[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section bb_built=”1″ use_custom_gutter=”on” gutter_width=”2″ specialty=”on” parallax_method_1=”off” parallax_method_2=”off” _builder_version=”3.0.74″ transparent_background=”off” prev_background_color=”#000000″ next_background_color=”#1d1d1d”][et_pb_column type=”1_3″][et_pb_sidebar admin_label=”Left Nav Sidebar” area=”et_pb_widget_area_1″ show_border=”off” module_id=”left-nav-menu” _builder_version=”3.0.74″ remove_border=”on”]<\/p>\n
[\/et_pb_sidebar][\/et_pb_column][et_pb_column type=”2_3″ specialty_columns=”2″][et_pb_row_inner admin_label=”Row” _builder_version=”3.0.47″][et_pb_column_inner type=”4_4″ saved_specialty_column_type=”2_3″][et_pb_text admin_label=”Information for healthcare professionals (copy)” _builder_version=”3.17.6″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” module_alignment=”left” use_border_color=”off”]<\/p>\n
Information for healthcare professionals<\/h1>\n
Find all the resources you need to process information about participants in the BILAG BR Study.<\/p>\n
[\/et_pb_text][et_pb_accordion _builder_version=”3.17.6″ border_color_all=”#ffffff” use_border_color=”off”][et_pb_accordion_item title=”Introduction ” open=”off” _builder_version=”3.17.6″ title_text_shadow_horizontal_length=”0em” title_text_shadow_vertical_length=”0em” title_text_shadow_blur_strength=”0em” body_text_shadow_horizontal_length=”0em” body_text_shadow_vertical_length=”0em” body_text_shadow_blur_strength=”0em”]<\/p>\n
Download an introductory presentation to BILAG BR<\/a> (PowerPoint required)<\/p>\n [\/et_pb_accordion_item][et_pb_accordion_item title=”Entering data” open=”off” _builder_version=”3.17.6″ title_text_shadow_horizontal_length=”0em” title_text_shadow_vertical_length=”0em” title_text_shadow_blur_strength=”0em” body_text_shadow_horizontal_length=”0em” body_text_shadow_vertical_length=”0em” body_text_shadow_blur_strength=”0em”]<\/p>\n If you are on the study delegation log for your centre and need a log in for the database, please contact the study team for this.<\/p>\n Please enter data for BILAG BR <\/strong>participants on the data entry website<\/a>.<\/p>\n [\/et_pb_accordion_item][et_pb_accordion_item title=”Documents” open=”off” _builder_version=”3.17.6″ title_text_shadow_horizontal_length=”0em” title_text_shadow_vertical_length=”0em” title_text_shadow_blur_strength=”0em” body_text_shadow_horizontal_length=”0em” body_text_shadow_vertical_length=”0em” body_text_shadow_blur_strength=”0em”]<\/p>\n Download all current documents for the study in a ZIP file<\/a> (3.6MB)<\/p>\n This includes all documents to consent, register and follow up participants on the study. If you are having any problems downloading these documents, please contact the team<\/a> and they will send you a zip file containing all current documents. <\/p>\n You can also download a delegation log<\/a> and enrolment log<\/a> for your records. <\/p>\n [\/et_pb_accordion_item][et_pb_accordion_item title=”Study recruitment” open=”off” _builder_version=”3.17.6″ title_text_shadow_horizontal_length=”0em” title_text_shadow_vertical_length=”0em” title_text_shadow_blur_strength=”0em” body_text_shadow_horizontal_length=”0em” body_text_shadow_vertical_length=”0em” body_text_shadow_blur_strength=”0em”]<\/p>\n A participant must give their consent before registration with the study.<\/p>\n It is preferred that all local staff working on the study who are responsible for obtaining consent undertake good clinical practice (GCP) training at the frequency specified by their Trust.<\/p>\n The participant should be given or sent a copy of the patient information sheet to read before signing the consent form for the study and patients must have the study information for at least 24 hours prior to consent.<\/p>\n To register a patient send a copy of the completed registration and consent form to the study team. Alternatively, this can be uploaded directly onto the BILAG BR database, where it will be encrypted and stored securely.<\/p>\n We can only accept these by encrypted email or post, so please do not<\/strong> send by regular email. We will then add the patient to the study database and their record will become available for online data entry.<\/p>\n [\/et_pb_accordion_item][et_pb_accordion_item title=”Data and sample collection” open=”on” _builder_version=”3.17.6″ title_text_shadow_horizontal_length=”0em” title_text_shadow_vertical_length=”0em” title_text_shadow_blur_strength=”0em” body_text_shadow_horizontal_length=”0em” body_text_shadow_vertical_length=”0em” body_text_shadow_blur_strength=”0em”]<\/p>\n You will need to collect routine clinical data, including disease activity measures, from patients at regular time points, and submit it using the online study database. We ask for this data:<\/p>\n However, as an observational study, we realise that clinic appointments may not always fit exactly with our follow up time points. If you are unsure about how to enter particular data, please contact us<\/a>.<\/p>\n ***Sample collection for the BILAG BR has now stopped***<\/strong><\/p>\n We also ask for blood and urine samples to be collected:<\/p>\n The table below has more details.<\/p>\n Type of participant<\/strong><\/p>\n<\/td>\n Prospective \u2013 samples collected before (next) treatment<\/strong><\/p>\n<\/td>\n Retrospective – samples collected after treatment<\/strong><\/p>\n<\/td>\n Biologic Retreatment of same biologic<\/strong><\/p>\n<\/td>\n<\/tr>\n <\/strong><\/p>\n<\/td>\n New Biologic Treatment (including switching within study) \/ Control<\/strong><\/p>\n<\/td>\n Control to biologic switch<\/strong><\/p>\n<\/td>\n 1st<\/sup> Biologic Treatment<\/strong><\/p>\n<\/td>\n<\/tr>\n Baseline<\/strong><\/p>\n<\/td>\n Red plain tube;<\/strong><\/p>\n purple EDTA tube<\/strong>;<\/p>\n blue mRNA tube<\/strong>;<\/strong><\/p>\n urine sample<\/p>\n<\/td>\n Red plain tube<\/strong>;<\/p>\n purple EDTA tube<\/strong>;<\/p>\n urine sample<\/p>\n <\/p>\n<\/td>\n Red plain tube<\/strong>;<\/p>\n purple EDTA tube<\/strong>;<\/p>\n urine sample<\/p>\n<\/td>\n<\/tr>\n 6 month<\/strong><\/p>\n<\/td>\n Red plain tube<\/strong>;<\/p>\n purple EDTA tube<\/strong>;<\/p>\n blue mRNA tube<\/strong>;<\/strong><\/p>\n urine sample<\/p>\n<\/td>\n Red plain tube<\/strong>;<\/p>\n purple EDTA tube<\/strong>;<\/p>\n urine sample<\/p>\n <\/p>\n<\/td>\n <\/p>\n No samples collected<\/p>\n<\/td>\n<\/tr>\n 12 month<\/strong><\/p>\n<\/td>\n Red plain tube<\/strong>;<\/p>\n purple EDTA tube<\/strong>;<\/p>\n urine sample<\/p>\n<\/td>\n No samples collected<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Patient questionnaires<\/strong> Patients will be asked to complete a set of questionnaires at regular intervals. For prospectively recruited patients, we would like to have these completed as close to the start of therapy as possible, we would therefore ask that these are given out in the clinic, with a prepaid envelope for their return. Otherwise, these will be sent out by the study team.<\/p>\n [\/et_pb_accordion_item][\/et_pb_accordion][\/et_pb_column_inner][\/et_pb_row_inner][\/et_pb_column][\/et_pb_section][et_pb_section bb_built=”1″ admin_label=”Connect Title” module_class=”footer-section” _builder_version=”3.0.90″ background_color=”#1d1d1d” custom_padding=”0px||0px|” prev_background_color=”#ffffff” global_module=”380″][et_pb_row admin_label=”row” global_parent=”380″ parallax_method_1=”off” parallax_method_2=”off” parallax_method_3=”off” module_id=”footer-row” _builder_version=”3.0.89″ locked=”off”][et_pb_column type=”1_3″][et_pb_text admin_label=”Contact Us Title” global_parent=”380″ _builder_version=”3.0.74″ text_text_color=”#ffffff” background_size=”initial” background_position=”top_left” background_repeat=”repeat” background_layout=”dark”]<\/p>\n [\/et_pb_text][et_pb_text admin_label=”Contact Us” global_parent=”380″ module_class=”contact-us” _builder_version=”3.0.87″ text_text_color=”#aaaaaa” background_size=”initial” background_position=”top_left” background_repeat=”repeat” use_border_color=”off” border_color=”#ffffff” border_style=”solid”]<\/p>\n +44 (0) 161 306 6000<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″][et_pb_text admin_label=”Find Us Title” global_parent=”380″ _builder_version=”3.0.74″ text_text_color=”#ffffff” background_size=”initial” background_position=”top_left” background_repeat=”repeat” background_layout=”dark”]<\/p>\n [\/et_pb_text][et_pb_text admin_label=”Address” global_parent=”380″ module_id=”address” _builder_version=”3.0.87″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” background_layout=”dark” use_border_color=”off” border_color=”#ffffff” border_style=”solid”]<\/p>\nData collection<\/h2>\n
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Sample collection<\/h2>\n
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