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@@ -1,5 +1,27 @@ | ||
{ | ||
"cells": [ | ||
{ | ||
"cell_type": "markdown", | ||
"metadata": {}, | ||
"source": [ | ||
"<!-- \n", | ||
" # Copyright (C) 2023-2024 Y Hsu <[email protected]>\n", | ||
" #\n", | ||
" # This program is free software: you can redistribute it and/or modify\n", | ||
" # it under the terms of the GNU General Public license as published by\n", | ||
" # the Free software Foundation, either version 3 of the License, or\n", | ||
" # any later version.\n", | ||
" #\n", | ||
" # This program is distributed in the hope that it will be useful,\n", | ||
" # but WITHOUT ANY WARRANTY; without even the implied warranty of\n", | ||
" # MERCHANTABILITY or FITNESS FOR A PARTICULAR PURPOSE. See the\n", | ||
" # GNU General Public License for more details\n", | ||
" #\n", | ||
" # You should have received a copy of the GNU General Public license\n", | ||
" # along with this program. If not, see <https://www.gnu.org/license/> \n", | ||
"-->" | ||
] | ||
}, | ||
{ | ||
"cell_type": "markdown", | ||
"metadata": {}, | ||
|
@@ -10,26 +32,32 @@ | |
"As the name indicated, the organization engages with clinical data community and creates and maintains data standards for clinical developments, \n", | ||
"such that the planning, creating, storing, using and exchanging of information and records can be processed at a higher level of consistency [^1].\n", | ||
"\n", | ||
"The modules started with `stdcd` include basic functions for processing data prepared with CDISC standards. " | ||
"The modules `stcdisc` include basic functions for processing data already prepared with CDISC standards. " | ||
] | ||
}, | ||
{ | ||
"cell_type": "markdown", | ||
"cell_type": "code", | ||
"execution_count": null, | ||
"metadata": { | ||
"vscode": { | ||
"languageId": "plaintext" | ||
} | ||
}, | ||
"outputs": [], | ||
"source": [ | ||
"## CDISC Foundational Standards\n", | ||
"\n", | ||
"CDISC standards are used through medicinal product development processes, including nonclinical and clinical data collection, processing, reporting, analyzing and more.\n", | ||
"CDSIC foundational standards include: \n", | ||
"\n", | ||
"- Standard for Exchange of Nonclinical Data (SEND),\n", | ||
"- Clinical Data Acquisition Standards Harmonization (CDASH),\n", | ||
"- Study Data Tabulation Model (SDTM),\n", | ||
"- Study Data Tabulation Model Implementation Guide (SDTMIG),\n", | ||
"- Data collection:\n", | ||
" - Clinical Data Acquisition Standards Harmonization (CDASH),\n", | ||
" - Clinical Data Acquisition Standards Harmonization Implementation Guide (CDASHIG),\n", | ||
"- Data Tabulation:\n", | ||
" - Standard for Exchange of Nonclinical Data (SEND),\n", | ||
" - Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG),\n", | ||
" - Study Data Tabulation Model (SDTM),\n", | ||
" - Study Data Tabulation Model Implementation Guide (SDTMIG),\n", | ||
"- Analysis Data Model (ADaM),\n", | ||
"- Questionnaires, Ratings and Scales (QRS), etc.\n" | ||
] | ||
|
@@ -75,13 +103,18 @@ | |
"cell_type": "markdown", | ||
"metadata": {}, | ||
"source": [ | ||
"## CDISC Resource\n", | ||
"## CDISC Library Resource\n", | ||
"\n", | ||
"To access CDISC library and documents, follow steps here to create cdiscID: https://www.cdisc.org/cdiscid-sign-insign-instructions\n", | ||
"\n", | ||
"Resource Links:\n", | ||
"\n", | ||
"- CDISC knowledge base: https://www.cdisc.org/kb" | ||
"After login, show API key and save that to local accessible to environment.\n" | ||
] | ||
}, | ||
{ | ||
"cell_type": "markdown", | ||
"metadata": {}, | ||
"source": [ | ||
"Please see API Reference for functions included in `stdcdisc.lib`." | ||
] | ||
}, | ||
{ | ||
|
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