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Cover SOP FKUB |
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Daftar isi SOP FKUB DOWNLOAD |
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Daftar Istilah dan terminologi SOP FKUB DOWNLOAD |
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SOP 1.1. Penulisan, Telaah (Review), Distribusi dan Perbaikan SOP EC FKUB DOWNLOAD |
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SOP 1.2 Panduan Penyusunan Pedoman DOWNLOAD |
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SOP 2.1. Pembentukan KEPK DOWNLOAD |
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SOP 2.2. Pernyataan Kerahasiaan dan Pernyataan Conflict of Interest DOWNLOAD |
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SOP 2.3. Pelatihan-EC FKUB |
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SOP 2.4. Pemilihan Konsultan Independen |
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SOP 3.1. Manajemen penerimaan prot-EC FKUB |
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SOP 3.2. Pengajuan Protokol utk telaah awal |
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SOP 3.3. Expedited review |
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SOP 3.4 Telaah protokol dalam rapat full board |
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OP 3.5 Form penilaian |
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SOP 3.6 Penelaan Protokol Penelitian Peralatan Kesehatan DOWNLOAD |
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SOP 4.1. Resubmission-protokol yg diajukan kmbali |
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SOP 4.2 Telaah amandemen protokol DOWNLOAD |
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SOP 4.3. Continue Review -telaah lanjutan |
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SOP 4.4 Final report- lap.akhir |
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SOP 5.1. Non-Compliance-penyimp.protokol |
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SOP 5.2. Response to Participant Request |
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SOP 5.3. Mgt. of Study Termination-Manj.terminasi penelitian |
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SOP 6.1. Telaah Laporan Serious Adverse Events (SAE) |
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SOP 7.1. Pemantauan lapangan |
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SOP 8.1 Agenda&minutes-revisi |
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SOP 8.2 Rapat Luar Biasa |
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SOP 8.3.Rekaman Komunikasi |
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SOP 9.1 pengelolaan file penelitian |
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SOP 9.2.pengarsipan dokumen-EC FKUB |
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SOP 9.3.menjaga kerahasiaan |
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SOP 10.1. Audit dan inspeksi |