1. Safety Reporting
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2. Incident/Deviation Reporting
ANYONE can report any deviations from protocol, trial specific procedures, or Good Clinical Practice to the ANODE Coordinating Centre at the NPEU at any time.
Definitions:
Serious breach
A serious breach is a breach which is likely to affect to a significant degree (a) the safety, physical or mental integrity of the participant(s) or the trial or, (b) the scientific value of the trial.
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3. Incident/Deviation Reporting
Trial-related deviation
A trial-related deviation is a departure from the approved trial protocol or other trial-related document or process, from the principles of GCP or from any applicable regulatory requirements.
Deviation is a general term and includes planned and unplanned deviations and changes made to avoid immediate harm to trial participants.
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4. Incident/Deviation Reporting
Report the incident/deviation at the earliest opportunity as soon as is practical on becoming aware of the occurrence.
Incidents can be reported to the ANODE Trial Co-ordinating Centre verbally or in writing using the ANODE Incident and Deviation Reporting Form (kept in the ANODE document box).
If an incident report is reported verbally, it must be followed up in writing.
Fax or (scanned and signed) the completed form to the ANODE Trial Co-ordinating Centre on fax: , or as soon as practical.
Ensure the ANODE Trial Co-ordinating Centre is confirms receipt.
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5. Incident/Deviation Reporting
Copy the completed ANODE Incident and Deviation Reporting Form, send original to the Trial Co-ordinating Centre.
Place the copy in the Investigator Site File (ISF); unless it contains confidential information, in which case its location should be flagged within the ISF.
If you are unable to record any ‘resolutions’ in the first instance – send the completed form and then re-send the form with ‘resolutions’ at a later date.
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6. Incident/Deviation Reporting
Allocated IMP not administered
If a woman is randomised, an IMP pack is taken and prepared but the woman does not receive the trial intervention this information does NOT routinely need to be reported using ANODE Incident and Deviation Reporting Form. This information must be captured on Form 1: Randomisation Form including full details of why the trial intervention was not administered.
Unblinding
Please report any deviation to planned unblinding via the incident reporting procedure.
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7. Safety reporting
The safety reporting window for this trial will be from administration of intervention to 6 hours post administration or discharge (whichever is sooner)
Recording Adverse Events: Non-serious adverse events will not be routinely recorded as the IMP is a licensed product which is being given at a standard dose. However AEs which are part of the study outcomes will be recorded in the CRF.
Reporting Serious Adverse Events (SAEs): All SAEs will be reported immediately (i.e. within 24 hours); except the following SAEs which are not considered to be causally related to the trial intervention:-
Birth defect/congenital anomaly
Hypertensive disorder of pregnancy (e.g. pre-eclampsia/eclampsia)
Early Post Partum Haemorrhage (PPH)
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8. Safety reporting
Complete Serious Adverse Event Report Form (CTIMP) Please ensure that a clinician signs this
Fax or the completed form to the ANODE Co-ordinating Centre by fax on or to The Co-ordinating Centre will confirm the form has been received
If faxed the person reporting the SAE must ensure the ANODE Trial Co-ordinating Centre is aware of the SAE and check they have received the form by telephoning ( ) or ing the Trial Co-ordinating Centre
Please refer to the ANODE Guidance Sheet 6 – Safety Monitoring - for further guidance
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9. Safety reporting
Follow-up information should be reported on a new SAE form and this forwarded to the NPEU by fax or or reported using OpenClinica©
The Chief Investigator or safety delegate will review all SAEs and assess the causality and expectedness of the event in relation to the safety reference information for the IMP
Review of SAEs will be timely, taking into account the reporting time for a potential SUSAR
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