introduction to medidata rave
79
INTRODUCTION TO MEDIDATA RAVE ANGELA SMITH CHRISTINE MCLEOD SWOG STATISTICAL CENTER SEATTLE 1
Transcript of introduction to medidata rave
INTRODUCTION TO MEDIDATA RAVE ANGELA SMITH CHRISTINE MCLEOD SWOG STATISTICAL CENTER SEATTLE
1
Background SWOG has had online data
submission for almost 10 years ◦ CRA Workbench website ◦ Developed and maintained by the
Statistical Center Most other Cooperative Groups also
have their own online data collection systems ◦ Also developed and maintained locally
2
Background PRO Allows for customization
CON Results in disparate systems Requires duplicative effort across
Groups
3
Background NCI purchased a license from the
commercial software company Medidata Rave is what Medidata calls their
electronic data capture (EDC) system All Cooperative Groups are mandated to
adopt Medidata Rave for new studies Two ways to submit data online: ◦ CRA Workbench – studies activated before
4/1/2012 ◦ Medidata Rave – studies activated after
4/1/2012
4
5
Presenter
Presentation Notes
So now you know we’re not talking about this kind of Rave
Background How many of you have heard of
Medidata Rave? How many of you have used Medidata
Rave for industry trials or for NCIC MA.32?
How many of you are still confused by the picture of people dancing?
6
Background Just in case you don’t remember our
every word: ◦ Online training videos From Medidata From SWOG ◦ Slides available on CRA Workbench ◦ Table at Open Forum
7
Background CTSU Help Desk ◦ 9:30am – 8:30pm ET ◦ 1-888-823-5923 ◦ [email protected]
8
Presenter
Presentation Notes
Your front line for technical support is the CTSU Help Desk. Their contact information is here, and will be advertised elsewhere in Rave.
Overview Accessing Rave Navigating to a study Navigating within a study Form organization Form submission CRA Workbench changes Timeframe
9
10
Overview
Presenter
Presentation Notes
3 concepts to keep separate: Medidata the company, which operates the iMedidata website, which is a portal to the Rave EDC application. Access Rave through iMedidata
Accessing Rave: Activate account Look for an email inviting you to activate
your new account. Click the link.
11
Presenter
Presentation Notes
There are a series of steps necessary to activate your account in iMedidata. Step 1: Watch for an email from iMedidata, inviting you to activate your account. Check your Junk mail folder too!
Complete the required fields on the iMedidata Account Screen ◦ Username: try CTEP IAM username first ◦ Password: use CTEP IAM password ◦ Security Question, Answer
12
Accessing Rave: Activate account
Presenter
Presentation Notes
Step 2: Complete the iMedidata Account page
Logon to iMedidata using the username and password you just set
13
Accessing Rave: Activate account
Presenter
Presentation Notes
Step 3: Logon to iMedidata
“Sign” the iMedidata Terms of Use using your CTEP IAM username and password
14
Accessing Rave: Activate account
Presenter
Presentation Notes
Step 4: You will need to “sign” this agreement one time.
Accessing Rave: Logon For all subsequent logons, reach this
page through ◦ CRA Workbench Medidata Rave link or ◦ https://login.imedidata.com/selectlogin
15
Presenter
Presentation Notes
You’re done with account activation! Future logons will be done through this URL. This will be available on the CRA Workbench, and this URL will be included in Rave protocols.
Accessing Rave: Logon First Logon, select CTEP-IAM IdP link
16
Presenter
Presentation Notes
The first time you logon, you’ll need to select your identity provider, which is CTEP-IAM.
Accessing Rave: Logon Logon using your CTEP IAM username and
password
17
Presenter
Presentation Notes
Then you’ll be presented with the logon page. This is where you’ll start for access to Rave from this point on.
18
Presenter
Presentation Notes
The iMedidata webpage.
Accessing Rave Accept any pending invitations ◦ You will see invitations to studies that your
site approves ◦ You will also get email notifications that these
invitations have been added ◦ Just click “accept” to access study
List of studies ◦ Studies for which you have accepted
invitations ◦ Search tool available ◦ Not accessible until eLearnings satisfied
19
Presenter
Presentation Notes
When your site IRB-approves a new Rave study, an invitation to that study will appear in iMedidata.
Accessing Rave Note eLearning requirements ◦ Required ◦ Rave 5.6 EDC Essentials for Clinical Research
Coordinators (45 min) ◦ EDC inspection readiness for Clinical Sites (30
min) ◦ Data Privacy Considerations for Clinical
Systems (50 min) ◦ Optional ◦ Rave 5.6 Advanced Rave EDC for Site Users
(20 min)
20
Presenter
Presentation Notes
A little over 2 hours worth of eLearnings are required for access to your studies in Rave. Only have to take the eLearnings once and they apply to all studies. If you’ve worked with Rave before and have already taken these eLearnings, then you should not have to take them again. It may be tempting to run these while doing other tasks, but there is a quiz and you have to get 80% to pass (and you have to pass). So pay attention.
Questions about Accessing Rave?
21
Navigating to a Study Rave is organized by study No cross-study reports or functions Select a study If multiple sites, select a site
22
Presenter
Presentation Notes
The study is the top level entrance point in Rave. There are no reports or functions within Rave that combine data from more than one study. Select a study from iMedidata, and if you belong to multiple sites, select a site.
Navigating to a Study Study-Site page: ◦ Subject List Subjects still enrolled via OPEN Search utility ◦ Task Summary (site level): lists subjects
with outstanding tasks ◦ Link to Icon Key on every page (whew!)
23
Presenter
Presentation Notes
This gets you to the Study-Site page, where you will see a list of patients you have registered to this study (via OPEN), and a summary of tasks that require your attention. Rave is icon-heavy. Luckily there is a link to an icon key on every page.
24
Presenter
Presentation Notes
The rest of this talk will use SWOG study S0820 as an example. Here I’ve selected S0820, and my site 99999. In the middle is the Subject List which reflects all the patients this site has registered to this study in OPEN. There is a search tool that can be used to find someone in a large list. On the right is my Task Summary for the study showing my outstanding tasks. I can click on the arrow to expand any one of these and see which patients are affected. The link to the Icon Key is at the bottom of every page in Rave.
Navigating Within a Study Select a subject Subject page: ◦ Folders and forms ◦ Upcoming Visits and Dates ◦ Task Summary (Subject level)
25
Presenter
Presentation Notes
To work on a patient, select the patient from the Subject List and then you’ll be at the subject page. The main areas on the Subject page include Folders and forms for that patient, upcoming visits and dates, and the patient-specific task summary.
26
Presenter
Presentation Notes
Folders and forms in the upper left Upcoming visits and dates in the middle Tasks on the right, now specific to this subject Hierarchical tabs appear as you drill down
Questions about Navigating to or within a study?
27
Form Organization Most of the study forms will be
organized in study-specific folders Paper CRFs will still be part of the
protocol, but will be for reference only Rave Form Schedule in the protocol
can help you find your forms
28
Presenter
Presentation Notes
Most study forms will be organized in folders. There will still be forms as part of the protocol document, but they are mainly for reference only. They will not be used directly to submit data. There will be a Rave Form Schedule in the protocol which will include notes about what folders hold what forms, and when they are displayed.
Form Organization Forms in Rave will look different from
their paper CRF counterparts Question order and content will be the
same A single paper CRF may become
multiple forms in Rave
29
Presenter
Presentation Notes
Formatting of Rave forms is limited, so while the question order and content will be the same as the paper CRFs, they may not look alike. A paper form may even become multiple forms in Rave for a variety of reasons.
30
Presenter
Presentation Notes
For example, take the S0820 Onstudy form This form has 3 distinct sections: patient and disease description
31
Presenter
Presentation Notes
Which spills onto page 2. Then laboratory values
32
Presenter
Presentation Notes
Then prior treatment
33
Presenter
Presentation Notes
That’s a lot of fields to put in one form, so in Rave, this is 3 forms When I click on the Onstudy folder, the forms are shown below and the first form is shown by default. Notice that 2 more tabs have also been added, one for the folder, and one for the form.
Form Organization Rave allows us to only show you the
parts of the form that apply to your patient
Some Rave forms may not appear unless certain questions are answered a certain way
34
Presenter
Presentation Notes
Another reason why the Rave form may not look like the paper form is that we might not be showing you the whole thing yet. Rave let’s us hide the parts of the forms that don’t apply to your patient so you don’t have to be bothered with those questions.
35
Presenter
Presentation Notes
For example, the S0820 Colonoscopy form first asks if a colonoscopy was performed. If yes, it asks for data about the report…
36
Presenter
Presentation Notes
…and if any adenomas were seen. If yes, it asks for data about the adenomas.
37
Presenter
Presentation Notes
In Rave, this is 3 forms Only the colonoscopy assessment form will show by default. See that I’ve answered Yes to the question “Was a colonoscopy performed?”
38
Presenter
Presentation Notes
When I save the Assessment form, a Colonoscopy Report form generates, because I said one was done. If I had said “no” then there would be nothing else for me to do with this form.
39
Presenter
Presentation Notes
On the colonoscopy report, one of the questions asks about adenomas. If this is answered yes, the adenomas form will appear.
40
Presenter
Presentation Notes
See now that the Report form is saved and because I said there were adenomas, now the Adenomas form appears Whole folders of forms can be generated this way. For example, when the Month 3 treatment form is submitted indicating that treatment will continue, the Month 6 folder of forms will appear.
Form Organization Some forms are available as needed
by using “Add Event” feature ◦ S0820 Audiometry ◦ S0820 Colonoscopy ◦ Off-Treatment Notice ◦ Follow-up Form ◦ Notice of Death
41
Presenter
Presentation Notes
As we know, there are forms in the study that may need to be submitted upon unpredictable events, or off-schedule, such as those listed here, including the Off-Treatment Notice, Follow-up Form and Notice of Death.
42
Presenter
Presentation Notes
These can be generated by YOU, by selecting them from the “Add Event” dropdown on the subject page. Only forms that apply can be added this way. (These are alphabetized and cannot be re-ordered) If I select Follow-up and click Add…
43
Presenter
Presentation Notes
A Follow-up folder appears
Questions about Form Organization?
44
Form Submission Parts of a Form System Queries Manual Queries Sticky Notes Logline Fields Submitting source documentation Save without submitting
45
Form Submission: Parts of a Form
Parts of a Form ◦ Question ◦ Entry field ◦ Status icon Click to see audit trail ◦ Edit icon ◦ Query icon
46
47
Presenter
Presentation Notes
Questions are left-justified, with maybe a little indent Entry fields are right-justified. The Status icon is a visual indicator of the status of the field. (this one means untouched). This is what you click to see the audit trail for the field. The paper icon at the top of this column will show you the audit trail for the form. All fields are editable the first time you visit a form, but after it’s been saved, you click the edit pencil to make any changes. You can click the pencil at the very top to make all the fields editable at once. This icon is what you would click to write a query for the field. You can see it’s crossed out because you don’t have permission to do this.
Form Submission: System Queries
System queries generated by Rave ◦ NonConformant data ◦ Required fields left blank ◦ Bad dates ◦ Values out of expected range
If response box present, may type response, rather than changing data
All system queries must be resolved before the data are sent to SWOG
48
Presenter
Presentation Notes
You might be wondering what error checks look like in Rave. They come in the form of “system queries”. Rave does not differentiate between errors and warnings, like the CRA Workbench does, but some system queries may allow you to respond, rather than change the data. Note that ALL system queries must be resolved before the data are sent to SWOG.
49
Presenter
Presentation Notes
I’ve entered some fields on this form. I left planned assessment blank, and I made a typo in the date.
50
Presenter
Presentation Notes
When I click Save, the first thing you probably notice is that some of the form is now different shades of pink. Note that light pink = dark pink. Same level of error. The first pink area now has a query. You can tell it’s a system query because it says “Opened to site from system”. A text box appears below the query, so that means I may choose to respond rather than change the data. The status icon is a question mark, and a drop-down box has appear next to the data entry field. For the second pink field, the status icon is an exclamation mark, and it has a similar drop-down. This means that non-conformant data has been entered (in this case, a bad date). There is no response text box, so data must be corrected. Note that the message at the top says the form is saved, but that all system queries must be resolved before the data are sent to SWOG. This is a static message; it will never change. But it is a reminder that SWOG won’t get the data so long as system queries like these remain outstanding.
51
Presenter
Presentation Notes
I’ve fixed the data. For any data change, you will be prompted for the reason you’re changing the data. Options are Entry Error, New Information and Per Query. Choose whichever seems most appropriate. Notice that because I chose to fix the data for the first query, the response box greyed out. In this case I can only do one or the other.
52
Presenter
Presentation Notes
Now the queries are resolved. Note the tiny delta triangles indicating which fields have been changed. Click on the status icon to see the audit trail for that field. Now the data has been sent to SWOG.
Form Submission: Manual Queries
Manual queries generated by Data Coordinator ◦ If response box present, must be filled in,
with or without changing data ◦ If response box not present, data must be
changed
53
Presenter
Presentation Notes
The response box acts a little differently for manual queries than system queries. Basically if it’s there, you have to fill it in, regardless if you’re correcting data or not. If there’s no response box, you have to correct the data.
54
Presenter
Presentation Notes
This query says “Opened to Site from DM” – this is a manual query (DM = data manager = data coordinator in SWOG) Here the data coordinator is asking to check the Month 36 selection against the date given. But, he’s allowed for a response because the error may be with Month 36, not the date.
55
Presenter
Presentation Notes
I fix the month, and note when I do so, the response box remains editable. This is your reminder that you also have to type in a response. I could have also just typed a response without changing the data in this case.
56
Presenter
Presentation Notes
Query resolved. Manual and System queries will only ever appear in the Rave system for Rave studies. They will not appear on any CRA Workbench query reports with non-Rave studies.
Form Submission: Sticky Notes
Sticky notes ◦ Will appear as reminders after saving
form ◦ Do not need response or data changes ◦ Must acknowledge ◦ Appear in task list
57
Presenter
Presentation Notes
Sticky notes are just used for short reminders. Don’t need to respond or change data, just acknowledge. Along with queries and nonconformant data, this is one of the items in task list.
58
Presenter
Presentation Notes
In this example I’ve completed the Month 3 AE Assessment form. Because I answered Yes to this question, a form to capture the events will appear. A sticky note shows up to point this out. Click the acknowledge box and save. The sticky will just disappear. There is no evidence it ever existed, and it’s not in audit trail.
Questions about Parts of a Form, System Queries, Manual Queries, or
Sticky Notes?
59
Form Submission: Logline fields
Logline fields ◦ Used to capture data about an unknown
number of events
60
Presenter
Presentation Notes
Loglines are used to capture repeating data about an unknown number of events.
61
Presenter
Presentation Notes
First let’s revisit the part of the Colonoscopy form that captures data about adenomas. There’s room to list up to 8 adenomas here, but what if you only need 2? What if you need 10?
62
Presenter
Presentation Notes
Here is that section in Rave. Instead of listing 8 lines, we only list 1. You add as many more as you need using the “Add a new logline” link at the bottom.
63
Presenter
Presentation Notes
Here I’ve completed 4 loglines to describe 4 adenomas. Oops, I added the 3rd one twice, in line 3 and 4. How do I get rid of it? Click Inactivate.
64
Presenter
Presentation Notes
It will ask you to identify which numbered line you want to inactivate and it will ask you for a reason. Choose the line number you want to inactivate, leave the reason alone (there is only one choice) and click Inactivate
65
Presenter
Presentation Notes
#4 is now inactivated. Note that it is only crossed out. It will never be deleted, even if you hadn’t filled anything in.
Form Submission: Source documentation
Submitting source documentation ◦ FAX not an option for Rave studies ◦ Rave has a special kind of field that
allows the upload of electronic documents ◦ Document MUST have any instances of
patient name, SSN and geographic information redacted first
66
Presenter
Presentation Notes
You may have had experience where a SWOG protocol required you to fax in source documentation such as op and path reports. Fax is NOT an option for Rave studies. Instead, you can upload electronic documents from your local system, but note that they must be redacted of any patient names, social security numbers and geographical information (e.g. address data incl. zip code) first.
67
Presenter
Presentation Notes
For example, if a study collects both an Op and Path report at baseline, a form may ask for the Date of Procedure and Document Type and then allow you to upload the reports. In this case I’ve made the document type and upload a logline so that you could add more than one. Use the Browse button to choose a document from your local network and click Upload.
68
Presenter
Presentation Notes
The browse button opens a window to my local directory where I can find the document I want to upload.
69
Presenter
Presentation Notes
After I click save, a link to the document appears.
70
Presenter
Presentation Notes
Here I’ve uploaded 2 documents. Note that the file name will be whatever it is in your local network. If you want to rename, do so before you upload.
Form Submission: Save without submitting CRA Workbench forms have “Submit”
and “Save without submitting” buttons ◦ Submit runs edit checks and sends the
data to SWOG if they pass ◦ Save without submitting simply saves the
data without running edit checks Rave only offers a “Save” button on its
forms
71
Presenter
Presentation Notes
For those of you who have submitted SWOG data online through the CRA Workbench, you will know that we offer the choice between Submit and Save without submitting buttons. Submit runs edit checks. Save without submitting just saves. Rave only has a Save button.
Form Submission: Save without submitting We added a “Save without submitting”
checkbox to the bottom of every form To save your data without sending to SWOG,
check the box and click Save A system query for the checked box will
prevent the data from being sent to SWOG Edit checks will run on other fields as well Be sure to use this option if you’re in danger
of session timeout. Rave will log you off after 75 minutes of inactivity and you will lose any unsaved changes
72
Presenter
Presentation Notes
To keep the “save without submitting” functionality, we added a question to the bottom of every form that directs you to check a box if you don’t want to submit the form yet. This will result in a system query that will prevent the data from being sent to SWOG. Edit checks will run. Make sure you use this question to save your work if you plan to leave your workstation so that you don’t timeout and lose your changes.
73
Presenter
Presentation Notes
This question will appear at the bottom of every form. Checking the box will force a system query which will prevent the data from being sent to SWOG.
74
Presenter
Presentation Notes
Here’s the query that will show up. Just uncheck the box to resolve the query when you’re ready to send to SWOG.
Questions about Loglines, Submitting Source Documentation, or Save
Without Submitting?
75
CRA Workbench Changes Many CRA Workbench tools and
utilities still available for Rave studies NOT: ◦ Data Submission ◦ Queries
76
Presenter
Presentation Notes
The CRA Workbench can still be considered your central portal for all things SWOG patient management. There will be a link to Rave, and references to Rave in appropriate spots. You will not find forms for Rave studies and you will not find queries for Rave studies in the CRA Workbench.
CRA Workbench Changes Rave Studies YES ◦ Link to OPEN ◦ Link to Rave ◦ Link to Specimen Tracking ◦ Expectation report ◦ IPR report ◦ Ineligible patients report ◦ Other SWOG tools, resources
Rave Studies NO ◦ Data/Form Submission ◦ Queries
77
Presenter
Presentation Notes
Here are many things that you can still do with Rave studies on the CRA Workbench. Just form submission and queries need to be done in Rave.
Timeframe So how soon do I have to care? First studies this summer ◦ Phase II GI S1115 ◦ Phase II GU S1107
All studies activated from this point on will be in Rave!
No studies activated earlier will be converted to Rave
78
Presenter
Presentation Notes
We expect our first Rave studies will roll out in June and July. A couple of Phase II studies to start with. But that’s just the beginning! All studies from here on out will be in Rave. This is a day-one-forward conversion. We don’t plan on converting any existing studies to Rave later.
More Questions??
79
