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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).
Field Name | Description / Instructions | Format | |
---|---|---|---|
Visit Date(m) | Enter the patient's registration date. | DD-MMM-YYYY | |
Gender(m) | Select the patient's gender:
| 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.
| 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:
| Use pick list. | |
Ethnicity(m) | Select one of the following OMB ethnicity categories: | 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. | |
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Registration Date | Enter Patient Registration Date | DD-MMM-YYYY | |
Randomization Seq# | Enter the sequential order of protocol randomization. | Use pick list. | |
Randomization Date | Enter 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:
| 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:
| Use pick list. | |
Infrantentorial Involvement | Indicate whether infratentorial sites were involved by disease:
| Use pick list. | |
Supratentorial Involvement | Indicate whether supratentorial sites were involved by disease:
| Use pick list. | |
Spinal Involvement | Indicate whether the patient's disease status includes involvement of the spine:
| Use pick list. | |
CSF Involvement | Indicate whether cerebrospinal fluid was involved by disease:
| 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 | |
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 Diagnosis | Select 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.
| 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. | 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.
| DD-MMM-YYYY |
Legend: (d) derived field, (m) RDC mandatory |
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, | 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, | 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 Institure | When 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, MRN02 | The 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. |
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. |