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Entering data

  • Bijgewerkt

Steps

  1. Navigate through Main menu - > CRF - > CRF-information;
  2. Click on the left side of the screen on the plus icon next to the site;
  3. Click on the left side of the screen on the plus icon next to a patient;
  4. Select a questionnaire;
  5. Enter data and click on one of the buttons above the questionnaire.

If you have made a new questionnaire, set up the template exactly the way you want it, and have entered one or multiple patients, you can advance to the next step: entering data. In de ResearchManager this is done in the CRF: the Clinical Research Form. In here you can see how the subchapters like the ones in the study template are made. Next, you can answer the questions per patient. In this manual you read how this works.

Extensive steps:

Go to https://myresearchmanager.com/NameCustomer . Log in with your username and password.

Attention: Does your organization use multiple modules within ResearchManager? In that case it could be that you first enter the module portal. Click on “EDC (Data management)”. Dependent on your settings it could be that you enter one of our other modules first. If you do not see “EDC (Data management)” in the top left corner of your screen,  click on the logo you do see to get to the module portal. Then, click on “EDC (Data management)” as well.

Step 1

Now you see the starting page. Place your mouse at the top, in the menu bar, on ‘CRF’ and then click on “CRF-information”.

DM_CRFDatainvoer_2_1.png

Now you find yourself on the page with the CRF. This exists of two parts: On the left the overview of patients, sorted by site, On the right information from what you selected on the left: the patient information when you click on a patient, the questionnaires when you click on a subchapter. You can fill it in immediately.

At the top of every questionnaire are a few buttons:

  • Empty all: Empty all the questions of the concerning subchapter. The subchapter gets the status empty An audit trail is kept for all questions.
  • Save as missing: You can save your subchapter as By giving the questionnaire this status, you save the data you have worked with up to then, but you indicate that there is still information missing. There will be no checks done on the mandatory fields, when you choose this status.
  • Save as unfinished incomplete: By saving your subchapter as incomplete you indicate that more information still needs to be added. This status will be given when a patient does not completely finish the subchapter through PSS.
  • Save as complete: When you have answered all the questions, you can save the subchapter as As soon as the subchapter has reached this status, the research specialist is able to sign it. So pay attention that you do not give this status when data still needs to be added.
  • Sign: As soon as a subchapter is complete, a research specialist or data manager can sign it. After this changes can no longer be made to the subchapter.
  • Monitor: This status is can be given to a subchapter by the monitor to indicate that he has seen and reviewed the subchapter.
  • Block: A subchapter can be blocked, which prohibits data form being entered into the subchapter. This can come in handy when for example, a patient no longer satisfies the inclusion criteria and any more data is no longer useful.
  • Unblock: If you have blocked a subchapter, but later decide you still want to change data, you can unblock it. This makes data entry possible again.
  • Log in as patient: By clicking on this button, you are logged out of research manager and in to Patient Self Service for the concerning patient. This can come in hand when for example, a patient can not yet use our PSS-module at home. Now he can still fill in his data using your computer, without him gaining access to things like the data of other patients.

If you have included a recurring subchapter in your template, you make a new copy for this in the CRF. Click on ‘Add [Name recurring subchapter]’ and fill in a reference. When you click on ‘Save’, the questionnaire opens. Above the questionnaire of a recurring subchapter is an extra button: ‘Remove’. With this you only remove the questionnaire you are in at that moment and not the entire recurring subchapter.