Protocol_Deviation

Records the documented deviations from the defined study protocol.

Columns

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

Indexes

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