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Purpose

Record the results of the procedures that are performed as part of the protocol. All laboratory results are to be recorded on the appropriate lab CRF. All procedures that are done as a result of an adverse event are to be recorded on the concomitant measures CRF

Procedures 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 field.

DD-MMM-YYYY

Course #(d)

Indicates the course number the procedure is related to based on their date and time.

5 digits

Day in Course(d)

Indicates the day since the beginning of course the procedure is related to based on their date and time.

5 digits

Date(m)

Enter the date that the procedure was done, not the date it was interpreted by the radiologist or investigator.

DD-MMM-YYYY

Time

Enter the time the procedure was done.

HH(24):MM

Procedure(m)

Select the procedure from the pick list.

Note: For CTMS monitored protocols, these are the only Procedures sent:

EKG Electrocardiogram
CXR Chest X-ray
BRNCHGRM Bronchogram
UPGISER Upper GI Series
LOGISER Lower GI Series
SKELSURV Skeletal Survey
HOLTMON Holter Monitor
BONESCAN Bone Scan
EEG Electroencephalogram
BMCELLUTY Bone Marrow Cellularity
UCASTS Urine Casts
MUGASCAN Muga Scan
ULTRASND Ultrasound
CATSCAN CAT Scan
MRI MRI
X-RAY X-ray
PETSCAN PET Scan
CULTURE Culture

Use pick list.

Body Site(m)

Select the body site from the pick list.
In the case of tests such as CATSCAN, MRI, and X-RAY record the applicable body site. For CAT Scan and MRI use thorax, abdomen, pelvis or brain.

Use pick list.

Abnormal Result?(m)

Select whether the finding results for the particular procedure / body site were either:
A - Abnormal
N - Normal

Use pick list.

Findings

If abnormal, enter as summary of the abnormal findings.

128 characters 200 characters for non-CTEP sponsored studies.

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

Validations

Code

Description

Resolutions

LBLL01

Procedure date is in the future.

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

LBLL02,
LBLL03

Findings were entered and Abnormal is not "A-Abnormal" or Abnormal is "A-Abnormal" and no brief description was entered in the Findings.

Abnormal Findings must have a brief description.

Derivations

Code

Field Name

Description

LL1001

Course #

Course number is derived based on the course initiation start dates and the procedure date.

LL1002

Day in Course

Number of days since the beginning of the course is derived from the course initiation start date and the procedure date.