ELECTRONIC DATA CAPTURE SYSTEM USER GUIDE

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The EDC for the Valentines Trial II will be used for data submission and data management during the trial. Upon identification of an eligible patient presenting with a De Novo lesion, who has undergone treatment with a DIOR drug-eluting balloon as part of the Valentines II Trial following all of your local regulatory requirements, a new record will be created in the Electronic Data Capture (EDC), and the electronic case report forms (eCRF) filled. A patient will only be considered a subject in the Valentines II Trial once the entire baseline eCRF has been completed and submitted.

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The eCRF is sub-divided into sections. The following sections are required for all subjects included in the Valentines Trial: 1.0 Inclusion Criteria 2.0 Exclusion Criteria 3.0 Demographics/Medical History 4.0 Baseline Presentation 5.0 Cardiac Enzymes 6.0 Procedural Medications 7.0 Discharge 8.0 Procedure (Lesions) 9.0 PI Signature

In addition, section 10.0 Narrative Form is available for completion as needed for enrolled patients.

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The following web browsers are recommended for optimal function of the Valentines Trial EDC:  Internet Explorer 7

 Internet Explorer 8  Firefox 3

 Safari 4

 Google Chrome 1.0

No plug-in or ActiveX Controls are needed, however cookies and Javascript must be enabled under browser settings for proper functioning of the EDC. In addition, screen resolution should be, at minimum, 1024x768 to view the site adequately.

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1. VALENTINES IITRIAL WEB ADDRESS

The Valentines II Trial EDC is located at the following web address: http://valentinesii.clinicalunity.com/ and may also be accessed via a link on the Valentines II Trial website, accessed via the following web address:

http://www.valentines-trial.com/. The Home screen has information regarding the Valentines II Trial, Technical

Requirements, and brief instructions for Submitting/Updating cases.

In the left margin of the webpage, there are links for Home, About and Contact. The Home link allows the user to return to the main screen of the EDC with the information described above. The About link provides a brief description of the Valentines II Trial. The Contact link provides the email address where EDC issues should be reported and technical assistance in using the EDC may be requested by the user. The email address

[email protected] should be used for all EDC related questions or concerns. Also located in the left

margin of the webpage is the link for the user to log in to the EDC.

2. USERNAMES AND PASSWORDS

Username and password combinations will be assigned to approved users, and will be provided via email prior to initiation of the trial. Usernames and passwords are case sensitive and must be entered in the initial log-in screen (pictured below) to access the EDC system. If there are issues with accessing the EDC, requests for new users to be added, or if a user name or password needs to be reset, please send inquiries to the technical support team via email address [email protected].

By clicking on the Login link on the main screen the user will access the Login screen. To access the EDC enter the assigned Username and Password, and click the Log In button. After logging in to the system, if the EDC is left inactive for 30 minutes or more, the system will time out and the user will have to log in again via the Login screen.

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After logging in to the EDC, the user will see the user name that is logged into the system in the top left corner of the screen. In addition, to the Home, About, and Contact links available prior to logging in to the system, a Logout link and a Patient Data link will be visible in the left margin of the webpage.

 Home: this button will navigate the user to the main information screen.

 About: this button will navigate the user to the general description of the Valentines II Trial.  Contact: this button will navigate the user to the email contact for technical questions and support

for the EDC.

 Patient data: this button is used to create a new subject record or to access existing subject records. The baseline electronic case report form fields, new and existing, may be accessed via the “Patient Enrollment” option in the Patient data link. After following the link for “Patient Enrollment all existing patient data may be accessed and edited via the “Patients in the study” table, new patients may be added via the New Patient ID field, and all eCRF sections may be accessed for the selected existing or new patient.

Log Out: this button will log the user out of their account.

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1. PATIENT IDENTIFICATION AND TRACKING

Each subject in the Valentines II Trial will be identified with a Patient ID. The site will assign a unique identifier in a numeric format to each subject. This field must not include patient identifiers, such as names, initials, or numeric codes that may be linked to the patient outside of the study records. This Patient ID will be maintained by the site personnel, and will be used to link the patient to the record, so the record can be easily identified for modification to the existing eCRF, or addition of follow up eCRFs after the initial eCRF data submission.

To create a new record in the EDC, the unique Patient ID assigned to the patient by the site must be entered in the New Patient ID field. Once a unique New Patient ID has been entered, click the “Add” button to create a new record for the Patient ID.

After clicking Add, if the Patient ID was successfully added, a confirmation message will appear.

The patient ID will then appear in the “Patients in the study” list as denoted below:

All patients entered at a site will be viewable and accessible for data entry and data editing from this list by all site users. This list of patient eCRFs can be sorted in ascending or descending order by clicking on the blue underlined column header.

Duplicate patient IDs cannot be assigned within a site. If a Patient ID is a duplicate the following message will appear next to the addition section:

Once the patient eCRF has been selected the eCRF will be highlighted in the summary list in pink.

The eCRF sections below the “Patients in study” table will display the data entered for the selected subject in the table, or blank sections that may be completed for the selected subject. The eCRF sections can be expanded for data entry, data review or data signature by clicking the respective blue arrows. A downward facing blue arrow indicates the eCRF section is hidden. An upward facing blue arrow indicates the form is displayed. When a patient is selected the patient ID will appear at the top of each expanded form below the red header label.

2. ECRFCOMPLETION

a. SECTION COMPLETION

Each section of the eCRF can be expanded and collapsed using the blue arrow adjacent to each section header. Upon initial data entry in each section, the fields must be added by clicking the “Add” button. For example, to enter the Exclusion Criteria; first expand the section by clicking the blue arrow to the left of the form name, then click Add to access the data fields.

All information recorded in the eCRF section should be obtained from the medical record or other source documents. Answer all items on each form. If certain required data elements are missing, the data that has been entered will not save unless the missing information is reconciled. If a required element is left blank and save is attempted for the section, a “*Required” label will appear next to the applicable field. Data will not be saved in the eCRF section until the required data has been added. If data is entered in a field in the incorrect format for that field (example: text entered in a numeric field, see below), a message will appear notifying the user of the data format error. Data will not be saved in the applicable section of the eCRF until the data entry is corrected or removed. Save each section after data entry has been completed by clicking the Save button. Once data is saved, the section will be disabled, and may only be edited by clicking the Edit button. The entered, unsaved data entry can be undone by clicking Cancel. If Cancel is clicked on a form which has not been saved, all entered data will be deleted.

Once data has been entered in a given section the data can be edited by clicking Edit for the expanded section.

The original Save and Cancel buttons will be accessible once in edit mode. b. REPEATING ELEMENTS

Several sets of fields in the eCRF may be completed more than once per patient record, and are therefore repeating elements. The repeating elements are included in the following sections of the eCRF:

8.0 Procedure

 Data regarding multiple lesions may be entered into the eCRF 8.9 thru 8.14 Drug Eluting Balloon Details

 Data regarding multiple DEBs may be entered into the eCRF

For all repeating elements, additional sets of blank fields may be added using the Add button (example ) after the first form has been saved. This button is located at the bottom and top of

each section that has the repeating function as listed above. To modify an existing repeating record, access the applicable record, and click the Edit button (example ) to modify the data, and save changes. Once multiple records have been created, a user may navigate through the records using the First, Previous, Next and Last links, as well as the record number links at the bottom of the section (see below).

3. ECRFFIELD TYPES

When completing free text fields (example: ), abbreviations and symbols should be avoided. To complete fields with radio buttons (example: ), select the single best choice by clicking the adjacent circle. For fields with check boxes (example: ), check all that apply.

4. DAYS CALCULATOR

The Days Calculator is located on the left panel of the screen, and can be utilized for all fields that require the reporting of “Days” between two dates. The “Date 1” and “Date 2” fields allow use of the calendar, which will be automatically accessed by clicking in these fields. A date can be selected on the calendar, or a date can be manually typed into the field in mm/dd/yyyy numeric format. After the input of two dates, to have the calculator display the days difference click the Days button below the Date 2 entry field.

5. DATA SAVING

Data in the eCRF is saved section by section. Once all required data has been entered into each section of the eCRF, click the “Save” button, located on the bottom left side of the eCRF section, to save the data. If the user does not wish to save the data, the Cancel button may be used to clear or undo all unsaved, entered data in the eCRF section. The Save, Cancel and Edit buttons only affect the data in the applicable section of the eCRF.

Once the Save button has been clicked, the user will not be able to update or change the data without clicking the Edit button.

7. PRINCIPAL INVESTIGATOR (PI)SIGNATURE

Once all sections of the eCRF have been filled with accurate and complete data, the PI will be required to apply his or her signature. The PI signature certifies his or her agreement that the data is complete and accurate in all sections of the eCRF for the subject. Only PI users at each site will have to ability to sign the patients’ records. For all other users, the signature fields will appear as inactive. To sign the eCRF, the PI must be logged into his or her account, and access the applicable patient and section of the eCRF. The signature box will list the record as Not approved until the signature has been applied. To apply the signature, the PI must enter his or her password in the applicable field, and click the Approve button. After the signature has been applied, the signature box will list the submission status as Approved.