November 2024 All Site Meeting Updates
Get the latest updates from the November 2024 all-site meeting including trial updates, changes in safety recording, and overview of SA004 modifications. Learn about site recruitment progress, key changes in protocols, and safety monitoring adjustments. Stay informed about critical updates to ensure smooth trial operations and participant safety.
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Presentation Transcript
All site meeting November 2024
Agenda Trial Update SA004 Changes Safety recording (MACRO) Summary of updated Documents www.icnarc.org www.icnarc.org
Trial Update Sites and Recruitment 69 sites open and recruiting 736 patients randomised! 39 patients were recruited in October (new monthly record!) 25 in November (so far) www.icnarc.org www.icnarc.org
Overview of SA004 3 main changes 1. Addition of timeframe to KRT immediately indicated in the exclusion criteria 2. Clarification of starting dose 3. Changes to safety recording and reporting procedures (and updated SmPC) www.icnarc.org www.icnarc.org
Change 1 Addition of timeframe to KRT immediately indicated A change to the wording for exclusion criterion #2, to include a timeframe of within 3 hours instead of immediately indicated . Sealed envelope and paper randomisation form updated also to reflect this www.icnarc.org www.icnarc.org
Change 1 Addition of timeframe to KRT immediately indicated The wording has been updated on Sealed Envelope Additional fields have been added Is the pH value above from the most recent ABG Was the baseline creatinine estimated? Enter the date of Baseline creatinine (if applicable) www.icnarc.org www.icnarc.org
Change 2 Clarification of starting dose Removal of the term starting dose throughout the protocol, and clarification that the both the initial dose after randomisation is 50ml infusion and any subsequent doses (when pH<7.3) are also 50ml infusions. This has been changed due to feedback from a site that the wording had caused confusion. Intervention flow chart also updated to V2.1 20 NOV 2024 Ensure the correct version is in your working file www.icnarc.org www.icnarc.org
Change 3 Changes to safety recording/ reporting procedures 1. Removed the requirement safety monitoring to resume if the patient is re-admitted to ICU within 90 days. Upon readmission to the critical care unit o Treatment is at the discretion of the clinician o Data collection does not restart. o Safety monitoring does not restart www.icnarc.org www.icnarc.org
Change 3 Changes to safety recording/ reporting procedures 2. A change to the SmPC oSodium Bicarbonate Injection BP 8.4% w/v. Summary of Product Characteristics Updated 25-Sep-2018 | Martindale Pharma, an Ethypharm Group Company]. oThis SmPC contains a more comprehensive list of expected events (section 4.8), compared with the current SmPC which only lists two (hyperosmolarity and hypernatremia). o Going forward this SmPC is to be used for adverse event reporting and therefore should be filed in section 7 of the ISF www.icnarc.org www.icnarc.org
Change 3 Changes to safety recording/ reporting procedures Several changes to safety recording / reporting procedures have been made Adverse events are now collected daily (on MACRO daily Adverse Events / Reactions forms) Only events that are serious (severe, life threatening or fatal) and deemed related (possibly, probably or definitely) to the IMP require reporting as an SAE to the trial team within 24hours Specified and non-specified For non-specified adverse events these will only need to be recorded on the CRF if defined as serious Do not need to be recorded if considered part of the natural history of the primary disease process or expected complications of critical illness www.icnarc.org www.icnarc.org
Safety recording and reporting New daily Adverse events/ reactions form For patients randomised after 20 Nov 2024 Complete each day the patient is in the critical care unit (along with the daily forms) Up until discharge or 90 days, whatever comes first www.icnarc.org www.icnarc.org
Safety recording and reporting If no new occurrences of AE on a particular day select No for Did the patients have any new occurrences of an AE on this day? This will immediately close the form, and no further action is required. www.icnarc.org www.icnarc.org
Safety recording and reporting For specified adverse events If none, select No specified events occurred today www.icnarc.org www.icnarc.org
Safety recording and reporting If a specified event occurs (regardless of severity) o Select yes for the event/s if occurred at least once that day o Select the severity o If more than one event that day use the worst severity o Select the relatedness (of the most severe) o Select no for any events that did not occur www.icnarc.org www.icnarc.org
Safety recording and reporting For the following specified events Extravasation Tissue Necrosis o Enter all events that occurred that day o If none select no on first line o Select the severity and relatedness for each event recorded www.icnarc.org www.icnarc.org
Safety recording and reporting For non specified events If none, select No non-specified events occurred today www.icnarc.org www.icnarc.org
Safety recording and reporting If a non-specifiedevent occurs (only record if severe, life threatening or fatal) o Enter the name of the event/s o Select the severity o Select the relatedness Remember Any events that are part of the natural history of the primary disease process or expected complications of critical illness do not need to be recorded here Death should not be reported as an adverse event www.icnarc.org www.icnarc.org
Serious Adverse Events (SAE) All events that are severe, life threatening or fatal AND deemed possibly, probably or definitely related to the IMP need to reported as an SAE A warning will flag on MACRO as a reminder A paper SAE form should be completed and uploaded to MACRO and email MOSAICC@icnarc.org to notify us this has been done within 24 hours of becoming aware of the event. www.icnarc.org www.icnarc.org
Concomitant medications Concomitant medications need to be collected for each event reported as an SAE to ICNARC. If the event is a SUSAR (Suspected Unexpected Serious Adverse Reaction) enter the past 3 months of concomitant medications. For SARs (Serious Adverse Reactions) that are expected, current concomitant medication (at the time of the event) should be collected and entered as a minimum. However, the timeframe for medication entered on this form should be directed by clinical opinion, as per protocol section 4.5.1.4. "Participants receiving any medicinal products mentioned in section 4.5 and 6.2 of the SmPC should be closely monitored by the treating clinical team as per routine clinical practice". www.icnarc.org www.icnarc.org
Questions? www.icnarc.org www.icnarc.org
Updated Documents ISF Checklist V7.0 (ISF Section 1) Protocol V5.0 (ISF Section 4) SmPC [Sodium Bicarbonate Injection BP 8.4% w_v] (ISF Section 7) Randomisation Form V3.2 (ISF section 8) CRF guidance V3.0 (ISF Section 8) Daily Adverse Event / Reactions worksheet (ISF Section 8) SAE reporting form V2.0 (ISF Section 8) Intervention flow Chart v2.1 Working file NOV24 https://www.icnarc.org/research-studies/mosaicc/for-sites/investigator-site-file/ www.icnarc.org www.icnarc.org
