Participant Tracking Functionality

Participant Tracking Functionality Opening a visit schedule to enrollment Before you are able to enroll a participant to a trial you must open the visit schedule to enrollment. Click on the visit schedule link Click Open Visit Schedule For Enrollment Then click the study title to get back to the main study space. Adding a New Participant To add a new participant you must be logged in as a member of the Study Team. You start by going to the workspace of the study and look for the New Participant button on the left hand side of the

workspace: IMPORTANT NOTE: if you do not see the New Participant button as shown in the above screen shots it s probably because the Visit Schedule(s) is not in the Enrolling state. Look at the list of Visit Schedules for the Study (click on Summary tab) and note their state. If they are in the Approved state then you need to open them for enrollment. To do so go to the workspace of the Visit Schedule and click on the Open Visit Schedule for Enrollment activity. Clicking the New Participant button will take you to the first page of the Participant Record smartform. This page is integrated with Wake s Enterprise Data Warehouse of patient information. To use it requires that you know the patient s MRN number. You enter the MRN into the space provided in

question #1 and click the Lookup MRN button. (You cannot hit enter ) Clicking the Lookup MRN button will query the EDW database. If the MRN is valid the system will pull back the patient s information (date of birth, first, last name, etc) and populate the remainder of the form for you. If the MRN is invalid the system will display and error message on screen. Epic Status Question #2 on the Participant Record smartform allows you to set the Epic status code. You can choose from the same set of codes available within Epic. When CRMS send a message to Epic, to associate the

participant with the same study in Epic, the status code you choose here will be reflected in Epic. After selecting the Epic status code in question #2, click the Continue button on the smartform. This is the action that sends a message to Epic. Epic will associate the same participant with the Study in Epic. Go to Epic and verify this. If Epic cannot find the participant, an error will be shown. Page 2 of the Participant Record smartform will display participant identification information from EDW. All fields on this page are read only and you will not be able to edit them. If any of the information is wrong then it should be corrected via the appropriate patient registration system.

After reviewing the read only information on the Participant Identification page, click the Continue button. This will take you to the third page of the smartform named Participant Information. Just like the previous page, all information displayed here is read only and comes from EDW. Click the Continue button again and you will be taken to the fourth page, named: Additional Participant Information. This page is editable and allows you to enter additional address, phone and email information. Also you can enter Emergency Contact information here. Click the Continue button one more time. The final page of the Participant Record smartform allows you to enter any Consent related information. Click the Add button and fill in the pop-up form. If the participant has not been consented yet then leave this page blank. You will have the opportunity to enter this data again, once the actual consenting takes place. The only consent information we capture within CRMS is the type of consent and the date. No need to upload the actual consent documents. Note adding the consent date here will NOT populate the start date in Epic. You will need to update that directly in Epic.

Clicking the Finish button on the Participant Record smartform will take you the workspace for this record: At this point the participant is now associated with the Study both within CRMS and Epic. In general the next steps in the process will be to consent the participant, to schedule a screening visit, to enter the results of the screening and, for successful screens, to enroll the participant into the Study. Along the way you will be able to update the participant s status within Epic. Update Consent Information Once the participant has signed any consent documentation then you should update CRMS with the information. On the left side of the Participant Record workspace you will see an activity called Enter Consent and Screening Info. This is used for both consent and screening information we will talk about screening below. For now we will concentrate on consent. Note before continuing note that the record is currently in the Pre-Treatment state see the orange area on the left hand side of the workspace.

Click the Enter Consent and Screening Info activity on the left side of the workspace and a form will open. Click the Add button to add a new consent item. Fill in the form with consent type and date of consent. Back on the main form indicate Yes the participant has completed consent actions. Under the Screening Information section - choose the option: Participant has not completed screening. Then click OK at the bottom of the activity form.

At this point look at the orange area of the participant record workspace. This indicates the state or status of the record. It will have changed from Pre-Treatment to Consented. Schedule a Screening Visit To schedule the screening click on the Add Visit-Screen/Unscheduled button on the left side of the participant record workspace. This will take you to a Visit smartform page. This button and form are used to create both screening visits and also unscheduled visits thus you will need to tell the system which you are creating by answering question #1. Q1 is a drop down list. It will always default to Unscheduled as if you were creating an unscheduled visit. In this case we want to create a screening visit click the drop down and you will see a list of all screening visits on all Visit Schedules defined for the Study. If the Study has multiple Visit Schedules you need to pick the one whose screening or initial visit contains the procedures needed for this participant screening. What you see in the drop down very much depends on how the Visits were set up in the Study s Visit Schedules. Choose the screening Visit which has the proper procedures for this participant.

Fill in the target date for question #2 this is the date in the future (or today) when the participant will come in for screening. Question #3 is the actual date the visit occurs which in some cases may be different than the target date. This is not required to be filled in at this point it is shown on the form in case the screening visit has already taken place and you are updating the system after the fact. For this testing fill in the Target Date only. Then click Continue on the smartform. Note: the actual date field has a time component i.e. you are entering both the Day of the visit and the Time. The next form shown will be a grid displaying all the procedures to take place during screening. The list of procedures will come from the screening visit you selected above. This grid will allow you to add additional: procedures, Personnel, or Other rows to the grid. If there are any other cost items that will take place (took place) during the visit, this is how you tell the system about them. Within the grid the Billing Indicator, Amount, Date Performed and Notes are editable for each row. If you are scheduling the visit in advance you would not enter any values for Date Performed yet. Add some additional procedures, personnel or other, then fill in the applicable columns (except date performed) and click Continue. As long as you have not entered an Actual Date of the visit yet, clicking Continue will take you to the workspace of this Visit. The workspace shows a summary of the procedures to be performed during the visit and also allows you to reschedule the visit if necessary or withdraw it (if it was created in error.

Complete the Screening Visit At this point you have scheduled the participant to come in for a screening visit. On the record workspace you can now see a summary of this visit (below the blue area): Clicking on the Edit link takes you to the Visit smartform. Clicking on the Name link takes you to the Visit workspace. For our test, click on the Edit link and go to the smart form of the screening visit. This time - enter a value in the Actual Visit Date field. Click the Continue button and go to the Procedure

Information page: On the Procedure Information page the date Performed values will default to the Actual Date you input on the previous page. You may update if needed. If for some reason a scheduled procedure was not performed during the visit, set the Date Performed to blank. If the procedure that was scheduled still needs to be performed you can add another Visit to the participant record and specify this procedure. To do this you use the Schedule Missed Procedures activity available from the workspace of the Visit which missed one or more procedures. Once you have fully filled out the Procedure Information page, click the Continue button. Now, since the visit has and actual date, you will go to a new page in the smartform - the Visit Completion page.

This page allows you to enter information to close out the Visit in the system: You can indicate if the CRF has been completed and, if sponsor monitoring was conducted, information about that plus any text summarizing the visit. Note: when originally filling out the Study smartform, the team will have indicated if CRF and/or Monitoring are required before the Sponsor can be invoiced. The answers to those questions are shown here - #1 and #2. This page uses validation logic if the Study indicates that CRF is required and you try to mark this Visit as complete without indicating the CRF is done the system will display an error message. The most important question on this page from a web site perspective is #4. Question 4 has five options to choose from. Four of the options are used to tell the system that the participant is no longer on study and for the most part only apply once a Subject is enrolled. In Question #4 select the Continue on Study this Visit is complete option. Then click the Finish button on the smartform. This tells the system that all actions associated with this Visit are now complete and the Participant will continue on the Study. Note: even if the participant failed screening, you should still select this option. You can record the screen failure in the next step.

The Finish button will return you back to the workspace of the participant record here you can see that the screening visit now shows a status of Completed. Enter Screening Results In the real world, at the conclusion of the screening visit a decision will be made. Our next step in the CMRS process is to tell the system the decision. Go to the workspace of the participant record and click on the Enter Consent and Screening Info activity on the left hand side. The activity form will open. We used this same activity above to enter consent information. This time we are going to enter screening information. Enroll Participant on Study

Once the status of the record is Eligible, a new set of activities will appear on the left side of the workspace, including the Enroll Participant activity. Click the Enroll Participant activity and a form will open up.

Fill in the form as follows: Enrollment Date this is important, enter the actual date the participant is enrolled on the Study. The system is going to generate a calendar of visits and the dates will be based on this value. Participant Study ID if the Study assigns ID numbers to participants you can enter it here. This number does show up on the workspace of the participant record. Randomization Date and ID if the sponsor provided randomization information, enter it here. Visit Schedule if the Study has more than one Visit Schedule defined and currently allowing enrollment you will see a list to choose from here. Remember from above that we previously choose a screening visit from a Visit Schedule. If applicable the same Visit Schedule should be chosen here. Arm chose the Study Arm to which this participant should be added. This is used for tracking purposes only, the site does not do anything with this data. With the form filled in, click the OK button at the bottom. The system will create a calendar of visits for the participant (based on the enrollment date entered above). The list of visits will now be displayed in the participant record workspace and the status of the participant will change from Eligible to On Study. At this point you should use the Update Epic Status activity to inform Epic that the participant is enrolled. The participant is now enrolled and On Study in the CRMS site. In real life the participant will now begin to come in for Visits. As a coordinator you can see the upcoming Visits and target dates from the workspace.

Projected vs. Scheduled Visits When a participant is first enrolled on a Study (goes into the On Study state) the system will generate a list of projected visits. A projected visit is more or less a placeholder in the system waiting to be scheduled. Projected visits do show up on the Participant Record Calendar View and on the overall Study Calendar view. They also will be displayed in the printable Visit Slip (Export Visit Slip activity). However they are not editable in the site. For example a projected visit does not have a smartform to enter the actual date or record the procedures, etc. In order to edit and process a Visit you must first schedule it. You do that by clicking on the Create link to the left of the Visit name in the participant record workspace: Clicking on the Create link will take you to the first page of the Visit s smartform where you can start filling out information about the visit. Scheduling a Visit As a coordinator you can use the system in two ways you can create the Visits before they occur (i.e. you can Schedule upcoming visits) or you can create them in the system after the actual visit has taken place. It doesn t really matter which way you do it. Either way clicking on the Create link will take you to the Visit smartform.

Go ahead and do this and put in an actual date if the Visit has already occurred, put in the actual date. If the Visit is in the future, put in the scheduled date. Fill out the remainder of the smartform. On the Visit Completion Data page be sure to answer as follows: 1. CRF Complete No 2. Monitored No 3. Summary enter some text 4. Next Steps leave blank. Do the same thing for two more visits. When done your participant record workspace should look like this showing three Scheduled Visits. At this point there are three scheduled Visits in the coming months. As the dates approach the actual date in the system can be updated as needed. Calendar View For a given Participant the site offers an online calendar view showing all Visits (projected, scheduled, completed, unplanned, etc.). This view is reached by clicking on the Calendar View link on the left side of the workspace. You can see it under the Add Visit-Screen/Unscheduled button.

The online display looks like this: You can print out this view by using the Print button on your browser. Export Visit Slip activity Printing the online calendar is not the only way to generate an output from the site which can be used by a coordinator or the participant him/herself. The site also offers ability to create a MS Word file showing all Visits for a participant and, if desired, the procedures scheduled for each one. From the record workspace, click on the Export Visit Slip activity. This will pop open a form which looks like this. To include a list of the scheduled procedures for each visit, place a check in the checkbox. When ready, click the OK button. The system will generate a MS Word file and place a link to it in the History Log of

the workspace. Go to the history log and click on the Visit Slip link. If MS Word or equivalent is installed on your computer the document will open an look like this. This document can be saved to your hard drive, emailed or printed out (always be sure to keep HIPAA requirements in mind when saving information regarding participants however). Completing a Single Visit In real life a participant comes into the facility and undergoes one or more procedures as specified by the protocol for that visit. Within the system we need to tell the site that the Visit is now completed and record the results which procedures were performed and what the next step is for this participant. To do this you start by going to the workspace for the participant and clicking on the Edit link for the Visit. That takes you to the Visit smartform. In the screenshot below you can see the mouse pointer

hovering over the Edit link for the Visit: Once on the Visit smartform you will have a chance to change the Actual Visit date if necessary (this would have previously been filled in when scheduling visits above). Clicking the Continue button on the smartform will take you to the Procedure Information page. This page shows a list of the procedure that were supposed to have taken place. If all the information is correct all the procedures did take place on the actual date then you can just click Continue again. If there are changes however we need to tell the system. Adding Additional Procedures, Personnel or Other If any additional procedures other than those scheduled were performed during this visit then we need to enter them into the system. Likewise with any personnel costs not otherwise accounted for or any other types of expenses. On this page you will see an Add button. To the left of the Add button is a

drop down list where you can specify: Procedure, Personnel or Other. For our test let s add a Personnel charge. Choose Personnel in the drop down then click the Add button. A new row will appear in the grid. Within this new row you will need to choose the role of the personnel and fill in the number of hours (30 min =.5hrs) and the date, if different than the actual visit date. The system will use the role you specify to determine the charge to the sponsor. Click the Save button to save your work. Edit a Scheduled Procedure The list of scheduled procedures comes from the Visit Schedule previously defined when the Study was initially set up and activated in the site. This includes the Billing Indicator value along with the amount (units) of the service. If for some reason these values need to be changed, you can edit them directly within this grid. For example, you can change the billing indicator from RES (research) to SOC (standard of care). This will result in the row being removed from the list of procedures to be invoiced to the

sponsor. If for some reason a scheduled procedure did not occur, you can tell the system by removing the value in the Date Performed cell just set it to blank. Do this for one of your procedures set the date performed to blank. When done, click the Continue button on the form. CRF, Monitor and Next Steps The next page in the visit smartform is to record visit completion data. Question #1 asks if the CRF is complete. In reality the visit may be complete but the CRF is not. If that s the case then you should stop here and come back to this form once the CRF has been completed. Visits within the site should not be marked as complete until all actions including CRF have been completed if the Study requires the completion of CRFs. If the visit was monitored by the sponsor, you can indicate such on this page and enter the date of monitoring. The key question on this page is #4. This is the question that completes the visit in the system. You have 5 options to select from if the Visit is complete but the participant will not continue on the study select the most appropriate from options 1-4. If the participant is continuing on the study, select the 5 th option Continue on Study this Visit is complete. For our testing, choose this option and then click

the Finish button: Doing so will return you to the participant workspace. The list of Visits will now show that the visit you just worked on is completed and that the participant is still On Study (orange area on left).

Scheduling a Visit for Missed Procedures Recall in the preceding scenario that we indicated on the Visit Procedures grid that one of the scheduled procedures did not occur (we removed the value in the date field). An occurrence like this may generate the need for a new Visit to complete that procedure or any others that were not in the original plan. To schedule the missed procedures, click on the name of the visit (the one we just completed) from the participant s workspace (see the cursor in the screen shot below): This will take you to the workspace for the Visit. Here you will see an activity named Schedule Missed Procedures click it: The form which opens up for this activity will show you a list of procedures that were scheduled during that Visit but were not performed. If you correctly indicated a procedure was not performed during the processing of the Visit, the form should look like this (note in this example there are four missed

procedures): Fill in a Target Date for the new Visit and click OK. Then navigate back to the participant record workspace and look at this list of Visits. This newly added visit will show up in the list of visits on the participant s workspace. The Status column will display Missed Procedures for the Visit you just added:

The procedures that were missed will show up on the smartform of this new Visit you just added. Go ahead and edit the smartform for this new Visit process it and mark it as complete once again choosing the completion option to continue on the Study. Updating Visit Notes When filling out the smartform for a Visit, on the Visit Completion page, question #3 allows you to enter notes or summary about the Visit. Once a Visit is marked as complete, the smartform becomes read only and hence you can no longer update these notes. Fortunately we have an activity that will help you. Exit the visit smartform and go to the visit workspace. On the left side see the Update Visit Notes activity click it.

Bulk Update of CRF, Monitor and Visit Completion As we have seen in the preceding scenarios, there is a requirement to fill out the smartform of every Visit. The first time you touch a Visit smart form is to schedule it to enter the scheduled or actual visit date. This may occur weeks or months before the date occurs. The 2 nd time you touch the smartform is after the actual visit occurs when you indicate what procedures were performed and add any additional procedures, personnel or other cost items. The 3 rd time you edit the Visit smartform is when you are ready to close it out the CRF is complete, Monitoring is complete if required and the Visit can be closed out in the system thus allowing it to be invoiced. In reality however this process can occur in fewer or more steps then the three outlined above. For example it is possible to do it all in one step (one editing of the Visit smartform). You don t technically need to do anything in the site for a given Visit ahead of time, you can wait until after the actual visit has occurred and all actions (CRF, etc.) are complete and then go into the site and retroactively input all data for a given visit in one session. On the other hand its also possible that you may want to record all steps as they happen. Typically the visit will occur and then at some point later the monitoring will be completed and then later still the CRF will be completed and perhaps some more processing is needed before actually marking the Visit as complete. Using the site in this way could entail multiple trips to edit the smartform of each Visit. When we start to think about a Study with a large number of participants and hence a large number of Visits this could become a very time consuming way to keep the system up to date. To help with this sort of scenario the site offers a special interface that allows you to update multiple Visits for different participants all from one web page. Before continuing make sure you have a Study set up and enroll two or more participants on it and then schedule all the visits for all participants. When that s done go to the workspace of the overall Study and notice on the left hand side there is a link: Record Monitored Visits/CRF Submission.

Click this link and the system will take you to an online view that looks like this: What this display shows us is a list of all Visits for all participants that have been scheduled but not yet marked as complete in one scrollable list. Notice in the Participant Name column in the screen shot above you can see several different participants. This display allows you to update several pieces of data about each Visit: the actual/scheduled visit date, the monitoring date (if required), whether or not the CRF is completed and finally, whether or not all actions are complete for a given Visit*. *Note: if you check the box to indicate all visit actions are complete, it is equivalent to selecting the 5 th option on the Visit Completion page of the Visit smartform. That s the one where you indicate all actions for the Visit are complete and the participant is continuing on the study. In effect you are saying that all the listed procedures occurred as specified in the protocol, no additional procedures were needed and all actions for the visit are complete. To test this pick a Row and note the name of the participant and the visit. Using one tab of your browser, go to the workspace for that Participant. Using the other tab of your browser edit the row in this gird. First just put in a monitor date and indicate the CRF is complete, then save the grid by clicking the Apply button. Then observe the Visit in the participant workspace by clicking on the Edit link for the Visit and reviewing the smartform. You will see that updating the grid, also updated the Visit s smartform. Now go back to the grid and for the same row put a check in the All Visit Actions Complete column and save. Then go to the participant s workspace and note that the Visit is no marked as complete. Transfer a Participant from one Visit Schedule to Another For a study with more than one Visit Schedule which is enrolling, you can transfer a Participant between Schedules.

In this example I have a study which has two enrolling Visit Schedules. There is a participant assigned to Visit Schedule 1 and has already attended several visits. What I want to do is transfer this participant to Visit Schedule 2. In the workspace of the Participant you will see an activity named Transfer Participant. Here is the workspace of the Study. Notice in the Components list there are two Visits Schedules and the State for both is Enrolling: Here is the workspace of a Participant, note in the summary area this participant is assigned to Visit Schedule 1. Also note that some Visits have already been completed while others are scheduled:

Click the Transfer Participant activity on the left side bar. A form will open and will show you any other Visit Schedules for this Study which are enrolling new participants. In this case there is only one: Select the new Visit Schedule and click the OK button. When complete, review the participant workspace again and notice that the visits associated with the new Visit Schedule have been added, the

old completed visits remain and the old scheduled visits have been removed. Completing a Participant In the site, a participant s record will stay in the On Study status until you tell the system otherwise. There are several scenarios for removing a participant from a Study. - The participant could complete all Visits and all aspects of the Study - The participant could withdraw from the Study. - The participant may die - Various other reasons why the participant will be removed from the Study. Within the site you have two ways of handling the above scenarios: 1) While filling out the smartform for the latest Visit, on the Visit Completion page, you can choose an option other than continue on Study. 2) You can use the Remove Participant from Study activity. Both ways end up accomplishing the same thing transitioning the participant s record out of the On Study state. Remove Participant from Study activity Regardless of where a participant is at in the study, you can remove him/her at any time by using this activity. Go to the workspace of a participant (who is in the On Study state) and see the activity on the

left side of the screen: Click the activity to open its form. This form will look very much like question #4 on the Visit Completion page of the Visit smartform: Notice there are four options. The text of each option explains what will happen if selected. Select one of the options and click OK at the bottom of the form. This will transition the record to a new status the one indicated by the option you selected.

Removing a Participant via the Visit Smartform The other way to remove a participant from a Study is to process a Visit. For example lets assume our participant has completed all scheduled visits and now you want to move him/her to a follow up status where monitoring or tracking may continue but no further Visits will take place. Go to the smart form of the final Visit for a participant. Work your way thru the smartform to the Visit Completion Data page. Fill out the page and pay special attention to question #4. Select the 2 nd option here Participant has completed basic visit schedule but follow-up or tracking actions remain transition to Off Study status.

After selecting the 2 nd option, click the Finish button. This will take you back to the participant record workspace where you will see the status (orange area on left) has changed from On Study to Off Study