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FORMULIR PELAPORAN SUBJEK TERHADAP EFEK SAMPING DIISI OLEH PENELITI

Peneliti Utama

Judul penelitian

Nama obat / alat uji

Sponsor

No. PermohonanNo. Protokol Tgl Pasien masuk penelitian

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Saat kejadian timbulnya efek samping :

Saat penelitian berlangsungSesudah penelitian berakhirSesudah subyek mengundurkan diri, sebelum penelitian berakhir

Nama Subjek

No. Rekam Medik

Umur

Janis Kelamin

Alamat

Riwayat Subjek

Hasil uji laboratorium

Terapi / perlakuan :

Berhasil

Sedang berjalan:...............................................................................................:................................................................................................:................................................................................................:................................................................................................:...............................................................................................:...............................................................................................:...............................................................................................:...............................................................................................:................................................................................................:................................................................................................

Uraian efek samping obat/ alat yang tidak diinginkan: ................................

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Tanda-tanda dan gejala yang ditemukan (efek samping obat)

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Keparahan : Kematian

Mengancam hidup

Perawatan

awal perpanjang Kecacatan/ketidakmampuan

berhubungan Kelainan bawaan

Lain -lain.........................Hubungan dengan obat alat studi Tidak berhubungan Mungkin Sangat mungkin Pasti Tidak diketahui

DIISI OLEH BADAN PENGAWAS

Rekomendasi mengubah protokol ? tidak ya, lampirkan proposal Rekomendasi mengubah naskah penjelasan ? tidak ya, lampirkan proposal

Dikaji oleh : Tgl :..................................Komentar : Tindakan :..................................................

Peneliti

Penanggung Jawab Penelitian

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(.............................................)20264/rev00/LIT/2012