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Adverse events

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TBB: Adverse events

Posted by Jolanda Strubel at October 21. 2016

Special thanks to Naomi van der Linden (Erasmus Medical Centre), Annelies Rotte (Trial Data Solutions) and Sander de Ridder (Netherlands Cancer Institute) for setting up this CRF.

 

The Adverse events (AE) building block is based on the CTCAE v4.0 terminology. In this CRF you can select the appropriate AE term directly from this list.

An example of the CRF is present in the sandbox environment ("TraIT_BB_General_Adverse_Events"). You need to be logged in, to open the link.

If you have any questions or suggestions for this particular CRF, please add a comment below.

Please find attached here:

- the actual CRF in Excel format (NOTE: please change the name of the CRF if you use it in your study)

- the so called "explanation sheet" containing information on which standards were used

- an overview of the conventions used for the setup of the building blocks

Attachments

Re: Adverse events

Posted by Jolanda Strubel at December 29. 2016

Version 1.2 has been uploaded (here in the forum and in OpenClinica). This version includes the "please select" change (as indicated in the conversation on the "Laboratory" BB). The "undo radio button" option could not be implemented here due to the amount of Java-script already present in the sections' instructions field.

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