Faculty of Medicine, Public Health

and Nursing
Universitas Gadjah Mada

Tentative Agenda – Rotavirus GCP Training
10—12 September 2019

Time Topics Facilitator
Day 1, Tuesday - September 10th 2019
08:00 – 08:45 Opening dr. Jarir At Thobari
Introduction of participants and facilitators
Ground Rules
Training objective and orientation
08:45 – 10:00 Essence of GCP & Principles of Ethics - dr. Jarir At Thobari
Lecture and discussion
10:00 – 10.30 Coffee break
10:30 – 11:30 Role and Responsibility of Ethical dr. Jarir At Thobari
Committee
Lecture and Discussion
11.30 – 12:30 Lunch
12.30 – 13.30 Essential Documents dr. Jarir At Thobari
(Lecture and discussion)
13.30 – 14:30 Group activity – Review of essential dr. Jarir At Thobari
documents
14:30 – 15:00 Coffee Break
15.00 – 16.00 Standard operating procedures (SOP) Dr. Niken Trisnowati
(Lecture and Discussion)
16:00 – 16.45 Development of SOP Dr. Niken Trisnowati
Group activity -
16.45 Evaluation of the day

Day 2, Wednesday – September 11th, 2019
08:00 – 08:45 Recapitulation day 1 dr. Jarir At Thobari
08:45 – 09:45 Informed Consent Process dr. Jarir At Thobari
Lecture and Discussion using Case Studies
09.45 – 10:30 Informed Consent Process dr. Jarir At Thobari
Case Studies - video
10:30 – 11:00 Coffee Break
11:00 – 12.00 Managing the data dr. Jarir At Thobari
Lecture and discussion using case studies
12.00 – 13.00 Lunch
13:00 – 13.30 Managing the data dr. Jarir At Thobari
Group activity - review of data in Source
 documents, logs and CRF
13:30 – 14:30 Product management dr. Dewiyani Indah
Lecture and Discussion using case studies Widasari, PhD

14:30 – 15:15 Recruitment and retention dr. Dewiyani Indah
Lecture and Discussion Widasari, PhD
15:15 – 15:45 Coffee Break
15:45 – 16.45 Quality Management System dr. Jarir At Thobari
Lecture and discussion
16:45 – 17.00 Evaluation of the day

Day 3, Thursday - September 12th, 2019
08:00 – 08:45 Recapitulation Day 2 dr. Jarir At Thobari
08:45 – 09.45 Safety Management dr. Jarir At Thobari
Lecture and Discussion using case studies
09:45 – 10.15 Coffee Break
10.15 – 11.15 Safety Management dr. Jarir At Thobari
Group discussion
11:15 – 12:00 Roles and responsibilities of Clinical Dr. Niken Trisnowati
monitor – Lecture & Discussion using case
studies
12:00 – 13:00 Lunch
13:00 – 14.30 Roles and responsibilities of Sponsor, dr. Jarir At Thobari
Investigator and Clinical monitor
Lecture and Group Activity
14.30 – 15.00 Post test and correction
15:00 – 15:30 Coffee break
15:30 – 16.00 Evaluation of course dr. Jarir At Thobari
Certificate Distribution
Closing