Preferred Label : Study Start Date;
NCIt related terms : Study Date; SSTDTC;
NCIt definition : The date on which a study began.;
Alternative definition : CDISC-GLOSS: The date on which the protocol-defined study start criteria are met.
NOTE: The US FDA defines the study start date for clinical studies as the earliest
date of informed consent among any subject that enrolled in the study. [US FDA, Providing
Regulatory Submissions In Electronic Format - Standardized Study Data Guidance for
Industry, June 2021] See study start. [US FDA, Providing Regulatory Submissions In
Electronic Format - Standardized Study Data Guidance for Industry, June 2021]; DICOM: Date on which the acquisition of the study information was started.; CDISC: The earliest date of informed consent among any subject (Date/Time of Informed
Consent, RFICDTC) that enrolled in the study. For studies conducted without informed
consent (i.e., emergency use) use the date of treatment. Dates for subjects who were
screen failures are not included. [After US FDA, Providing Regulatory Submissions
In Electronic Format - Standardized Study Data Guidance for Industry, June 2021];
Origin ID : C69208;
UMLS CUI : C2348558;
Semantic type(s)
- concept_is_in_subset
