Supporting Document 600-GDMS040-005 Local Lab Normal Range Management Tool (LNMT) Site Job Aid for Late Stage Development Version 1.0
Revision History Version Effective Date Revised by Changes 1 01-Jan-2012 Johnson Li Nancy Calamunci Pam Masciotti Initial Publication Version 1.0 Page 2 of 7
TABLE OF CONTENTS PAGE 1.0 SCOPE... 4 2.0 POST DEPLOYMENT OF INFORM AND PRIOR TO FIRST PATIENT SCREENED... 4 3.0 ERROR LISTING... 4 4.0 USING THE EXPORT/IMPORT FUNCTIONALITY OF LNMT... 4 Version 1.0 Page 3 of 7
LNMT Site Job Aid for Late Stage Development 1.0 Scope The purpose of this job aid is to outline the expectations and tasks to be performed by the site for managing Local Lab Normal Ranges in the EDC (electronic data capture) application using the Local Lab Normal Range Management Tool (LNMT). These work instructions are applicable to the following job roles: Site Primary Investigator Site Study Coordinator Clinical Research Associate 2.0 Post-deployment of InForm and prior to First Patient Screened 2.1 Site Study Coordinator Enters all local lab vendor information and associated normal ranges per the ecrf Entry Guidelines. The access role for InForm will provide you with the access you need to the LNMT tab. 2.2 Clinical Research Associate Perform SDV on 100% of local lab normal ranges after first patient is enrolled. 2.3 Site Study Coordinator When local lab results are entered into the visit for the patient, be sure that the correct Lab ID of the local lab vendor is entered into the local lab ecrf Lab ID field That Lab ID association will allow LNMT to extract the appropriate normal ranges for the subject and provide the normal range as well as whether or not the result is within the normal range for every lab result on the local lab ecrf. See ecrf Entry Guidelines for the correct format of the Lab ID 3.0 Obtaining a Listing of Local Lab vendors or associated normal ranges using the Export functionality of LNMT 3.1 How to produce a listing of all lab vendors Click on the Lab List tab Filter for Lab IDs that pertain to your site. o You can perform a wild card search, for example, Lab ID of 1* would produce a listing of all lab IDs that begin with the number 1. Export to Excel by choosing Download Lab List in the upper right corner of the screen. Version 1.0 Page 4 of 7
This will provide you with an Excel spreadsheet of all lab vendors listed on your screen including the Lab ID, Lab Vendor Name and address. 3.2 How to produce a listing of a lab vendor s normal ranges To Download the normal ranges for a Lab vendor, click on the lab vendor from the Lab List tab This will bring you to the normal ranges for that lab vendor You can then download to Excel by clicking on the appropriate download link in the upper right corner of the screen. Version 1.0 Page 5 of 7
4.0 Error Listing 4.1 Site Study Coordinator Check the Error Listing tab which will list all errors for your site s Lab IDs o Correct any mistakes. o LNMT matches local lab normal ranges to the local lab ecrfs by comparing the following fields: Lab ID Lab Test Lab Unit Gender Age From Date To Date o If any of the fields in the above bullet do not match or are missing, then an error will appear in the Error Listing tab. Here is the list of Errors that can appear on the Error Listing tab and the required action to resolve. Values in [ ] will be the actual value of the variable. Error Message {Lab ID / Sample Date / Unit / DoB / Gender} missing. Enter data for the missing item(s) in InForm. Examples: Lab ID missing. Enter data for the missing item(s) in InForm Sample Date missing. Enter data for the missing item(s) in InForm Action to Resolve Enter the missing data items in InForm local lab ecrf. Version 1.0 Page 6 of 7
Error Message Lab ID: [value] does not exist in LNMT system. Example, Lab ID: 1010 does not exist in LNMT system. Lab normal range not available for Lab Test: [value] for Lab ID: [value] Example, Lab normal range not available for Lab Test: WBC for Lab ID: 001 Lab normal range not available for Lab Test: [value] and Lab Collection date: [value] for Lab ID: [value] Lab normal range not available for Lab Test: [value] and Lab Collection date: [value] and Unit: [value] for Lab ID: [value] Lab Normal missing for Lab Test: [value] for Patient specified gender and age combination Either enter normal range that is Gender independent and Age independent or Enter Gender/DOB for the patient in InForm Lab normal range is available in LNMT but not for the Patient's age Either enter Gender in InForm or Enter Gender independent Lab normal range for Patient's age Lab normal range is available in LNMT but not for {Male/Female} patient Either enter Patient DOB in InForm or Enter age independent Lab normal range for {Male/Female} patient Action to Resolve Enter the missing LabID and Normal Ranges in LNMT or else correct the Lab ID that was entered into InForm local lab ecrf. Add the missing Lab Test normal range in LNMT or correct the Lab ID if incorrect in InForm local lab ecrf. Add or update the normal range for the given Lab ID in LNMT for the Lab Test and Lab Collection date OR correct the Lab ID if incorrect in InForm local lab ecrf. Add or update the normal range for the given Lab ID in LNMT for the Lab Test, Lab Collection date and Unit OR correct the Lab ID if incorrect in InForm local lab ecrf. Update the normal range for the given Lab Test to include the gender and age provided for the patient. Normal range can be entered as applicable to both genders and all ages in which case the gender and DOB would not be necessary to make a match. If that is not the case, then gender and DOB must exist in InForm. Update the normal range to include the patient's age or else correct the patient's date of birth in InForm. If normal range should apply to both genders, update the normal range or else enter missing gender in InForm. Update the LNMT normal range to include the specific patient's gender. Enter LNMT normal range that is applicable to all ages or else enter missing date of birth in InForm. LNMT runs on a schedule of every 2 3 hours, determined by each protocol, and that is when you will see the local lab ecrfs updated with the corrected local lab normal ranges. Note, the site should never add comments to the LNMT returned normal ranges or else they will not populate. After corrective actions to resolve errors are taken and the next scheduled LNMT run occurs, the errors will automatically disappear from the Error List. Version 1.0 Page 7 of 7