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Essential Guide to Protocol Compliance in NHSBT Clinical Trials Unit

This comprehensive guide provides an overview of protocol adherence in the NHSBT Clinical Trials Unit, detailing critical aspects such as documentation processes, role delineation for consenting training, patient data handling, and exclusion criteria. It covers essential topics like managing major bleeding events, reporting serious adverse events, and monitoring neonates during studies. This resource is crucial for ensuring safety, compliance, and effective communication among clinical trial staff and participants.

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Essential Guide to Protocol Compliance in NHSBT Clinical Trials Unit

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  1. NHSBT CTU Staying true to the protocol VidheyaVenkatesh

  2. The Delegation Log • GCP training • CVs • Delineation of roles: consenting training

  3. The Screening log • Removal of Patient identifiable data • Remember to send monthly

  4. NHSBT Clinical Trials Unit NHSBT CTU Pre randomisation • Excluding major bleed • Documenting scan HVP

  5. NHSBT CTU Who is excluded? • Major/life-threatening congenital malformations • Recent major haemorrhage within the last 72 hours • All fetal intracranial haemorrhages • Known immune thrombocytopenia • Neonates unlikely to survive • Neonates not given parenteral vitamin K

  6. Who is not excluded? • Previous thrombocytopenia • Previous transfusions • 72 hours after bleed if not actively bleeding • Older babies

  7. Passing your data monitoring visit

  8. NHSBT CTU Parents will be approached for consideration of immediate study participation. Documenting consent When platelets <100x109/L When platelets <50x109/L Document on PlaNeT-2 log book

  9. Documenting randomisation

  10. What is a protocol deviation? When not to give platelets NHSBT Clinical Trials Unit NHSBT CTU Keeping in the right arm

  11. NHSBT CTU The Paperwork F8 F9 F10 F13 F14 F15

  12. NHSBT CTU F5 – Bleeding Assessment Tool (BAT)

  13. NHSBT CTU Major bleed reporting

  14. PlaNeT-2: Major/Severe bleed form • All new major bleeding events will be reported to the CSU without disclosing allocation arm. • Each report will be forwarded to the Independent Data Monitoring Committee for review as soon as it is received at the CSU. • In cases of uncertainty the local team may contact one of the CIs or neonatal medical experts.

  15. NHSBT CTU Modified WHO Bleeding Assessment Score • Grade 1 – Minor Haemorrhage • Any bleed from the • skin, umbilical cord, skin around stoma, surgical scar, mucosa. • Any pink frothy or old bleed from the ET tube. • H1 haemorrhage on cranial US (Germinal Layer Haemorrhage, GLH) • Grade 2 – Moderate Haemorrhage • Any frank bleed from • the stoma • macroscopic haematuria, • IVH (H2 or H3) without dilatation (V0), • Acute fresh bleed through ETT without ventilatory changes • Grade 3 – Major Haemorrhage any: • Frank Rectal • Acute fresh bleed through ETT with ventilatory change. • Intracranial bleedAn intracranial bleed is defined as a major bleed if any of the following apply: Neurosurgical intervention is required; Scans show a midline shift; Clinical signs and symptoms of neurolgical deficit with significant derangement of laboratory investigations • Major IVH is defined as H2 or H3 with ventricular dilatation (V1); H1, H2, H3 with parenchymal involvement (P3) ; Any evolution of intracranial haemorrhage to H2V1, H3V1, or (H1, H2, H3) with parenchymal involvement (P3) • Grade 4 – Severe Haemorrhage • Shock defined as life threatening major bleed associated with hypotension, hyopovolaemia or any other haemodynamic instability and/or bleeding requiring volume boluses, red cell transfusion in the same 24 hours, fatal major bleeding

  16. NHSBT Clinical Trials Unit NHSBT Clinical Trials Unit NHSBT Clinical Trials Unit NHSBT CTU Safety reporting

  17. NHSBT CTU F14 – Serious Adverse Event

  18. PlaNeT-2: Serious Adverse Event (SAE) A SAE is an adverse event that results: • in death • is life-threatening • requires hospitalisation or prolongation of existing hospitalisation (including readmission within 28 study days if discharged home earlier) • there is a likelihood of persistent or significant disability or incapacity

  19. NHSBT CTU Adverse events

  20. NHSBT CTU Defining NEC/Sepsis • Necrotising enterocolitis ≥ Stage 2 defined as per Bells Criteria (Bell et al,1978) • Sepsis: culture positive sepsis or culture negative sepsis where a course of at least 5 days of antibiotics is to be administered for proven or clinically-suspected sepsis. • All episodes of NEC and sepsis must be recorded on the adverse event form • A listing of adverse events will be reported six monthly to the Independent Data Monitoring Committee.

  21. NHSBT CTU Primary outcome: 28 days 28 day scan

  22. NHSBT CTU End of Study

  23. NHSBT CTU F11 – Cranial USS at the end of study

  24. NHSBT CTU PlaNeT-2:Transfer out of recruiting unit • Inform the local PlaNeT-2 team if neonate transferred out of recruiting unit • Use transfer pack • Receiving hospital should: • Collect information as required by the protocol thereafter until 38 weeks CGA or discharge.

  25. NHSBT CTU Thank you!

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