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Contents

Purpose

Record the patient's lab results.

The following table lists the standard lab CRFs (see appendix III  for the tests for each).

• Blood Chemistries

• CSF

• Respiratory Functions

• Blood Gases

• Hematology

• Serology

• Bone Marrow

• Lymphocyte Phenotype

• Serum Electro

• Drug Level

• Other Serum Chemistries

• Urinalysis

• Coagulation

• Other Urinary Results

• Urine Immune Electro

 

C3D will only include the specific lab CRFs needed according to the BTTC protocol.

Instructions for Non-NCI external sites: Outside labs need to be manually entered in C3D at each required time point per protocol.

Instructions for NCI site: Patients on NCI/CCR's intramural studies who have their labs drawn at the Clinical Center will use the Lab Load Interface (LLI) tool to select which labs results to electronically transfer into C3D. The selected results are then loaded onto the appropriate Lab Panel CRFs overnight. Instructions on how to use the LLI tool are in appendix IV. 2007 and earlier C3D Studies, in general, do not use the LLI tool and labs done in the Clinical Center are automatically loaded directly in C3D. It takes at least 48 to 72 hours for Clinical Center Labs to become available to C3D.

It is common to have several forms of the same kind of lab for a patient. Click on the C3D RDC worksheet column header labeled "Show unplanned visit" to see all these extra lab results. Refer to the 'Inserting Unplanned Visits' section of the General Instructions of this manual.

Labs eCRF

Field Name

Description / Instructions

Format

Visit Date(m)

Enter the date the lab sample was collected.

DD-MMM-YYYY

Time(m)

Enter the lab sample collection time in military format (24 hours). Seconds are optional and default to 00 if not entered.

Ex: 13:56:00 (for 1:56:00 PM)

In RDC Onsite studies, the lab time will be empty when the CRF is saved with time 00:00:00. Such time is being saved and simply not being displayed.

There is no way to indicate an 'unknown' lab time right now.

HH(24):MM:SS

Lab

Select the source of the lab results.
Dlm - Lab results automatically loaded from another system. (Note: This field is only used by NCI sites, when appropriate)
Dlm$Diabetic - Not in use. Do not use.
Outside - Outside lab results entered manually. (Note: BTTC external sites will always use this field)
Respfunc - Not in use. Do not use.

Use pick list.

Course #(d)

Indicates the course number this lab is related to.

5 digits

Day in Course(d)

Indicates the day since the beginning of course this lab is related to.

5 digits

Lab Test(d)

Pre-defined name of the lab test. Each lab panel has a different set of tests which are listed at the appendix III.

20 characters

Value

Enter the lab test result value as reported.

20 characters.

UOM

Select the appropriate lab test value unit of measurement.

Use pick list.

Normal Range

NCI sites: For labs loaded from the MIS/CRIS system, the range is automatically populated.
External sites: For labs obtained outside the NCI Clinical Center, enter the appropriate normal range.

30 characters

Range Indicator(d)

Indicates how the lab result value compares to the lab test normal range.
NORMAL - Falls within the normal range.
HIGH - Above the normal range.
LOW - Below the normal range.
NONNUM - Not a valid number (e.g. "No Data").
NORANG - No normal values are provided.

12 characters

Grade(d)

Derived from the lab test result value and the lab test ranges from the version of the NCI Common Terminology Criteria for Adverse Events (CTCAE) specified by the Protocol.

Note: The age and gender are also factors in some cases.

13 characters

Value (Numeric)(d)

Derived from lab test result value.

12 characters

Value in Preferred UOM(d)

Derived the lab test result value in the preferred unit of measurement which is pre-defined by the institute.

12 characters

Preferred UOM(d)

The preferred unit of measurement for the specified lab test.

20 characters

Legend: (d) derived field, (m) RDC mandatory

Validations

Code

Description

Resolutions

LB01

Lab test has grade higher than zero or than the most recent baseline lab test grade but no relevant Adverse Event exists.

Correct the lab grade or make sure a relevant Adverse Event exists.

LB03

Two labs exist for the same date and time.

Review both labs and delete/correct one of them.

Derivations

Code

Field Name

Description

LBAL1003

Course #

Course number is derived from the course initiation start date and the lab date (visit date).

LBAL1004

Day in Course

Number of days since the beginning of the course is derived from the course initiation start date and the lab date (visit date).

LBAL1001

Range Indicator

Derived based on the lab value result and normal high/low range.

LBAL1002

Grade

Derived from the lab test result value, unit of measurement and the lab test normal range.
Last updated by Blackburn, Katie (NIH/NCI) [C] on Apr 18, 2017