Presentation on theme: "Dunstan Horng, ACRIN Associate II"— Presentation transcript:
1 Dunstan Horng, ACRIN Associate II ACRIN Incidence and Significance of Extracolonic Findings on CT Colonography: Retrospective Analysis of National CT Colonography Trial Data Medidata Rave Clincial Research Associate TrainingDunstan Horng, ACRIN Associate II
2 Outline Rave-Setting up your account iMedidata versus Rave EDC Medidata Rave Clinical Research Associate TrainingGeneral Rave EDC
4 After this training, you will receive an email invitation from: Click on the link to set up your account within 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
5 iMedidata vs RaveiMedidata is the user portal- you can access all Medidata Rave URLs you have permissions to from hereRave is the URL where the database is built and managedYou will always sign in through iMedidataIf you are on a CTEP trial as a site PI:You will have 2 accounts associated with RaveOne that is maintained by CTSU (your CTEP IAM account)One that is maintained internally by ACRINThis account will need a different user name and address
6 Medidata Rave Clinical Research Associate Training
7 7151 Case ListA list of 7151 cases will be given to you by ACRIN Data ManagementA master list of cases will be kept and reviewed regularly by ACRIN Data Management
8 After you receive your case assignment Sign into iMediata using your user name and password
9 Select Rave EDC under 7151 from your list of studies
10 If you don’t see 7151, you need to accept the invitation Join 7151 (Dev)
14 This is where the folder, forms, and due dates would be found This is where the folder, forms, and due dates would be found. ACRIN 6700 is not using this featureThis section is where all folders available for the patient can be foundIcon Key
16 Patients task summary. This includes all forms you have view access to.
17 General 7151 Rave Layout There is one folder, entitled Local Review All forms are contained in the Local Review folderThe folder initially contains the LR – Local Medical Record Review formIf “no” is indicated for Questions 9 or 10 on the LR, then a LI – Incomplete/Not Received Local Medical Records form will appear in the Local Review folder beneath the LR form.If “yes” is indicated for Question 7 on the LI, then another copy of the form will appear underneath the original LI.
18 Local Review Folder for 7151 You will have Read Only Access to the abstractor folders and forms. Do not make any edits, answer queries, or sign anything in any folder other than the Local Review folder
19 Click on the Local Review folder to see the forms that are to be completed by the Clinical Research Associate
21 LR Local Medical Review form This form must be completed and saved firstThe following questions on this form are requiredQ1 (7151 Consent status), Q6 (Were you able to identify any medical records during this date range?), Q9 (Were all requested medical records received?), Q10 (Were the received medical records complete?)If the patient has consented to 7151, then the date of consent must be provided in Q2 (Date the 7151 study-specific consent form was signed)If the patient is deceased, then Q3 (Date of death) and Q4 (Source of death discovery) must be provided.The Start of date range and End of date range fields will be pre-populated by ACRIN from the date range of medical record review that can be found on the 7151 case list that is provided by ACRIN. These fields are non-editable.If “no” is marked for either Q9 (Were all requested medical records received) or Q10 (Were the received medical records complete), then the LI Incomplete/Not Received Local Medical Records form will appear underneath the LR form on the forms side menuIf “Some records received” is answered for Q9 and the form is saved, a textbox will appear, beside which you will be prompted to describe what recordsare missing and when they will be received. When the final status of the record request is ascertained, return to the LR form and change “Some records received” toeither “no” or “yes.”Remember to hit save when you complete each form
22 Medical Record Identification If “yes” is answered for Q6 (Were you able to identify any medical records during this date range?) on the LR form, then an will be generated and sent to ACRIN.ACRIN will review the submitted data and then transmit the notification to CARE. In the meantime, your site needs to send the patient’s medical records to CARE.
23 LI Incomplete/Not Received Local Medical Records Form
24 This form must be completed and saved first LI Incomplete/Not Received Local Medical Records formThis form must be completed and saved firstThe Incomplete/Not Received Local Medical Records form is to be completed for all listed cases provided by ACRIN that contain incomplete received medical records .The LI form is created when “no” has been answered for either Q9 (Were All Requested Medical Records Received?) or Q10 (Were the Received Medical Records Complete?) on the LR Local Medical Record Review form.The LI form should be completed when:It is ascertained that your site will not receive requested medical records.It is ascertained that your site will not receive requested complete versions of medical records that your site has received incomplete.The LI form is not to be completed when:All requested medical records have been received.All received medical records are complete.Some medical records have been received, and additional records are expected.Due diligence, in the form of three follow-up phone calls and one follow-up letter, must be observed before the LI form can be completed.Keep in mind that the LI form is not meant to log these follow-up communication attempts as they occur.The dates of these attempts must be entered on the LI form after it is established that the medical record requests will not be fulfilled.To document multiple missing or incomplete medical records, fill out one LI form for each missing / incomplete medical record
25 RI – Relevant Care Records Incomplete/Not Received This form is in the Abstractor Review folderMost of this form is to be completed by CARE and not by your site.However, you will receive an if Q7 (Does the site need to be contacted for missing/incomplete records) is answered “yes” by CARE. This will contain the subject’s ACRIN case number and will indicate that Q7 has been answered “yes.”You should then follow up on CARE’s inquiry regarding missing/incomplete records.After the inquiry has been resolved, access the RI form. The only field visible to you will be a question that states “Have complete versions of the missing/incomplete records requested by CARE been obtained?”This question is a Yes/No question. If Yes is answered, then click Save. If No is answered, an AI form will appear in the Abstractor Review folder. Document the missing/incomplete record on this form.This process is in the developmental stage and will be demonstrated in its entirety to your site once the CARE abstraction forms have been finalized.
26 Remember to hit save when you complete each form The following questions on this form are required:Q1 (Medical Record Type)Q2 (Medical Record Status)Q4 (Response from provider/facility)Q5 (Record dates of attempts to obtain this medical record)Q6 (Reason for missing and/or incomplete medical records)Q7 (Additional incomplete/not received medical records to report)Use Q3 (Date of missing/incomplete medical record – if available) to indicate the dates of missing/incomplete records. This field is free text to allow entry of partial, estimated date, or date range information.At least one Reason for missing and/or incomplete medical records (listed under Q6) must be provided.If “Other reason(s)” is selected for Q6, the “Describe Other reason(s) for missing/incomplete medical records” text field will appear when you click “save.” This field is requiredIf “yes” is marked for either Q7 (Additional incomplete/not received medical records to report?), then another copy of the LI Incomplete/Not Received Local Medical Records form will appear underneath the LI form on the list of forms that is located on the left-hand side of the screenRemember to hit save when you complete each form
28 To edit a field that has been saved Click on the pencil iconSelect the reason for the revision
29 To edit a field that has been saved, contd Click saveAny field that has been edited after saving will have the delta icon
30 QueriesQueries will appear when a mandatory field is missing, a field is out of range, or if a field is not compliant with other formsQueries appear after the form is saved as a red highlighted box with the iconThe query viewable below the questionIf the data is revised, the reason for revision must be providedThe form will appear with the query icon until the query has been resolvedThe response field is not required unless the data is correct as isThe response field will be greyed out once the data is changed/providedIf data is correct as is and a response is provided, the field will still appear highlighted in red, but will have the answered query iconResponse fieldQueryReason for Revision options