I agree with Lindsay - contemporaneous is not the same thing as simultaneous, contemporaneous can span even many years.
I would add to Lindsay's requirements the need to optionally specify the sponsor (name and email address) as the sponsor has a similar need for a contemporaneous feed.
Also the encryption could be done with public/private key, as one-time passwords can get lost if the investigator does not perform the download immediately.
My main concern with this policy is the assumption that the investigator will be the authoritative owner of the data for all time - as we know investigators move on, and/or lose the data for their old studies. But that problem is not for this forum to solve
Gerben and others,
I am surprised that this become an issue at a meeting with Swedish GCP inspectors. All clinics in Sweden are required by law to keep any data collected from a patient in their local EHR or paper system. Therefore a complete source data verification is essential. OpenClinica has an excellent was of creating records of such SDV. Thus this should fulfil the GCP requirements as the OpenClinica data is then an exact copy of the investigator data. All EHR systems do NOT have an audit trail so we can not be sure that the two databases stay in synch. In a few cases we have installed OC on a server in the hospital which is a small task with OpenClinica. This approach should satisfy any GCP inspector!
Swedish EHR systems leave a lot to be desired. I have described some of the issues in our paper:
KJ, Ljunggren H, Gustafsson LL: Data extraction from a semi-structured electronic medical record system
for outpatients: a model to facilitate the access and use of data for quality
control and research.
Informatics J; 2009 Dec;15(4):305-19 . PMID: 20007655.
Further to above I would ad that it would be very simple to set up an OC database with an identical copy of the locked final database on an investigator PC. Using the community edition of OC this would not be a cost and the time to set it up is no more than 15-30 minutes. Would this satisfy the GCP inspectors? If in doubt this database could always be compared with the locked production database to satisfy the inspectors. The ease of doing this is definitely a manor advantage of OC. Even if you had to give them a small laptop for this purpose the cost would be nothing compared to the study cost, if this would solve the issue. Today you can find a laptop for less than 500 USD including WIN 8.1.