/
Deviation Log (Report)

© 2025 IQVIA - All Rights Reserved

Deviation Log (Report)

Goal

The deviation log report contains a listing of all timing deviated data collected during a trial. Deviations in this report are reflective of the amount of time outside of an established deviation window for each scheduled activity.

Overview Video

Filters

There are no filters available for this report. You can generate the deviation log report from either of the following paths:

  • Study > Report > Utilities > Report Type > Deviation Log

  • Study > Report > Deviation Log

  • Clicking Generate will start the job execution, enabling you to view the results on the reporting tab. You can download the results by clicking on the download hyperlink.

Output

The downloaded file is in Excel format and contains details of the timing deviation collection for the study.

This report provides the following information:

Column

Content Description

Example

Column

Content Description

Example

Subject

Subject ID associated with the corresponding study.

1004 / S0004 / S0004

Epoch

The assigned study Epoch for the subject.

TREATMENT

Cohort

The assigned study cohort for the subject.

Cohort 2

Study Event

The study event name that corresponds with the activity outlined in the activity plan

Day 1

Timepoint

The scheduled data collection time points at which the activity is expected to occur.

01:25:00 (1)

Scheduled Time

The scheduled time at which the data collection is expected to occur.

2018-12-24T15:22:23-07:00

Collection Time

The time of study data collection.

2018-12-24T12:58:11-07:00

Deviation Seconds

Any deviation from the scheduled time is recorded in seconds. If the activity was late, then the value will be positive. If the activity was early, then the value will be negative.

-8352

Deviation Windows (Pre Seconds)

Acceptable pre-deviation window for timed activity, as configured in the activity plan.

300

Deviation Windows (Post Seconds)

Acceptable post-deviation window for timed activity, as configured in the activity plan.

300

Item Group Name

The details of the data item group related to the study.

Vital signs Position

Item Group Repeat Key

The repeat number associated with the data item in the item group

1

Item Group Data Annotations

The comments updated due to deviations from the timed activity.

Example deviation comment

User

The data entry user details

Data entry user

 

 

Related content

Exported and Printed Copies Are Uncontrolled