Data Management Data capture & electronic Case Report Form - - PowerPoint PPT Presentation

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Data Management

Data capture & electronic Case Report Form

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Introduction

• GARFIELD investigators enter clinical data into the

electronic Case Report Form (eCRF)

• The eCRF is provided by Dendrite Clinical Systems,

Henley-upon-Thames, UK

• The eCRF is the main point of interaction with the

study for investigators, but there are other important

• nline resources:

– GARFIELD website – GARFIELD training portal

• Quintiles initiating sites using training portal
• TRI will manage portal access once start-up process completed

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eCRF History

• To date over 22,000 patients have been enrolled in the eCRF in

Cohorts 1 and 2

• Cohort 3 recruitment began on 20 June 2013

– Patients are eligible if and only if date of AF diagnosis is after 22 April 2013

• The eCRF has been updated and the changes have been implemented

from the launch of Cohort 3

• Changes to the eCRF have been made to:

1. Make the system more intuitive and easier to use 2. Refine the clinical data being captured to improve future analyses

• Changes were made in response to feedback and proposals made by

GARFIELD investigators

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CRF CONTENT

Patient data journey

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Patient data journey

4 MONTHS 6 WEEKS

DATE OF DIAGNOSIS DATE OF ASSESSMENT 4-MONTH FOLLOW-UP 8-MONTH FOLLOW-UP 12-MONTH FOLLOW-UP 16-MONTH FOLLOW-UP 20-MONTH FOLLOW-UP 24-MONTH FOLLOW-UP

4 MONTHS 4 MONTHS 4 MONTHS 4 MONTHS 4 MONTHS

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• Date of diagnosis is the date that a patient is first diagnosed with atrial fibrillation
• The patient must be assessed for eligibility according to the registry inclusion/exclusion criteria within 6

weeks of diagnosis

• Baseline data should be entered once the patient is assessed

as eligible and has provided written informed consent

• Baseline data should reflect the status of the patient

at the time of diagnosis

• 6 baseline data pages

Patient data journey: baseline

4 MONTHS 6 WEEKS

DIAGNOSIS ASSESSMENT 4-MONTH 8-MONTH 12-MONTH 16-MONTH 20-MONTH 24-MONTH

4 MONTHS 4 MONTHS 4 MONTHS 4 MONTHS 4 MONTHS

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Entering a new patient

1. Create the record 2. Confirm eligibility and enrol patient

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Demographics at diagnosis

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AF Diagnosis

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Treatment at diagnosis (Treatment)

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Treatment at diagnosis (Stroke prophylaxis)

Similar set of questions asked for Antiplatelet drugs

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Cardiovascular history (Cardiovascular history)

Grey questions are conditional on previous questions (only required if brought live by previous answer)

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Cardiovascular history (More cardiovascular history)

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Additional medical history

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Patient data journey: events

4 MONTHS 6 WEEKS

DIAGNOSIS ASSESSMENT 4-MONTH 8-MONTH 12-MONTH 16-MONTH 20-MONTH 24-MONTH

4 MONTHS 4 MONTHS 4 MONTHS 4 MONTHS 4 MONTHS

• Event data should be entered throughout the patient’s time in GARFIELD
• 9 event data pages
• For patients treated with

VKAs, INR values should be entered as well as events

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Event summary page

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Rhythm/Vital signs

Included within Event summary page (captured as part of every event)

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Stroke/TIA

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Bleed

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Peripheral embolism

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Myocardial infarction/Acute Coronary Syndrome

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Cardioversion

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Hospitalization/Procedure/Consultation

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Treatment change/interruption (treatment change)

This page is auto-populated with previous data (baseline or most recent event). Only new information requires entry.

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Treatment change/interruption (Stroke prophylaxis)

This page is auto-populated with previous data (baseline or most recent event). Only new information requires entry. Similar set of questions asked for Antiplatelet drugs

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Medical history update (Cardiovascular update)

This page is auto-populated with previous data (baseline or most recent event). Only new information requires entry.

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Medical history update (Additional med. hist. update)

This page is auto-populated with previous data (baseline or most recent event). Only new information requires entry.

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Patient data journey: end-of-study events

4 MONTHS 6 WEEKS

DIAGNOSIS ASSESSMENT 4-MONTH 8-MONTH 12-MONTH 16-MONTH 20-MONTH 24-MONTH

4 MONTHS 4 MONTHS 4 MONTHS 4 MONTHS 4 MONTHS

• Patients can exit the study prior to 24 months of follow-up if an end-of-study event occurs
• 3 end-of-study event pages
• End-of-study events must

be locked using the principal investigator PIN

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Death Lost to follow up & Patient withdrew consent

Included as part of Event summary page

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Patient data journey: follow-up records

4 MONTHS 6 WEEKS

DIAGNOSIS ASSESSMENT 4-MONTH 8-MONTH 12-MONTH 16-MONTH 20-MONTH 24-MONTH

4 MONTHS 4 MONTHS 4 MONTHS 4 MONTHS 4 MONTHS

• Follow-up records act as data milestones to confirm that all data has been entered for a 4-month period
• GARFIELD is strictly observational: no patient visit is mandated for the follow-up record
• When a follow-up record is locked, the data entered prior to this milestone is eligible for analysis
• A follow-up record can only be locked if all previous follow-up records are locked

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Follow-up records

All previous follow-up records must be locked before a follow-up record can be locked All events must have been entered and all fields completed before a follow-up record can be locked

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INR values can be entered as part of events or follow-up records

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CRF FUNCTIONALITY

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Patient data journey

4 MONTHS 6 WEEKS

DATE OF DIAGNOSIS DATE OF ASSESSMENT 4-MONTH FOLLOW-UP 8-MONTH FOLLOW-UP 12-MONTH FOLLOW-UP 16-MONTH FOLLOW-UP 20-MONTH FOLLOW-UP 24-MONTH FOLLOW-UP

4 MONTHS 4 MONTHS 4 MONTHS 4 MONTHS 4 MONTHS

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Enter Clinical Data

• Proceed to eCRF

Export my Data

• Download Excel sheet of site data

Documents

• Study-related documents available to download (e.g. protocol)

Entry into database

“Site information” page

Site information page

Functionality This page has to be completed by every site, but only has to be completed once. The page appears when a user logs in (and appears again at each login until it is completed). Answers should apply to the investigating centre (not particular investigators or patients). The page must be locked using the principal investigator pin (PI PIN). The page asks the following 3 questions: 1. Site care setting 2. Site research experience 3. Site ethics committee/IRB name Reason To provide specific information about GARFIELD investigator sites.

TRI32

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Patient demographics screen

Patient records are colour coded according to data status

Features of Patient demographics page

Patient demographics page

Functionality 1. Summary table shows number of patients enrolled 2. Cohort identification 3. Name of event included along with date of event (in drop down menu) 4. Only possible to enter a new follow-up record if a follow-up record is due 5. “Events” and “Followup records” listed separately

3 4 5 1 2

TRI82, Q20, Q23, TRI38, Q8, Q18

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Navigation

Previous page and Next page navigate between pages in baseline and event sections Save & Exit saves any changes to the section and returns user to summary screen Drop down menu can be used as shortcut to any page in a baseline or event section Double click on a record to open baseline pages Use drop-down menu to select events/follow-up records already entered Use New button to create events and follow-up records New patients can be added from this screen

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Inclusion & Exclusion criteria page: Incomplete Patient

All fields must be completed before a patient can be enrolled

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Inclusion & Exclusion criteria page: Ineligible patient

All eligibility criteria must be met before a patient can be enrolled If a record is created for a patient that is then found to be ineligible, that record should be HIDDEN

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Inclusion & Exclusion criteria page: Complete and eligible patient

Once all fields have been completed and all eligibility criteria have been met the patient can be enrolled

“Other cardiac medication” question

Treatment at diagnosis baseline page

Functionality Other cardiac medication question has been split into 2 parts in Cardiovascular history baseline page: 1. “Prior cardiac medication (present at AF diagnosis)” - to be completed according to patient’s medication at the time of their diagnosis with AF 2. "Continuing/new cardiac medication (continued after AF diagnosis)“ - to be completed according to patient’s medication continued after/started at the time of their diagnosis with AF

• Answers given in Prior question are pre-populated in Continuing question, and user can remove

medications that have been stopped to complete Continuing question (as well as adding any newly- started medications)

Reason It will be important to identify which medications are stopped at diagnosis in some of the data analyses.

TRI77

“Cardiac condition” question

Cardiovascular history baseline page

Functionality Cardiac condition question has been split into 2 parts in Cardiovascular history baseline page: 1. History of cardiac condition (to be completed according to entire medical history) 2. Current cardiac condition (to be completed according to cardiac condition at the time of diagnosis)

• Answers given in History question are pre-populated in Current question, and user can remove

cardiac conditions that have been resolved to complete Current question

Reason It will be important to distinguish between historical conditions and current conditions in some of the data analyses.

1 2

TRI85c

Baseline bleeding history

Bleeding history baseline page

Functionality If users selects “Yes” in “History of bleeding”, then a “Bleeding history” page is created. Functionality of Bleeding history baseline page: 1. Possible to delete individual historical bleeding events entered in Bleeding history baseline page 2. Only possible to select “No” in answer to “History of bleeding” (Cardiovascular history baseline page) if there are zero bleeding events in the Bleeding history baseline page. Reason To ensure complete and accurate entry of historical bleeding data. Users cannot change the answer of “History of bleeding” from “Yes” to “No” unless there are zero bleeding events in the Bleeding history baseline page.

1 2

TRI57a, TRI57b

Event summary page captures some information for all events

Event summary page

Functionality The Event summary page serves two purposes: 1. To create additional event pages 2. To capture general information related to all events (not specific event type) Reason To ensure consistent entry of key data points. To simplify data entry by removing duplication through a single point of data entry.

TRI48, Q41, Q41a

1 2

Features of Event summary page

Event summary page

Change 1. All questions on Event summary page must be answered for each event

• Unknown/Not measured options are available in case vital signs/rhythm are not available

2. Event can be created just for completion of Event summary page questions

• Changes to vital signs/rhythm should be entered as an event if they are measured in isolation

3. There is a prompt and link from the Follow-up record if any vital signs/rhythm measurements have not been entered Reason for change To ensure comprehensive data capture for every event.

2 1

Q41b, Q41c

3

Hospitalization/Procedure page to be completed as part of all clinical events

Hospitalization event page

Change Hospitalization page will automatically be added to all clinical events

• User is prompted and given opportunity to remove Hospitalization/Procedure page if appropriate

Reason for change A Hospitalization page should be included as part of all clinical events (unless the event occurred without the patient requiring and hospitalization/medical consultation/procedure).

• Clinical events are defined as the following: Stroke/TIA, Peripheral embolism, Bleed, MI/ACS, Cardioversion

TRI88

Hospitalization/Procedure page to be completed as part of all clinical events

Hospitalization event page

Functionality Reason for medical contact question is only asked if no clinical event is selected

• No duplication of data entry: question is not presented if a clinical event is selected

Reason If a Hospitalization page is entered along with a clinical event, then it is inferred that the clinical event is the reason for medical contact. A Hospitalization page should be included as part of all clinical events (unless the event occurred without the patient requiring and hospitalization/medical consultation/procedure).

• Clinical events are defined as the following: Stroke/TIA, Peripheral embolism, Bleed, MI/ACS,

Cardioversion

If no clinical event is selected If a clinical event is also selected TRI88a, TRI88b

“Intervention required” question captures cardiovascular procedures

Hospitalization event page

Functionality All surgical procedures should be entered in the Hospitalization event page. Reason The Hospitalization event page should be used to capture all interventions and procedures. Ablation should always be entered as a procedure in Hospitalization event page. All/any ablations that occur after the date of diagnosis should be entered as a procedure in Hospitalization event page (even if it occurred before the date of assessment).

TRI92, TRI92a, TRI92b

Cardioversion event page can be created from baseline as well

Cardioversion event page

Functionality Data related to cardioversion will always be captured in the Cardioversion event page. If a cardioversion is performed before the baseline data is entered into the eCRF, then ticking “Yes” in the cardioversion question at baseline will create a Cardioversion event page (and associated Hospitalization/Procedure page), and information relating to the procedure should be entered in the event pages. Reason Cardioversion is frequent amongst newly-diagnosed AF patients, and will be an important area of investigation in GARFIELD. The Cardioversion event page allows comprehensive and consistent data entry for cardioversion procedures regardless of when they are performed.

Baseline (Treatment at diagnosis) Follow-up (Event summary) TRI67

“Clear data” button in pre-populated event page

Medical history update event page

Functionality There is a “Clear data” button on the Medical history update event page. Clicking this button clears data from all fields on this page.

Reason The Medical history update event page pre-populates historical data so that users only have to update the fields that apply to a particular event, rather than re-enter data in all fields. However, it may be that so much has changed that the easiest way to enter the data is to clear all fields and begin data entry in a clear page. In order to un-select an event in the Event summary page, all fields in the event page must be cleared. Users can use the Clear Data button to clear all fields and then un-select the event in the Event summary page.

Q47

Treatment change/interruption can be deleted

Event summary page and Treatment change/interruption event page

Functionality The treatment change/interruption event page can be deleted from an event by un-ticking the event page name in the Event summary page. Un-ticking the event box in the Event summary page clears data from all fields on the page and deletes the page.

Reason The Treatment change/interruption event page pre-populates historical data so that users only have to update the fields that apply to a particular event, rather than re-enter data in all fields. However, clearing some fields in this page (e.g. Anticoagulant drugs) makes other fields required (e.g. Termination date). Therefore it is not possible to clear all fields prior to deleting the page. Un-ticking the event in the Event summary page automatically deletes the page without requiring the fields to be cleared.

Q47

“Treatment period” and “Treatment interruption” questions

Treatment baseline page, Treatment change/interruption event page

2 1

1. Treatment period question is asked for a particular drug class when that drug class is ticked in the “Anticoagulant drugs” question at baseline or in event pages (and similar questions are asked for drug classes ticked in “Antiplatelet drugs” questions). 2. When a drug class is selected, “Ongoing” is populated and the “Start date” field is active and required . 3. Unticking “Ongoing” unticks associated drug class field. 4. Unticking “Ongoing” makes “Termination date” field active and required (unless “Start date” field is blank, in which case entire question is inactive and not required). 1. Treatment interruption is conditional on “Ongoing” being ticked for associated treatment period question. 2. Ticking “Yes” makes “Start date” and “End date” fields active and required. 3. “Yes” can only be switched to “No” if both date fields are empty.

2 1

Change Reason for Change Information relating to the duration and interruption of antithrombotic treatment is essential for GARFIELD. All initiations, interruptions and terminations of antiplatelet and anticoagulant drugs should be entered in the eCRF.

TRI100

2 1

Automatic data clearing for Anticoagulant drugs questions

Treatment at diagnosis baseline page and Treatment change/interruption event page

Change It is no longer necessary to un-tick the conditional questions that follow the Anticoagulants drugs question in order to un-tick a particular anticoagulant drug class. Users can un-tick any anticoagulant drug class, and the system will automatically remove answers from the conditional questions that follow, (with a prompt: "This will clear the following related questions [lists related questions]. Do you want to continue?“). Reason for change To make it easier for users to update anticoagulant treatment information, in particular treatment switching/termination.

TRI64b

All treatment information to be entered in Treatment change page

Hospitalization/Procedure/Consultation event page, Treatment change/interruption event page

Reason Information relating to the duration and interruption of antithrombotic treatment is essential for GARFIELD. All initiations, interruptions and terminations of antiplatelet and anticoagulant drugs should be entered in the Treatment change/interruption event page.

TRI100

Functionality The first question in the Hospitalization event page asks whether there was a treatment change at this event – If Yes is selected, then a treatment change/interruption page is added to the event – All treatment changes should be captured in Treatment change/interruption (including peri-

• perative therapy)

“Cardiac condition” question

Medical history update event page

Functionality Cardiac condition question in Medical history update event page has two parts: 1. Cardiac condition (to be completed according to cardiac condition at the time of event) 2. Cardiac condition worsened (to be completed according to cardiac condition that has worsened since last event)

• It is only possible to select conditions for worsening that are selected in original Cardiac

condition question

Reason for change It will be important to record worsening cardiac conditions in some of the data analyses.

1 2

TRI85d

“Site of bleed” list does not include intra-cranial bleed

Bleeding event page

Functionality Answer options for “Site of bleed” do NOT include options for intra-cranial bleeds (intra-cranial bleeds should be entered in the Stroke event page) Reason Intra-cranial bleeds should be entered in the Stroke event page.

TRI89

Death in Bleeding event connected to Death page

Bleeding event page

Change If “Patient died” is selected in answer to “Outcome of bleed” in Bleeding event page, then a Death event page is automatically created. Reason for change It is not possible to record a fatal bleed without entering a Death event page.

TRI69

Primary endpoint checks at Follow-up record page

Follow-up record page

Change 3 questions seek to confirm non-occurrence of endpoints at Follow-up record page:

• These questions are only live if the original “Have all events been entered so far” question is answered “Yes”, and

if no death/stroke/bleed event had been entered in the preceding 4-month milestone period.

• These questions are used to prompt users to ensure that all events have been entered for each 4-month

milestone, and to identify records where the investigator is not certain that no event has occurred (even when no event has been entered).

Reason for change To ensure that all primary endpoint events are entered for every 4-month milestone.

TRI25

All fields must be completed

Baseline pages and Event pages

Functionality All fields in the baseline pages must include an answer before the baseline record can be locked. All fields in each event page must include an answer before a follow-up record can be locked. All fields have an answer option for “Unknown” (or “Not measured”). Reason All fields are important for data analyses, and investigators should only use the “Unknown” option if there is no way to find the answer to a particular question.

Q46

When all baseline fields are completed, user should lock baseline record

Baseline pages

Function Button for “Lock baseline record” Reason for change Users are required to lock the baseline record before any additional information (event pages, follow- up records) can be entered. All fields in the baseline pages must be locked before the baseline record can be locked. Clicking “Lock baseline record” whilst in the baseline pages locks the baseline record, but does not lock the entire patient record: event pages and follow-up records can still be entered.

Q34

Prompt to lock baseline record

Baseline pages

Functionality The system will prompt users to lock the baseline record when all fields in the baseline pages have been completed.

• The user will be prompted to lock the baseline record if they attempt to save and exit a record in which all

fields are complete. Reason To ensure that the baseline record is locked once all baseline data is complete. Users are required to lock the baseline record before any additional information (event pages, follow-up records) can be entered. All fields in the baseline pages must be complete before the baseline record can be locked.

Q30

Missing data list and hyperlinks to missing fields

Baseline and Follow-up record/event pages

Functionality 1. Each page prompts users about missing fields when clicking away from the page. 2. If a user attempts to lock a record (baseline or follow-up) when there is missing data, a list of fields that have not been completed is presented to the user to identify missing fields. The list will automatically direct users to missing fields via hyperlinks. Reason This resource is designed to make the completion of baseline and event pages simpler and easier for users. Users do not have to search for pages with missing fields before locking a follow-up record, but can use the missing data list to identify and open these pages to complete the data.

TRI81

1 2

End-of-study events require complete data

Death, Lost to follow-up, Patient withdrew consent event pages

Change An end-of-study event (Death, Lost to follow-up, Patient withdrew consent) cannot be locked until all previous data has been completed. An end-of-study event cannot be locked if a previous follow-up record is unlocked. An end-of-study event cannot be locked if a previous event page is missing data. Only principal investigators can lock a record. Reason for change Locking an end-of-study event closes the patient record, so that no additional data can be entered. Therefore all data should be entered and complete before an end-of-study event can be locked.

TRI54

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Follow-up records can be unlocked

Reason To ensure that all data is captured in the database, even when it is available after first lock. To make it easier for users to provide additional information about events that occurred in the past and have already been locked. Functionality Users can unlock locked follow-up records. A follow-up record can be unlocked even if a later follow-up record is already locked.

• For example, if the 4-month, 8-month and 12-month follow-up records are locked, the 8-month follow-up

record can now be unlocked without unlocking the 12-month follow-up record.

Languages

Functionality The eCRF is available in 15 languages. Reason There are GARFIELD investigators in 34 countries speaking 15 languages.

TRI47

Automatic logout period

All pages

Change The eCRF system has an automatic logout period set to 30 minutes. If a user is logged in for 30 minutes without taking any action, the system will automatically log the user out.

Reason for change The automatic logout period is in place to maintain the security of the system.

TRI19

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Audit Functionality

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SITE SUPPORT

Patient limit (30 patients per cohort)

When adding Patients Extension of quota beyond 30 is subject to TRI review: Requests for extension should be submitted to TRI "There is no quota available for this cohort"

Log in issues: Forgotten password

• Select the Login Help from

the Home screen

• Select Password reminder
• Submit Username

Log in issues: User already logged on

Message appears: User “already logged on” Add “/override” to Username and submit password

Always remember to Exit using this button

PIN Number Information

Records are often incomplete because PI PIN is missing End-of-study events and 24M follow-up require PI PIN. The PIN number is only applicable for the PI (Principal Investigator) and can

• nly be entered by users with designated PI accounts.

The record is not locked and completed until this PI PIN is entered. The baseline and 4M-20M follow-up records do not require the PIN to be entered.

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