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Purpose

The purpose of this case report form (CRF) is to record information about the patient's enrollment information at the time of study entry (time when patient signs informed consent).

For studies that require de-identified patient data, certain fields will not be required (such as date of birth, patient initials, date from which to start including labs, etc).

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(m)

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)

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).

 

Use pick list.

Primary ID(m)

 For external BTTC sites (not NCI-NOB): Enter the Unique Identification number provided by the Central Registration Office. This number is a combination of a site code and patient position code.

For the NCI-NOB BTTC site: 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. These medical record numbers are used to load the patient's lab data.

12 characters

Patient Subgroup

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.

 

  
Registration DateEnter Patient Registration Date

DD-MMM-YYYY

Randomization Seq#Enter the sequential order of protocol randomization.

Use pick list.

Randomization DateEnter the date the patient was randomly assigned to the treatment arm of a protocol.

DD-MMM-YYYY

   

Disease Status at Registration

Select status of disease at the timepoint of patient registration into a clinical trial:

  • Newly Diagnosed

  • Recurrent/Progression

  • Stable

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.

Date of Initial Diagnosis of Primary Tumor

Enter the initial date of pathological confirmation of the disease based on a specimen obtained from an invasive procedure.

DD-MMM-YYYY

Basis of Initial Diagnosis

Select the name of the technique or modality used to document the initial diagnosis of a patient:

  • Clinical

  • Histology

  • Imaging

Use pick list.

Infrantentorial Involvement

Indicate whether infratentorial sites were involved by disease:

  • Yes

  • No

  • Unknown

Use pick list.

Supratentorial Involvement

 Indicate whether supratentorial sites were involved by disease:

  • Yes

  • No

  • Unknown

Use pick list.

Spinal Involvement

Indicate whether the patient's disease status includes involvement of the spine:

  • Yes

  • No

  • Unknown

Use pick list.

CSF Involvement

Indicate whether cerebrospinal fluid was involved by disease:

  • Yes

  • No

  • Unknown

  • Not Done

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

Initial Histology DiagnosisSelect the appropriate brain tumor histologic term.

Use pick list.

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 )

Most Recent Progression Date

Enter the most recent date of progression of patient's disease.

DD-MMM-YYYY

Treatment Assignment Code(m)

Select the appropriate code for the patient's treatment assignment as specified. For BTTC studies, "Treatment Assignment" codes are based on the treatment schedules described in the protocol. Please contact the BTTC Coordinating Center team for advice on TAC formulation and modification.

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

(undergoing update)

This date, the Registering Institution and the Patient ID (Medical Record Number) control the electronic transfer of lab data from the NIH Clinical Center into C3D. This date is usually prior to the patient's informed consent in order to include the lab results to confirm eligibility.

This field is only applicable (mandatory) for patients with Registering Institutions containing NCI or NIH as part of the Institute abbreviate code (Ex: NCI-NOB).

DD-MMM-YYYY

Legend: (d) derived field, (m) RDC mandatory

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.

ENR21
(under development)
 Data from which to start including labs is missing and Registering Institute is an NCI or NIH InstitureWhen using a Registering Institute which contains NCI or NIH, the Date from which to start including labs is required in order for lab data to transfer from the NIH Clinical Center into C3D. 
MRN01, MRN02The Format for Primary ID is invalid or the ID is invalid.

Note: Only applicable for NIH Clinical Center Medical Record Numbers.

Primary ID (MRN) must be 7 digits, or 10 (with dashes). Validation checks MRN format and validity (checkdigit). Verify MRN.

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.

Last updated by Fontinha, Marcelo (NIH/NCI) [C] on Aug 15, 2017