e-CRF Overview Oracle® Clinical Remote Data Capture Training (Version 4.6 HTML) e-CRF Completion John McDonach Manager CDM, PPD

E-CRF Completion General Instructions E-CRF is to be completed within 2 days after completion of a study visit/assessment At the time of LPLV the data should be entered within 24 hrs Connect every day to the database during preparation for the database lock periods Complete CRFs and respond to queries within 1 day during database lock periods Check your site status regularly in Oracle RDC: missing pages, data entry status, and query status 2

Page Availability Until the patient is indicated as eligible for study entry (Screening log) only the pages required for screen failures will be available. Remainder of screening pages and later visits will become available when eligibility is confirmed. Pregnancy test pages will only be available for entry once patients gender has been entered as female and of child bearing potential on the Vis_Demog page. The following pages; Ae Yn, Priorcm_Yn , Conmeds_Yn, Trans_Yn, Med_Hx_Yn, are lead in pages. A response of ‘Yes’ is required before the ‘Data’ pages are available to enter data.

Example of Lead in Page Ae_Yn, ‘Yes’ is selected

Single Part Date Field Considerations Dates can be inserted using the Pop-up Calendar or by manually entering the date into any date field. If partial or unknown dates are allowed in the body of the eCRF, enter 00 in the field that is unknown. Example unknown day: 00-APR-2008 Example unknown day and month: 00-00-2005 Note: Very few dates where only year is acceptable. Certain dates such as AE’s full date is expected. Discrepancy will always fire where full date is not used, just need to confirm response. Please Note: The date should always be recorded using the DD-MON-YYYY format. No other date format should be used as the system will interpret dates entered as DD-MM-YYYY in US format (i.e. date of 12 February 2008 that was entered as 12-02-2008 would automatically be updated to 02-DEC-2008 by the system).

Screen Failures Patients who sign an informed consent but fail to be started on treatment for any reason will be considered a screen failure. ‘Screen failures’ data must be recorded on the following eCRF pages: Demography eCRF. Informed Consent eCRF. Inclusion/Exclusion eCRF. Screening Log eCRF. Adverse event (AE) eCRF should be completed for any Serious Adverse Events (SAEs) that occurred during the screening phase.

eCRF Completion at Visit 1 Informed consent should be one of the first pages to be completed (enter at the same time as Demography) Mention Summary page

Dosage Administration Record eCRF ‘Day 1’ - if and when a subject gets randomized and takes their first dose - it would be strongly advised to complete the start date of that first dose in the DAR (summary pages)

Adding an additional assessments page – Add Other Pages – e. g Adding an additional assessments page – Add Other Pages – e.g. Hematology

Fact-Lym e-CRF The questionnaire pages are very busy and you may find that it takes longer than other pages to move from question to question. Care should be taken when entering data. Sometimes, if the person entering data is working very quickly, they may tab past one question by mistake. Upon saving the page please review the questionnaires for consistency with your responses. 10

Fact-Lym e-CRF (5 Pages) 11

Question Availability Certain pages may not be available for entry (Greyed out) until appropriate response is provided. 12

Medical Resource Use e-CRF Medical resource use – Review against potential adverse events/serious adverse events. Complete AE if the hospitalization is due to the following: Non-routine treatment or monitoring of the studied indication, and associated with any deterioration in condition Not elective or pre-planned treatment for a pre-existing condition unrelated to the indication under study and has worsened since signing the informed consent Treatment on an emergency outpatient basis for an event fulfilling any of the definitions of a SAE and not resulting in hospital admission Social reasons and respite care due to any deterioration in the patient’s general condition

Laboratory Results e-CRF Laboratory Pages with ranges associated with fields Discrepancy will fire if value is not in expected range Should be recorded as an absolute value and not % Should be recorded as a % and not an absolute value

Laboratory Results e-CRF Contd. - Laboratory number The Laboratory Number entered will be advised by the Field Monitor. This will consist of the Study Site number and the number assigned by the Field Monitor to the Normal Laboratory Ranges received from the local laboratory. The first 3 digits will define the center number. This four-digit site number will be pre-defined by the Novartis Project Liaison Manager (range 0001-9999). The last 2-digits will define the laboratory used (01-99) and the applicable lab ranges. This number is assigned by the FM. e.g. : the Lab Number for site 0301 lab 01 should be recorded as “30101”. If a secondary laboratory is used, this will be assigned a new unique lab number by the Field Monitor and the normal ranges received from the secondary lab will be submitted.