Study documentation

After selecting the study, information on the study can be retrieved by clicking on 'Documentation' in the left part of the screen.

 You will be redirected to the study documentation portal where you can access the investigator study file, on-line protocol training (if available) and the study information page.

Investigator study file

This part is showing the structure and contents the investigator study file should have on site. The investigator study file consists of all the documents which should be kept at the site in the investigator study file (e.g. protocol documents, CRF completion guidelines, IB, ...). The general documents (not site specific) are directly available on-line on this study documentation page. This is the case of blank paper forms such as quality of life or SAE forms, CRF completion guidelines, which can thus be easily consulted during data entry in RDC. 

By clicking on the grey bars, additional information appears and the PDF documents can be opened directly and printed for filing. 

On-line protocol training

When available for the study, on-line protocol training can be followed from the study documentation page by clicking on the link 'On-line protocol training'. Different training slides can be accessed and when the training is finished, the trainee can confirm online that the training has been followed and a training certificate will be provided by email.

 

Study information page

The study information page contains information on the specific protocol (trial status, targeted sample size, drug, study staff, ...).