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Unit number this reference belongs to.
G
U
USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; Evaluation +
5.3.6 +
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.4 +
5.3.6 +
I
W
5.4.1 +
I
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.6.3-002 +
5.4.1 +
G
5.4.1 +
