Good Clinical Practice - CRC
the Malaysian Guideline for Good Clinical Practice following the revision of International Council for Harmonisation (ICH) E6 Good Clinical Practice guidance in November 2016. The revision is intended to increase the efficiency and quality of clinical trials with the
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An Introduction to: Good Data Management Practice …
www.crc.gov.myExcel, for example, does everything in memory, so that any unsaved data may be lost if your system crashes. Databases write data to the hard drive immediately. •Databases can handle more data. Sure, Excel can technically handle more than 65,000 rows of data, but doing so will likely bog down even the fastest PC. •Conclusion:
PENGGUNAAN media sosial - CRC
www.crc.gov.myBahan rasmi yang hendak dimuat naik hendaklah disemak dan mendapat pengesahan/kelulusan daripada Pengarah Bahagian/Institut/JKN dan mengikut Prosedur Operasi Standard (SOP). Manakala bahan rasmi yang diambil dari portal seperti Portal MyHealth atau Portal Infosihat yang hendak dimuat naik tidak perlu disemak dan disahkan sekiranya tiada penambahan
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Guideline on the content, management and archiving of …
www.ema.europa.eu(Directive 2001/20/EC and Directive 2005/28/EC), as well as ICH E6 Good Clinical Practice (GCP) Guideline (‘ICH GCP guideline’), regarding the structure, content, management and archiving of the clinical trial master file (TMF). The guidance also applies to the legal representatives and contract
Chapter 10 - Serious Adverse Event (SAE)
www.crcourses.com1. Investigator Site to Sponsor/CRO; lICH-GCP recommendations: Immediately 2. Investigator Site to Ethics Committee; lICH-GCP recommendations: As per the applicable regulations 3. Sponsor/CRO to Regulatory Agency; lICH-GCP recommendations: a) Fatal or life-threatening unexpected adverse drug reactions- Within 7 calendar days