Donor Clinical Data Guidelines
Overview
This guide provides information on how to submit donor clinical data and how to interpret the validation rules/checks.
Field | Definition | Terms |
---|---|---|
donor_vital_status | Donor's last known vital status. |
|
disease_status_last_followup | Donor's last known disease status. |
|
donor_relapse_interval | If the donor was clinically disease free following primary treatment, and then relapse or progression (for liquid tumours) occurred afterwards, then "donor_relapse_interval" is the length of the disease free interval (in days). | |
donor_survival_time | How long has the donor survived since primary diagnosis, in days. If source data was collected in months, use a multiplier value of '30.44' to convert values to days when preparing your submission. | |
donor_interval_of_last_followup | Interval from the primary diagnosis date to the last followup date, in days. ICGC requests that patients be followed up every 6 months while alive. If source data was collected in months, use a multiplier value of '30.44' to convert values to days when preparing your submission. | |
donor_primary_treatment_interval | Interval between primary diagnosis and primary treatment, in days. |
Summary of Donor Clinical Field requirements:
This table summarizes the required fields (for data completeness), and describes the rules which ensure the clinical data is correct
disease_status_last_followup |
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complete remission partial remission stable NED (no evidence of disease) |
progression relapse |
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donor_vital_status |
alive |
donor_relapse_interval = donor_survival_time = donor_interval_of_last_followup = Checks: If data provided for "donor_survival_time" and "donor_interval_of_last_followup":
|
donor_relapse_interval = donor_survival_time = donor_interval_of_last_followup = Checks:
If data provided for "donor_survival_time":
|
deceased |
donor_relapse_interval = donor_survival_time = donor_interval_of_last_followup = |
donor_relapse_interval = donor_survival_time = donor_interval_of_last_followup = Checks:
|
Clinical Data Events and Time Relationship:
This diagram summarizes how the different donor clinical events relate to time.
If the patient is alive, the "donor_survival_time" should be equal to the "donor_interval_of_last_followup" (124 days)
However, if the the patient is deceased, the "donor_survival_time" (163 days) should be less than (or equal) to the "donor_interval_of_last_followup" (175 days)
Description of Script Restrictions for Donor Clinical Fields:
1.
Field: "donor_interval_of_last_followup"
Description:
If the disease status at last followup was progression or relapse:
-
- "donor_interval_of_last_followup" field is required
2.
Field: "donor_survival_time"
Description:
When donor is deceased:
- The field "donor_survival_time" is required.
When donor is alive:
- If "donor_survival_time" and "donor_interval_of_last_followup" have values, "donor_survival_time" must equal "donor_interval_of_last_followup"
3.
Field: "donor_relapse_interval"
Description:
If the donor's disease status at last followup was progression or relapse:
- The field "donor_relapse_interval" is required.
- If the donor is alive:
- "donor_relapse_interval" should be less than or equal to "donor_interval_of_last_followup"
- If donor is deceased:
- "donor_relapse_interval" should be less then or equal to "donor_survival_time".
4.
Field: "donor_primary_treatment_interval"
Description:
The donor_primary_treatment_interval should be less than or equal to donor_survival_time
If the patient's disease status at last followup was progression or relapse:
If the patient is alive:
- The combination of the donor_primary_treatment_interval and donor_relapse_interval should be less than or equal to the donor's interval of last followup.
If the patient is deceased:
- The combination of the donor_primary_treatment_interval and donor_relapse_interval should be less than or equal to the donor's survival time
5.
Field: "donor_age_at_diagnosis"
Description:
- If the donor is older than 90 years, default value of 90 should be used.
- The donor's age at diagnosis should be less than or equal to the donor's age at enrolment
6.
Field: "donor_age_at_enrollment"
Description:
- If the donor is older than 90 years, default value of 90 should be used.
- The donor's age at enrolment should be less than or equal to the donor's age at last_followup