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Purpose

Record information summarizing episodes of infection associated with treatment. This case report form is only to be used when the primary endpoint for the study is to assessing infectious episodes, either types and or number of events. Additional comments may, if needed, be reported in the comment tab.

Infection Episode eCRF

Field Name

Description / Instructions

Format

Visit Date

The Visit Date is optional on this case report form. Hit the "Tab" key to leave it empty and move to the Date of Onset field.

DD-MMM-YYYY

Course #(d)

Indicates the course number that this infection episode occurred in as derived from the course initiation start date.

5 digits

Day in Course(d)

Indicates the day since the beginning of course that this infection episode occurred in as derived from the course initiation start date.

5 digits

Date of Onset(m)

Enter the date the infection episode began.

DD-MMM-YYYY

Date Resolved

Enter the date the infection episode resolved.

DD-MMM-YYYY

Infection Type(m)

Select the infection type. For example: pneumonia, UTI, URI, etc.

Use pick list.

Primary Site(m)

Select the primary site of the infection.

Use pick list.

Infectious Agent

Select the actual infectious agent, determined from culture or other appropriate test.

Use pick list.

Treatment

Select the treatment (or lack of) given for this infection. This treatment should also be recorded on the Concomitant Measures / Medications case report form.

Use pick list.

Procedure

Select the procedure (or lack of) done for this infection. This procedure should also be recorded on the Procedures case report form.

Use pick list.

Outcome

Select the outcome of this episode.
1. Recovered
4. Died

Use pick list.

Legend: (d) derived field, (m) RDC mandatory, (c) for CTEP reporting only.

Validations

Code

Description

Resolutions

IFE01

Date of Onset of the Infection Episode is greater than the Resolve Date.

Date of Onset must be prior than Resolve Date

IFE02,
IFE03

Date of Onset and/or Date Resolved are/is in the future.

Enter a date that is equal to or prior to the current date.

IFE05

Date of Onset, Infection Type, Treatment and Procedure appear more than once.

An Infection Type, Treatment and Procedure can only be entered once for a particular Date of Onset.

IFE06

Resolved Date provided, but Outcome is missing.

Outcome must be entered if Date Resolved is provided.

IFE07

Date Resolved is missing, but Outcome was provided.

Date Resolved must be entered if Outcome is provided.

IFE08

A Concomitant Measure / Medication with an Agent matching the Infection Episode Treatment with the same Start Date and Date of Onset was not found.

An Infection Episode Treatment must have an entry in the Concomitant Measure / Medication case report form with the Start Date the same as the Date of Onset.

IFE09

A Concomitant Measure / Medication with a Procedure matching the Infection Episode Procedure with the same Start Date and Date of Onset was not found.

An Infection Episode Procedure must have an entry in the Concomitant Measure / Medication case report form with the Start Date the same as the Date of Onset.

Derivations

Code

Field Name

Description

IFE1001

Course #

Course number is derived based on the course initiation start dates and the infection episode Date of Onset.

IFE1002

Day in Course

Number of days since the beginning of the course is derived from the course initiation start date and the infection episode Date of Onset.