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Purpose

Record detailed information about the collection of biological samples for analysis of the presence and quantity of the study agent and/or its metabolites. Since this form is intended to stand alone, some of the fields may duplicate items found in other case report forms.

Pharmacokinetics eCRF

Field Name

Description / Instructions

Format

Visit Date(m)

Enter the date the study agent administration was started.

DD-MMM-YYYY

Course Number(d)

Course number derived from the study agent start date and course initiation start dates.

5 digits

Day in Course(d)

Number of days since the start of the course. Derived from the study agent start date and course initiation start dates.

5 digits

Study Agent(m)

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

Start Date(m)

Enter the date the study agent administration was started.

DD-MMM-YYYY

Start Time(m)

Enter the time the study agent administration began.

HH(24):MM

Stop Date

Enter the date the study agent administration was stopped

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

DD-MMM-YYYY

Stop Time

Enter the time the study agent administration was stopped.

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

HH(24):MM

Specimen Sampled(m)

Select the body fluid that is being collected for the biological samples.
A - Apheresis Cells
B - Whole Blood
C - Cerebrospinal
E - Pericardial Effusion
F - Abdominal Effusion
M - Peripheral Blood Mononuclear Cells
P - Plasma
S - Serum
T - Tumor Tissue
R - Pleural Effusion
V - Saliva

Note: Urine sample collection will be documented on the Urinary Excretion Case Report Form.

Use pick list.

Sample ID Number

If the specimen acquisition labeling process uses a bar code (or similar) system, enter the unique sample identification number for each of the planned interval time points samples.

10 digits

Planned Interval

Planned interval pre-determined per protocol.

80 characters

Sample Collected?(m)

Indicate whether or not the specimen is collected.
YES - then the Sample ID (if applicable), Actual Start Date and Time should be entered
NO
UNKNOWN

Use pick list.

Planned Interval

Planned interval pre-determined per protocol.

80 characters

Sample Collected?(m)

Indicate whether or not the specimen is collected.
YES - then the Sample ID (if applicable), Actual Start Date and Time should be entered
NO
UNKNOWN

Use pick list.

Actual Start Date

Enter the specimen collection date.

DD-MMM-YYYY

Actual Start Time

Enter the specimen collection time.

HH(24):MM

Time Interval(d)

Actual interval in minutes from the study agent start time.

6 digits

Parent Study Agent Assay 1

Enter the results of the parent assay for the study agent indicated in the study agent field.
If the results are below the sensitivity threshold of the test, record the value as 0 (zero). Baseline assay values may be entered as Interval 0 (zero).

8 digits and 3 decimals

Parent Study Agent Assay 2

If the planned interval time point specimen was tested a second time, enter the results of the second parent assay for the study agent indicated in the study agent field.

8 digits and 3 decimals

Parent Study Agent Assay Mean

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

Note: This will not be completed if a second assay result is not available.

8 digits and 3 decimals

Parent Study Agent Assay UOM

Select the appropriate concentration units of measurement for the parent study agent assay(s) (e.g.: mg/dL or mmol/l).

Use pick list.

Metabolite Assay 1

If applicable, enter the first metabolite assay results for the parent study agent.

8 digits and 3 decimals

Metabolite Assay 2

If applicable, enter the second metabolite assay results in the biological samples.

8 digits and 3 decimals

Metabolite Assay Mean

Enter the metabolite assay mean concentration, if available.

Note: This will not be completed if a second assay result is not available.

8 digits and 3 decimals

Metabolite Assay UOM

Select the appropriate concentration units of measurement for the metabolite assays (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

PHM01

Start Date is less than or equal to the Enrollment Date of informed consent signed.

Start Date must be after the Enrollment Date of informed consent signed.

PHM02

Start Date is in the future.

Enter a date earlier than or equal to the current date.

PHM03

Sample ID number is repeated.

Sample ID number must be unique.

PHM05

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

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

PHM06

Parent Study Agent UOM entered, but Assay 1, Assay 2 and Mean Concentration are missing.

Enter a Parent Study Agent Assay 1, Assay 2 and/or Mean Concentration.

PHM07

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

Enter the Parent Study Agent UOM.

PHM08

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

Enter a Metabolite Assay 1, Assay 2 and Mean Concentration.

PHM09

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

Enter the Metabolite UOM.

PHM15

Stop Date is in the future.

Enter a date earlier than or equal to the current date.

PHM16

A Study Medication with a Medication/Agent matching the Pharmacokinetic with the same administration Date and Time was not found.

Note: Study Medications with the following routes are ignored: PO, CIV and Topical.

Verify that the pharmacokinetics study agent administration is recorded on the study medication form.

PHM17

Collected Pharmacokinetics samples does not have corresponding sample ID, Date and Time.

Enter Sample ID, Actual Start Date and Time if ‘Sample Collected’ is ‘YES’.

Derivations

Code

Field Name

Description

PHM1001

Course #

Course Number is derived from the Study Agent Start Date and the Course Initiation Start Dates.

PHM1002

Day in Course

Day in course is derived from the Study Agent Start Date and the Course Initiation Start Dates

PHM1003

Time Interval

Actual Time Interval is derived from the Actual Date and Time and the Start Date and Time.