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Monitoring Plan

Monitoring Plan. Lotte Skoulund Laursen, GCP-Coordinator GCP Unit Copenhagen University Hospital. Monitoring of SafeBoosC. Studies involving non-CE marked medical devices carried out in Denmark require approval from - the National Competent Authority and

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Monitoring Plan

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  1. Monitoring Plan Lotte Skoulund Laursen, GCP-Coordinator GCP Unit Copenhagen University Hospital

  2. Monitoring of SafeBoosC Studies involving non-CE marked medical devices carried out in Denmark require approval from - the National Competent Authority and - an Independent Ethics Committee This will apply for most European countries – if not all

  3. Monitoring of SafeBoosC • Medical Device Studies are obliged to follow the requirements of the ISO Standard 14155 • The ISO Stardard 14155 is in most aspects similar to the ICH-GCP requirements

  4. Monitoring of SafeBoosC According to the ISO Standard 14155 the sponsor in charge of a medical device study is responsible for the appropriate monitoring of the study

  5. Monitoring of SafeBoosC • The purpose of the monitoring is to verify and ensure that the clinical trial is conducted according to: • The approved protocol • Subsequent amendments • The ISO standard (in all essence ICH-GCP) • National regulatory requirements

  6. Monitoring of SafeBoosC Furthermore: The experience of the monitoring of SafeBoosC will lay the foundation for the design and organisation of a potential large-scale RCT regarding cerebral monitoring using NIRS

  7. Monitoring of SafeBoosC A provisional Monitoring Plan has been approved This plan determines ”the minimum required level of monitorering at each site” Each site is later required to develop their own Monitoring Plan, taking into account local and national requirements

  8. The visits The Monitoring Plan describes the three components of the monitoring: • The Initiation Visit • The on-site Monitoring Visits • The Close-Out Visit

  9. Initiation Visit An initiation visit must take place at each site before inclusion of the first participant The investigator Site File will be checked for all required documents

  10. Initiation Visit Essential documents must be available, such as • the ID-list for registration of participants • informed consent forms • the forms for registration of Serious Adverse Events • the written procedures regarding storage of biological samples Resources, facilities and equipment will be evaluated Training of trial personnel must be documented

  11. Monitoring Visits Each site will have on-site monitoring visits during the trial (the number of visits reflects the number of included participants) The first visit must take place soon after enrollment of the first participant

  12. Monitoring Visits • Selected data will be verified according to Source Data (SDV = Source Data Verification) • Not all data are monitored for all participants: • Some data are monitored for all participants • Some data are monitored for selected participants • Some data are monitored/controlled centrally in Copenhagen

  13. Monitoring Visits • For all children the following will be verified: • Correct identification of trial participants • Correctly signed informed consent forms • For all children the following data will be monitored: • Date and time of birth • Gestational age • Date of discharge • Whether or not the child is alive at time of discharge • Date of eventual death of the child

  14. Monitoring Visits • For the first two children and for each 5th child hereafter, the following data will be monitored: • Registration of serious adverse reactions (according to protocol and national legislation) • Registration of burn marks • Discharge diagnosis for necrotizing enterocolitis/NEC • Discharge diagnosis for retinopathy of prematurity/ROP • Discharge diagnosis for bronchopulmonary dysplasia/BPD

  15. Monitoring Visits • For the first two children and for each 5th child hereafter, the following study procedures will be monitored: • Follow up of serious adverse reactions • The use of aEEG according to protocol • The use of cUS according to protocol • The storage, handling and labelling of blood samples

  16. Centrally monitored data Some data will be transferred directly to Copenhagen University Hospital / Rigshospitalet. These will be monitored centrally Among these are: • Treatment according to randomisation • Timely placing of the NIRS (within 3 hours after birth) • Burden of hypo- and hyperoxia during the first 72 hours (primary end point) • Blood biomarkers • Registration of concomitant medication • Reporting of serious adverse reactions to the appropriate authorities

  17. Close-out Visit • When a site has completed the trial, a Close-out Visit must be planned with the monitor • The visit will ensure • that the Investigator Site File is complete and ready for archiving • that all relevant authorities have been notified timely and correctly about the completion of the trial

  18. Forms and reports All monitoring units will be provided with ready-made report forms for: • the Initiation Visit • the Monitoring Visits • the Close-out Visit If national regulations provide for more data to be monitored, the report forms can be adjusted to that

  19. Questions?

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