Entering Outside Laboratory Data in the Cancer Central Database (C3D)

Purpose: To identify the steps to be completed when entering laboratory data submitted from organizations outside NIH into the Cancer Central Clinical Database (C3D).

STEP 1: Receipt and Review of Outside Laboratory Data

1. Outside lab data on a patient is received by research team via fax, mail, or electronic format.
2. Investigator/Research Nurse will review the outside labs and associated reference range to determine if any abnormal labs are adverse events and/or a dose modification is required.
3. All outside lab adverse events will be documented on a progress note in the patient’s medical record (i.e., CRIS).
4. The data will be entered on the protocol-specific Electronic Case Report Form (eCRF) in C3D.

STEP 2: Enter Outside Laboratory Results and Outside Laboratory Reference Ranges into C3D

1. Enter each actual lab result (numeric value + unit of measure from pick list) for each lab test into the appropriate protocol-specific eCRF.
2. Enter each lab test’s reference range, including the numeric value and unit of measure for both the lower limit of normal (LLN) and the upper limit of normal (ULN) and the unit of measure for each lab.
3. If the C3D pick list does not have the exact unit of measure needed for a lab result, Data Management staff should enter the lab result, leave the unit of measure blank and contact the Team Lead assigned to their team. See SOP CDM-10 How to Request C3D Pick List Changes.
   • A discrepancy will be raised initially. Once the unit of measure has been added to the pick list and entered in the CRF, subsequent batch validations will clear the discrepancy.
4. Data Management staff will enter appropriate lab-related Adverse Events on the Adverse Event eCRF.

STEP 3: Submit All Outside Laboratory Results to Medical Records

1. Place Clinical Center patient label in bottom-left corner of each sheet of the outside lab documents.
2. Mail or drop off at the Clinical Center’s Medical Records Department.