CRF Form 1 Section D5 Clarification Yellow Baseline Booklet version 1.0, – – The next version (2.0, 14-Jul-2017) of Yellow Baseline booklets will have clearer instructions for Form 1 Section D5. – Section D5 Date of haemodialysis session is this the patients first ever dialysis? – Yes. If only the Year is trial, please enter the date in this format: uu/uu/YYYY (where u is unknown). Date of first dialysis session is this the first dialysis session since BISTRO trial – randomisation? Yes. To which date the pre-dialysis BP/weight and post-dialysis weight/BP refers to? This is to establish the baseline for the BISTRO proceed with standard procedure in reporting pre-dialysis BP/weight and post-dialysis weight/BP at participating sites. Which envelopes should I use for what function? There are 3 types of envelopes provided by Sponsor: Small envelope for signed consent forms only it is marked as – – “CONFIDENTIAL”, you can post more than 1 signed consent form per envelope A4 Keele CTU self-addressed envelope (with gusset) for CRF (white, original – pages), Participant Questionnaires and MoCa Assessments this is provided with 1st or – 2nd class postage. A4 BISTRO Trial envelopes for Participant Questionnaires to be used locally by site – – teams this is optional. – If you require more envelopes please your request to the BISTRO trial team at Keele CTU. QUESTIONNAIRES MoCA Is this assessment available in different languages? – Yes. Please contact the Trial Manager to check if the language required is available. MoCA Can this assessment be administered to visually impaired participants? – Yes. Your participant can still be administered the MoCA, but you will have to skip the visual questions (top 2 rows, which would give you a potential total score of 8 points). So your participants MoCA becomes a Total Score of 22 instead of 30 - see below for conversion. MOCA-BLIND - How do I score the MoCA-Blind?
CRF Form 1 – Section D5 Clarification – Yellow Baseline Booklet version 1.0, The next version (2.0, 14-Jul-2017) of Yellow Baseline booklets will have clearer instructions for Form 1 – Section D5. Section D5 Date of haemodialysis session – is this the patients first ever dialysis? Yes. If only the Year is please enter the date in this format: uu/uu/YYYY (where u is unknown). Date of first dialysis session – is this the first dialysis session since BISTRO trial randomisation? Yes. To which date the pre-dialysis BP/weight and post-dialysis weight/BP refers to? This is to establish the baseline for the BISTRO trial, proceed with standard procedure in reporting pre-dialysis BP/weight and post-dialysis weight/BP at participating sites. Which envelopes should I use for what function? There are 3 types of envelopes provided by Sponsor: Small envelope – for signed consent forms only – it is marked as “CONFIDENTIAL”, you can post more than 1 signed consent form per envelope A4 Keele CTU self-addressed envelope (with gusset) – for CRF (white, original pages), Participant Questionnaires and MoCa Assessments – this is provided with 1st or 2nd class postage. A4 BISTRO Trial envelopes – for Participant Questionnaires – to be used locally by site teams – this is optional. If you require more envelopes please your request to the BISTRO trial team at Keele CTU. QUESTIONNAIRES MoCA – Is this assessment available in different languages? Yes. Please contact the Trial Manager to check if the language required is available. MoCA – Can this assessment be administered to visually impaired participants? Yes. Your participant can still be administered the MoCA, but you will have to skip the visual questions (top 2 rows, which would give you a potential total score of 8 points). So your participants MoCA becomes a Total Score of 22 instead of 30 - see below for conversion. MOCA-BLIND - How do I score the MoCA-Blind?
BISTRO_FAQs_v1.0_24Aug2017_a.docx