Good Clinical Practices

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Roche's phase III IMmotion151 study of Tecentriq & Avastin to treat advanced/metastatic RCC meets co-primary endpoint

Info for participants displayed on e-platform should be approved by EC

August 06, 2025

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Real-world study requires review by EC before approval

July 01, 2025

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Ethics Committee should consider all ethical issues with a specific focus

June 04, 2025

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RSI is used to assess expectedness of all suspected SARs

April 30, 2025

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Investigator or co-investigator should be medical person in a clinical trial

April 02, 2025

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Any deviation of approved protocol version is a serious breach

March 05, 2025

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Patient narratives refer to narratives of deaths, adverse events

February 05, 2025

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Clinical trials conducted in paediatric should include paediatric experts

January 01, 2025

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IEC should oversee all stem cell research in the institute

December 04, 2024

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GCP protocol doesn’t permit enrolment of illiterate participants

November 06, 2024

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GCP of contract mentions investigator, institution separately

October 03, 2024

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ICMR 2017 guidance considers diagnostic agents, devices as interventions

September 06, 2024

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FDA GCP inspection observations are captured in EIR

July 31, 2024

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If a non-serious AE becomes serious, it should be recorded as AE

July 03, 2024

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GCP guidelines say rights to withdraw from a clinical trial

June 05, 2024

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Rules make AV consent mandatory for phase III clinical trial

May 01, 2024

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There are issues to be considered while implementing participant recruitment website as a recruitment tool

April 03, 2024

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ICH GCP 8.3.14 mandates investigator should keep copy of CRF

March 06, 2024

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Sponsor is responsible for validation of clinical trial processes

January 31, 2024

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US FDA guidance says volunteers for clinical evaluation should be free from abnormalities

January 03, 2024

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Results Found: 225

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