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Purpose

Record the course assessment information when the course is completed, and the patient is evaluated or taken off treatment.

Course Assessment eCRF

Field Descriptions and Instructions

Field Name

Description / Instructions

Format

Visit Date^(m)^

Enter the date the course started.

DD-MMM-YYYY

Start Date of Course^(d)^

Shows the Start Date of Course entered in the Course Initiation case report form.

DD-MMM-YYYY

Dose change from TAC entered on Course Initiation CRF^(m)^

Indicate if the patient's treatment was different from that specified by the Treatment Assignment Code (TAC) for this course as entered on the Course Initiation CRF. If the treatment was different, indicate whether this was planned or unplanned, and record the reason, e.g. dose reduction due to toxicity, on the Comments tab of this CRF.

Note: optional for non-CTEP sponsored studies.

1 - Yes, Planned - change in treatment had been decided before the start of the course, e.g., due to toxicity on a previous course.
2 - Yes, Unplanned - change was not intended at the start of the course, e.g., shortening the course (and thus lowering the dose level) due to adverse events or if there was a drug administration error.
3 - No - patient received the treatment specified in the Course Initiation TAC
9 - Unknown - only when the actual treatment cannot be determined, e.g., when the patient is uncooperative in reporting self-administration of study medication.

Use pick list.

Course Disposition^(m)^

A "completed" course is one that has been conducted in accordance with the protocol with respect to length including the observation period (two day variance allowed). A course is regarded as "discontinued" if it was shorter than specified in the protocol. Select one of the following values:
Comp- Completed
Dis- Discontinued

Use pick list.

Response Assessment^(m)^

Select the patient's best disease state as assessed during the course. This determination must be adequately documented in the patient's medical record.
NE - Not Evaluable - State the reason in the "Response Note" field.
NA - Not Assessed - State the reason in the "Response Note" field.
NP - Protocol does not require a response assessment during the specific course.
TE - Too Early to confirm a response.
CRU - Complete Response Unconfirmed – Complete response assessed but not confirmed as per protocol timeframe.

Unless the protocol includes specific response evaluation criteria, the following guidelines should be observed:

CR - Complete Response - There is a disappearance of all evidence of disease as assessed relative to the baseline at start of treatment, not to previous courses. They must be confirmed by repeat assessments to demonstrate a disappearance of all evidence of disease.
PR or MR - Partial Response or Marginal Response - Response is assessed relative to the baseline at start of treatment, not to previous courses. They must be confirmed by repeat assessments. Subsequent evaluations at which tumor sizes are substantially unchanged should be assessed again as the same PR/MR.
PD - Progressive Disease - Response relative to the best disease status (smallest tumor measurement) since treatment began. Thus a tumor re-growth after a PR would be assessed as PD not an MR. A PR or MR cannot follow a complete response "CR".
SD - Stable Disease - Tumor growth or shrinkage since the start of treatment is not enough to justify a CR/PR/MR response or a PD progression. Once an actual CR/PR/MR response or PD progression has occurred, an SD assessment is not valid.
DU - Disease Unchanged - Patient's disease is unchanged relative to the previous assessment. This code may be used when a CR/PR/MR/PD response is not merited but SD is inappropriate.

For protocols not using RECIST criteria in assessing response, the following might be applicable to use. Consult/follow protocol for definition and usage criteria.
MX - Mixed Response
RP - Response
NR - No Response

*RECIST:*Many protocols specify that the following RECIST criteria be used in assessing response. Please use the following selections when assessing response using RECIST criteria only.

Note: CTEP's link to an article in the European Journal of Cancer: New response evaluation criteria in solid tumors: Revised RECIST guideline (version 1.1) guideline (version 1.1)

Evaluation of target lesions:
CR - Complete Response - Disappearance of all target lesions.
PR - Partial Response At least a 30% decrease in the sum of the LD (longest dimension) of target lesions, taking as reference the baseline sum LD.
PD - Progressive Disease - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded startedon study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
SD - Stable Disease - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Evaluation of non-target lesions:
CR - Complete Response - Disappearance of all non-target lesions and normalization of tumor marker level
NON-CR/NON-PD - Non Complete Response and Non Progressive Disease - Persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits. Non-CR/Non-PD is preferred over ‘Stable Disease’ for non-target disease since SD is increasingly used as endpoint for assessment of efficacy in some trials so to assign this category when no lesions can be measured is not advised.
PD - Progressive Disease - Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Use pick list.

Response Notes

Enter the reason why the Response Assessment is Not Evaluable (NE) or Not Assessed (NA). Some examples could include: protocol not followed, poor quality of scan, patient already treated.

32 characters

Date of Response

Enter the date of the earliest evaluation which, upon confirmation, justifies an assessment of
CR, PR, MR, or SD/DU. This date will be the same date as the scan, or other method of disease assessment.
For NE, record the date the patient's disease was assessed and deemed to be Not Evaluable.

Note: The original date of onset of response should be used for responses that persist through several courses.

DD-MMM-YYYY

Date of Progression

Enter the date of the evaluation used to determine the patient's disease status of progressive disease. Enter a date of progression if the disease progression occurred after an assessed better response (i.e. PR, CR, SD).

DD-MMM-YYYY

Any Adverse Events in this Course?(m)

Select "Yes" if any adverse event has occurred during this course. This includes adverse events with onset date belonging to a previous course that resolved during this course or that remain ongoing at the conclusion of this course.
Select "No" if no adverse events occurred during this course.

Note: The event(s) must be recorded on the Adverse Events case report form.

Use pick list.

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

Validations

Code

Description

Resolutions

CAS02, CAS03

Date of Response or Onset Date of Progress must not be future dates.

Change the date to a value no later than the current date.

CAS05

Response Notes entered and Response Assessment is different than "Not Evaluable" and "Not Assessed".

Remove the Response Notes if Response Assessment is different than "Not Evaluable" and "Not Assessed". Otherwise change the Response Assessment to "Not Evaluable" and "Not Assessed".

CAS06

Response Assessment is "Not Evaluable" or "Not Assessed" and no Response Notes were entered.

Enter the Response Notes if Response Assessment is "Not Evaluable" or "Not Assessed". Otherwise change the Response Assessment to a selection other than "Not Evaluable" and "Not Assessed".

CAS07

Date of Response is required when Response Assessment is CR, PR, MR, SD, or DU.

Enter the Date of Response or Review the Response Assessment.

CAS08

Date of Progression is required when Response Assessment is PD.

Enter the Date of Progression or Review the Response Assessment.

CAS09

Course Assessment marked as having adverse events, but there are no adverse events with an onset date that falls within this course start and end dates.

Change the field "Any Adverse Events in this Course?" to "NO" if no related adverse events exist. Otherwise enter the appropriate adverse events or adjust the appropriate adverse events dates.

CAS10

Course Assessment marked as not having adverse events, but there is at least one adverse event with an onset date that falls within this course start and end dates.

Change the field "Any Adverse Events in this Course?" to "YES" if the related adverse events are appropriate. Otherwise remove the adverse events or correct the adverse events dates.

Derivations

Code

Field Name

Description

CAS1001

Start Date of Course

The Start Date of Course entered in the Course Initiation case report form.

CAS1002

End Date of Course

The day before the start date of the following course or the off treatment date.