Whether you are a Clinical Research Associate (CRA), Clinical Research Coordinator (CRC) or a Clinical Data Manager (CDM), you all face some common issues with reference ranges.
This blog is written by focusing on RAVE but many issues are common in RAVE and other eDC such as OCRDC.
Let’s discuss them one by one:
Most common issue is “missing ref ranges”
Clinical data manager (DM) shares the missing ranges listing/report to CRAs and then CRAs share this with CRCs based on issue types.
Below are the common reasons for missing reference ranges in the database (RAVE)
If Lab name and associated ref ranges are available : In this case, CRAs send this to CRC to select the concerned lab name. Once CRC selects the Concerned lab name, then associated ref ranges start populating and the issue is fixed.
If CRA identifies that the wrong lab name is selected, then he/she can inform CRC to select the correct ref range.
If CRA identifies that Lab name and associated ref ranges are not entered then he/she has to enter all the ref ranges. Once all the ranges are entered, CRC can select the lab so that ref ranges can be populated.
But there are some special reasons as well for missing ranges:
- Age type
- Effective Date
- Parameter code
- LNR document issue
- Qualitative parameter
- Discrepancy in the unit/ref ranges
If CRA has selected the wrong “age type” in the lab module (back-end to enter the ranges) then ref ranges will not populate and In this case, we have to correct age types. It is different for Adult population and pediatric population. It means Correcting the age type will be the solution for “missing ranges”.
Age for which ref ranges are applicable should match with subject age.
Effective date of ref ranges should accommodate /cover the collection date of the lab performed.
Gender is selected wrongly. Subject is male and CRA selects female in lab module for that particular parameter
Parameter code is wrongly selected . Lab modules should have parameter code as per annotated CRF (case report form). for example cardiac troponin I code is TRONINI and the lab module has TROPONIN3 then ref ranges will not be populated. CRA has to inform CDM in this case so that programming issue can be fixed
LNR (local lab ref ranges) received by the CRA from the site may not have all the parameters which are present in the CRFs, in this case, CRA has to contact local lab administration, CRA/PI to provide the all the ref ranges.
Few parameters may not have ref ranges:
Few parameters/ lab results are qualitative and may not have ref ranges.
DM should excluded those qualitative parameter before sending reports to CRA. Some examples are: Hepatitis B/C and HIV antigen test etc where results are reported as positive or negative. Some parameters which are quantitative such as creatinine clearance may not have ref ranges. It should be double check with protocol or other guidance document for the same.
Discrepancy in the reported unit and ref ranges are corrected by CRA by selecting the correct unit or range and if desired unit is not available, a synonymous unit can be used (conversion factor should remain same).
Other interesting readings for all CRA, CRC and DM:
- Difference between Investigator Brochure and Clinical Trial Protocol
- Clinical Study Report
- Beginner’s Guide to Clinical Research Coordinator
- Parts of a clinical trial protocol and Clinical Data Management (CDM) prospective to review
- Complete Guide for writing effective Pharma- Resume: Your First Impression