OpenClinica Manual Data Entry NONSEDA

Transcription

1 OpenClinica Manual Data Entry NONSEDA - The OpenClinica system is found here: Login When entering the system you will be met with a login screen. Use the credentials provided by CTU. If you have forgotten your username or password, please contact CTU (ema.erkocevic@ctu.dk). Figure 1: Login screen to data entry in OpenClinica. Home screen After login, you will enter the home screen for your site. For your role as a Clinical Research Coordinator, if you are located in Kolding, the home screen will look like this: Figure 2: Home screen of an investigator in Kolding.

2 The subject matrix will still contain the Events named (Kolding) for sites other than Kolding; however no CRF will be found within these Events. Each site has its own Subject Matrix. The matrix in figure 2 contains three subjects where data entry has been started for 1001, 1002 is a screening failure, and 1003 has been added and scheduled but has no data entered yet. Screening failures will occasionally be moved to a Screening Failures site to prevent cluttering of the site s Subject Matrix. The events of the NONSEDA trial are listed in the top row on the Subject Matrix: CRF , CRF 5, CRF 6+7, etc. The first column shows the subject ID, which in your case will be the Screening Number, while the last column shows the actions available for your specific role in OpenClinica. The only action available is the View action which brings you to a screen showing events and their associated CRFs. An Event is a collection of one or more CRFs. An Event has to be scheduled to enable data entry. This will be explained below. The icons in the Subject Matrix represent the status of the Event. The most common Event statuses are listed below. A complete list can be found on your Home Screen in the left pane. The statutes listed below are also applicable to a CRF. Not started. The event has not been scheduled yet. Scheduled. The event has been scheduled; data entry has not been started. Data Entry Started. Data has been entered into one or more CRFs and at least one CRF is not completed. Stopped. The event has been marked as stopped. The event CRF for Screening Failures should be given a status of Stopped. Completed. The CRFs in the event has all been marked Complete. Locked, data entry cannot be performed. Note that this status is seen on CRFs where the corresponding Event has been marked as Stopped. Figure 3: The menu bar for a Clinical Research Coordinator The menu bar gives access to the basic tasks performed by a Clinical Research Coordinator. Figure 3 shows the menu bar with the Tasks list expanded. Home: Takes you to your Home screen. Subject Matrix: Takes you to the Subject Matrix. Only difference between Home and Subject Matrix is the line Notes and Discrepancies Assigned to me: XX. Add Subject: Click here to add a new subject. Notes & Discrepancies: Takes you to an overview of the notes and discrepancies addressed to you.

3 Tasks > View Events: Changes the view of study data, focusing on events. This view provides functionality to filtering study events associated with the subjects of your site. You can filter by Study Event Definition, status of the events and dates. Tasks > Update Profile: Update information about yourself such as name, address and institutional affiliation. You can also change your password. Changing current site In the top left corner of the home screen is the name of the study and which site you currently are logged in to. If you are affiliated with several sites and want to change to another, click Change Study/Site. Now you will be presented with all sites which you are affiliated to. In this case Kolding and Odense: Figure 4: Affiliated sites for this particular user.

4 Adding a new subject to a site To add a new subject, click Add Subject in the menu bar: Figure 5: Adding a new subject The Study Subject ID (Screening Number) will be generated by OpenClinica automatically in a consecutive order across all sites. Secondary ID and Sex are optional (note: sex is collected within a CRF). Date of Enrolment will have a default value of today s date, but can be changed if the enrolment happened another day. When done, click Save and Assign Study Event. You will be shown the following screen: Figure 6: Scheduling a study event.

5 Select the first event and click Proceed to Enter Data. You can schedule more than one Event here by clicking Schedule Another Event. Trial participants (i.e. not Screening Failures) need to have more than the first Event scheduled in order to enter data into the CRFs within those Events. Please see elsewhere in this manual for scheduling Events for existing Study Subject. When clicking Proceed to Enter Data, the following screen will be shown. Figure 7: Overview of CRFs within the scheduled Event. Enter data in CRF To enter data in a CRF, click the icon in the Actions column to begin data entry:

6 Figure 8: Data entry in the CRF called CRF1 Screening

7 The date in question (1) is a date field. Use either the date picker by clicking the Calendar icon or type the date manually. The date format is DD-MM-YYYY (e.g ). The orange stars indicate required fields. Data for these fields must be provided before OpenClinica will save the CRF. If you do not enter data for a required field you will be prompted with a warning message: Figure 9: Warning message in case of a unfilled required field. If you for some reason do not have the required data, click the flag ( ) next to the field and add a reason for why you are not able to provide this information. This information is stored in Discrepancy Notes. Figure 10: Stating a reason for missing data (Adding a Discrepancy Note)

8 Some fields of the CRFs have validation routines attached. E.g. in CRF 1 Screening you will be prompted with a warning if not all inclusion criteria are answered with Yes and all exclusion criteria answered with No. See below: Figure 11: Failed validation. A "No"-answer to an inclusion criteria. Either change the data or add a Discrepancy Note. It could be that the Study Subject is not endotracheally intubated and should therefore have a No answer, leading to the Study Subject being a Screening Failure. Completing data entry in a CRF You can save the data entered and come back to the CRF later and finish data entry. However, if data entry is completed check the Mark CRF Complete checkbox in the top or bottom of the data entry screen, click OK on the question popup and click the Save button. Figure 12: Marking the CRF complete.

9 After pressing save, you will return to the Event overview. The status of the CRF has changed accordingly. Figure 13: Four CRF in an Event. One CRF started but not completed, one completed and the remaining two not started. To continue data entry, click the -icon and continue as described above. Editing completed CRFs If you need to change data in a CRF already marked as Complete (Status icon ), click the -icon and perform the change in data. Since the CRF was already marked as Complete, you will be asked to enter a Reason for Change. Use the flag to add a Discrepancy Note. Figure 14: Change in a CRF already marked as complete.

10 Scheduling events for existing Study Subjects To schedule an Event (e.g. the next event) for an already existing Study Subject, go to Subject Matrix, click the Event you wish to schedule and click Schedule. In case the event has already been scheduled and new data has to be entered, click the Event in the Subject Matrix and click View/Enter Data. Scheduling a repeating Event Several events in NONSEDA are repeating, allowing the CRFs within to be filled more than once. The CRF 5 Daily Data should be filled every day until discharge from ICU, hence it is placed in a Repeating Event. Each instance of the Repeating Event must be scheduled: Figure 15: CRF 5 is a Repeating event and has been scheduled once already. Click the Event and click Add Another Occurrence to scheduled yet another instance. When multiple Events exist, you can use the small arrows to scroll. Alternatively, and with a better overview, use the View action on the Subject Matrix to see a list of all scheduled Events and their containing CRFs. Marking a Study Subject as a Screening Failure The CRF named CRF1 Screening should be completed for all Screening Failures. Next, the status of the Event should be changed to Stopped. Click the Event and click View/Enter Data, and click Edit Study Event :

11 Figure 16: Marking a subject as a screening failure. You will be prompted with the following screen: Figure 17: Changing status of an event to stopped. Change the Status to Stopped and click Submit Changes. Return to the Subject Matrix where the Event status for the Study Subject, in this case 1004, will be marked as Stopped with the -icon.