch | Lunch |
| 13:00~14:00 | Introduction and Project Overview (In-Jin Jang) |
Interface of Human-Animal Influenza Viruses (Jin Il Kim) |
SOPs on Clinical Trials (HyeWon Kim) |
| Refreshment Break | Refreshment Break | ||
| 15:00~16:00 | Introduction to Research Facility of SNU (SeungHwan Lee) |
Laboratory Techniques of Influenza Viruses (Sehee Park) |
Clinical Development of Anti-viral agents: Case study (MinKyu Park) |
| 16:00~17:00 | Introduction to Clinical Research and Training Program for Researchers at Korea (Soyoung Lee) |
SOP: Standard Operating Procedure (Jin Il Kim) |
-
2018 – Develop a customized SOP for the local research center
- Topic: Developing a customized SOP for the local research center
| Content | ||||
|---|---|---|---|---|
| Time | Day 1 | Day 2 | Day 3 | Day 4 |
| A.M. | Regulation related to clinical trials – Research ethics – Regulations on regulatory affairs of advanced countries – Research plans – Roles and responsibilities of IRB; who and how to screen | Review draft SOPs for the research facilities of the local research center – Conduct by sector, e.g. test facility operation, researcher job training, analysis method, and etc. | Review draft SOPs for the research facilities of the local research center – Conduct by sector, e.g. management of medical and pharmaceutical products, storage of clinical samples, and etc. – Review draft SOPs for operating the pharmacy and the core lab of the clinical trial center | SOP reporting session for the research facilities of the local research center – Sector: Testing facilities of infectious diseases – SOPs of testing facilities. |
| P.M. |
Review draft SOPs for research facilities at the local research center – Conduct by sector, e.g. research facilities, equipment, and etc. – Review draft SOPs for operating the wards at the clinical trial center – Review draft SOPs for operating the pharmacy at the clinical trial center – Review draft SOPs for operating the core lab at the clinical trial center |
Review draft SOPs for the research facilities of the local research center – Write research notes by sector – Check-up and due diligence |
Present advanced case studies on infectious diseases – Present and discuss advanced case studies of international collaborative research for infectious diseases |
SOP reporting session for the research facilities of the local research center – Sector: Clinical research facilities (clinical trial center, wards, core lab, pharmacy, and etc.) |
-
2019 – Build capacity for clinical research
- Topic: Build capacity for clinical research
| Content | ||||
|---|---|---|---|---|
| Time | Day 1 | Day 2 | Day 3 | Day 4 |
| A.M. |
Reporting and feedback on how SOPs were applied to the infectious disease test facilities of the local research center – Feedback on how SOPs were applied for operating test labs – Feedback on how SOPs were applied for analysis techniques – Feedback on how SOPs were applied for verifying analysis techniques – Feedback on research record SOPs; writing research notes; and etc. |
Practice courses for researching infectious diseases in the test lab – Theory and practice courses to isolate and culture influenza viruses – Theory and practice courses on influenza virus titration (HA Assay) |
Practice courses for designing a clinical research – Definition and objectives of clinical trials for medical and pharmaceutical products – Definition and objectives of clinical trials for medical devices |
Practice courses for designing a clinical research – Calculating the sample size – Evaluating PKPD – Evaluating immunogenicity |
| P.M. |
Reporting and feedback on how SOPs were applied to the clinical research facilities of the local research center – Feedback on how SOPs were applied for the wards of the clinical trial center – Feedback on how SOPs were applied for the pharmacy of the clinical trial center – Feedback on how SOPs were applied for the core lab of the clinical trial center |
Practice courses for researching infectious diseases in the test lab – Theory and practice courses for serum typing (HI Assay) influenza viruses |
Practice courses for designing a clinical research – Designing early- and late-phase clinical trials for the treatments of infectious diseases (antibiotics, antivirals, and etc.) – Designing clinical trials for vaccines – Designing clinical trials of medical devices for diagnosing infectious diseases |
Practice courses for designing a clinical research – Evaluating safety – Evaluating efficacy – Analyzing statistics |
-
2020 – Boost capacity for clinical research
- Topic: Boost capacity for clinical research
| Content | ||||
|---|---|---|---|---|
| Time | Day 1 | Day 2 | Day 3 | Day 4 |
| A.M. |
Amending SOPs for the research facilities of the local research center – The wards of the clinical trial center – The pharmacy of the clinical trial center – The core lab of the clinical trial center |
Present clinical research examples of developing advanced medical and pharmaceutical products related to infectious diseases – Vaccines – Malaria treatments – Dengue treatments – Anti-virals |
Practice courses for researching infectious diseases in the test lab – Theory course for researching molecular virology in the test lab (genes and proteins of influenza virus) – Practice course for analyzing the genetic sequencing of influenza virus (multi-segment RT-PCR) |
Practice courses for processing clinical researches – Business techniques – Communication techniques – Rental business |
| P.M. |
Amending SOPs for the research facilities of the local research center – The wards of the clinical trial center – The pharmacy of the clinical trial center – The core lab of the clinical trial center |
Present clinical research examples of developing advanced medical devices related to infectious diseases – Clinical research examples of developing new kits to diagnose new types of infectious diseases |
Practice courses for researching infectious diseases in the test lab – Practice course for analyzing the genetic sequencing of influenza virus (multi-segment RT-PCR) – Designing a clinical trial for medical devices that diagnose infectious diseases |
Practice courses for processing clinical researches – Monitoring – Due diligence of regulatory affairs |
-
2021 – Meet full capacity for clinical research
- Topic: Meet full capacity for clinical research
| Content | ||||
|---|---|---|---|---|
| Time | Day 1 | Day 2 | Day 3 | Day 4 |
| A.M. |
Reporting and feedback on how SOPs were amended for the clinical research facilities of the local research center – The wards of the clinical trial center – The pharmacy of the clinical trial center – The core lab of the clinical trial center – Feedback on practice courses including clinical research performances |
Training on how to develop test lab research protocols for infectious diseases – Conduct epidemiology study and collect genetic information/how to develop a series of protocols that can be shared |
Creating a template for infectious disease treatment clinical trial plans – Create a customized template that reflects the requirements of the local system |
Discuss on how to establish strategies to develop overseas local-based research centers – Discuss about any examples of international collaborative research on infectious diseases that can be used as a model |
| P.M. |
Reporting on the development trends of medical and pharmaceutical products and medical devices related to infectious diseases – Global – Korea – South East Asia |
Creating a template for clinical trial plans to develop medical devices that diagnose infectious diseases – Create a customized template that reflects the requirements of the local system |
Creating a template for vaccine development clinical trial plans – Create a customized template that reflects the requirements of the local system |
Discuss on how to establish strategies to develop overseas local-based research centers – Discuss about any examples of international collaborative research on infectious diseases that can be used as a model |
※ Above training program is subject to changes, upon request by the trainees.
Includes yearly training programs for establishing test facilities
- Request local research center floorplans to best utilize each facility for training. Carry out regular due diligence to check local research centers and facilities.
- Include two-day theory and practice courses for each week.
- 2017: Study training materials related to virus; complete training programs; and provide training (simulation).
- 2018~2021: Training and practice courses on the basic theory of virology, lab safety, lab performance analysis technique, and animal tests.
- Possible to add (short-term) maintenance training programs on the sideline upon request while the main training is in session.
SOP offshore training at local sites
- Develop basic training program materials in English.
- Use professional interpreters who speak local languages to facilitate the understanding of training materials.
Possible to provide regular maintenance training programs for overseas local researchers
using the existing GCP training method at SNUH