Participants of the workshop learn the necessary background information and techniques to diagnose Sars-CoV-2 using the mobile diagnostic laboratory. The laboratory is shipped ready to use with all devices, reagents, certificates, and protocols. After one day of preparation together with a local assistant, a five-day course is given where every step is carried out by each participant. Experts accompany the learning process with written teaching materials, video training, virtual live coaching, and short exams to verify the learned content.

1. MOBILE CORONA DIAGNOSTIC LAB
DATA MANAGEMENT
Leo Sprengel

2. WHAT IS DATA MANAGEMENT?
July 8th, 2021
MOBILE CORONA DIAGNOSTIC LAB | Diagnostic Methods and Data Management slide 2
• Ensures that data are continuously of the same quality
• Regulations include sharing, preservation, access and reusage of data
• Data must allow a full and complete reconstitution and evaluation of a process
⮚ Includes original records, source data, metadata and all subsequent transformations
Data OBTAINED from patients
• Name, address
• Birthdate
• Contact information
• …
Data PRODUCED for patients
• SARS-CoV-2 test result
• RT-LAMP picture of sample
• RT-qPCR raw data
• RNA extraction record

3. HOW DO WE ENSURE GOOD DATA MANAGEMENT?
July 8th, 2021
MOBILE CORONA DIAGNOSTIC LAB | Diagnostic Methods and Data Management slide 3
• Continuously monitor processes to ensure adequate quality of resources
• Ensure proper infrastructure:
o maintenance of buildings, equipment and systems; provide power and water for the lab
o Training of personnel in good documentation practices and the ALCOA principles
• Apply risk management to assure product quality and validity of data
o Monitor arising problems to be aware of possible data integrity risks
o Set realistic and achievable expectations based on the capabilities of a method and the staff
• Use double-verification routines for important data

4. DATA INTEGRITY
July 8th, 2021
MOBILE CORONA DIAGNOSTIC LAB | Diagnostic Methods and Data Management slide 4
• Ensure that the collection of data is complete, consistent and accurate
⮚ Thorough and gapless end-to-end documentation of every process
• Protect data from modifications, manipulation and deletion or loss
• Use audit trails to monitor any alterations on original electronic records
o Using individual user accounts allows tracing of individual activities
o Document user IDs using an electronic time- and date-stamp
o Track the generation, modification and deletion of data (who, what, when, why)

5. THE ALCOA CONCEPT FOR DATA DOCUMENTATION
July 8th, 2021
MOBILE CORONA DIAGNOSTIC LAB | Diagnostic Methods and Data Management slide 5
• Attributable: all recorded information can be traced back to an individual person
⮚ Use unique user accounts to link individuals to the creation and modification of data
⮚ Work with electronic signatures
• Legible, traceable and permanent: data have to be understandable and reproducible
⮚ Do backups and use secure electronic archives
• Contemporaneous: Data have to be recorded at the time they are generated
⮚ Use time- and date-stamped audit trails to record all actions
• Original: all data must be recorded and stored in their original form
⮚ Be aware of data and metadata on stand-alone instruments, e.g. UV/Vis, LC-MS, MRI, …
• Accurate: Data are correct, truthful, valid, and reliable
⮚ Calibrate and maintain equipment, validate all analytical methods and processes
⮚ Implement a quality management system

6. GENERAL PRINCIPLES OF GOOD DATA MANAGEMENT
July 8th, 2021
MOBILE CORONA DIAGNOSTIC LAB | Diagnostic Methods and Data Management slide 6
• Records and documentation must allow the full reconstitution of all processes and activities
• Management governance:
o Ensure the integrity of all personnel, ensure that no commercial, political or financial pressures are extorted
o Allocate adequate human and technical resources
• Quality audits ensure an effective quality control
o Track invalid and aberrant data to reveal problems in procedures
o Review audit trails to prevent incorrect processing of data
• Manage your record-keeping system
o Restrict the user access rights to control data access
o Review and update systems as necessary
• Risk management helps to ensure good data management
o Have control strategies to ensure the integrity of your data and protocols to handle errors and discrepancies

7. THE DATA LIFECYCLE
July 8th, 2021
MOBILE CORONA DIAGNOSTIC LAB | Diagnostic Methods and Data Management slide 7
• Collection and recording
o Verify critical data (e.g. patient ID) by a second person
o Apply risk management strategies to protect critical data
• Processing
o Should be objective, free from bias and only based on validated and verified protocols
o Use established standards or reference materials to account for instrument variabilities
• Data review and reporting
o Take into consideration all data, including atypical and suspect data
o Continuously monitor your process to enhance the efficacy, quality and safety of the process
• Retention and retrieval
o Do backups and securely archive electronical data as well as all metadata
o Also check for metadata in separate folders and system logs

8. July 8th, 2021
MOBILE CORONA DIAGNOSTIC LAB | Diagnostic Methods and Data Management slide 8