Protocol Deviations Log

Protocol Deviations Log

data(violog)

Format

A data frame with 4087 rows and 16 variables

Details

A dataset with variables as follows:

• RID N NA Participant roster ID

• SITEID N NA Site ID

• VISCODE T NA Visit code

• USERDATE S NA Date record created

• USERDATE2 S NA Date record last updated

• RECNO N NA

• VIOTYPE N NA Deviation applies to: (check one)

• VIODES N NA Please select the most appropriate description: (check one)

• VIODESO T NA If Other specify:

• INEXNUM T NA If Inclusion/Exclusion Criteria: Item number

• IRB N NA Was IRB informed of Protocol Deviation?

• IRBDATE D NA If yes, indicate date reported:

• RIGHTS N NA Have the rights, safety or well-being of participant been compromised?

• EVENTDES T NA Description of Event

Examples