as a total rookie to both openclinica and prospective randomised controlled trials I am trying to figure out how and when to anonymize the database. Please forgive me if I the questions are too silly to answer.
To accomplish a 100%follow-up of the subjects enrolled I need their address, phone, name etc (which is protected information). Is it possible to anonymize patients while the trial is still running? And is it any good at all if I can get the patients' informed consent to keep such private information within the database?
If it's possible to anonymize during the trial, how do I de-identify the subjects? Can I do that in openclinica? Do I need an external application? Is the random subject ID generation enough for this purpose?
Is it possible to create a de-identification key which would be destroyed after successfully closing the trial and so provide for the database anonymization?
2. is there a "tool" within openclinica for randomisation of subjects into 2 study arms?
Department of Thoracic Surgery