Michael Duvenhage / Tarun Bhatnagar. 08 Aug 2018
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1 Michael Duvenhage / Tarun Bhatnagar 08 Aug 2018
2 Agenda Dataflow and regional collection strategies (3 options) Data Management Tasks Data collection hot zone considerations Data sharing agreements Safety and SAE reporting - by whom, frequency, to whom Data Safety Monitoring Board Randomization Future outbreak(s) Data Management critical tasks Data management / SOPs Data analysis Case Report Form Review 2
3 Dataflow and regional collection strategy (1) ICMR administer clinical database (1 global database) CRFs electronically transferred (scanned/photos) to ICMR for entry ICMR (centrally) responsible for data entry and data management activities INDIA CHINA BANGLADESH MALAYSIA INDONESIA 3
4 Dataflow and regional collection strategy (2) ICMR administer clinical database (1 global database) All sites have access to clinical database CRFs entered by sites directly into clinical database Data management activities shared shared across sites INDIA CHINA BANGLADESH MALAYSIA INDONESIA 4
5 Dataflow and regional collection strategy (3) Site specific database All sites have access to their own site database CRFs entered by sites directly into site clinical database Data management activities managed at each site Data transfers (sharing) required to ICMR INDIA CHINA BANGLADESH MALAYSIA INDONESIA 5
6 Data Management Tasks Data Management task Data Management strategy CRF Transmission Sites NA NA Data Entry ICMR Sites Sites Query Management ICMR ICMR Sites Query Resolution Sites Sites Sites Data Reporting ICMR ICMR Sites Quality Control ICMR Sites Sites Data Transfers NA NA Sites Data Strategy 1 Central ICMR DB 2 Central ICMR DB with direct site entry into DB 3 Multiple Site DBs 6
7 Data collection Hot zone considerations Ensuring efficient way of getting data out of the hot zone Data transmission equipment & procedures Scanners / photos Identifying a secure online storage service (other than google drive) External hard drive to store downloaded files File electronic naming conventions Storing of potentially contaminated CRF & source documents Data connectivity (wifi equipment outside of hot zone however coverage within the hot zone ). 7
8 Data sharing agreements Formal data sharing agreements between Indian Council of Medical Research (ICMR) all participating countries / sites Frequency of data transfers to be agreed-upon IMPORTANT: Data to remain blinded post-outbreaks Country specific regulatory issues regarding data sharing agreements to be addressed asap. 8
9 Safety and SAE Reporting Recording of Grade 3/4 AEs on CRFs DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.1, July 2017 Recording & reporting of all SAEs Reported on the SAE CRF Deaths and immediately life threatening to be reported within 1 business day to ICMR data center All other SAEs to be reported within 3 business days to the ICMR data center SAEs (possibly, probably, or definitely related) to the research will be reported to the IRB within 7 calendar days Investigators are responsible for reporting according to their IRB/Regulatory requirements 9
10 Data Safety Monitoring Board (DSMB) Independent DSMB will review the study at least twice a year (additional reviews might be required) All SAEs, Unanticipated Problems, and all Safety Reports will be reported by the ICMR data center to the DSMB The PI will submit the DSMB summary open reports (with the DSMB recommendations) to the IRB DSMB will monitor safety and may pause enrollment in the event of study-related deaths or SAEs that are considered study-related DSMB will review the completeness of follow-up and other aspects of study conduct DSMB will recommend continuing the study, modification, or terminating the study 10
11 Randomization REDCap Randomization Treatment code is provided ensuring the treatment is blinded 11
12 Future outbreak(s) Data Management critical tasks Data Management (future outbreak) critical task Data Management strategy CRF completion training X X X Data Management Plan training X X X Database entry training - X X Query resolution training X X X Database (user) access - X X Database replication / implementation - - X Data transmittal infrastructure ( hot zone ) X X X Data Strategy 1 Central ICMR DB 2 Central ICMR DB with direct site entry into DB 3 Multiple Site DBs 12
13 Data Management Plans / SOPs CRF completion CRF transmission / storage ( Hot zone ) Data entry Randomization Query management and management of CRF updates Quality control Data transfers Database lock User management and access control 13
14 Data Analysis - RACI Data Analysis ICMR NIAID WHO Clinical Site Statistical Analysis Plan R C C I DSMB Reporting (Tables and listings) R C I I Randomization schema???? Unblinding???? Final Analysis R C C I 14
15 Case Report Form Review CRF Review Refer to handouts 15
16 Questions 16
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