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Purpose

Record the patient's enrollment information at the time of study entry.

For studies that require de-identified patient data, fields such as Date of Birth (year only is acceptable), Patient Initials, Date from which to Start Including Labs, Primary ID, Country Code, Postal Code, Method of Payment will not be used.

Enrollment eCRF

Field Name

Description / Instructions

Format

Visit Date^(m)^

Enter the patient's registration date.

DD-MMM-YYYY

Gender^(m)^

Select the patient's gender:

  • FEMALE
  • MALE
  • UNKNOWN
  • UNSPECIFIED

Use pick list.

Date of Birth^(m)^

Enter the patient's date of birth.

DD-MMM-YYYY

Age at Entry^(d)^

Age is derived from the patient's birth date at the enrollment and it remains the same throughout the study.

Note: For children less than 5, a fractional age (rounding to one decimal place is sufficient) will be derived to indicate the number of months since the last birthday. (For example, a child with a birth date of January 1 having passed his fourth birthday and entering the study on July 1 would have his age recorded as 4.5 years.)


5 digits and 2 decimal

Patient Initials^(m)^

Enter the patient's initials. Usually 3 characters – first, middle and last name initials.

4 characters

Race^(m)^

There are five race fields.Use each field's pick list to select a race. The following races are available in the pick list:
White: a person having origins in any of the original peoples of Europe, the Middle East, or North Africa.
Black or African American: a person having origins in any of the black racial groups of Africa.
Asian: a person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent (including the Philippine Islands).
American Indian or Alaska Native: a person having origins in any of the original peoples of North, South, and Central America and who maintains tribal affiliation or community attachment.
Native Hawaiian or other Pacific Islander: a person having origins in any of the original peoples of Hawaii, or other Pacific Islands.
Not Reported: patient refused or data not available.
Unknown: patient is unsure of their race(s)

Note: If "Not Reported" or "Unknown" is selected, then no other race can be selected.


Use pick list.

Ethnicity^(m)^

Select one of the following OMB ethnicity categories:
Hispanic or Latino: a person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race.
Non-Hispanic or Latino: a person not meeting the definition for Hispanic or Latino.
Unknown: a person of unknown ethnicity.
Not Reported: Not provided or available

Use pick list.

Registering Institution^(m)(c)

Enter the unique CTEP Institute Code where the patient was originally registered on study (e.g., institution where the patient signed the informed consent form).

Note: This field is not mandatory for non-CTEP studies.


Use pick list.

Primary ID^(m)^

Enter the patient's medical record number for the selected Institution. The Clinical Center's medical record numbers have the following format:
99-99-99-9
For non clinical center patients, enter the Unique Identification number provided by the Central Registration Office. This number is a combination of a site code and patient position code.
These medical record numbers are used to load the patient's lab data.

12 characters

Patient Subgroup^(c)^

Select the appropriate unique code for identification of uniform groups of patients for separate analysis or treatment as defined in the Clinical Data System (CDS).Patient "Subgroup" codes are provided by CTEP to the investigator at the time of protocol approval, and are updated as required following approval of protocol amendments.

Use pick list.

Registering Group^(c)^

Enter the unique CTEP Group code (as listed on the CTEP Web site) from which the patient was originally registered on study.

Note: This is required for Inter-Group trials only – otherwise leave blank.


Use pick list.

Country Code^(c)^

Required for non-US residents. For patients from outside the U.S., enter the foreign country code. Please use the International Standards Organization (ISO) Country codes which can found at CTEP Country codes list.

Use pick list.

Postal Code^(c)^

For U.S. residents, enter the patient's home 5 digit zip code. Do not enter the last 4 digits of the complete zip code to assure patient confidentiality. Also do not enter the dash "-".

10 characters

Method of Payment^(c)^

Select the patient's primary method of payment using the following codes:
1 - Private Insurance
2 - Medicare
3 - Medicare and Private Insurance
4 - Medicaid
5 - Medicaid and Medicare
6 - Military or Veterans Sponsored NOS
6A - Military (including CHAMPUS or TRICARE)
6B - Veterans Sponsored
7 - Self pay (no insurance)
8 - No means of payment (no insurance)
98 - Other
99 - Unknown

Use pick list.

Primary Disease Site^(m)^

Select the primary disease site of the malignancy from the pick list.

Use pick list.

Disease Term^(m)^

Select a disease term. Use the list of Disease Terms ("MedDRA") as listed on the CTEP Web site.

Use pick list.

Disease Stage at Entry

Select the stage of the disease at the time of study entry if appropriate. Otherwise, leave it blank.

Use pick list.

Disease T Stage

Select the stage of disease based on the primary tumor.

Use pick list.

Disease N Stage

Select the stage of disease based on the nodes present.

Use pick list.

Disease M Stage

Select the stage of disease based on the metastases present.

Use pick list.

Histology / Cytopathology

State briefly the type of histology or cytopathology found at the time of original diagnosis. Do not state broad categories (e.g., "lymphoma", but rather state "Non-Hodgkin's lymphoma").

50 characters
( 40 reported )

Date of Confirmation of Histology

Enter the date when the patient's disease status was confirmed, at the treating institution, prior to study entry (if required by the protocol).

DD-MMM-YYYY

Grade of Histology

Enter the grade of histology at study entry, if appropriate. Leave it blank otherwise.

Note: Grade of Histology is the Gleason Score for Prostate Patient.


10 characters( 4 reported )

Date of Diagnosis

Enter the first date of original diagnosis (e.g., when a positive biopsy or surgical result was obtained). Do not give the start date of symptoms as the date of diagnosis.

DD-MMM-YYYY

Treatment Assignment Code^(m)^(c)

Select the appropriate code for the patient's treatment assignment as specified. For non-CTEP studies, "Treatment Assignment" codes are based on the treatment schedules described in the protocol. Please contact the Informatics team for advice on TAC formulation and modification. For CTEP sponsored studies, "Treatment Assignment" codes are provided by CTEP to the investigator, in the form of a coding letter, at the time of protocol approval, and are updated as required following approval of protocol amendments. Advice on TACs is available from the CTEP's Protocol and Information Office
(pio@ctep.nci.nih.gov) (mailto:(pio@ctep.nci.nih.gov)).

Use pick list.

Date Informed Consent Signed^(m)^

Enter the date the patient signed the informed consent form.

DD-MMM-YYYY

Date of Informed Consent Version^(m)^

Enter the date of the informed consent version of the IRB-approved informed consent form that was signed by the patient at the time of study entry.
This will be the date that is displayed on page one of the consent form in the section entitle: "Latest Amendment Approved:" or the date displayed on the "Latest IRB Review" when the amended date is N/A.

DD-MMM-YYYY

Date from which to Start Including Labs^(m)^

Enter the date indicating when lab results data should be start being loaded from the centralized lab. Usually prior to the patient's informed consent.

DD-MMM-YYYY

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

Validations

Code

Description

Resolutions

ENR01

Date Informed Consent Signed is before Date of Birth.

Change the Date Informed Consent Signed to be after the Date of Birth.

ENR02, ENR04,
ENR05, ENR06, ENR17

Date of Birth, Date of Confirmation of Histology, Date of Diagnosis, Date Informed Consent Signed, Date of Informed Consent Version are in the future.

Enter a date that is prior or equals to today's date.

ENR07

All Races are unchecked.

Select at least one Race.

ENR09, ENR10,
ENR11, ENR12

Birth Date is after the Date from which to include labs, Date of Confirmation of Histology, Date of Diagnosis, Date Informed Consent Signed, Informed Consent Version Date.

Correct the Date of Birth or the other date fields.

ENR14

Date of Diagnosis is after Date of Histology Confirmation (if provided).

Correct Diagnosis Date or Date of Histology Confirmation.

ENR15, ENR16

Cannot select another Race when "Unknown" or "Not Reported" Race is selected.

Unselect the other Races and select only "Unknown" or "Not Reported". Or unselect both "Unknown" or "Not Reported" and select other Races.

ENR18

Registering Institution not found on the patient's Medical Record Numbers case report form.

Please review the Institutions on both case report forms.

ENR20

Enrollment only has part of the TNM Disease Stage information available

If one of the TNM fields is answered, the rest should be available.

Derivations

Code

Field Name

Description

DM1001

Age

The age is derived from the patient's Informed consent signed date and the date of birth. Note: Age is expressed in decimals to accommodate patients under the age of 5.