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Purpose

Record the patient's baseline symptoms prior to starting treatment.

Baseline Symptoms are symptoms that are present when the patient starts treatment (e.g., Cycle 1 Day 1 pre-dosing). These are not symptoms that occurred and resolved between the time screening studies/exams/procedures are done and Day 1/pre-treatment. For those symptoms, consider adding to Medical History.

Baseline Symptoms eCRF:

Field Descriptions and Instructions

Field Name

Description / Instructions

Format

Visit Date(m)

Enter the date the form was initiated.

Note: If a new baseline symptom is revealed once treatment has begun, do not change the visit date. Record the new symptom information in the appropriate fields as indicated below.

DD-MMM-YYYY

Date of Onset(m)

Enter the date that the symptom was first observed/experienced.

DD-MMM-YYYY, MMM-YYYY

Date Resolved

Enter the date the baseline symptom was resolved.(i.e.: no longer exists at any grade).

DD-MMM-YYYY

CTCAE Term(m)

Use the pick list to select a CTCAE (Common Terminology Criteria for Adverse Events) Term.

Note: This pick list does not show all the CTCAE Terms. User must type in a search criterion and then click on the ellipsis perform the search and display the resulting matched CTCAE Terms. Ex: type %ypo% to list all the terms that include the lower characters ‘ypo’ somewhere in the CTCAE Term.

Note: Visit CTEP’s CTCAE webpage for latest version.

Use pick list.

System Organ Class(d)

Broad classification of adverse events based on anatomy and/or pathophysiology. Within each class there is the adverse event term/description.

Note: For studies using CTCAE version 3.0, this field is ‘ CTC category’. This field is derived from the selected CTCAE Term.

40 Characters

Symptom Description

Enter a succinct clinical description of the symptom.

Note: This field is mandatory for 'Other, Specify…' CTCAE terms. For example: Immune system disorders - Other (Specify, __).

It might be also used to further describe symptom such as “Eye pain” by entering “Left eye”.

100 characters(Only 33 characters are reported for CTMS monitored studies.)

Grade(m)

Enter the severity of the symptom by using the protocol’s specified CTCAE Version. If the symptom is not explicitly mentioned it should be coded in the appropriate "other" category and graded according to the general criteria:
1. Mild – barely noticeable, does not influence functioning
2. Moderate – makes subject uncomfortable, influences functioning
3. Severe – severe discomfort, treatment given
4. Life threatening – immediate risk of death

Use pick list.

Related to Disease?(m)

Indicate whether or not the symptom is related to the study disease by selecting one of the following options:
Y- Yes
N- No
U- Unknown

Use pick list.

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

Validations

Code

Description

Resolutions

BS01

Date of Onset is in the future.

Enter a Date of Onset that is equal or earlier than the current date.

BS02

Baseline Symptom CTC/CTCAE Term Grade is not valid or is missing.

Select a Grade from the pick list.

BS03

Resolved Date is prior to Date of Onset.

Resolved Date must be after or equals to the Date of Onset.

BS10

Symptom Description missing for CTCAE Term that requires a description. (Allergy/Immunology - Other (Specify, __))

Enter a Symptom Description for the corresponding CTCAE Term.

Derivations

Code

Field Name

Description

BS1001

System Organ Class(SOC)

Broad classification of the CTC Adverse Event Term derived from the pick list selection.