Before defining a CRF, you need to create the CRF you will use as a basis:
- From the Tasks menu, in the Study Setup module, select Build Study.
The Build Study page displays.
- For the Create CRF task, click the View icon.
The Manage Case Report Forms (CRFs) page opens.
- From the Manage Case Report Forms page, download the CRF you will use as a basis for defining the CRF.
Note that when you save the Excel file in this process, the Excel filename (the name that precedes .xls) is not used by OpenClinica in any way.
Choose one of the following options to download the CRF you will use as a basis:- Download an Existing Defined CRF: When you want to define a CRF to be similar to one already in your OpenClinica system, download the existing defined CRF to use as a basis.
- From the Manage Case Report Forms page, click the Download icon in the Actions column for the version of the CRF you want to download.
- Save the file to your computer using a unique, descriptive name.
(Note that this is not the same as Creating a New Version of an Existing CRF)
- Download a Defined CRF from the CRF Library: You can use a defined CRF from the OpenClinica library as a basis for the CRF you are defining. The library includes CRFs for common types of clinical forms that were defined by OpenClinica experts and are aligned with CDISC Clinical Data Acquisition Standards Harmonization (CDASH) standards, as well as CRFs defined by the OpenClinica community.
- Go to the CRF Library page of the OpenClinica documentation site.
- Click Login, then log in using your OpenClinica username and password.
The CRF Library page displays. - Select the link for the version of OpenClinica that you are using.
The list of available eCRFs displays: - Click the link for the domain you are interested in. For example, Adverse Events.
The domain page displays and may include multiple versions of forms. - Select the link for the form that best meets your needs.
If applicable, Rules associated with the form are available and should be downloaded in addition to downloading the form. - Save the CRF and associated Rules to your computer using unique, descriptive names.
- Download a Blank CRF Template: If you have experience defining CRFs or there are no existing CRFs that are similar to what you need, use a blank template:
- From the Manage Case Report Forms page, click Blank CRF Template.
- Save the template to your computer using a unique, descriptive name.
- Download an Existing Defined CRF: When you want to define a CRF to be similar to one already in your OpenClinica system, download the existing defined CRF to use as a basis.
After creating the CRF, provide content for it using Excel, then upload the defined CRF to OpenClinica.