281

3.1.1 Number of Selected Affiliate Institutions Included in Research Consortium

3.1.1.1 Establishment of the Consortium for Collaborative Research

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Immunogenicity Study Meeting (Partnership Agreement)

Collaboration Meeting

To discuss the MOU component between RSHS, Unpad, and Biofarma

Traditional (Face to Face)

2

Bandung

Meeting Room CCR-ARI UNPAD

Unpad

 

 

 

 

 

 

None

 

 

 

 

 

 

This meeting was a continuation of the previous meeting in order to discuss the MOU draft between Unpad, RSHS, and Biofarma regarding the immunogenicity study. This meeting is attended by Unpad team (dr Atik, dr Kartika, Bu Wulan), RSHS team (dr Iwan, Bu Fatrisia, Pa Agus, Pa Ibnu, Pa Uswarudin, Pa Suryandrizal), and Bio Farma team (dr Mita, Pa Fariz).

Summary of the discussion are mentioned below: •CCR-ARI is obligated to insure all the subjects; •Omitting Clause 10 of the MOU that stated Bio Farma will provide the vaccine without any guarantee of the vaccine used in the study. This was omitted due to the obligation of Bio Farma to ensure the quality of its product (vaccine); •RSHS will charge the study team for the operating cost (electricity, water) and institutional fees. The amount of the institutional fees is not yet determined because it depends on the total budget of the study; •The vaccine from Bio Farma will be stored in Pharmacy Department RSHS. According to the SOP, the vaccine expiration date of all the vaccine stored in RSHS must be more than 6 months period; •The term clinical trial on the MOU will be change to study as this study is not considered a clinical trial.

N/A

N/A

•Revise the MOU; •Send the budget report to the RSHS accounting team.

N/A

N/A

N/A

9

9

Bagus Farrel, Mega Dita, Hari Baskara, Evan Deni, Agatha Linda, Ayuni Neng, Haryadi Dharma, Sudirman Erfan, Emilia Raya, Isra Ayi, Dana Wahyu, Andre Doni, Syamsul Slamet