RSCM

RSUPN Dr. Cipto Mangunkusumo

Jl. Diponegoro No. 71 Jakarta 10430
Telp: (021) 3918301 Fax: (021) 3148991

FORMULIR PELAPORAN SUBJEK TERHADAP EFEK SAMPING

DIISI OLEH PENELITI

Peneliti Utama

:..............................................................................................

Judul penelitian

:..............................................................................................

Nama obat / alat uji

:..............................................................................................

Sponsor

:..............................................................................................

No. Permohonan

:..............................................................................................

No. Protokol

:..............................................................................................

Tgl Pasien masuk penelitian

:..............................................................................................

Saat kejadian timbulnya efek samping :

Saat penelitian berlangsung

Sesudah penelitian

Sesudah subyek mengundurkan

berakhir

diri, sebelum penelitian berakhir

Nama Subjek

:...............................................................................................

No. Rekam Medik

:................................................................................................

Umur

:................................................................................................

Janis Kelamin

:................................................................................................

Alamat

:...............................................................................................

Riwayat Subjek

:...............................................................................................

Hasil uji laboratorium

:...............................................................................................

Terapi / perlakuan :

:...............................................................................................

Berhasil

:................................................................................................

Sedang berjalan

:................................................................................................

0264/rev00/LIT/2012

RSCM
RSUPN Dr. Cipto Mangunkusumo
Jl. Diponegoro No. 71 Jakarta 10430
Telp: (021) 3918301 Fax: (021) 3148991

Uraian efek samping obat/ alat yang

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

tidak diinginkan: ................................

..................................................................................................

............................................................. ..................................................................................................
............................................................. ..................................................................................................
............................................................. ..................................................................................................
............................................................

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Keparahan :

Hubungan dengan

Kematian

Tidak berhubungan

Mengancam hidup

Mungkin

Perawatan

Sangat mungkin

awal

perpanjang

obat

alat

studi

Pasti
Tidak diketahui

Kecacatan/ketidakmampuan
berhubungan
Kelainan bawaan
Lain -lain.........................
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

(....................................)

(.............................................)

0264/rev00/LIT/2012