Preferred Label : Document;

NCIt synonyms : Document Type;

NCIt related terms : documentation; DOC;

NCIt definition : A physical object, or electronic counterpart, that is characterized by containing writing which is meant to be human-readable.;

Alternative definition : CDISC-GLOSS: All records, in any form (including but not limited to written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken. [ICH E6 Glossary]; BRIDG 3.0.3: An organized representation of information in publishable, human-readable form (that persists over time). EXAMPLE(S): Adverse Event Report, Expedited Adverse Event Report, Institutional Review Board (IRB) Report, X-Ray Report, Lab Summary Report, Autopsy Report. NOTE(S): A document groups the various document versions and has the following characteristics: 1) Stewardship, 2) Potential for authentication, 3) Wholeness, 4) Human readability, 5) Persistence, 6) Global vs local context (the person that signs it is the author of all sections unless otherwise noted). Regulatory processes require the submission of documents from the Applicant to the Regulatory Authority. These documents are varied in focus and are often defined by the field of study or by the regulatory application requirements of the region or Regulatory Authority (e.g., Integrated Summary of Safety, Pharmacokinetics Written Summary).; BRIDG 5.3: An organized representation of information in publishable, human-readable form (that persists over time). EXAMPLE(S): Study Protocol, Adverse Event Report, Expedited Adverse Event Report, Institutional Review Board (IRB) Report, X-Ray Report, Lab Summary Report, Autopsy Report OTHER NAME(S): NOTE(S): A document groups the various document versions and has the following characteristics: 1) Stewardship, 2) Potential for authentication, 3) Wholeness, 4) Human readability, 5) Persistence, 6) Global vs local context (the person that signs it is the author of all sections unless otherwise noted). Regulatory processes require the submission of documents from the Applicant to the Regulatory Authority. These documents are varied in focus and are often defined by the field of study or by the regulatory application requirements of the region or Regulatory Authority (e.g., Integrated Summary of Safety, Pharmacokinetics Written Summary).;

NCIt note : Used here to organize a wide variety of concepts that are characterized by writing or text;

NCI Metathesaurus CUI : CL414404;

Details


Main resources

You can consult :


https://sante.gouv.fr/IMG/pdf/2023_07_18_doc_d_aide_au_signalement_des_ps_vf.pdf
2023
France
technical report
Document
spouse abuse
couples
Health Professional
Atherogenic Index of Plasma
Without Help
With Some Help
Acute Interstitial Pneumonia
breast
Assistance
Document
health
Violence
caregivers
AIP Gene
violence
Female Breast
cues
Single-Stranded DNA Cytosine Deaminase
AH Receptor-Interacting Protein
Couple
AICDA wt Allele
Reporting
paper
Male Breast
Murine Breast

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12/05/2024


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