INDIA NATIONAL MEETING FEBRUARY 2008

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Congratulations to all our Collaborators who attended the CRASH-2 India National Meeting in Cochin. All of you contributed to the meeting and made it very successful.

Thanks especially to Dr Ravi and family for the brilliant organisation and to all of you for all your questions and good practice tips. We have summarised some of the questions and tips below.

Group photo of India meeting

Should any treatment be withheld from patients in this trial?
NO! Please inform patients and/or their families that they will be receiving all the treatments required and that the CRASH2 treatment is given as an additional treatment.

How is it decided whether the patient receives the treatment or placebo?
We randomise so that each patient has a known, usually equal, chance of being allocated to either group and importantly the allocation cannot be predicted. This ensures that both groups will be equal for all the variables (patient’s characteristics, other interventions received etc) except for the intervention under study – tranexamic acid.

How can I increase recruitment?
Ensuring good lines of communication between all members of your team including nurses.
Building a team of doctors to help with randomisation and with completing and sending the data forms.
Passing on some of the incentives we send to you to any person who helps you is a good way of motivating them.
Ensure all relevant staff e.g. everyone in the emergency department, are informed about the trial, including those working in the blood bank. We can provide posters, newsletters or even formal letters to help with this process.

What should I do if a trial patient is moved to a different department?
Ensure the staff in that department are aware of the study. You can do this by sending them a cover letter with your contact details should they require further information, and a Protocol Summary. We are happy to write a letter to the head of any other department to aid this, if you wish.

How do I make sure I am conducting the trial to Good Clinical Practice standards?
It is vital that all investigators working on CRASH2 complete Good Clinical Practice training. We provide training for collaborators on the trial intranet. Please let us know if you need access.
All staff helping you with the trial should also be trained in the trial procedures using the PowerPoint presentation which is included in your site file.

I am losing eligible patients to local hospitals what should I do?
Please try your best to get your local hospitals to collaborate. Send us their contact details and we will try to get the trial started there!

Please see the FAQ section for more questions and answers or email us at crash@Lshtm.ac.uk. Remember also to refer to your Site File for answers!
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