665

1.1.1 Number of Short-Term Training Courses Held

1.1.1.1 Short Course on Research Methods

- -

 

 

 

Course and Workshop on Applied Good Clinical Practice

Workshop

 

Traditional (Face to Face)

16

Bandung

Bandung

-

 

112340000

22990000

 

84960450

16533325

None

 

 

 

 

 

 

Good Clinical Practice (GCP) is a standardized training provided for individuals taking the role of study investigators, especially those involving human subjects, as outlined by the International Conference on Harmonisation. As a proof of competency in designing, conducting, recording, and reporting clinical trials resulting from such trainings, a certificate is issued following participation in such courses. Therefore, GCP courses are usually taken from reputable institutions from which certificates are recognized. Considering that Padjadjaran University is not currently a recognized GCP training provider, the CCR decided to contract out the activities Prodia CRO whose GCP training and its certificate are recognized by The Indonesian Association for The Study of Medicinals as the association for clinical trial investigators in Indonesia. The CCR, on the other hand, provided the necessary infrastructure and logistics for the successful conduct of the training. The two-full-days training was conducted in the form of a workshop, combining lectures and in-class practice, at the Faculty of Medicine Padjadjaran University building, Bandung. We anticipated that a total of 40 individuals would participate in study, including seven scholars from partnering local universities (2 each from Aceh, Banjarmasin, and Mataram, and 1 from Ambon). Three speakers were planned to deliver the training materials. Participants were evaluated based on attendance and mastery of the training materials, as shown by a post-test result. A certificate of attendance would be issued for those participating in training in full. In addition, a certificate of competency would be issued for participants who responded correctly to at least 80% of the post-test questions (one opportunity for a retake was offered for those who failed the first time). The training successfully met its objectives. A total of 40 participants attended and successfully completed the two-day training, including seven scholars from local partner universities. A slight change was made in the course rundown, because an additional speaker was invited (Dr Keri Lestari from Padjadjaran University) to deliver training materials on investigator responsibilities. This change, however, did not affect the quality of the training.

The primary goals of the training were to 1) improve participants understanding on the principles adopted in clinical research studies using human subjects, and eventually 2) to conduct clinical research studies according to internationally recognized standard of practice. Objective 1 was met as demonstrated by the 100% of participants successfully passed the post test in their first attempt and thus earned their certificates of competency. The achievement of the second objective is implied by the achievement of the first. The result of the post test attached in another file.

The training was conducted very successfully and with no difficulty. Among other things, 1) the course logistics and speakers are organized by a third party - who is reasonably experience in organizing such a course, 2) the structure of the training (in class lectures) was very simple to manage, and 3) participation rate was high because GCP certification is required by many, if not all, clinical trial sponsors for every investigators involved in such trials, but on the other hand courses are not often offered, especially in-house and without charges.

Most of the participants satistfied with the overall activity. Even though, some factors need to be optimalized, e. g: course materials (grammar, choosing the right words for spesific object, too many materials for two days, and especially the venue facilities. We will convey to the training provider regarding participants feedback about the course materials and prepare the venue facilities more thourougly.

The training will be followed by development of research protocols by CCR scholars.

 

Highest score on the test was 95, reached by one participant and the lowest score was 70, reached by two participants, average score was 82. 5 (details attached in another file)

All the 40 participants passed the minimum requirement of the test (80% attendace, minimun score 70). Material of post-test is attached in another file.

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Rendy Cakra, Supriyanto Zulfikar, Melinda Wulan, Shafwan Ridwan, Xena Tari, Hasan Ilham, Wawan Yanto, Azzahra Dian, Yasin Qais, Intan Eira, Kartika Fitri, Angela Debby, Fitri Devina, Indri Nina, Putri Indira, Agnes Lia, Dinda Adinda, Utami Ananda, Hafiz Zulyanto, Laras Silvia, Fatimah Aisyah, Jaka Dana, Balqis Lina, Dinda Shafira, Mega Putri, Winda Aurelia, Abhiram Elang, Raya Elisa, Satria Omar, Aqilla Raisa, Yuniar Aaliyah, Rini Farah, Prabowo Rahmad, David Tri, Aisha Susana, Vivi Putu, Agatha Yulia, Yuli Rina, Susan Niken, Rika Ghania