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
Description / Instructions
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.
Date of Onset(m)
Enter the date that the symptom was first observed/experienced.
Enter the date the baseline symptom was resolved.(i.e.: no longer exists at any grade).
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.
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.)
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:
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:
Use pick list.
Legend: (d) derived field, (m) RDC mandatory, (c) for CTEP reporting only.
Date of Onset is in the future.
Enter a Date of Onset that is equal or earlier than the current date.
Baseline Symptom CTC/CTCAE Term Grade is not valid or is missing.
Select a Grade from the pick list.
|BS03||Date of Onset is after the Start Date of the first Course.||Verify that Date of Onset is prior or equal to the first course start date.|
Resolved Date is prior to Date of Onset.
Resolved Date must be after or equals to the Date of Onset.
Symptom Description missing for CTCAE Term that requires a description. (Allergy/Immunology - Other (Specify, __))
Enter a Symptom Description for the corresponding CTCAE Term.
System Organ Class(SOC)
Broad classification of the CTC Adverse Event Term derived from the pick list selection.