Protocol Deviations Log

data(devlog)

Format

A data frame with 603 rows and 20 variables

Details

A dataset with variables as follows:

  • PDDATE D YYYY-MM-DD Date of deviation

  • PDREVIEW N NA Was deviation reviewed in advance by Coordinating Center or Project Director?

  • PDRISK N NA Assessment of risk to participant:

  • PDTYPE N NA Deviation Type:

  • PDCONSENT N NA If deviation related to Informed Consent, select details:

  • PDRAND N NA If deviation related to Enrollment, select details:

  • PDPROC N NA If deviation related to Protocol Procedures, select details:

  • PDASSESS N NA If deviation related to other protocol procedure, select assessment/procedure impacted:

  • PDEXMED N NA If deviation related to Excluded Concurrent Medications, select details:

  • PDPERSON N NA If deviation related to Site Personnel, select details:

  • PDDESC T NA Description of Event

  • PDVISIT T NA Select visit(s) impacted

  • PDCOMM T NA Comments:

  • RID N Participant roster ID

  • SITEID N Site ID

  • VISCODE T Visit code

  • USERDATE S Date record created

  • USERDATE2 S Date record last updated

Examples

# NOT RUN {
\donotrun{
describe(devlog)
}
# }