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Showing 20 pages using this property.
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EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 5.1 +
5.1  +
U
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.1 +
5.1  +
E
EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 5.1 - 5.2-001 +
5.1 - 5.2  +
EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 5.1 - 5.2-002 +
5.1 - 5.2  +
W
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.12 +
5.12  +
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.13 +
5.13  +
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.14 +
5.14  +
U
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.2 +
5.2  +
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.1 +
5.3.1  +
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.2 +
5.3.2  +
I
ICH ICH E8 Guideline R1 (2021) 5.6 +
5.6  +
W
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.6 +
5.6  +
U
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.6.6.1 +
5.6.6.1  +
I
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.7 +
5.7  +
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.2 +
5.8.2  +
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.3 +
5.8.3  +
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.4 - 5.8.6 +
5.8.4 - 5.8.6  +
U
USA FDA - HUMAN DRUG CGMP NOTES Volume 8, Number 3 6 +
6  +
W
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 6 +
6  +
I
ICH ICH E19 Guideline 2022 6 +
6  +
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