Open Clinica General Data Entry Instructions

Transcription

1 Open Clinica General Data Entry Instructions Version Table of contents 1. Log on to Open Clinica Change profile and password Log on to the correct study Add a new patient to the study Scheduling a patient to an event Data entry initializing Data Entry and discrepancy management Updating events Removal of a patient or translocation between sites Audit Trail Logging out of Open Clinica

2 1. Log on to Open Clinica To access the production environment of Open Clinica, please navigate to using Microsoft Internet Explorer. Please log on using a user and password that was supplied to you by the project team. 2

3 2. Change profile and password Once logged on in Open Clinica, please navigate to Tasks, followed by Update Profile. In the box Change user profile the user s personal information including password can be changed. It is recommended to do this the first time when approaching Open Clinica. 3. Log on to the correct study To go to the correct study (it can happen an user is involved in and assigned to more than one study) by clicking on the Change study/site link located in the upper part of the screen. Within the Change your current study box, select the correct study to navigate to and confirm. 4. Add a new patient to the study Navigate to the subject matrix from the main menu via tasks followed by subject matrix. The subject matrix provides an overview of all assigned patients and status of each event. (Each part of the CRF in open clinica is called event) Event A Event B Event C Event D 3

4 Press Add New Subject. A new box will appear: Fill out the mandatory fields (indicated by an asterix) and press add. All new added patients will be assigned with status not started for each event. Please find below all relevant icons corresponding to open clinica event status for each patient: 4

5 5. Scheduling a patient to an event For each new patient assigned or existing patients, each relevant event to be filled out must be scheduled within Open Clinica. After scheduling this event, the status will be changed from not started to scheduled. From the main menu, press task, followed by scheduling event. The event of choise to be scheduled can be determined using the drop down box within the study event definition drop down box. The study subject ID can be read from the subject matrix. (see section 4) Please fill out all mandatory fields indicated with an asterix (*) and proceed. In the subject matrix the icon corresponding to the event for this subject ID, has been changed accordingly. 5

6 6. Data entry initializing Start from the subject matrix. (see section 4) By clicking on a patient specific event icon having status scheduled, a short dialogue box will appear: Press view/enter data. A new menu will appear. Make sure that always the highest version of the CRF has been selected (using the drop down box under versions) and continue to go to the e-crf by pressing the enter data icon located under actions: The event status will change accordingly to initial data entry (data entry started) 6

7 7. Data Entry and discrepancy management Entry and saving of data After completing step 4, a data entry screen of the event appears. The first two sections within the event are appearing on a tab in the upper, the next sections within the event can be selected by dropped down the box in the upper right: ( Select to jump ). Mandatory fields to be filled out are indicated with an asterix (*). For entry of dates, the corresponding date has to be selected using the calendar box on the right of the corresponding date field: After data entry is completed, save must be pressed, otherwise entry actions are simply cancelled. Open Clinica will give the following message: Each CRF section within an event can be data- entered and saved separately. After successful saving, the status will still be initial data entry (data entry started). 7

8 Save in combination with mark as complete In the bottom of the data entry screen a tickbox Mark as complete can be marked when data entry is done. This is for administrative purposes: Please be certain all data has been filled out before marking this question (and before doing the double data entry). Otherwise, the event status has to be manually changed for all patients (will be a lot of work). The event status will change to data entry complete: and can only be re-edited in administrative mode! 8

9 Opening and activating sub-forms within a data entry form. Sometimes entry in data-entry sub-form is required. Entry of e.g. concomitant medication, medical history or adverse events are often filled out using a sub form. These sub-forms do not appear instantly when opening a CRF, but have to be activated after answering a head question: For example: The head question Did u use medication? can be answered with Yes or No. When Yes is indicated, a sub-form has to be opened for entering number of medication taken and a specification of type of medication taken. A sub-form will open and becomes active after the following handlings: 1 Fill out all CRF data, including the head question, with the exception of data to be filled out in a sub-form; 2 Save the data using the save button. The sub-forms now appear. In Open Clinica, sub-forms appear in yellow. 3 Enter data in the CRF sub-form and save the data again using the save button. 9

10 Unsuccessful data entry and query assignments Open Clinica does a verifying after each saving of data, determining if all data had been entered in the correct format and correct data range. If not, the corresponding unaccepted data fields are marked with a red exclamation mark. A description for the reason for nonacceptance is provided in the upper in red: Reasons for non-acceptance can be: - Mandatory data required for empty data fields; - Input data is out of range corresponding to the reference range; - Data not passing an additional data entry check. Generating a discrepancy note ( query ) is the only way out, next to - of course entering the correct data. This is done by generating a note, that can be achieved by pressing on a flag on the right of the corresponding data field: 10

11 A new dialog box will appear then for entering a note. Please fill out all requirements and hold the description short. Details can be filled out within the detailed note field. Types of query: - Query: The doctor or monitor is asked for checking out the correct information. - Annotation: A remark about the data. Can be checked by the monitor or doctor. - Reason for change: This is when existing data is overwritten by new data. This is the case when data is changed that had previously been marked as complete (data entry complete status of event) - Failed Validation check Note that a failed validation check can only be filled out if no correct data exists: Data is permanently missing Data is truly out of range Data cannot be solved using the source data. 11

12 Query status can be set to: - New: In case a new query arises by filling out new data - Updated: An existing query is updated with new information - Resolution proposed: A resolution can be proposed for an existing query. - Closed: An existing query can be closed Assigned to user: Only a query to an investigator, monitor or CRN/CRA can be assigned for substantive reasons (ICH-GCP).In case of technical problems the project team must be contacted by (preferably) or by phone in case of real urgency. 12

13 Notes and discrepancies After pressing submit, the query will be saved in the main menu Notes and discrepancies where queries can be reviewed. First some small summary statistics (i.e. number of types of queries) is provided: Followed bv a per-patient overview of all queries involved (including current queries and solved): 13

14 Under menu actions: 1 The corresponding data record can be viewed on which the query is applicable. 2 By clicking on view, the query can be viewed and solved. Depending on permissions, the viewer can update the query, propose a resolution or can close the query. 14

15 8. Updating events This can be achieved (depending on permissions) by going to the subject matrix (see step 1). Press on the event specific status icon. In the next popping menu, Edit study event must be pressed: The following menu then appears: 15

16 The event status for a scheduled event can be changed to: Data entry started (initial data entry) Stopped Skipped The event status for a started event can only be changed to stopped. The event status of a skipped event can be changed to: Data entry started (initial data entry) Stopped The event status for a stopped event can be changed to: Data entry started (initial data entry) Completed Skipped Locked / Frozen The event status for a complete event can be changed to: Data entry started (initial data entry) Skipped Locked / Frozen Unlocking a frozen event: Can only be done in the view events mode (tasks menu > view events menu) 16

17 9. Removal of a patient or translocation between sites Removal / restoring a patient In the subject matrix, a complete removal (= inactivating ALL events) of a patient can be done by pressing the X button within the actions menu. Please note that reactivating of events require a reactivating of the whole patient. This can be achieved using the reactivation button if the patient had been removed. Reassigning a patient to another site This can be achieved by pressing the reassign button form the actions window (Depending of user permissions) 17

18 10. Audit Trail Open clinica logs each data within the Open Clinica Audit Trail (ICH-GCP). The audit trail can be seen in the main menu under Study Audit Log. 11. Logging out of Open Clinica On the upper right of the screen, the Open Clinica session is logged out by pressing logout. It is recommended to log out from each session. 18