I-Inductive ClinDataSphere iwuhlelo lokusebenza lokuqala lweselula lwe-EDC (Electronic Data Capture) oludizayinelwe izifundo zomtholampilo Zobufakazi Bomhlaba Obungokoqobo (RWE). Inika amandla abasebenzi besizinda somtholampilo, Abaphenyi Abayinhloko (ama-PIs), kanye nabaqaphi ukuthi bathwebule ngokuphephile, babuyekeze, futhi baqinisekise idatha yesihloko - ngokuqondile kuma-smartphone noma amathebulethi abo.
🔑 Okabani:
• Abaxhumanisi bocwaningo lwemitholampilo
• Abaphenyi Abayinhloko (PI)
• Abaqaphi bemitholampilo nababuyekezi be-SDV
📲 Ongakwenza:
• **Ukufakwa Kwedatha Yesihloko** - Thwebula amafomu omtholampilo phakathi nokuvakasha kwesayithi ngokusekelwa kwemithetho, izibalo (isb. i-BMI), nokulondoloza ngokuzenzakalelayo.
• **PI e-Signature** – Vumela abaphenyi ukuthi basayine amafomu ngedijithali besebenzisa ukungena ngemvume okuvikelekile, okunikezwe ukutadisha.
• **Ukuqinisekiswa Kwedatha Yomthombo (SDV)** - Yenza lula ukubuyekezwa okukusayithi noma ukude nokuqinisekiswa kwedatha efakiwe.
• **Ukuphathwa Kwesihloko** – Landelela isimo sesihloko, umlando wokuvakashela, namafomu abhalisiwe endaweni eyodwa.
• **Layisha Amadokhumenti** – Namathisela imibiko ngelebhu noma amadokhumenti omthombo usebenzisa ikhamera noma isikhi samafayela.
• **Ukufinyelela Okuvikelekile** - Ngena ngemvume ngemininingwane eqondene nesifundo; idatha ibethelwe kwezokuthutha futhi iphumule.
• **Ukuvumelanisa Kwesikhathi Sangempela** - Gcina idatha yeselula ivunyelanisiwe neseva emaphakathi ye-EDC ukuze uthole ukulandeleka okugcwele kokuhlolwa.
💡 Idizayinelwe ukusekela izifundo ezidinga ukuthotshelwa:
• 21 CFR Ingxenye 11 (FDA)
• I-GDPR (EU)
• I-HIPAA (US)
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Ithuthukiswe yi-Inductive Quotient Analytics Inc.
Ukuze isetshenziswe ezindaweni ezilawulwayo zocwaningo lwezokwelapha kuphela.
Kubuyekezwe ngo-
Jul 28, 2025