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Purpose

Record a brief description of major medical and surgical events during the patient's lifetime, excluding the events related to their cancer therapy.

Screening Physical Exam findings should be entered on the Screening Physical Exam eCRF.

Baseline Medical History eCRF:

Field Descriptions and Instructions

Field Name

Description / Instructions

Format

Visit Date^(m)^

Enter the date the form was completed (i.e. the date information was gathered).

DD-MMM-YYYY

Date of Examination^(m)^

Enter the date that the patient was examined and the medical history was documented. Since only one Baseline Medical History
form is used, if the information has been assembled over a period of time, enter the date of the latest examination.

DD-MMM-YYYY

Body System

Predefined Body System. It cannot be changed.

text

Finding Results^(m)^

Indicate whether the finding results for the particular body system were either:
N - Normal
A - Abnormal
Z - Not Assessed
L - Not Applicable
Comments are required for abnormal finding results.

Note: Do not select ‘Normal” if the body system was not specifically assessed (i.e.: not mentioned in the progress note in the medical record). ‘Not Assessed’ means a discussion on the body system was not raised or the body system was not assessed.

5 digits

Medical History if Abnormal

Enter a brief description of major medical and surgical events during the patient's lifetime (i.e.: hypertension under cardiovascular, appendectomy as child under abdomen).
Enter the history for the appropriate body system to which the information refers. For "Other" indicate the body or organ system in the history.

128 characters

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

Validations

Code

Description

Resolutions

MH01

Date of Examination is in the future.

Enter a date that is earlier or equals to the current date.

MH02

Date of Examination is after the first Course Initiation Start Date.

Review the Date of Examination and/or the first Course Initiation Start Date.

MH03

‘Finding Result’s is marked abnormal and ‘Medical History if Abnormal’ details were not provided.

Enter the details of the ‘Medical History if Abnormal’ or change the ‘Finding Results’ selection.

MH04

‘Medical History if Abnormal’ details were specified and ‘Finding Results’ is not marked abnormal.

Change the ‘Finding Results’ to abnormal or remove the provided ‘Medical History if Abnormal’ details.