[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-seo-234031-113":3,"detail-sidebar-cat-1-id-113":74,"doc-detail-234031-id":108},{"code":4,"msg":5,"data":6},0,"ok",{"site_id":7,"language":8,"slug":9,"title":10,"keywords":11,"description":12,"schema_data":13,"social_meta":67,"head_meta":69,"extra_data":71,"updated_unix":73},113,"id","standard-operating-procedure-sop-research-ethics-committee-faculty-of-medicine-hasanuddin-university-kep-fkuh-revision","Prosedur Operasional Baku (SOP) Komite Etik Penelitian Fakultas Kedokteran Universitas Hasanuddin (KEP FKUH) - Revisi","","Dokumen memuat Prosedur Operasional Baku (SOP) Komite Etik Penelitian Fakultas Kedokteran Universitas Hasanuddin (KEP FKUH) sebagai pedoman penerbitan dan pelaksanaan prosedur etik penelitian. Halaman pengesahan menetapkan tanggal, nama ketua dan tim penyusun, serta riwayat revisi pada beberapa tahun. Daftar SOP merangkum topik dari persiapan penyusunan panduan, pembentukan komite, pelatihan, penilaian formulir protokol, hingga proses review, laporan, audit, pengelolaan dokumen, kerahasiaan, dan pernyataan konflik kepentingan. Bagian kata pengantar menegaskan tujuan SOP untuk memastikan standar operasional yang konsisten dan beretika dalam praktik kedokteran serta membantu anggota dan peneliti memahami prosedur persetujuan etik penelitian.",{"@graph":14,"@context":66},[15,34,49],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/id/template/","Template",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/id/template/presentasi/","Presentasi",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/id/template/standard-operating-procedure-sop-research-ethics-committee-faculty-of-medicine-hasanuddin-university-kep-fkuh-revision/234031/",4,{"url":32,"name":10,"@type":35,"author":36,"headline":10,"publisher":39,"fileFormat":42,"inLanguage":8,"description":12,"dateModified":43,"datePublished":43,"encodingFormat":42,"isAccessibleForFree":44,"interactionStatistic":45},"DigitalDocument",{"name":37,"@type":38},"Graffin","Person",{"url":19,"name":40,"@type":41},"DocShare","Organization","application/pdf","2026-09-10",true,{"@type":46,"interactionType":47,"userInteractionCount":4},"InteractionCounter",{"@type":48},"ViewAction",{"@type":50,"mainEntity":51},"FAQPage",[52,58,62],{"name":53,"@type":54,"acceptedAnswer":55},"Dokumen ini membahas apa?","Question",{"text":56,"@type":57},"Dokumen membahas Prosedur Operasional Baku (SOP) Komite Etik Penelitian Fakultas Kedokteran Universitas Hasanuddin (KEP FKUH) beserta ruang lingkup prosedur etik penelitian.","Answer",{"name":59,"@type":54,"acceptedAnswer":60},"Bagaimana status revisi pada SOP ditetapkan?",{"text":61,"@type":57},"Halaman pengesahan memuat riwayat revisi beserta tanggal revisi dan susunan tim yang menyusun pada masing-masing revisi.",{"name":63,"@type":54,"acceptedAnswer":64},"Topik apa saja yang tercakup dalam daftar SOP?",{"text":65,"@type":57},"Daftar SOP mencakup persiapan penyusunan panduan, pembentukan komite, pelatihan, pemilihan konsultan independen, pengajuan dan review protokol, telaah laporan, audit dan inspeksi, pengelolaan dokumen, serta pernyataan kerahasiaan dan konflik kepentingan.","https://schema.org",{"og:url":32,"og:type":68,"og:title":10,"og:site_name":40,"og:description":12},"article",{"robots":70,"canonical":32},"index,follow",{"doc_id":72,"site_id":7},234031,1789082916,{"code":4,"msg":75,"data":76},"success",[77,81,85,89,93,96,100,104],{"id":78,"doc_module":22,"doc_module_name":25,"category_name":79,"show_sort_weight":4,"slug":80},178,"Faktur","faktur",{"id":82,"doc_module":22,"doc_module_name":25,"category_name":83,"show_sort_weight":4,"slug":84},192,"Formulir","formulir-192",{"id":86,"doc_module":22,"doc_module_name":25,"category_name":87,"show_sort_weight":4,"slug":88},180,"Media Sosial","media-sosial",{"id":90,"doc_module":22,"doc_module_name":25,"category_name":91,"show_sort_weight":4,"slug":92},179,"Poster","poster",{"id":94,"doc_module":22,"doc_module_name":25,"category_name":29,"show_sort_weight":4,"slug":95},176,"presentasi",{"id":97,"doc_module":22,"doc_module_name":25,"category_name":98,"show_sort_weight":4,"slug":99},177,"Resume","resume",{"id":101,"doc_module":22,"doc_module_name":25,"category_name":102,"show_sort_weight":4,"slug":103},182,"Surat","surat-a95d00d3aaf04f3b854ecf140f00d385",{"id":105,"doc_module":22,"doc_module_name":25,"category_name":106,"show_sort_weight":4,"slug":107},183,"Umum","umum-07d1ff437201438088836b2b1ed3c90f",{"code":4,"msg":75,"data":109},{"doc_id":72,"user_id":110,"nickname":37,"user_avatar":111,"doc_module":22,"category_id":94,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":112,"file_id":113,"file_url":114,"file_type":115,"file_size":116,"view_count":4,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":117,"language":118,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":119,"faqs":120,"seo_title":121,"seo_description":12,"update_tm":73,"read_time":122},3573418547284,"https://eur-avatar.wpscdn.com/davatar_994ba38a5ba835b3df7d355c54d3ed8d","PROSEDUR OPERASIONAL BAKU  \n(SOP)  \nKomite Etik Penelitian Fakultas Kedokteran Universitas  \nHasanuddin (KEP FKUH)  \nJl. Perintis Kemerdekaan KM 10, Tamalanrea, Makassar 90245  \nHALAMAN PENGESAHAN SOP  \nMakassar, 18 Mei 2024  \nKetua Komite Etik Penelitian Universitas Hasanuddin  \nProf. dr. Muh. Nasrum Massi, Ph. D, Sp.MK (K)  \nTim SOP KEP FKUH  \n(Revisi 6, 18 Mei 2024)  \nProf. Muh. Nasrum Massi, Ph. D, Sp. MK (K), Subsp. Bakt Prof. dr. dr. Suryani As’Ad, MSc, Sp.GK(K) Dr. dr. Warsinggih, M. Kes, Sp. B, Subsp. BD(K)  \nTim SOP KEP FKUH  \n(Revisi 5, 19 Agustus 2022)  \nProf. dr. dr. Suryani As’Ad, MSc, Sp.GK(K) Prof. Muh. Nasrum Massi, Ph. D, Sp. MK (K), Subsp. Bakt Prof. dr. Agussalim Bukhari, M.Clin. Med, Ph. D, Sp.GK(K) Dr.dr. Berti Julian Nelwan. ,SpPADr.dr. Ema Alasiry. ,Sp.A (K) Dr.dr. Irawaty Djaharuddin, Sp. P(K) dr. Uleng Bahrun, Ph. D, Sp,PK(K)  \nTim SOP KEPK FKUH-RSUH-RSWS  \n(Revisi 4, 1 Februari 2016)  \nProf. dr. dr. Suryani As’Ad, MSc, Sp.GK(K) Prof. Muh. Nasrum Massi, Ph. Ddr. Agussalim Bukhari, M.Clin. Med, Ph. D, Sp. GK(K) dr. Berti Nelwan. ,SpPADr.dr. Ema Alasiry. ,Sp.A (K) Dr.dr. Irawaty Djaharuddin, Sp. P(K) dr. Uleng Bahrun, Ph. D, Sp,PK(K)  \nTim SOP KEPK FKUH-RSUH-RSWS  \n(Revisi 3, 20 Oktober 2014)  \nProf. dr. dr. Suryani As’Ad, MSc, Sp.GK(K) Prof. Muh. Nasrum Massi, Ph. Ddr. Agussalim Bukhari, M.Clin. Med, Ph. D, Sp. GK(K) dr. Berti Nelwan. ,SpPAdr. Andi Muhammad Ichsan, Ph. D.Sp. Mdr. Muh. Iqbal Basri, Sp. Sdr. Uleng Bahrun, Ph. D, Sp,PK(K)  \nTim SOP KEPK FKUH-RSWS  \n(Revisi 2, 11 April 2014)  \nProf. dr. dr. Suryani As’Ad, MSc, Sp.GK(K) Prof. Muh. Nasrum Massi, Ph. Ddr. Agussalim Bukhari, M.Clin. Med, Ph. D, Sp. GK(K) dr. Berti Nelwan. ,SpPAdr. Andi Muhammad Ichsan, Ph. D.Sp. Mdr. Muh. Iqbal Basri, Sp. Sdr. Uleng Bahrun, Ph. D, Sp,PK(K) Dr. drg. Marhamah, M. Kes Dr. dr. Nova Audrey Lueha Pieter, Sp.THTDr. dr. Haeruddin Djawad, Sp. KK  \nTim SOP KEPK FKUH  \n(Revisi 1, 7 Maret 2011)  \nProf. dr. dr. Suryani As’Ad, MSc, Sp.GK(K) Prof. Muh. Nasrum Massi, Ph. Ddr. Agussalim Bukhari, M.Clin. Med, Ph. D, Sp. GK(K) dr. Berti Nelwan. ,SpPANs. Takdir Tahir, S. Kep  \nTim SOP KEPK FKUH  \n(1 September 2010)  \nProf. dr. dr. Suryani As’Ad, MSc, Sp.GK(K) Prof. Muh. Nasrum Massi, Ph. Ddr. Andi Muhammad Ichsan, Ph. D.Sp. Mdr. Agussalim Bukhari, M.Clin. Med, Ph. D, Sp. GK(K) dr. Berti Nelwan. ,SpPANs. Takdir Tahir, S. Kep  \nDaftar Prosedur Operasional Baku (SOP)  \n\n| No | Topik/Judul SOP | No. SOP | Hal |\n| --- | --- | --- | --- |\n| 1 | Persiapan Penyusunan Panduan | SOP/001/04.0 | 1-10 |\n| 2 | Pembentukan KEP | SOP/002/0.0 | 1-12 |\n| 3 | Pelatihan | SOP/003/04.0 | 1-6 |\n| 4 | Pemilihan Konsultan Independen | SOP/004/04.0 | 1-5 |\n| 5 | Manajemen Penerimaan Protokol | SOP/005/04.0 | 1-9 |\n| 6 | Penggunaan Penilaian Formulir Protokol | SOP/006/04.0 | 1-36 |\n| 7 | Expedited Review | SOP/007/04.0 | 1-6 |\n| 8 | Pengajuan Protokol Untuk Review Awal | SOP/008/04.0 | 1-14 |\n| 9 | Penelaahan Protokol Penelitian Peralatan Kesehatan | SOP/009/04.0 | 1-15 |\n| 10 | Telaah Protokol yang Diajukan Kembali | SOP/010/04.0 | 1-8 |\n| 11 | Review Amandemen Protokol | SOP/011/04.0 | 1-10 |\n| 12 | Review Lanjutan Protokol Penelitian | SOP/012/04.0 | 1-10 |\n| 13 | Telaah Laporan Akhir | SOP/013/04.0 | 1-4 |\n| 14 | Intervensi Terhadap Kesalahan/ Penrimpangan Protokol / NonComplianre | SOP/014/04.0 | 1-6 |\n| 15 | Menanggapi Keinginan Subjek Penelitian | SOP/015/04.0 | 1-5 |\n| 16 | Manajemen Terminasi Penelitian | SOP/016/04.0 | 1-7 |\n| 17 | Telaah Laporan Serious Adverse Event (SAE) | SOP/017/04.0 | 1-10 |\n| 18 | Kunjungan Pemantauan Ke Lokasi Penelitian | SOP/018/04.0 | 1-7 |\n\n\n| 19 | Persiapan Agenda, Prosedur dan Notulen Rapat | SOP/019/04.0 | 1-13 |\n| --- | --- | --- | --- |\n| 20 | Rapat Luar Biasa | SOP/020/04.0 | 1-4 |\n| 21 | Rekaman Komunikasi | SOP/021/04.0 | 1-4 |\n| 22 | Pengelolaan Dokumen Aktif Penelitian | SOP/022/04.0 | 1-7 |\n| 23 | Pengarsipan, Pemusnahan dan Pencarian Dokumen | SOP/023/04.0 | 1-8 |\n| 24 | Menjaga Kerahasian Dokumen | SOP/0","cbCaim2wIz8vjO1R","https://ap.wps.com/l/cbCaim2wIz8vjO1R","pdf",2632785,262,"Indonesian","# Halaman Pengesahan SOP\n# Daftar Prosedur Operasional Baku (SOP)\n## Persiapan, pembentukan, dan pelatihan\n## Review protokol dan pelaporan\n## Intervensi, terminasi, dan pemantauan\n## Rapat, komunikasi, dan pengelolaan dokumen\n## Kerahasiaan, audit, inspeksi, dan konflik kepentingan\n# Judul dan Informasi Publikasi\n# Kata Pengantar","[{\"question\":\"Dokumen ini membahas apa?\",\"answer\":\"Dokumen membahas Prosedur Operasional Baku (SOP) Komite Etik Penelitian Fakultas Kedokteran Universitas Hasanuddin (KEP FKUH) beserta ruang lingkup prosedur etik penelitian.\"},{\"question\":\"Bagaimana status revisi pada SOP ditetapkan?\",\"answer\":\"Halaman pengesahan memuat riwayat revisi beserta tanggal revisi dan susunan tim yang menyusun pada masing-masing revisi.\"},{\"question\":\"Topik apa saja yang tercakup dalam daftar SOP?\",\"answer\":\"Daftar SOP mencakup persiapan penyusunan panduan, pembentukan komite, pelatihan, pemilihan konsultan independen, pengajuan dan review protokol, telaah laporan, audit dan inspeksi, pengelolaan dokumen, serta pernyataan kerahasiaan dan konflik kepentingan.\"}]","Prosedur Operasional Baku (SOP) Komite Etik Penelitian Fakultas Kedokteran Universitas Hasanuddin (KEP FKUH) - Revisi | PDF",92]