From : PREZIOSI, Marie-pierre <preziosim@who.int>
To : Tengiz Tsertsvadze <tt@aidscenter.ge>
Subject : RE: [EXT] Re: URGENT - Request to complete follow up information
Cc : M Georgia <tgabunia@moh.gov.ge>; akaki abutidze <akakiabutidze@yahoo.com>; Ekaterine Adamia <eadamia@moh.gov.ge>
Received On : 29.06.2020 10:24
Attachments :

Dear Akaki,

 

Thank you very much for the rapid reply and action. This is quite clear, thank you.

 

In order to delete the record from the system, could you please submit a protocol violation form, just clarifying this. You can find the form in the report section of the platform.  

 

 

Wishing you a good day,

 

 

Marie-Pierre

 

Marie-Pierre Preziosi, MD PhD
Co-Lead R&D Blueprint

Universal Health Coverage / Life Course

World Health Organization
Office +41 22 791 3744 - Mobile +41 79 516 5978

 

 

From: Tengiz Tsertsvadze
Sent: 28 June 2020 19:35
To: PREZIOSI, Marie-pierre
Cc: M Georgia ; akaki abutidze ; Ekaterine Adamia
Subject: [EXT] Re: URGENT - Request to complete follow up information

 

Dear Marie-pierre, 

 

Thank you for your kind email. Let me respond to you on behalf of Prof. Tsertsvadze. 

 

Please be informed that we have not yet started enrollment of patients into the Solidarity trial. The patient record GEO-GEIDAI-0001 has been created in the system, just for the practice reason. We wanted to be sure that system was working fine. Accordingly this record is actually empty and does not contain any information on a patient. We will appreciate if you can delete this record from our system. 

 

As soon as we randomise the first patient, we will let you know. Hopefully the system will run smoothly. 

 

Thank you very much in advance for your kind consideration and we apologize for this inconvenience. 

 

Best regards, 

 

Akaki Abutidze MD, MPH, PhD

Infectious Diseases, AIDS and Clinical Immunology Research Center

Tbilisi 

 

On Thu, Jun 25, 2020 at 11:29 PM PREZIOSI, Marie-pierre <preziosim@who.int> wrote:

Dear Professor Tengiz Tsertsvadze and Dr Tamar,   

 

I hope you are well. As you are aware, we are in the process of completing some interim analysis for the Solidarity Trial.

 

The DSMC has strongly recommended that we approach all the Investigators and request their help to complete the follow-up information from all patients. The current database indicates outcome information is missing for one patient. Please see the attached list of patients without follow up.

 

In the outcomes part (section 7) of the eCRF, we have introduced two new options as noted below.

 

Thanks for reviewing the attached list and completing the patient eCRF by COB next Monday  29 June 2020

 

Many thanks in advance.

Kind regards,

 

Marie-Pierre

+41 79 516 5978

______________________

 

Still in hospital today  NEW

 Death in hospital

 Discharged to palliative care

 Discharged alive, expecting recovery

       

Withdrawn from the study NEW

 Reason - free text -------

 

______________________