From: Gabriela Prokůpková [mailto:[email protected]
Sent: Wednesday, November 21, 2007 10:38 AM
To: Yufang Wang; [email protected]
Cc: Jeff Halperin; Baranníková; Petr Bartík; [email protected]
; Jan Červený; Lahovský
Subject: Open Clinica questions
I would like to ask you for answers to some questions regarding Open Clinica.
1) Double Data Entry philosophy – we tested this possibility however could you confirm me the procedure?: the investigator enters data, than other person or the same person who entered the initial data will check the accuracy and completeness of this data according to source data for the second time– if it is OK this person will check “Mark complete” item on e-CRF. Is our assumption right?
2) Possibility to monitor data entered. In other e-CRF systems there is a module for “Data Monitoring”. The person who performs monitoring (monitor) is able only “check” data according to source documentation, he/she is not allowed to correct anything, he/she can enter comments or discrepancy notes. After data monitoring the icon “M” will appear in the respective item. We have not found yet the way how to manage such as monitoring in Open Clinica.
Would so kind and try to answer the above questions?
Gabriela and our data management team
Ing. Gabriela Prokupkova, Ph.D.
Clinical Research Associate
K Ohrade 528/2
155 00 Prague 5
Phone:+420-251 081 244 - personal
+420-251 081 230 - office
Mobil: +420-739 432 805
Fax: +420-251 081 247
E-mail: [email protected]