Informasi Protokol Penelitian
A. Scientific Issue Evaluation
| No |
Topic / Pertanyaan |
Catatan Peneliti |
| 1 |
Apakah latar belakang penelitian cukup dijelaskan? |
|
| 2 |
Apakah kualifikasi peneliti utama dan tim sesuai? Do the investigator(s) have the necessary expertise, skills, and experience to conduct the study? Apakah ada potensi konflik kepentingan dengan sponsor/institusi/pihak lain? Any Disclosure or Declaration of Transparency and Potential Conflicts of Interest to the sponsor or other parties? |
|
| 3 |
Apakah rationale studi ini dicantumkan dengan jelas? (nilai kebaruan?) Does this study have a clear rationale? Is there any novelty in this study? |
|
| 4 |
Apakah tujuan umum dan tujuan khusus cukup jelas? Are the general and specific aim clear? |
|
| 5 |
Apakah (parameter) endpoint dicantumkan dengan jelas? Bisa menjawab hipotesis (bila ada)? Is the parameter/endpoint clearly stated and answer the hypothesis? |
|
| 6 |
Apakah disain/metode penelitian dapat menjawab tujuan studi? Is the research design/method clear? |
|
| 7 |
Apakah populasi studi dijelaskan dengan tepat? Is there a clear description of the study population? |
|
| 8 |
Apakah jumlah peserta cukup? Is the number of participant sufficient? |
|
| 9 |
Apakah ada penjelasan atau perhitungan mengenai jumlah partisipan/subyek yang akan direkrut? (termasuk rumus yang digunakan-bila ada) Is there any explanation or sample size calculation regarding the number of participants/subjects? |
|
| 10 |
Apakah kriteria inklusi dan eksklusi sudah dijelaskan dengan tepat? Are subject inclusion and exclusion criteria, acceptable? |
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| 11 |
Apakah menggunakan control arm (placebo)? Does the research use control arm (misal placebo, dll) |
|
| 12 |
Apakah dijelaskan dengan detil mengenai sumber data (primer, sekunder) dan/atau cara rekrutmen partisipan/subyek? Atau cara pengambilan sampel (rekam medis, bahan biologi tersimpan, dokumen, dsb). Does the participants recruitment clearly explained? or sample collection (medical records, biological specimen, documents, etc)? |
|
| 13 |
Apakah analisis data yang akan dilakukan sudah dijelaskan? Is there a statistical analysis? Is it appropriate? |
|
| 14 |
Apakah tempat (site) dan waktu studi telah sesuai? Is the study site appropriate? |
|
| 15 |
Apakah melibatkan peneliti setempat dan komunitas dalam penyusunan protokol? Involvement of local researchers and communities in the protocol preparation |
|
| 16 |
Apakah ada pengiriman sample atau jaringan darah ke luar negeri? Are blood or tissue samples sent abroad |
|
| 17 |
Community consultation? |
|
| 18 |
Lain-lain (others) |
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D. Masalah Lainnya (Other Issues)
| No |
Uraian (Topic) |
Peneliti |
|
1 |
Anggaran (Budget) |
|
|
2 |
MoU / MoA / Agreement / Publication |
|
|
3 |
Material Transfer Agreement (MTA) |
|
|
4 |
PP No. 41 Tahun 2006 tentang Perizinan bagi Peneliti Asing yang Melakukan Penelitian di Indonesia (Involving Foreign Researchers in Indonesia) |
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5 |
Lain-lain (Others) |
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