Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}
IRD
Any amendments which take place after the trial has begun will be submitted to SCARF (India), the HMSC of the ICMR (India), Jinnah Postgraduate Medical Centre (Pakistan), Karwan-e-Hayat (Pakistan), IRD IRB (Pakistan) and QMUL REC for approval and the amendment history will be tracked via version and date control of protocols.