Contents

Purpose

Record detailed information about the collection of urine samples for analysis of the presence and quantity of the study medication and/or its metabolites.

Note: This CRF will be put on the cycle section.

Urinary Excretion 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 Dosing field.

DD-MMM-YYYY

Course Number(d)

Indicates the course number that this urinary excretion sample is related to as derived from the course initiation start date.

5 digits

Day in Course(d)

Indicates the day since the beginning of course that this urinary excretion sample is related to as derived from the course initiation start date.

5 digits

Start Date of Dosing(m)

Enter the date the study agent was administered.

DD-MMM-YYYY

Start Time of First Injection(m)

Enter the time of the first injection of the study agent, or if appropriate, for taking the study agent via any "non-IV" route of administration (for example, enter the time that the agent is administered orally or rectally).

HH(24):MM

Study Agent(m)

Enter the name of the study agent (investigational or commercial) which is the subject of the urinary excretion study.

Note: Only one study agent is allowed per case report form. Separate forms should be used when more than one study agent is being studied.

Use pick list.

Stop Date of Dosing

Enter the date the study agent administration was stopped.

Note: This field will be used for infusional therapies only.

DD-MMM-YYYY

Stop Time of First Injection

Enter the stop time of the first injection of the study agent, or if appropriate, for taking the study agent via any "non-IV" route of administration (for example, enter the time that the agent is administered orally or rectally).

Note: This field will be used for infusional therapies only.

HH(24):MM

Planned Interval

Planned interval pre-determined per protocol.

80 characters

Sample Collected?(m)

Indicate whether or not the specimen is collected.
YES - then the Start Date, Time and Urine Volume should be entered
NO
UNKNOWN

Use pick list.

Start Date

Enter the collection start date.

DD-MMM-YYYY

Start Time

Enter the collection start time even if the assay results are not available.

HH(24):MM

Stop Date

Enter the collection end date.

DD-MMM-YYYY

Stop Time

Enter the collection end time even if the assay results are not available.

HH(24):MM

Urine Volume

Enter the urine volume collected in milliliters.

4 digits.

Parent Study Agent Assay 1

Enter the first parent study agent assay results in the biological samples.
If results are not available, record at least the collection times on the case report form.

8 digits and 3 decimals

Parent Study Agent Assay 2

Enter the second parent study agent assay results in the biological samples.
If results are not available, record at least the collection times on the case report form.

8 digits and 3 decimals

Parent Study Agent Assay Mean Concentration

Enter the parent study agent assay mean concentration, if available.

8 digits and 3 decimals

Parent Study Agent in Void

Enter the parent study agent assay in void results in the biological samples.
If results are not available, record at least the collection times on the case report form.

8 digits and 3 decimals

Parent Study Agent UOM

Select the appropriate Study Agent units of measurement (e.g.: mg/dL or mmol/l).

Use pick list.

Metabolite Assay 1

Enter the first metabolite assay results in the biological samples.
If results are not available, record at least the collection times on the case report form.

8 digits and 3 decimals

Metabolite Assay 2

Enter the second metabolite assay results in the biological samples.
If results are not available, record at least the collection times on the case report form.

8 digits and 3 decimals

Metabolite Mean Concentration

Enter the metabolite mean concentration, if available.

8 digits and 3 decimals

Metabolite in Void

Enter the metabolite in void results in the biological samples.
If results are not available, record at least the collection times on the case report form.

8 digits and 3 decimals

Metabolite UOM

Enter the appropriate Metabolite units of measurement (e.g.: mg/dL or mmol/l).

Use pick list.

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

Validations

Code

Description

Resolutions

UE01, UE02,
UE07, UE15

Urinary excretion dates are in the future.

Enter dates that are equal to or prior to the current date.

UE06

Collection End Date/Time is prior to the collection Start Date/Time.

Collection End Date/Time must be after the collection Start Date/Time.

UE08

Start Date / Time and Stop Date / Time pair appears more than once – duplicate entry.

Remove the duplicate record or correct the Start Date / Time and Stop Date / Time of one of them.

UE11

Study Agent UOM entered, but Assay 1, Assay 2, Mean Concentration and Amount in Void are missing.

Enter a Study Agent Assay 1, Assay 2, Mean Concentration and/or Amount in Void.

UE12

Study Agent Assay 1, Assay 2, Mean Concentration and/or Amount in Void entered, but UOM is missing.

Enter the Study Agent UOM.

UE13

Metabolite UOM entered, but Assay 1, Assay 2, Mean Concentration and Amount in Void are missing.

Enter a Metabolite Assay 1, Assay 2, Mean Concentration and/or Amount in Void.

UE14

Metabolite Assay 1, Assay 2, Mean Concentration and/or Amount in Void entered, but UOM is missing.

Enter the Metabolite UOM.

UE16

Collected Urinary Excretion sample does not have corresponding Start Date, Time and Urine volume.

Enter Start Date, Time and Urine Volume if ‘Sample Collected’ is ‘YES’.

Derivations

Code

Field Name

Description

UE1001

Course #

Course number is derived based on the course initiation start dates and the infection episode onset date.

UE1002

Day in Course

Number of days since the beginning of the course is derived from the course initiation start date and the infection episode onset date.
Last updated by Karuppiah, Ramesh (NIH/OD) [E] on Jun 07, 2018