Originally Posted by
a123456
The big question is why are copies of consent forms being sent to a coordinating centre?
What is the coordinating centre doing with all this Personally Identifiable Information (PII)? How is the information used? If it is only used for project management logistics, is this a suitable use of sensitive personal information and all the attendant risks involved?
Should alternatives be considered? For instance faxing or E-Mailing a recruitment/enrolment form that details that subject 12345 gave consent on date, time and whether they then qualified to be enrolled after subsequent screening, etc. This way no PII is transmitted, but project management information is available to the coordinating centre. In fact eCRFs or IVRS or IWRS are good systems to use to collect data on subjects status.
Faxing documents that contain Personally Identifiable Information (PII) is a risky process. The fax may go to a wrong number and also not all fax machines are password protected such that only the authorised recipient has access to the output. If using fax technology it is always advisable to get verification of the safe receipt by the authorised recipient of all faxes.
How are the faxes stored? Handling PII always includes the risk that there may be a violation of subject confidentiality. Suitable measures must be taken to ensure that PII is securely and confidentially maintained. How will they be archived in the long term or will these copies be confidentially destroyed? Long term storage of PII also includes long term risks that confidentiality could be violated at a later date.
As copies are faxed it must be true that the originals are safely stored by the PI at the investigator site.