ACRIN 4703 Detection of Early lung Cancer Among Military Personnel Study 1 (DECAMP 1): Diagnosis and Surveillance of Indeterminate Pulmonary Nodules

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1 ACRIN 4703 Detection of Early lung Cancer Among Military Personnel Study 1 (DECAMP 1): Diagnosis and Surveillance of Indeterminate Pulmonary Nodules Data Management Training Lindsey Dymond, Senior Research Associate ldymond@acr.org

2 Outline Registration Accessing the ACRIN Web Data Center Registering a Patient Data Collection Rave Setting up your account imedidata versus Rave EDC 4703 Rave General Rave EDC

3 Registration Accessing the ACRIN Web Data Center Registering a Patient

4 Registration Use the A0 worksheet to assess eligibility Collects Demographics and Inclusion/Exclusion Data All Patients are Registered through the ACRIN Web Data Center The web form matches the A0 worksheet

5 Registration Accessing the ACRIN Web Data Center

6 Access 4703 Registration

7 Select ACRIN- Protocols under the ACTIVE section

8 Enter your ACRIN login and password

9 Select Your Institution

10 Scroll to bottom of page and select Continue to Main Menu

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12 Registration Registering a Patient

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20 Data Collection Rave Setting up your account imedidata versus Rave EDC elearnings 4703 DECAMP 1 in Rave General Rave EDC

21 Rave Setting up your account

22 In order to set up your account, follow the instructions in the invitation from: imedidata Check your junk box if you do not receive it. Please remember the user name and password you specify it will be required at each login and for future access to imedidata and Rave

23 imedidata versus Rave EDC

24 imedidata vs Rave imedidata is the user portal you can access all Medidata Rave URLs you have permissions to from here Rave is the URL where the database is built and managed You will always sign in through imedidata Note: If you have an existing CTEP IAM account, you can also sign in through the CTSU portal

25 elearnings

26 Required and Optional elearnings Required These elearning's must be taken in order to gain access to EDC Rave 5.6 EDC Essentials for Clinical Research Coordinators (~45min) ECOG ACRIN Supplemental elearning (~10min) Optional Data Privacy Considerations for Clinical Systems (~50min) EDC Inspection Readiness for Clinical Sites (~30min) Access to assigned elearning's

27 4703 DECAMP 1 in Medidata Rave

28 After the case is registered via the ACRIN Web Data Center Sign into imediata using your user name and password

29 Select Rave EDC under ACRIN 4703 DECAMP 1 from your list of studies

30 Rave EDC Homepage

31 Subjects Home Page

32 This section is where all folders available for the patient can be found Icon Key Add Event This is where the folder, forms, and target dates are found.

33 Icon Key Available on Each Page

34 General DECAMP 1 Rave Layout Folders are titled by time point and form types Folders appear on the patient page in the order they should be completed Most forms are contained in folders Forms appear in the folders in the order they should be completed Folders/Forms are rolled out according to data entered in the existing forms For example, the medical history form does not appear in the Eligibility/Registration visit folder until it is indicated on the Registration Visit form the medical history was obtained

35 Initial Folders Enrollment Forms Contains registration (A0) data. All forms are read only Eligibility Registration Visit Contains forms that should be completed the day of registration Patient Completed Questionnaire Contains forms that the patient completed questionnaire data should be entered Biospecimen Collection Contains forms related to the biospecimen collection and transmittal to the core lab Follow up 2 Year Contains forms that should be completed 2 years (+/ 6 months) after registration All forms in the folder will be made available 1 ½ years after registration

36 The Enrollment Forms Folder Enrollment Forms is where the entered A0 data is available The primary form is the subject enrollment form. This form contains administrative data related to registration (case number, site #, enrollment date, etc )

37 Click on a folder to see the forms

38 Enrollment Forms All data in the enrollment forms folder and on the subject enrollment form is read only. Note: If there is an entry error, the revised A0 form confirmation must be sent into ACRIN HQ

39 Initial Folders Forms Eligibility/Registration Visit Folder Complete the Registration Visit Form 1 st If all protocol required procedures/assessments are completed, the corresponding forms will be added to the folder after the Registration Visit Form is saved Physical exam, medical history, concomitant medications, pulmonary function text/spirometry, and CT imaging forms Make sure to complete all questions on the form, some questions will appear after the form is saved Ex: If sputum instructions and sample collection kit are distributed to the patient, the date they were distributed to the patient will appear after the form is saved All Forms in the folder are required and can be considered complete when they have the icon Note: The Core Lab QC form is completed by the ACRIN imaging core lab technician and will be read only Initial View After Entry of Registration Visit Form

40 Initial Folders Forms Patient Completed Questionnaire Each form in Rave corresponds to a separate section of the paper Patient Completed Questionnaire Each section in the paper form has a title that corresponds to the form in Rave The Rave forms have the option of pt left field blank for all questions All questions must have an answer entered or it indicated the pt left the field blank A scanned copy of the completed questionnaire should be uploaded into Rave (on the Conclusion form) All Forms in the folder are required and can be considered complete when they have the icon

41 Initial Folders Forms Patient Completed Questionnaire

42 Initial Folders Forms Biospecimen Collection Forms should be completed right after the corresponding biospecimen collection is performed All forms in the folder are required Each form has a field to indicate if collection/transmittal was not done The Biospecimen Transmittal Forms should be completed once the samples are mailed to Boston All Forms in the folder are required and can be considered complete when they have the icon

43 Initial Folders Forms Follow up 2 Year This form is entry restricted until 6 months prior to the target date Example: The patient was registered September 20, 2012, the target date for completion of the folder is Sep 20, The form will be made available for data entry March 20, 2014 Target Date (grey) All forms in the folder are required The Study Evaluation and Diagnosis Form matches the Study Evaluation and Diagnosis worksheet Make sure that the logic instructed on the worksheet is followed when it is completed data entry is restricted to this logic All Forms in the folder are required and can be considered complete when they have the icon

44 Add Events Adverse Events Adds the Adverse Event folder, which contains the AE form that should be completed if a reportable adverse event occurs Follow up Adds the Follow up Folder, which contains forms that should be completed every time the participant has lung related SOC follow up Images Sent to Core Lab Adds the Images Sent to Core Lab Folder, which contains forms related to the submission of all lung related imaging done as part of SOC follow up Off Study Adds the Off Study Form, which should be completed if the patient withdrawals prior to study completion or at the end of the study

45 Add Events Adverse Events The Adverse Event folder will be added to the task list every time the event is added Adverse Event Reporting Only AEs that are considered possibly, probably, or definitely related to the study related biospecimens collection procedures require reporting to ACRIN (refer to your local IRB s policies and procedures regarding reporting of expected AEs) Refer to Section 10.0 of the Protocol for more details on Adverse Event Reporting When the folder is added, it contains only the Adverse Event Form Once the Adverse Event Form is saved, the form name is updated with the date of the AE If the AE is a serious adverse event, the Serious Adverse Event form will be added to the folder Initial View View after saving View after saving the AE, if it was marked as a SAE

46 Add Events Follow up This event should be added every time the patient has a lung related follow up visit The Follow up Add Event adds the SOC Follow up Visits Folder to the task list The SOC Follow up Visits Folder contains 2 forms, the SOC Follow up Form and the Study Evaluation and Diagnosis Form The folder name is updated with the date of SOC follow up after submission of the SOC Follow up Form SOC Follow up Form If the pt had surgery and samples were collected, the specimen transmittal forms will be added to the folder for entry Study Evaluation and Diagnosis Form Rave version of the Study Evaluation and Diagnosis Worksheet The worksheet must be completed by the patients treating physician, but can be entered by the site RA Initial View View after submission of SOC View after submission of SOC if surgical specimens were collected

47 Add Events Images Sent to Core Lab All imaging the patient has related to their lung SOC follow up should be submitted to ACRIN This does not include the imaging done that determined eligibility, which is submitted in the Eligibility/Registration Visit Folder Each time imaging is submitted, the Images Sent to Core Lab event should be added The first time the event is added, the Images Sent to Core Lab Folder is added to the task list, which contains the Image Transmittal Worksheet and the Images Received in Core Lab Form Image Transmittal Worksheet Completed by Site Images Received in Core Lab Completed by ACRIN Core Lab All subsequent submissions of the event add these 2 forms to the same folder The form names are updated with the date of imaging after submission Initial View View after multiple submissions

48 Add Events Off Study The Off Study Add Event adds the Off Study Form to bottom of the task list The form should only be completed in the event: The protocol defined follow up is completed DM instructs you the patient must be taken off study due to a protocol violation Patient withdrawals consent The investigator determines the patient must be taken off study due to other factors, such as adverse events, death, etc.. This form must be electronically signed by the site principal investigator

49 General Rave EDC Navigation

50 Unknown Day/Month Rave has the functionality to allow entry of unknown days and months Record UNK for unknown months and UN for unknown Days This functionality is only enabled on appropriate date fields Medical History Date of Diagnosis Concomitant Medications Start Date Image Transmittal Worksheet Date of Birth Note: Dependent on site regulations, some sites are not allowed to report the day and month of birth during registration. If this applies to your site, please ensure you do not report the date and month on any other forms.

51 Dynamic Fields and Forms Rave has the functionality to add fields/forms dynamically to a form/folder/subject All fields that trigger a dynamic function are in italics and appear in either blue or purple font Blue font means the field triggers another field to appear on the form Purple font means the field triggers another form to appear Note: Purple font may also mean that another field and folder are triggered All Forms in the folder are required and can be considered complete when they have the icon For example: The first time the Endobronchial Brushing Form is opened, only one question appears

52 Dynamic Fields and Forms Initial View of Endobronchial Brushing Form

53 Dynamic Fields and Forms View after 1 st question is answered of Endobronchial Brushing Form

54 Paginated Tables Some tables may be automatically paginated, dependent on your settings. Ensure that you enter data for the entire form by selecting Show All Lines at the bottom of the table The lines per page are set by the user (via My Profile ). Default is 20 lines

55 Queries Queries will appear when a mandatory field is missing, a field is out of range, or if a field is not compliant with other forms Queries appear after the form is saved as a red highlighted box with the icon The query viewable below the question If the data is revised, the reason for revision must be provided The form will appear with the query icon until the query has been resolved The response field is not required unless the data is correct as is The response field will be greyed out once the data is changed/provided If data is correct as is and a response is provided, the field will still appear highlighted in red, but will have the answered query icon Response field Query Reason for Revision options

56 Questions?