Records the documented deviations from the defined study protocol.

Name Type Description Foreign Key
protocol_deviation_accession varchar(15) Primary key
description varchar(4000) Free text to expand upon details
is_adverse_event_related varchar(1) (Y/N) field to indicate whether an adverse event suffered by the subject contributed to the protocol deviation.
reason_for_deviation varchar(250) Description for the reason for deviating from the study protocol
resolution_of_deviation varchar(500) Description of the action taken to prevent deviation from re-occuring
study_accession varchar(15) Foreign key reference to the STUDY table study.study_accession
study_end_day int(11) Reported value
study_start_day int(11) Reported value
subject_accession varchar(15) Foreign key reference to the SUBJECT table subject.subject_accession
subject_continued_study varchar(1) An indicator (Y/N) as to whether the subject continued to participate in the study
workspace_id int(11) Foreign key reference to WORKSPACE table workspace.workspace_id
Name Column Description
PRIMARY protocol_deviation_accession BTREE
idx_procotol_deviation_study study_accession BTREE
idx_procotol_deviation_subject subject_accession BTREE
idx_procotol_deviation_workspace workspace_id BTREE
Tables that Reference this Table
Name Column Table Reference Column Reference