- Navigate through the main menu - > CRF - > CRF-information;
- Fold out a site by clicking on the plus icon;
- Click on ‘add patient’;
- Fill in any possible patient information;
- Click on ‘Save & new’ or on ‘Save & open’.
If you have made a new study and have set up the template exactly the way you want, you can advance to the next step: the Clinical Research Form. Here you can create new patients and fill in all the relevant information, of course in compliance with the Dutch Data Protection Act. Then you can immediately begin with entering data. In this manual you read about how you create new patients and what you need to look out for.
Go tohttps://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: Navigate towards CRF information
Now you see the starting page. Place your mouse at the top, in the menu bar, on ‘CRF’ and then click on ‘CRF-information’.
Step 2: (filling in) Patient details
Now you find yourself on the page with the CRF. This exist out of two parts: on the left the overview of patients, sorted by site. On the right the information from what you select on the left: the patient information when you click on a patient, the questionnaires when you click on a subchapter.
To add a patient , first fold out a site by clicking on the plus icon next to the sitename.
Now you see “Add patient”. Click on this. On the right side the form in which you need to fill in the needed information appears. What you need to fill in exactly depends on a few settings of your study.
This mandatory field fills itself in, unless “automatically generate patient numbers” is on.
If this is on for your study, you can fill in the e-mail address of the patient here. Questionnaires will be sent to this address. The enrolment date of the patient is also asked. The date can differ from the moment the patient is added to the CRF. By filling in the right date, questionnaires will be sent on the date you want (for example, a month after the enrolment date).
Attention: when there is no known e-mail address or enrolment date for the patient, there will not be any questionnaires sent for this patient.
Randomization and stratification
If this is turned on for your study, and it is mandatory to fill in the date of birth of a patient before they can be randomized, this is the place where you fill it in.
This is always available and can be freely filled in. If for example, there is information about relevant allergies, you can say something about that. ResearchManager advises not to fill in personal data with regard to the Dutch Data Protection Law.